On May 12, 2022 NeoTX reported the acquisition of InterX. InterX, is a drug discovery company utilizing advanced proprietary tools of biomolecular computation for the discovery and design of novel therapeutic molecules based on Nobel Prize Laureate Prof Michael Levitt’s discoveries (Press release, NeoTX, MAY 12, 2022, View Source [SID1234640355]). These tools allow a detailed quantum mechanical process assessment of biochemical interactions resulting in faster, more accurate and efficient drug discovery. In addition to the discovery engine, this acquisition also comes with a pipeline of early drugs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to be expanding NeoTX capabilities to include a suite of proprietary drug discovery technologies. InterX is a world class team that includes three Nobel Laureates who have developed technologies that have the potential to increase the speed of drug discovery. These technologies augment traditional Computer Assisted Drug Discovery (CADD) and are designed to replace much of the typical synthesis and testing cycles that are needed after obtaining results from the traditional CADD process, while potentially saving three-plus years of the typical drug discovery timeline" said CEO, Asher Nathan.

"InterX’s technology is the most advanced in the industry, and when combined with the development expertise of NeoTX, we will be able to advance best-in-class drug candidates, increase the value of our pipeline, and strive to contribute to improvement of quality of life within society," said Nobel Prize Laureate Prof. Roger Kornberg, Chief Scientist of NeoTX and cofounder of InterX. InterX will benefit from the experience and infrastructure of NeoTX while maintaining a culture of innovation and creativity. Post-merger, Prof. Kornberg has also assumed the role of Chairman of the Board of NeoTX.

On May 12, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, LianBio, MAY 12, 2022, View Source [SID1234614312]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"LianBio continues to solidify our standing as the partner of choice to bring clinically validated therapeutic candidates to Greater China and other Asian markets," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Several of our partners have recently reached significant global milestones, including a U.S. FDA approval, positive pivotal trial results, and an acquisition. We congratulate our development partners on these important achievements. In China, we are committed to accelerating patient access to potentially transformative therapeutics, and we remain on track to complete enrollment in our ongoing Phase 3 EXPLORER-CN trial of mavacamten and to initiate three additional pivotal studies this year."

Recent Business Highlights and Clinical Development Updates

BMS receives FDA approval for mavacamten and presents additional positive Phase 3 clinical trial results

In April 2022, LianBio’s partner Bristol Myers Squibb (BMS) presented data from two clinical trials of mavacamten at the American College of Cardiology 71st Annual Scientific Session. Data from the EXPLORER-LTE clinical trial demonstrated sustained improvements in clinically meaningful cardiovascular outcomes at weeks 48 and 84 in patients with symptomatic oHCM receiving mavacamten. Data from the Phase 3 VALOR-HCM clinical trial demonstrated the addition of mavacamten significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic oHCM who had been appropriate for SRT at baseline.

In April 2022, BMS announced the U.S. Food and Drug Administration (FDA) approval of mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM to improve functional capacity and symptoms.
Mavacamten development progress continues in China

In January 2022, LianBio initiated the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM. Patient enrollment is ongoing.

In February 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation in China for mavacamten for the treatment of patients with oHCM.

In May 2022, LianBio announced topline results from the Phase 1 pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers. A single oral administration of mavacamten in Chinese healthy adult subjects showed no new safety signals. The data demonstrated a favorable PK, safety and tolerability profile comparable to that observed in the Phase 1 pharmacokinetic study of mavacamten conducted by LianBio’s partner, MyoKardia, now a wholly owned subsidiary of BMS, in healthy volunteers in the United States.
TP-03 met all primary and secondary endpoints in Tarsus’s second U.S. pivotal trial

In May 2022, Tarsus announced positive topline data from the Phase 3 Saturn-2 clinical trial of TP-03 in Demodex blepharitis (DB) patients. The clinical trial met all primary and secondary endpoints and TP-03 was well-tolerated.

Based on these data, Tarsus announced that it will submit a New Drug Application to the U.S. FDA in the second half of 2022.
Development partner ReViral Ltd. entered into definitive agreement to be acquired by Pfizer Inc.

In April 2022, Pfizer and ReViral entered into a definitive agreement under which Pfizer will acquire ReViral and its respiratory syncytial virus therapeutic candidates, including sisunatovir.
Formation of Scientific Advisory Board

In April 2022, LianBio formed a Scientific Advisory Board (SAB). The LianBio SAB is comprised of industry leaders in global drug development who are serving as strategic advisors to the Company.
Appointment to the Board of Directors

In April 2022, LianBio appointed Wei Wei Chen to the Board of Directors. Ms. Chen brings over 17 years of experience serving as chief financial officer of companies in the consumer, retail and healthcare sectors.
Business is well-positioned to achieve anticipated milestones

Current cash runway is projected to extend through mid-2024.
Key Milestones Anticipated in 2022

Mavacamten

Enrollment is ongoing in the EXPLORER-CN Phase 3 clinical trial of mavacamten in Chinese patients with oHCM. LianBio expects to complete enrollment in the second half of 2022.
TP-03

LianBio remains on track to initiate a Phase 3 clinical trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval in China.
NBTXR3

LianBio expects to begin dosing Chinese patients in Nanobiotix’s ongoing global pivotal Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
Infigratinib

Enrollment is ongoing in LianBio’s Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.

LianBio expects to begin dosing Chinese patients in QED’s ongoing global pivotal Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA) patients with FGFR2 gene fusions/translocations in the second half of 2022.
First Quarter 2022 Financial Results

Research & Development Expenses
Research and development expenses were $12.3 million for the first quarter of 2022 compared to $53.4 million for the first quarter of 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.

General & Administrative Expenses
General and administrative expenses were $16.1 million for the first quarter of 2022 compared to $7.1 million for the first quarter of 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.

Net Loss
Net loss was $27.7 million for the first quarter of 2022 compared to net loss of $61.6 million for the first quarter of 2021.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at March 31, 2022 totaled $389.1 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan through mid-2024.

On May 12, 2022 AbbVie (NYSE: ABBV) reported that it will present 46 abstracts across eight types of cancer during the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (June 3-7) and the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (June 9-17) (Press release, AbbVie, MAY 12, 2022, View Source [SID1234614329]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"AbbVie continues working to transform the standards of care for cancer treatments as a result of our commitment to patients, innovation and partnerships," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology development, AbbVie. "The data being presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) will provide a look at our continued research advancements in cancer across our expanding oncology portfolio and pipeline."

During both meetings, AbbVie will present nine abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, including data from multiple arms of the ongoing phase 1b/2 EPCORE NHL-2 clinical trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of various types of B-cell non-Hodgkin lymphoma (NHL). Additionally, data will be presented from the Phase 2 REFINE study of investigational compound navitoclax + ruxolitinib in JAK inhibitor-treatment-naïve patients with myelofibrosis.

At this year’s ASCO (Free ASCO Whitepaper) annual meeting AbbVie will be presenting on its solid tumor research with data from telisotuzumab vedotin (Teliso-V) in non-small cell lung cancer.

During the EHA (Free EHA Whitepaper) Congress, the five-year update from the CLL14 trial of a combined regimen of venetoclax + obinutuzumab versus obinutuzumab + chlorambucil comparing the efficacy and safety in participants with untreated chronic lymphocytic leukemia (CLL) will be presented.

Details about presentations are as follows:

ASCO 2022 Abstracts

Abstract

Presentation Details

All Times in CT

Ibrutinib

Primary Results From the Double-Blind,
Placebo-Controlled, Phase III SHINE Study of
Ibrutinib in Combination With Bendamustine-
Rituximab (BR) and R Maintenance as a
First-Line Treatment for Older Patients (Pts)
with Mantle Cell Lymphoma (MCL)

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Friday, June 3, 2022

1:00 – 4:00 p.m. CT

Oral

Fixed-Duration (FD) Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Treatment
(tx) of Chronic Lymphocytic Leukemia
(CLL)/Small Lymphocytic Lymphoma (SLL)
3-year Follow-up From the FD Cohort of the
Phase 2 CAPTIVATE Study

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Phase 1/2 Study of Zilovertamab and Ibrutinib
in Mantle Cell Lymphoma (MCL) or Chronic
Lymphocytic Leukemia (CLL)

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

3:00 – 4:30 p.m. CT

Poster

Prognostic Testing and Treatment Patterns in
Black Patients (Pts) With Chronic
Lymphocytic Leukemia (CLL) From the
Inform CLL Prospective
Observational Registry

Abstract Publication Only

Upper Gastrointestinal (GI) Morbidity, Peptic
Ulcer Risk, and Proton Pump Inhibitor
(PPI)/H2 Blocker (H2B) Use in Patients (Pts)
Treated With Bruton’s Tyrosine Kinase
Inhibitors (BTKis) During Routine Care

Abstract Publication Only

Characteristics and Clinical Outcomes
Among Patients Receiving Either Ibrutinib or
Anti-CD20 Monotherapy as First-Line (1L)
Treatment for Chronic Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)
A Retrospective Analysis in Community
Oncology Practice

Abstract Publication Only

Real-World Clinical Outcomes in Patients
Receiving Either Ibrutinib or Chemo-
Immunotherapy (CIT) as First-Line (1L)
Treatment for Chronic Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)
A Retrospective Analysis

Abstract Publication Only

Venetoclax

Efficacy and Safety of Venetoclax
in Combination With Azacitidine or Decitabine in
an Outpatient Setting in Patients with
Untreated Acute Myeloid Leukemia

Session: Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Epcoritamab*

First-Line Treatment (Tx) With Subcutaneous
(SC) Epcoritamab (Epco) + R-CHOP in
Patients (Pts) With High-Risk Diffuse Large
B-Cell Lymphoma (DLBCL): Phase 1/2 Data
Update

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Subcutaneous Epcoritamab With Rituximab +
Lenalidomide (R2) in Patients (Pts) with
Relapsed or Refractory (R/R) Follicular
Lymphoma (FL): Update from Phase 1/2 Trial

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Subcutaneous Epcoritamab + R-DHAX/C in
Patients (Pts) With Relapsed or Refractory
(R/R) Diffuse Large B-Cell Lymphoma
(DLBCL) Who Are Eligible for Autologous
Stem Cell Transplant (ASCT): Preliminary
Phase 1/2 Results

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Epcoritamab (Epco) with Gemcitabine +
Oxaliplatin (GemOx) in Patients (Pts) With
Relapsed or Refractory (R/R) Diffuse Large
B‑Cell Lymphoma (DLBCL) Ineligible for
Autologous Stem Cell Transplant (ASCT)
Induces High Response Rate Even in Pts
Failing CAR T Therapy

Session: Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Navitoclax

Navitoclax Plus Ruxolitinib in JAK inhibitor-
Naïve Patients (Pts) With Myelofibrosis:
Preliminary Safety and Efficacy in a
Multicenter, Open-Label Phase 2 Study

Session: Hematologic Malignancies –
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

8:00 – 11:00 a.m. CT

Poster

Saturday, June 4, 2022

1:15 – 2:45 p.m. CT

Poster Discussion

Lemzoparlimab

Lemzoparlimab (Lemzo) with Venetoclax
(Ven) and/or Azacitidine (Aza) in Patients
(Pts) With Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS)
A Phase 1b Dose Escalation Study

Session: Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Teliso-V

Phase 1/1B study of Telisotuzumab Vedotin
(Teliso-V) + Osimertinib (Osi), After Failure
on Prior Osi, in Patients (Pts) With Advanced,
c-Met Overexpressing, EGFR-Mutated Non-
Small Cell Lung Cancer (NSCLC).

Session: Lung Cancer – Non-Small Cell
Metastatic

Monday, June 6, 2022

8:00 – 11:00 a.m. CT

Poster

1:15 – 2:45 p.m. CT

Poster Discussion

Telisotuzumab Vedotin (Teliso-V)
Monotherapy in Patients (Pts) With
Previously Treated c-Met-Overexpressing
(OE) Advanced Non-Small Cell Lung Cancer
(NSCLC)

Session: Lung Cancer – Non-Small Cell
Metastatic

Monday, June 6, 2022

8:00 – 11:00 a.m. CT

Poster

1:15 – 2:45 p.m. CT

Poster Discussion

The ASCO (Free ASCO Whitepaper) 2022 Annual Meeting abstracts are available here.

EHA 2022 Abstracts

Abstract

Presentation Details

All Times in CT

Ibrutinib

Immune Restoration and Synergistic Activity
with First-Line (1L) Ibrutinib (IBR) Plus
Venetoclax (VEN): Translational Analyses of
CAPTIVATE Trial Patients with CLL

Session: CLL: Translational Research

Saturday, June 11, 2022

9:30 – 10:45 a.m. CT

Oral

Primary Results From the Phase 3 Shine Study
of Ibrutinub in Combination With
Bendamustine-Rituximab (BR) and R
Maintenance as a First-Line Treatment for
Older Patients With Mantle-Cell Lymphoma

Session: Indolent and Mantle Cell Lymphoma

Saturday, June 11, 2022

4:30 – 5:45 a.m. CT

Oral

Absence of BTK, BCL2, and PLCG2 Mutations
in Relapsing Chronic Lymphocytic Leukemia
(CLL) After First-Line Treatment with Fixed-
Duration Ibrutinib (I) Plus Venetoclax (V)

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30-10:45 a.m. CT

Poster

Fixed-Duration (FD) Ibrutinib + Venetoclax for
First-Line Treatment of Chronic Lymphocytic
Leukemia (CLL)/Small Lymophocytic
Lymphoma (SLL): 3-Year Follow-up From the
Phase 2 CAPTIVATE Study FD Cohort

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Cross-Trial Analysis of Fixed-Duration Ibrutinib
(I) Plus Venetoclax (V) Vs Fludarabine (F),
Cyclophosphamide (C), And Rituximab (R) As
First-Line Treatment for Chronic Lymphocytic
Leukemia (CLL)

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Abstract Publication Only

Venetoclax***

Venetoclax-Obinutuzumab for Previously
Untreated Chronic Lymphocytic Leukemia: 5-
Year Results of the Randomized CLL14 Study

Session: CLL: Clinical

Sunday, June 12, 2022

4:30 – 5:45 a.m. CT

Oral

VIALE-M: A Randomized, Double-Blind, 2-Arm,
Multicenter, Phase 3 Study of Venetoclax and
Oral Azacitidine Versus Oral Azacitidine as
Maintenance Therapy for Patients With Acute
Myeloid Leukemia in First Remission After
Intensive Chemotherapy

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

VIALE-T: A Randomized, Open-Label, Phase 3
Study of Venetoclax in Combination With
Azacitidine After Allogeneic Stem Cell
Transplantation in Patients With Acute Myeloid
Leukemia

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

The Impact of Post-Remission Granulocyte
Colony-Stimulating Factor Use in the Phase 3
Studies of Venetoclax Combination Treatments
in Patients With Newly Diagnosed Acute
Myeloid Leukemia

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Transfusion Independence Among Newly
Diagnosed Acute Myeloid Leukemia Patients
Receiving Venetoclax-Based Combinations Vs
Other Therapies: Results from the AML Real
World Evidence (ARC) Initiative

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Clinical Outcomes in Patients With
Higher-Risk Myelodysplastic Syndromes
Receiving Hypomethylating Agents:
a Large Population-Based Analysis

Session: Myelodysplastic syndromes – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Venetoclax in Patients With Chronic
Lymphocytic Leukemia With 17p Deletion: 6-
Year Follow-Up and Genomic Analyses in a
Pivotal Phase 2 Trial

Session: CLL: Clinical

Friday, June 12, 2022

4:30 – 5:45 a.m. CT

Oral

Treatment Sequences and Outcomes of
Patients (Pts) with CLL Treated With Targeted
Agents in Real-World Settings

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Healthcare Resource Utilization and Costs Of
Therapy With Fixed-Duration Venetoclax
Among CLL Patients (Pts)

Abstract Publication Only

Transcriptomic Characterization of MRD
Response and Non-Response in Patients (Pts)

Treated With Fixed-Duration Venetoclax-
Obinutuzumab

Session: CLL: Translational

Saturday, June 11, 2022

9:30 – 10:45 a.m. CT

Oral

Fixed-Duration (FD) Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Treatment
(Tx) of Chronic Lymphocytic Leukemia (CLL) /
Small Lymphocytic Lymphoma (SLL): 3-Year
Follow-Up From the FD Cohort of the Phase 2
CAPTIVATE Study

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

PedAL/EuPAL International Collaboration to
Improve the Outcome of Children With
Relapsed or Refractory Acute Myeloid
Leukemia (AML)

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Cross-Trial Analysis of Fixed-Duration Ibrutinib
(I) Plus Venetoclax (V) Versus Fludarabine (F),
Cyclophosphamide (C), and Rituximab (R) as
First-Line Treatment for Chromic Lymphoma
Leukemia (CLL)

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Abstract Publication Only

Safety and Effectiveness of Venetoclax
Monotherapy in Relapsed/Refractory CLL
Patients (Pts) With or Without Risk-Associated
Genetic Markers – Data from the Observational
VeRVe Study

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Effectiveness and Safety of Venetoclax in
Combination with Rituximab (VenR) in
Relapsed/Refractory CLL Patients With or
Without Risk-Associated Genetic Markers –
Data from the Observational VeRVe Study

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Real-Life Efficacy and Safety of Venetoclax
Monotherapy in Relapsed/Refractory Chronic
Lymphocytic Leukemia – Interim Analysis of
Multicentric Study VERONE

Session: Chronic lymphocytic leukemia and
related disorders – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Venetoclax in Combination With Obinutuzumab
in First Line Chromic Leukemia in Argentina: A
Cost-Effectiveness Analysis

Session: Quality of life, palliative care, ethics
and health economics
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Lemzoparlimab**

Lemzoparlimab (Lemzo) With Venetoclax (Ven)
And/Or Azacitidine (Aza) in Patients (Pts) With
Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS): A Phase
1b Dose Escalation Study

Session: Acute myeloid leukemia – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Epcoritamab*

Assessing Safety, Tolerability, and Efficacy of
Subcutaneous Epcoritamab in Novel
Combinations With Anti-Neoplastic Agents in
Patients (Pts) With Non-Hodgkin Lymphoma in
an Open-Label Phase 1B/2 Study

Session: Aggressive Non-Hodgkin lymphoma
– Clinical
Abstract Publication Only

Subcutaneous (SC) Epcoritamab + R-CHOP in
Previously Untreated Patients (Pts) With High-
Risk Diffuse Large B-Cell Lymphoma (DLBCL):
Phase 1/2 Data Update

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Subcutaneous (SC) Epcoritamab With
Rituximab + Lenalidomide (R2) in Patients
(Pts) With Relapsed or Refractory (R/R)
Follicular Lymphoma (FL): Update From Phase
1/2 Trial

Friday, June 10, 2022

4:30 – 5:45 p.m. CT

Poster

Subcutaneous (SC) Epcoritamab + R-DHAX/C
in Patients (Pts) With Relapsed or Refractory
(R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Who Are Eligible For Autologous Stem Cell
Transplant (ASCT): Preliminary Phase 1/2 Data

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Epcoritamab With Gemcitabine + Oxaliplatin
(GemOx) in Patients (Pts) With Relapsed or
Refractory (R/R) Diffuse Large B Cell
Lymphoma (DLBCL) Who Are Ineligible for
Autologous Stem Cell Transplant (ASCT):
Phase 1/2 Data

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Navitoclax

Navitoclax Monotherapy in Patients (Pts) With
MF Previously Treated With JAK-2 Inhibitors:
Safety and Tolerability

Session: Myeloproliferative neoplasms – Clinical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Navitoclax plus ruxolitinib in JAK Inhibitor-naïve
Patients with Myelofibrosis: Preliminary Safety
and Efficacy in a Multicenter, Open-label Phase
2 Study

Session: Treatments and complications in MPN
Friday, June 11, 2022

4:30 – 5:45 a.m. CT

Oral

The EHA (Free EHA Whitepaper) 2022 Congress abstracts are available here.

*Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ broad oncology collaboration.

**Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.

***Use of venetoclax in myelodysplastic syndromes (MDS) is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Ibrutinib (IMBRUVICA)
IMBRUVICA (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc. IMBRUVICA blocks the Bruton’s tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, to multiply and spread.1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.3

IMBRUVICA is approved in more than 100 countries and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 ongoing or completed Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA.

IMBRUVICA was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include adults with CLL/small lymphocytic lymphoma (SLL) with or without 17p deletion (del17p) and adults with Waldenström’s macroglobulinemia (WM), as well as adult patients with previously treated mantle cell lymphoma (MCL)*, adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy*, as well as adult patients with previously treated chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.4

*Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Since 2019, the National Comprehensive Cancer Network (NCCN), recommends ibrutinib (IMBRUVICA) as a preferred regimen for first-line treatment of CLL/SLL, with Category 1 status for previously untreated patients without del17p. Additionally, IMBRUVICA is a preferred treatment regimen for previously untreated patients with del17p. Since January 2020, the NCCN Guidelines recommend IMBRUVICA as a category 2A preferred regimen for the treatment of relapsed/refractory MCL. Since September 2020, the NCCN Guidelines recommend IMBRUVICA with or without rituximab as a Category 1 preferred regimen for both untreated and previously treated WM patients.

For more information, visit www.IMBRUVICA.com.

*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Side Effect Information5
Before taking IMBRUVICA, tell your healthcare provider about all of your medical conditions, including if you:

have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA for any planned medical, surgical, or dental procedure.
have bleeding problems.
have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
have an infection.
have liver problems.
are pregnant or plan to become pregnant. IMBRUVICA can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA.
Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA and for 1 month after the last dose.
Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA and for 1 month after the last dose.
are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects.

How should I take IMBRUVICA?

Take IMBRUVICA exactly as your healthcare provider tells you to take it.
Take IMBRUVICA 1 time a day.
Swallow IMBRUVICA capsules or tablets whole with a glass of water.
Do not open, break or chew IMBRUVICA capsules.
Do not cut, crush or chew IMBRUVICA tablets.
Take IMBRUVICA at about the same time each day.
If you miss a dose of IMBRUVICA take it as soon as you remember on the same day. Take your next dose of IMBRUVICA at your regular time on the next day. Do not take extra doses of IMBRUVICA to make up for a missed dose.
If you take too much IMBRUVICA call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking IMBRUVICA?

You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA. These products may increase the amount of IMBRUVICA in your blood.
What are the possible side effects of IMBRUVICA?
IMBRUVICA may cause serious side effects, including:

Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
Infections can happen during treatment with IMBRUVICA. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA.
Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter), heart failure, and death have happened in people treated with IMBRUVICA, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles, or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA dose.
High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
Second primary cancers. New cancers have happened during treatment with IMBRUVICA, including cancers of the skin or other organs.
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
The most common side effects of IMBRUVICA in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

diarrhea
tiredness
muscle and bone pain
rash
bruising
The most common side effects of IMBRUVICA in adults with cGVHD include:

tiredness
bruising
diarrhea
mouth sores (stomatitis)
muscle spasms
nausea
pneumonia
Diarrhea is a common side effect in people who take IMBRUVICA. Drink plenty of fluids during treatment with IMBRUVICA to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA for a condition for which it was not prescribed. Do not give IMBRUVICA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA that is written for health professionals.

Please click here for full Prescribing Information.5

About VENCLEXTA/VENCLYXTO (venetoclax)6

VENCLEXTA/VENCLYXTO (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers. Venetoclax is approved in more than 80 countries, including the U.S.

Important Safety Information7

What is the most important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions,
including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. 

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. 

Indications and Important Venclyxto (venetoclax) EU Safety Information8

Indications

VENCLYXTO in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

VENCLYXTO monotherapy is indicated for the treatment of CLL:

In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Contraindications

Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as Venclyxto efficacy may be reduced.

Special Warnings & Precautions for Use

Tumour Lysis syndrome, including fatal events, has occurred in patients when treated with Venclyxto. For CLL and AML, please refer to the indication-specific recommendations for prevention of TLS in the Venclyxto summary of product characteristic (SmPC).

Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS. The risk of TLS is a continuum based on multiple factors, including comorbidities. Venclyxto poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venclyxto and at each dose increase. During postmarketing surveillance, TLS, including fatal events, has been reported after a single 20 mg dose of venetoclax.

Neutropenia (grade 3 or 4) has been reported. Complete blood counts should be monitored throughout the treatment period.

In patients with AML, neutropenia (grade 3 or 4) is common before starting treatment. The neutrophil counts can worsen with Venetoclax in combination with a hypomethylating agent. Neutropenia can recur with subsequent cycles of therapy. Dose modification and interruptions for cytopenias are dependent on remission status.

For CLL and AML, please refer to the indication-specific recommendations for dose modifications for toxicities in the Venclyxto SmPC.

Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment, including antimicrobials and dose interruption or reduction as appropriate.

Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

Drug Interactions

In CLL and AML CYP3A inhibitors may increase Venclyxto plasma concentrations.

In CLL, at initiation and dose-titration phase, Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, please refer to the recommendations for dose modifications in the Venclyxto SmPC.

In AML, please refer to the AML-specific recommendation for dose modifications for potential interactions with CYP3A inhibitors, in the VENCLYXTO SmPC.

Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.

CYP3A4 inducers may decrease Venclyxto plasma concentrations. Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations.

Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

Adverse Reactions

CLL

The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

The most frequently occurring serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.

Discontinuations due to adverse reactions occurred in 16% of patients in both combination studies (CLL14 and MURANO). In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.

Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in the CLL14 study, in 15% of patients treated with the combination of venetoclax and rituximab in the Murano study, and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia.

AML

The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in combination with azacitidine or decitabine in the VIALE-A and M14-358, respectively, were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite, haemorrhage, dizziness/syncope, hypotension, headache, abdominal pain, and anaemia.

The most frequently reported serious adverse reactions (≥5%) in patients receiving venetoclax in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, the most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.

Discontinuations due to adverse reactions occurred in 24 % of patients treated with venetoclax in combination with azacitidine in the VIALE-A study, and 26% of patients treated with venetoclax in combination with decitabine in the M14-358 study, respectively.

Dosage reductions due to adverse reactions occurred in 2% of patients in VIALE-A, and in 6% of patients in M14-358. Venetoclax dose interruptions due to adverse reactions occurred in 72% and 65 % of patients, respectively. The most common adverse reaction that led to dose interruption (>10%) of Venetoclax in VIALE-A, were febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia. The most common adverse reactions that led to dose interruption (≥5%) of venetoclax in M14-358 were febrile neutropenia, neutropenia/neutrophil count decreased, pneumonia, platelet count decreased, and white blood cell count decreased.

Special Populations

Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.

For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.

Venclyxto may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.

This is not a complete summary of all safety information. See Venclyxto (venetoclax) SmPC at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.9 Epcoritamab was developed with selective, silencing mutations that may limit, systemic non-specific activity.10 CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.11,12 Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ broad oncology collaboration.

About Lemzoparlimab
Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.

About Navitoclax
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway.13 Navitoclax is not approved by any regulatory authority. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.

AbbVie is currently recruiting for two Phase 3 trials of navitoclax (TRANSFORM-1 and TRANSFORM-2) in combination with ruxolitinib for the treatment of myelofibrosis that will enroll more than 500 patients. The company anticipates pivotal trial readouts and regulatory submission for navitoclax in 2023.

About Telisotuzumab Vedotin
Teliso-V is an investigational antibody-drug conjugate (ADC) targeting c-Met, a receptor tyrosine kinase that is overexpressed in tumors including NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy are under evaluation.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit View Source

On May 12, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in cell-free, enzymatic DNA production, reported consolidated financial results for the second quarter of fiscal 2022, ended March 31, 2022 (Press release, Applied DNA Sciences, MAY 12, 2022, View Source [SID1234614346]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We delivered strong momentum in revenue growth with a second consecutive quarter of record revenues that reduced cash burn while advancing our strategic priority to develop and further position our LinearDNA platform as a novel approach for the production of the increasing number of nucleic acid-based therapeutic applications under development by the biotherapeutics industry," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Our clinical lab subsidiary, ADCL (Applied DNA Clinical Labs), continues to power our topline performance in the first half of fiscal 2022 with revenues that exceed total revenues for the entirety of fiscal 2021. During the quarter, COVID-19 testing demand remained durable due to our largely academic and corporate client base that continues to test to protect their stakeholders and mitigate disruptions to their operations.

"Similarly, we are starting to realize the value from investments made last year to optimize and advance our LinearDNA platform to commercialization. We are generating compelling data, most recently concluding in vitro studies that demonstrated that LinearDNA encapsulated by LNP expresses well and giving us greater confidence that a LinearDNA-LNP platform is the best delivery means for LinearDNA as a direct therapeutic agent. We concurrently progressed the use of the platform as a rapid IVT templating and production system for RNA-based therapeutics that is, we feel, the most proximal path to incremental biotherapeutic revenues. The second half of the fiscal year should also feature data on the applicability of our LinearDNA platform to the manufacture of advanced therapies, including mRNA, adoptive cell therapies, and DNA-based vaccines. In many instances, a key gating factor to rapid and broader adoption of novel and potentially clinically invaluable therapies is the bottleneck of plasmid DNA."

Continued Dr. Hayward, "Looking ahead to the second half of the fiscal year, our ability to continue to mitigate cash burn and further commercialize the LinearDNA platform will be informed by the durability of ADCL-generated revenues, as well as the conversion of supply chain security opportunities into CertainT platform orders. We expect COVID-19 testing demand to attenuate over the summer months, given our concentration of academic clients but foresee a path to demand resumption in the fall with the start of the new academic year. We have continued to diversify our client base, most notable of which was the addition of an investment management organization after the close of the reported quarter. In addition, we will begin validation of a new testing platform in ADCL that empowers several forms of high-value genetic testing, including pharmacogenetics, for which we believe consumer demand is growing.

"Furthermore, after the close of the reported quarter, our cotton merchant partner received a request to ship the first quantities for traceable tagged cotton that is directly attributable to the recent passage of the Uyghur Forced Labor Prevention Act (the "Act"), a new Federal law. Our team has presented to many members of Congress, Federal agencies, and Committees regarding the utility of our platform in enforcing the Act. Though not expected to be material to revenue in the current fiscal year, the shipment anticipates a global brand’s multi-year commitment to our CertainT platform through a scaled deployment across its many supply chains. We believe that the passage of the Act is a trigger point for the wider adoption of our CertainT platform that holds the potential for molecular taggant sales for textile fiber applications to become a second material revenue stream along with ADCL revenue. With less than 45 days before the Act goes into force, we believe interest in CertainT by brands and their supply chains has never been higher."

Concluded Dr. Hayward, "We believe the business model of Applied DNA is unique in the biotechnology sector. Our expertise in polymerase chain reaction (PCR) empowers the Company to commercialize DNA technologies across targeted industries to give us multiple sources of revenue growth and cash flow to help support the development of the LinearDNA platform to produce biotherapeutic DNA."

Recent Operational Highlights:

Further to a recent Letter of Intent entered into with Spindle Biotech Inc. ("Spindle Biotech"), Applied DNA and Spindle Biotech have formalized a research collaboration and initiated a Proof-of-Concept study (the "PoC") to generate mRNA at high yields. The companies believe the combination of their respective platforms provides for a simplified, high yield, and 100% cell-free workflow that is differentiated from current mRNA production that uses pDNA. In addition to increased speed and purity, the use of LinearDNA as an IVT template for mRNA production removes several complex manufacturing steps necessitated by plasmid DNA. The companies intend to present results from the PoC study upon its conclusion.
The Company entered into a research agreement to advance LinearDNA-based vaccine research and discovery for animal diseases with agricultural biosecurity implications with a leading college of veterinary medicine at a leading university on the East Coast, USA. The research agreement seeks to combine LinearDNA as a platform for rapid drug development with the college’s expertise in viral vector design to advance a differentiated approach to animal vaccine development.
Corporate Updates:

The Company initiated a branding refresh aligned with its positioning of the LinearDNA platform as a novel, cell-free manufacturing foundation for nucleic acid-based therapies. As part of the brand refresh, a LinearDNA-specific website will be launched in the coming months dedicated to showcasing LinearDNA’s attributes to therapy developers and manufacturers.
Dr. Hayward voluntarily waived 50% of his cash compensation effective March 7, 2022, as part of a cost management program implemented by the Company in the reported quarter.
Second Quarter Fiscal 2022 Financial Highlights:

Revenues increased 130% for the second quarter of fiscal 2022 to $6.1 million, compared with $2.7 million reported in the same period of the prior fiscal year and increased 48% from $4.2 million for the first quarter of fiscal 2022. The increase in revenues year-over-year was due primarily to an increase in clinical laboratory service revenues from the safeCircle COVID-19 testing platform of $3.9 million. This increase was offset by a decrease in product revenues of approximately $557 thousand due mainly to a decrease of approximately $605 thousand in sales of the Linea 1.0 COVID-19 Assay Kit.
Gross profit for the three months ended March 31, 2022, was $2.5 million, or 40%, compared with $1.7 million and 65% for the same period in the prior fiscal year. The decline in gross margin was primarily the result of a higher portion of clinical laboratory service revenues coming from the managed services testing contracts where ADCL also provides and staffs test collection centers, as these contracts have higher costs associated with them compared with ADCL’s surveillance testing contracts. The Company saw an improvement in gross profit percentages for the second quarter of fiscal 2022 to 40% as compared to 28% for the first quarter of fiscal 2022. The improvement was the result of the decrease in COVID-19 positivity rates as sample pooling returned during the second fiscal quarter, and sample numbers remained at higher levels.
Total operating expenses increased to $4.5 million for the second quarter of fiscal 2022, compared with $4.0 million in the prior-year quarter and decreased from $5.7 million for the first quarter of fiscal 2022. The year-over-year increase is primarily attributable to an increase in payroll of approximately $740 thousand. The increase in total payroll is due to the three months ended March 31, 2021, having a reversal of an accrual of approximately $817 thousand for an accrued bonus that was forgiven by the CEO. The increase was also due to an increase in insurance expense of approximately $129 thousand, which was primarily the result of increased Directors and Officers insurance premiums. These increases were offset by a decrease of approximately $376 thousand and $169 thousand in stock-based compensation and professional fees, respectively. To a lesser extent, the increase was attributable to an increase in Research and Development expenses of $114 thousand.
Net loss applicable to common stockholders for the second quarter of fiscal 2022, was $1.8 million, or $0.23 per share, compared with a net loss of $1.5 million, or $0.21 per share, for the prior-year quarter.
Excluding non-cash expenses, Adjusted EBITDA was negative $1.6 million and negative $1.5 million for the second quarters of fiscal 2022 and 2021, respectively. See below for information regarding non-GAAP measures.
Cash and cash equivalents stood at $6.5 million on March 31, 2022, compared with $6.6 million as of September 30, 2021. Cash and cash equivalents include net proceeds of $3.7 million from a registered direct offering closed on February 24, 2022.
Second Quarter Fiscal 2022 Conference Call Information

The Company will hold a conference call and webcast to discuss its second quarter fiscal 2022 financial results today, Thursday, May 12, 2022, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On May 12, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Vincerx Pharma, MAY 12, 2022, View Source [SID1234614364]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In April, we presented positive preclinical and preliminary clinical data on PTEFb/CDK9 inhibitor VIP152 at AACR (Free AACR Whitepaper). These data, coupled with our findings presented at ASH (Free ASH Whitepaper) last year, suggest that VIP152 has the potential to provide new treatment options for patients across various MYC and MCL-1-driven tumor types," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx.

"We continue dosing patients in our VIP152 clinical program and are seeing improvements in trial enrollment following a challenging pandemic year," added Dr. Hamdy. "This June, we are excited for our poster presentation at the annual European Hematology Association (EHA) (Free EHA Whitepaper) meeting, which will show data from patients with lymphoma treated with VIP152. We remain on track to initiate Phase 2 studies of VIP152 in the second half of this year."

"Looking to the second half of this year and into 2023, we look forward to continuing to advance our preclinical bioconjugation platform – a diverse, modular platform of linkers and payloads that can be conjugated with antibodies and small molecules to create novel targeted therapeutics for a broad range of solid tumors and hematologic malignancies. We remain on track to file an IND in the second half of this year for VIP236, a small molecule drug conjugate (SMDC) engineered to bind an αvß3 integrin adhesion molecule that is abundantly expressed in advanced metastatic solid tumors. αvß3 is a hallmark of aggressive cancers and poor prognosis. We also remain on-target to file INDs in the second half of 2023 for our two initial antibody drug conjugates (ADCs), VIP943, an anti-IL3RA-KSPi, and VIP924, an anti-CXCR5-KSPi, both with a CellTrapper moiety. From a financial perspective, our current cash resources position us to continue to pursue our upcoming regulatory and clinical milestones," concluded Dr. Hamdy.

RECENT CORPORATE HIGHLIGHTS

VIP152

Abstract accepted for poster presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, titled "VIP152 is a novel CDK9 inhibitor with improved selectivity, target modulation, and cardiac safety in patients with lymphoma."

Presenting author: Melanie Frigault, PhD

Abstract number: P1269

Session date and time: Friday, June 10, 2022; 16:30-17:45 CEST

Presented poster, "VIP152, a selective CDK9 inhibitor, demonstrates sensitivity in gynecologic cell lines that are cisplatin sensitive or resistant and delivers in vivo antitumor efficacy," at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022.

Bioconjugation Platform

Invited talk on the Company’s modular assets that can build innovative and high-potency ADCs titled, "ADCs with KSP-Inhibitor Payloads and a Tailored Design of Linker and Metabolite Profile," at the Festival of Biologics meeting March 2022.

Continue to advance our next generation modular bioconjugation platform, comprised of a first-in-class SMDC for solid tumors (VIP236) and two best-in-class preclinical-stage assets for hematologic malignancies (VIP943 and VIP924).

VIP236 consists of an αvß3 integrin binder and a linker that is cleavable by neutrophil elastase. The payload is an optimized camptothecin derivative designed for high cellular permeability and low efflux. IND filing in solid tumors expected in 2H 2022.

VIP943 (anti-IL3RA) and VIP924 (anti-CXCR5) are two antibodies linked to a KSP inhibitor – a novel payload class in ADCs. These ADCs also have a stable linker specifically cleaved by legumain, a tumor associated protease. The payload (i.e., KSP inhibitor) is modified to be trapped in the cell by the CellTrapper moiety. Manufacturing is underway and IND filings expected in 2H 2023.

FIRST QUARTER FINANCIAL RESULTS

Vincerx Pharma had $96.5 million in cash as of March 31, 2022, as compared to $111.5 million as of December 31, 2021. Based on its current business plans and assumptions, Vincerx believes its available cash will be sufficient to meet its operating requirements through 2023.

Research and development (R&D) expenses for the quarter ended March 31, 2022 were $16.0 million, as compared to $4.8 million for the same period in 2021. The increase was primarily related to increases in manufacturing services of approximately $4.0 million, including the initiation of manufacturing associated with our ADC program, new employee salaries of approximately $2.5 million, third party research and preclinical work of approximately $2.0 million, clinical services of approximately $1.4 million and stock-based compensation of approximately $0.8 million.

General and administrative (G&A) expenses for the quarter ended March 31, 2022 were $5.6 million, as compared to $4.8 million for the same period in 2021. The increase was primarily related to new employee salaries and increases in legal (patent protection and filings), accounting and other professional services in support of our operations as a public company.

For the quarter ended March 31, 2022, Vincerx reported a net loss of $16.4 million, or $0.79 per share. For the quarter ended March 31, 2021, Vincerx reported a net loss of $6.3 million, or $0.46 per share.