On May 12, 2022 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, being held in Vienna, Austria, and virtually, June 9-12 (Press release, Genmab, MAY 12, 2022, View Source [SID1234614319]). The presentations will include data from various clinical trials, including multiple arms of the phase 1b/2 EPCORE NHL-2 trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

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Additionally, results from several clinical trials evaluating Janssen Biotech, Inc. (Janssen’s)’s subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform will be presented. Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab’s DuoBody technology platform.

All abstracts accepted for presentation have been published on the EHA (Free EHA Whitepaper) website.

"We are looking forward to presenting the results from a variety of clinical trials evaluating the safety and efficacy of epcoritamab at this year’s EHA (Free EHA Whitepaper), which shows the significant progress we have made developing epcoritamab," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we continue to evaluate epcoritamab in a variety of clinical settings and patient populations, with the shared commitment of potentially delivering a new treatment option to patients in need."

Abstracts accepted for presentation at EHA (Free EHA Whitepaper) include:

Epcoritamab (DuoBody-CD3xCD20):

Abstract #: P1214. Subcutaneous epcoritamab + R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma: phase 1/2 data update; Clausen et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1135. Subcutaneous epcoritamab in combination with rituximab + lenalidomide in relapsed or refractory follicular lymphoma: phase 1/2 trial update; Belada et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1215 Preliminary phase 1/2 results of subcutaneous epcoritamab + R-DHAX/C in patients with relapsed or refractory diffuse large B-cell lymphoma eligible for autologous stem cell transplant; Cordoba et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1213. Subcutaneous epcoritamab with GemOx induced high response rates in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplant; Wahlin et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Publication: Assessing safety, tolerability, and efficacy of subcutaneous epcoritamab in novel combinations with anti-neoplastic agents in patients with non-Hodgkin lymphoma in a phase 1b/2, open-label study; Sehn et al

Daratumumab:

Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) Alone in Chinese Patients With Relapsed or Refractory Multiple Myeloma (RRMM): Updated Analysis of LEPUS; Fu et al
Efficacy and safety of daratumumab (DARA) in pediatric and young adult patients (pts) with relapsed/refractory T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): results from the phase 2 DELPHINUS study; Hogan et al
Daratumumab (DARA) in combination with bortezomib plus dexamethasone (D-Vd) or lenalidomide plus dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analysis of the phase 3 CASTOR and POLLUX studies in patients (pts) with early or late relapse after initial therapy; Spencer et al
Time to response, duration of response, and patient-reported outcomes (PROs) with daratumumab (DARA) plus lenalidomide and dexamethasone (D-Rd) vs lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of the phase 3 MAIA study; Facon et al
Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): a post hoc analysis of sustained minimal residual disease (MRD) negativity from GRIFFIN; Rodriguez et al

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.i Epcoritamab was developed with selective, silencing mutations that may limit systemic, non-specific activity.ii 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.iii,iv Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.v,vi,vii

Please see local country prescribing information for all labeled indication and safety information.

On May 12, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that will share new research during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress from June 9-12 (Press release, Astellas, MAY 12, 2022, View Source [SID1234614318]). A total of 13 abstracts from the company’s expanding portfolio of approved and investigational therapies will be presented across both meetings, underscoring the company’s commitment to advancing treatment options for advanced and rare cancers, including prostate, pancreatic and urothelial cancer, as well as acute myeloid leukemia (AML).

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"While a robust Phase 3 clinical trial program in gastric/gastroesophageal junction cancer for our investigational therapy zolbetuximab is well underway, the ASCO (Free ASCO Whitepaper) Annual Meeting will include the first trial-in-progress presentation from our expanded Phase 2 clinical trial in Claudin 18.2-positive pancreatic cancer," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The progress of these clinical studies reflects our enthusiasm to continue investigating the potential to benefit patients by targeting the emerging Claudin 18.2 biomarker."

"At Astellas, our mission is to not only advance innovative science, but to create value for patients and the oncology community," said Erhan Berrak, M.D., Vice President of Global Medical Affairs, Oncology, Astellas. "Our advanced prostate cancer data at ASCO (Free ASCO Whitepaper), which range from new analyses of our ARCHES pivotal trial in metastatic hormone-sensitive prostate cancer to data on patient preferences and prescriber treatment decisions, will help inform discussions between patients and providers about novel hormone therapies."

Highlights at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:

An overview of the expanded Phase 2 open-label, randomized study of zolbetuximab in combination with nab-paclitaxel and gemcitabine as an investigational first-line treatment for patients with Claudin 18.2-positive metastatic pancreatic cancer
Long-term (24-month) data from the Phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor
Four post-hoc analyses from the Phase 3 ARCHES study, which compared enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Highlights at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress include:

Encore data from the COMMODORE Phase 3 confirmatory study of gilteritinib versus salvage chemotherapy in FLT3 mutation-positive relapsed or refractory AML in China and other countries
An overview of the CLEVO non-interventional investigational study of FLT3 mutation frequency in patients with AML in Europe and the U.S.
Astellas Presentations at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

Long-term outcomes in EV-301: 24-month findings from the Phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma

J. Rosenberg

Type: Poster Discussion

Abstract Number: 4516

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Poster Discussion Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 4:30 – 6 p.m. CDT

Benchmarking maintenance therapy survival in first-line advanced urothelial carcinoma using disease modeling

M. Galsky

Type: Poster Presentation

Abstract Number: 4575

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Real-world treatment patterns and clinical outcomes with first-line therapy in cisplatin-eligible and ineligible patients with advanced urothelial carcinoma

G. Sonpavde

Type: Poster Presentation

Abstract Number: 4565

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible

D. Petrylak

Type: Poster Presentation

Abstract Number: 4582

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Enzalutamide

Presentation Title

Lead Author

Presentation Details

Radiographic progression in the absence of prostate-specific antigen (PSA) progression in patients with metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analysis of ARCHES

A. Armstrong

Type: Poster Presentation

Abstract Number: 5072

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Prevalence of DNA damage repair (DDR) alterations in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide (ENZA) or placebo (PBO) plus androgen deprivation therapy (ADT): ARCHES post hoc analysis

A. Azad

Type: Poster Presentation

Abstract Number: 5074

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

The association of germline HSD3B1 genotype with outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without enzalutamide (ENZA) [ARCHES]

N. Sharifi

Type: Poster Presentation

Abstract Number: 5022

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Clinical outcomes and safety of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) in patients aged <75 and ≥75 years: ARCHES post hoc analysis

R. Szmulewitz

Type: Poster Presentation

Abstract Number: 5069

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Reasons for oncologist and urologist treatment choice in metastatic castration-sensitive prostate cancer (mCSPC): A physician survey linked to patient chart reviews in the United States

S. Freedland

Type: Poster presentation

Abstract Number: 5065

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Patient preferences for treatment and outcomes in hormone-sensitive prostate cancer (HSPC)

D. George

Type: Abstract publication

Abstract Number: e18757

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

Zolbetuximab plus gemcitabine and nab-paclitaxel (GN) in first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer (mPC): Phase 2, open-label, randomized study

W. Park

Type: Poster Presentation

Abstract Number: TPS4186

Date: Saturday, June 4, 2022

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Presentation: 8 – 11 a.m. CDT

Astellas Presentations at EHA (Free EHA Whitepaper) 2022 Hybrid Congress

Gilteritinib

Presentation Title

Lead Author

Presentation Details

CLEVO: a non-interventional study to investigate clonal evolution of FMS-like tyrosine kinase 3 (FLT3) gene mutations during disease progression in patients with acute myeloid leukemia

P. Vyas

Type: Abstract publication

Abstract Number: PB1834

Gilteritinib versus salvage chemotherapy for relapsed/refractory FLT3-mutated acute myeloid leukemia: a Phase 3, randomized, multicenter, open-label trial in Asia

J. Wang

Type: Poster session

Abstract Number: P554

Enfortumab Vedotin and the Astellas and Seagen Collaboration
Astellas and Seagen are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin. In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Enzalutamide and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.

On May 12, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that the company management team, along with guest key opinion leaders (KOLs), will provide an update for the investment community on Thursday, June 2nd at 4:30 PM (Press release, Aptose Biosciences, MAY 12, 2022, View Source [SID1234614316]). The event will include an up-to-date review of clinical data available for Aptose’s two investigational products under development for hematologic malignancies: HM43239, an oral, myeloid kinome inhibitor in an international Phase 1/2 trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib, an oral, dual lymphoid and myeloid kinome inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory B-cell malignancies, and in a separate Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS).

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The slides will be available on Aptose’s website here and a recording of the presentation will be archived shortly after the conclusion of the event.

Separately, preclinical data for HM43239 also will be presented in a poster at the EHA (Free EHA Whitepaper)2022 Hybrid Congress, to be held in Vienna, Austria June 9 – 17, 2022 and virtually. The accepted abstract is being published today, Thursday, May 12th at 16:00 CEST / 10:00 AM ET.

On May 12, 2022 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that two abstracts highlighting data and information for zandelisib, an investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies, will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress to be held June 9 – 17, 2022 (Press release, Kyowa Hakko Kirin, MAY 12, 2022, View Source [SID1234614315]).

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Oral Presentation Title: Efficacy and Safety of Zandelisib Administered by Intermittent Dosing (ID) in Patients with Relapsed or Refractory (r/r) Follicular Lymphoma: Primary Analysis of the Global Phase 2 Study TIDAL
Session Title: Indolent & mantle cell non-Hodgkin lymphoma – Clinical
Presenter: Andrew David Zelenetz, PhD, MD
Time: June 11, 11:30am-12:45pm CEST
Abstract Code: S208

Poster Title: Zandelisib on Intermittent Dosing as a Single Agent or in Combination with Rituximab or Zanubrutinib in Relapsed or Refractory (r/r) Follicular Lymphoma (FL): Results from a Multi-Arm Phase 1b Study
Session Title: Indolent & mantle cell non-Hodgkin lymphoma – Clinical
Time: June 10, 2:30pm-3:45pm CEST
Presenter: Jacob Drobnyk Soumerai, MD
Abstract Code: P1114

The abstracts are available on the EHA (Free EHA Whitepaper) Annual Congress website. All presentations will be made available on the EHA (Free EHA Whitepaper) website for on-demand viewing on June 10, 2022.

On May 12, 2022 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported first quarter 2022 financial results and summarized recent program developments (Press release, Monopar Therapeutics, MAY 12, 2022, View Source [SID1234614314]).

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Recent Program Developments

Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting

The VOICE trial continues to enroll patients and add additional clinical sites, with the interim analysis anticipated to occur in 2H-2022.

Camsirubicin – Phase 1b Dose-Escalation Trial, Actively Recruiting

Monopar has cleared the third dose-level and is currently enrolling the fourth dose-level cohort. The fourth dose-level is approximately double the highest dose of camsirubicin ever tested in a prior trial.

Early signs of clinical benefit have been observed with camsirubicin in this Phase 1b trial.

MNPR-101 Radioimmunotherapeutic ("RIT")

Monopar is currently evaluating pathways to initiate a first-in-human study with the MNPR-101-PCTA radioimmunotherapeutic/radiodiagnostic candidate that Monopar generated with its partner NorthStar Medical Radioisotopes, LLC.

MNPR-202

Monopar’s collaborator, the Cancer Science Institute of Singapore at the National University of Singapore, is testing MNPR-202 in preclinical cancer models and the Company is awaiting initial results.

Results for the First Quarter Ended March 31, 2022, Compared to the First Quarter Ended March 31, 2021

Cash and Net Loss

Cash and cash equivalents as of March 31, 2022 were $17.8 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through at least June 2023. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development through and beyond the ongoing open-label, dose escalation Phase 1b clinical trial.

Net loss for the first quarter of 2022 was $2.5 million or $0.19 per share compared to net loss of $1.9 million or $0.16 per share for the first quarter of 2021.

Research and Development (R&D) Expenses

R&D expenses for the three months ended March 31, 2022 were $1,678,000, compared to $1,207,000 for the three months ended March 31, 2021. The increase of $471,000 is attributed to (1) an increase of $244,000 in Validive clinical trial-related and clinical material manufacturing-related expenses, (2) an increase of $193,000 in R&D personnel expenses and (3) a $34,000 net increase of other R&D expenses.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended March 31, 2022 were $779,000, compared to $688,000 for the three months ended March 31, 2021. The increase of $91,000 is primarily attributed to an increase in G&A personnel expenses.