On June 9, 2022 AstraZeneca reported that it will showcase data demonstrating the Company’s commitment to redefine care in haematology at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, 9 to 12 June 2022 (Press release, AstraZeneca, JUN 9, 2022, View Source [SID1234615829]).

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!

A total of five approved and potential new medicines from AstraZeneca will be featured across 16 abstracts, including one oral presentation. These include long-term follow-up data for Calquence (acalabrutinib) in adults with previously untreated and relapsed or refractory chronic lymphocytic leukaemia (CLL).1,2 Additionally, Alexion, AstraZeneca’s Rare Disease group, will present an analysis of long-term survival data from the clinical trial programme evaluating Ultomiris (ravulizumab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).3 One-year safety and efficacy data from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris will also be presented.4

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "At this year’s European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, we are demonstrating our strength across a broad spectrum of haematological malignancies, and specifically in chronic lymphocytic leukaemia, to help improve outcomes for these patients. The data from our portfolio and pipeline represent the outcome of years of dedication and passion focused on delivering improved treatment options that can have a long-term impact for patients with chronic, hard-to-treat and rare blood conditions."

Christophe Hotermans, MD, PhD, Senior Vice President, Global Medical Affairs, Alexion, said: "The collective clinical and real-world data being presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting will strengthen the body of scientific evidence supporting the effective and well-tolerated use of targeted C5 complement inhibition, which is the standard of care in paroxysmal nocturnal haemoglobinuria. The data reinforce targeting of the terminal complement system through C5 inhibition to reduce intravascular haemolysis and thrombosis in this devastating disease."

Redefining expectations for patients with CLL

Updated data from the ELEVATE-TN Phase III trial at approximately five years of median follow-up will highlight longer-term safety, progression-free survival (PFS) efficacy results and overall survival rates for Calquence in combination with obinutuzumab and alone compared to obinutuzumab plus chlorambucil in adults with previously untreated CLL.1
Updated data from the ASCEND Phase III trial at approximately four years of median follow-up will highlight longer-term safety and PFS efficacy results of Calquence alone compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab in adults with relapsed or refractory CLL.2
A pooled analysis of data among previously untreated and relapsed or refractory CLL patients with higher-risk genomic features taking Calquence will explore the efficacy of Calquence-based regimens for these sub-groups of patients, regardless of line of therapy.5
A crossover analysis from the ELEVATE-TN trial will test the hypothesis that treatment crossover upon disease progression from the obinutuzumab plus chlorambucil arm to the Calquence arm bolstered overall survival for the obinutuzumab plus chlorambucil arm at 47 months of follow-up.6
Improving understanding of hard-to-treat blood cancers

A post-hoc analysis of the ACE-LY-004 Phase II trial will highlight the clinical benefit seen with patients taking Calquence who had one prior therapy and with highly proliferative variants of relapsed or refractory mantle cell lymphoma (MCL).7
Final results at five-year median follow-up from the WM-001 Phase II trial will highlight response rates and tolerability seen with Calquence in patients with previously untreated or relapsed or refractory Waldenström macroglobulinemia (WM).8
Early results from a Phase II trial will show the efficacy and tolerability of Calquence in patients with relapsed or refractory marginal zone lymphoma (MZL).9
Advancing treatment and care for patients with PNH

Pooled, long-term, survival data for more than four years from the Ultomiris PNH clinical trial programme will highlight long-term use of Ultomiris in the treatment of adults with PNH.3 Ultomiris has the largest clinical trial programme in PNH, with the longest follow-up, and demonstrates the benefits of immediate, complete and sustained terminal complement inhibition in this rare disease.
Data through one year on the efficacy, safety and treatment administration satisfaction will be presented from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris with an on-body delivery system in adults with PNH who had received prior intravenous treatment with Soliris (eculizumab).4
Key AstraZeneca presentations during EHA (Free EHA Whitepaper) 2022

Lead author

Abstract title

Presentation details

Calquence (acalabrutinib)

Sharman, JP

Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naive Chronic Lymphocytic Leukemia: 5-Year Follow-up of ELEVATE-TN

Abstract # P666

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Ghia, P

Acalabrutinib vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Results at ~4 Years of Follow-up

Abstract # P668

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Davids, MS

Long-term Efficacy of Acalabrutinib-Based Regimens in Patients With Chronic Lymphocytic Leukemia and Higher-risk Genomic Features: Pooled Analysis of Clinical Trial Data

Abstract # P667

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Gaitonde, P

Adjusting Survival Data for Treatment Crossover in the ELEVATE-TN Trial by Using a Historical Cohort of Patients Treated with Chemoimmunotherapy in Front-Line Chronic Lymphocytic Leukemia

Abstract # PB1877

e-Publication

Online Only

12 May 2022

Le Gouill, S

Post Hoc Analysis of Patients With Highly Proliferative Variants of Mantle Cell Lymphoma Treated With Acalabrutinib

Abstract # P1131

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Owen, R

Acalabrutinib in Treatment-Naive or Relapsed/Refractory Waldenström Macroglobulinemia: 5-Year Follow-up of a Phase 2, Single-Arm Study

Abstract # P1130

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Strati, P

Acalabrutinib in Patients With Relapsed/Refractory (R/R) Marginal Zone Lymphoma (MZL): Results of a Phase 2, Multicenter, Open-label Trial

Abstract # P1129

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Ultomiris (ravulizumab)

Kulasekararaj, A

Long-Term Complement Inhibition and Survival Outcomes in Patients with Paroxysmal Nocturnal Hemoglobinuria: An Interim Analysis of the Ravulizumab Clinical Trials

Abstract # P812

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Yenerel, M

Efficacy, Treatment Administration Satisfaction and Safety of Subcutaneous Ravulizumab Through 1 Year in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Prior Intravenous Eculizumab

Abstract # P813

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Soliris (eculizumab)

Nishimura, J

Real-World Outcomes of Eculizumab Treatment in Patients with Paroxysmal Nocturnal Hemoglobinurea: A Systematic Literature Review and Evidence Synthesis

Abstract # PB1934

e-Publication

Online Only

12 May 2022

Rovó, A

Real-World Evidence of Safety and Effectiveness of Eculizumab and Switch to Ravulizumab in a Swiss Patient Population With Paroxysmal Nocturnal Hemoglobinuria

Abstract # P834

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

ALXN1820

Kim, S

Properdin-Blocking Antibodies Attenuate Complement Alternative Pathway Activation Triggered by Cell-Free Heme in Sickle Cell Disease Models

Abstract # S267

Oral Presentation

Session – Sickle Cell Disease: Novel Biomarkers and Therapies

12 June 2022

11:30 – 12:45 CEST

Notes

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. We have expanded our commitment to patients with haematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide innovative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

By targeting haematological conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On June 9, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Wednesday, June 15th at 8:40 a.m. PT / 11:40 a.m. ET (Press release, SpringWorks Therapeutics, JUN 9, 2022, View Source [SID1234615827]).

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!

To access the live webcast please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On June 9, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported data from a preclinical combination study of SON-1010 with a commercially available anti-PD1 compound (Press release, Sonnet BioTherapeutics, JUN 9, 2022, View Source [SID1234615826]). These results suggest that dosing of SON-1010 (IL12- FHAB) in combination with anti-PD1 demonstrated strong efficacy in the B16F10 mouse melanoma model, historically known as an immunologically insensitive model to anti-PD1.

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!

Checkpoint inhibitors provide viable treatment alternatives to chemotherapy and/or radiation for patients with solid tumors, but there remains a robust need for more effective combination treatment regimens. With the objective of improving the checkpoint inhibitor response rate, Sonnet BioTherapeutics is developing a targeted approach using the company’s Fully Human Albumin binding (FHAB) platform. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only Interleukin 12 (IL-12), but a variety of synergistic and potent immunomodulators. SON-1010 is currently undergoing Phase 1 clinical study in cancer patients and this preclinical study was designed to explore the combination potential with a checkpoint inhibitor (anti-PD1).

"We are excited to see that the combination of SON-1010 with an anti-PD1 antibody yielded compelling data in this preclinical model" said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer, and further added that, "These data support our strategy of pairing SON-1010 with a checkpoint inhibitor, with the goal of developing an improved treatment option for cancer patients."

Experimental Study Design: Three randomized cohorts of nine mice (n = 27), each with 150 mm3 B16F10 melanoma tumors, were dosed with 3µg IL12-FHAB and/or 10µg anti-PD1 antibody on days 0, 4 and 8 while the placebo cohort was not treated. Mean tumor volumes were measured every two or three days through an 18-day period.

Table 1: Mean Comparisons of Tumor Volume Growth Inhibition

Test Article

Mean Tumor
Volume (mm3) – Day 14

Tumor Growth Inhibition Ratios
( % Inhibition )

Placebo (n = 9)

2260

–

Anti-PD1 antibody (n = 9)

2016

10.7%

Anti-PD1 + IL12-FHAB (n = 9)

472

79.1%

Compared to the tumor-bearing placebo group at day 14, the treatment groups administered three doses of anti-PD1 antibody or three doses of the IL12-FHAB + anti-PD1 antibody combination resulted in 10.7% and 79.1% tumor growth inhibition, respectively.

Survival data for study mice at 18 days further supports the efficacy synergy of IL12-FHAB co-injected with anti-PD1 by improving the survival rate: (i) for anti-PD1 administration, only one mouse survived out of a total of nine, and (ii) for anti-PD1 + IL12-FHAB administration, seven mice survived out of a total of nine. Additionally, the mice cohorts used in the preclinical efficacy study did not show any weight loss during the study in either the single agent or combination dosing arms.

"We are excited to have demonstrated these important data in an immunologically distinct animal model when IL12-FHAB was dosed in combination with an anti-PD1 antibody," said John Cini, Ph.D., Sonnet’s Chief Scientific Officer. "Further, this study evaluated the sequence of test article administration, whereby co-injection of IL12-FHAB and anti-PD1 antibody was optimal when compared to administration of either anti-PD1 or IL12-FHAB first. Targeting the tumor by linking IL-12 to an albumin-binding domain extends the cytokine half-life in the body, and we believe that is the key to inducing a successful local immune response in the tumor microenvironment."

On June 9, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that it will host a virtual update on its ELAINE Phase 2 clinical programs on Wednesday, June 15 at 10:00 a.m. EDT (Press release, Sermonix Pharmaceuticals, JUN 9, 2022, View Source [SID1234615825]).

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!

The event will feature presentations from Key Opinion Leaders (KOLs) Sarah Sammons, M.D. (Duke University) and Senthil Damodaran, M.D., Ph.D. (The University of Texas MD Anderson Cancer Center) who will discuss lasofoxifene, Sermonix’s investigational treatment for metastatic breast cancer with an acquired estrogen receptor 1 (ESR1) mutation.

Dr. Sammons will provide an overview of the ELAINE-1 study, an open-label, randomized, multicenter study evaluating the activity of lasofoxifene versus fulvestrant (the current standard of care) in patients who have progressed following treatment with an aromatase inhibitor (Al), including in combination with a CDK 4/6 inhibitor.
Dr. Damodaran will then provide an analysis of efficacy and safety data from the ELAINE-2 study, an open-label multicenter study evaluating lasofoxifene in combination with Lilly’s CDK 4/6 inhibitor abemaciclib (VERZENIO), which was provided by Eli Lilly and Co for the study.
Following Dr. Damodaran and Dr. Sammons’ presentations, the Sermonix leadership team will provide a company overview and update.

Interested participants are required to register in advance for the event and may do so here.

Key Opinion Leader Biographies

Sarah Sammons, M.D.

Sarah Sammons, M.D. is currently an assistant professor of medicine at Duke University/Duke Cancer Institute. Her clinical focus is in breast medical oncology and she has expertise in treating patients with all subtypes of metastatic breast cancer. She serves as assistant director of breast cancer clinical research at Duke Cancer Institute and as breast leader for the Centers of Brain Metastases and the Cancer Immunotherapy Research.

Her research focuses on the development of novel therapies for the treatment of metastatic breast cancer. She has designed and implemented several institutional, national and international clinical trials in advanced breast cancer. She also has a translational focus on understanding breast tumors that may respond to immunotherapeutic strategies and how to enhance them.

Senthil Damodaran, M.D., Ph.D.

Senthil Damodaran, M.D., Ph.D. is a medical oncologist/physician scientist with expertise in breast cancers, cancer genomics and development of novel targeted therapies. Dr. Damodaran serves as assistant professor in breast medical oncology with a joint appointment in investigational cancer therapeutics at MD Anderson Cancer Center.

He focuses on 1) genomics-driven clinical trials, 2) application of genomics for target discovery in breast cancers, and 3) characterization of secondary drug resistance mechanisms. At MD Anderson, he led their department’s genomic-directed clinical/translational efforts.

Dr. Damodaran is actively involved in several National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) initiatives. He serves as the chair for the NCI MATCH (Molecular Analysis for Therapy Choice) trial (Sub-protocol Z1F) and co-chair for upcoming ComboMATCH studies. He also serves as PI for genomically matched NCI-ETCTN study evaluating copanlisib in combination with trastuzumab and pertuzumab in HER2 +ve MBC with PIK3CA or PTEN alterations. Additionally, Dr. Damodaran serves as PI for the INTERACT study, which employs real-time ctDNA monitoring to identify secondary ESR1 alterations as well as genomically targeted study of futibatinib (TAS120) in MBC patients with FGFR amplifications. He also serves as the co-lead for post-mortem tissue collection protocol for metastatic breast cancer, a first of its kind at MD Anderson. In addition, he serves on the ABIM/ASCO Breast Question Writing group and the ASCO (Free ASCO Whitepaper) biomarker expert panel.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On June 9, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that the company will participate in the 43rd Annual Goldman Sachs Global Healthcare Conference (Press release, Revolution Medicines, JUN 9, 2022, View Source [SID1234615824]). Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will be the featured participant in a live fireside chat at the event.

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!

Details of the company’s participation are as follows:

Conference Date: June 13 – 16, 2022
Fireside Chat Details: 1:20 p.m. Pacific on Wednesday, June 15, 2022
A live webcast of the fireside chat can be accessed at: View Source An archived replay of the webcast will be available on the investors section of the company’s website for at least 14 days following the event.