On November 23, 2020 The South Korean biotech company Y-Biologics and the French pharmaceutical group Pierre Fabre reported their plans to form a strategic partnership in the field of immuno-oncology research (Press release, Y-Biologic, NOV 23, 2020, View Source [SID1234571628]). The decision has been acknowledged through a letter of intent signed by both parties and will be confirmed in the coming months through a detailed agreement. The collaboration is set to run for three years, with the possibility of a two-year extension.

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!

Y-Biologics, which specializes in the discovery of monoclonal antibodies, and the Pierre Fabre group, France’s second-largest private pharmaceutical laboratory, plan to combine their areas of expertise with the aim of identifying and developing novel therapeutic monoclonal antibodies targeting key immunosuppressive mechanisms activated within solid tumors.

It has been shown that key cellular components of the tumor microenvironment play an important role in helping the tumor thwart the body’s immune response. Cancer immunotherapies work by specifically reactivating the immune system so that it can destroy the tumor cells. The partnership between Pierre Fabre and Y-Biologics aims to provide patients with novel therapies based on the use of therapeutic monoclonal antibodies that are capable of reprogramming some cell types to stimulate and/or restore the anti-tumoral response exerted by the immune system.

Under the terms of this agreement, Y-Biologics will contribute through its human antibody display platforms to generate therapeutic and diagnostic monoclonal antibodies directed against key molecular targets designated by Pierre Fabre. For its part, Pierre Fabre will contribute its expertise in immuno-oncology leveraging the skills of its teams located at the Pierre Fabre Immunology Centre (CIPF) in Saint-Julien-en-Genevois (discovery and validation of immunosuppressive targets, targeted biotherapies) and at the Pierre Fabre R&D Centre on the Oncopole campus in Toulouse (translational medicine, pharmacology, toxicology, clinical development).

Young Woo Park, CEO of Y-Biologics, stated : « Utilizing Y-Biologics’ human antibody display platform, we are extremely pleased to have entered into the joint study and optional license agreement for antibody discovery for novel immuno-oncology targets proposed by Pierre Fabre. We take great pride in enabling Pierre Fabre, an important stakeholder in oncology, to recognize our antibody discovery platform and expand our technology globally. Y-Biologics hope that the candidates we have discovered can step forward into preclinical and clinical stage by Pierre Fabre and we are all very pleased to see that this partnership broadens the opportunities for subsequent co-development. We look forward to continuing our strong relationship with Pierre Fabre through this project. »

«Innovation in oncology is one of our strategic priorities, therefore we are very excited to partner with Y-Biologics in the discovery and development of cutting-edge monoclonal antibodies. The agreement with Y-Biologics is another testimony of Pierre Fabre´s commitment to accelerate identification of innovative therapies for patients who are refractory or resistant to current treatments » added Jean-Luc Lowinski, Medical Care Business Unit CEO at Pierre Fabre.

Under the planned partnership, Pierre Fabre would have the option to acquire all rights on the antibodies that will be developed under the collaboration. These rights will be subject to payments of discovery fees, milestones and royalties to Y-Biologics.

On November 23, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved two Phase Ib/II clinical studies of its novel Bcl-2 inhibitor APG-2575; one for APG-2575 as a single agent or in combination with ibrutinib/rituximab for the treatment of patients with Waldenström macroglobulinemia (WM), and the other one for APG-2575 as a single agent or in combination with lenalidomide/dexamethasone for the treatment of patients with multiple myeloma (MM) (Press release, Ascentage Pharma, NOV 23, 2020, View Source [SID1234571619]).

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!

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. APG-2575 is the first China-developed Bcl-2 inhibitor having entered clinical development in China. APG-2575 has received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, and the US, and is currently being developed in a range of hematologic malignancies globally. Of those studies, the Phase Ib/II study of APG-2575 as a single agent or in combination with ibrutinib/rituximab for the treatment of WM is a global multicenter trial with centers in Australia, China, and the US.

The Phase Ib/II study of APG-2575 as a single agent or in combination with ibrutinib/rituximab for the treatment of patients with WM
This global multicenter, open-label Phase Ib/II dose-expansion study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of APG-2575 as a single agent or in combination with ibrutinib/rituximab for the treatment of patients with WM.

WM is a rare indolent B-cell lymphoma, accounting for <2% of all non-Hodgkin’s lymphoma (NHL) cases. Treatment recommendations for WM from current guidelines suggest an objective response rate (ORR) of about 80% with contemporary therapies, but they deliver a very low rate of very good partial response (VGPR) or deeper responses (20% or lower), with most patients eventually relapsing or experiencing further disease progression. Furthermore, patients are diagnosed with WM at a median age of 70, when many individuals are intolerant of aggressive therapies because of poor health conditions, hence presenting an urgent clinical need for more effective therapies[1].

Preclinical study data of APG-2575 have shown responses generated in WM models resistant or insensitive to ibrutinib, as well as the synergistic effect with ibrutinib in various models of NHL, including follicular lymphoma, diffuse large B-cell lymphoma, and WM.

The Phase Ib/II study of APG-2575 as a single agent or in combination with lenalidomide/dexamethasone for the treatment of patients with MM
This multicenter, open-label Phase Ib/II dose-escalation study to be carried out in China is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of APG-2575 as a single agent or in combination with lenalidomide/dexamethasone in patients with relapsed/refractory MM.

MM is a plasma cell proliferative disorder with manifestations like hypercalcemia, anemia, renal failure, and bone disease. MM remains incurable. As reported, MM accounts for about 1.8% of all malignant tumors and 18.2% of all hematopoietic neoplasms. MM is the second most common hematological malignancy[2]. The age-standardized incidence rate of MM in the US is approximately 6.9 per 100,000[3]. The incidence rate of MM in China has increased significantly in recent years, and the mortality rate increased with age, especially for patients over 60 years. The median age at diagnosis in China is 59 years, much younger than US (~69 years). The incidence also increases with age. With an aging population and advanced diagnostic capabilities, the prevalence of MM is anticipated to keep growing in China[4].

In the preclinical studies of Ascentage Pharma, APG-2575 demonstrated potent antiproliferative activity in MM cell lines bearing the chromosomal t (11;14). I And in MM cell lines without t (11;14), the combinations with lenalidomide or pomalidomide and dexamethasone greatly enhanced APG-2575 cell sensitivity and triggered more potent cell death.

"APG-2575 is a key drug candidate in our apoptosis-targeted pipeline, and the first China-developed selective Bcl-2 small-molecule inhibitor, with great therapeutic potential as a single agent or in combinations in a range of hematologic malignancies including WM and MM," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "There is a growing emphasis on combination therapy in cancer treatments. We will accelerate these studies of APG-2575 and strive to develop a new treatment option for patients in need."

References:

[1] NCCN Clinical Practice Guidelines in Oncology for Waldenström Macroglobulinemia, Version 1.2020-December 6,2019

[2] Siegel, R. L., Miller, K. D., & Jemal, A. (2019). Cancer statistics, 2019. CA: a cancer journal for clinicians, 69(1), 7-34.

[3] Cancer Stat Facts: Myeloma; Surveillance, Epidemiology, and End Results Program, US National Cancer Institute. View Source Accessed on 2020.3.18

[4] Liu, J., Liu, W., Zeng, X., Ma, J., et al. Incidence and Mortality of Multiple Myeloma in China, 2006-2016: An Analysis of the Global Burden of Disease Study 2016. J Hematol Oncol. 2019; 12: 136.

About APG-2575

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Ascentage Pharma has previously commenced Phase I studies of APG-2575 single agent in China, Australia, and the United States. Since March 2020, the company has received approvals and clearances for several Phase Ib/II studies of APG-2575 in China, Australia, and the US, and is advancing clinical development of APG-2575 for a variety of hematologic malignancy indications, including relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, Waldenström macroglobulinemia, relapsed/refractory multiple myeloma, and relapsed/refractory acute myeloid leukemia. APG-2575 was recently granted two orphan drug designations by the US Food and Drug Administration in the treatment of Waldenström Macroglobulinemia and Chronic Lymphocytic Leukemia.

On November 23, 2020 OneOncology, the national partnership of independent oncology practices, and Genentech, a member of the Roche Group (SIX: RO, ROG;OTCQX: RHHBY), reported the first clinical trial available to patients through OneR, the OneOncology Research Network (Press release, OneOncology, NOV 23, 2020, https://www.prnewswire.com/news-releases/oneoncology-partners-with-genentech-to-bring-personalized-cancer-research-to-patients-at-community-oncology-sites-301178283.html [SID1234571618]). The companies also unveiled a first-of-its-kind, multi-year strategic partnership to collaborate on various clinical trials, scientific research and real-world data studies that will advance personalized cancer care at community oncology centers across the United States. The partnership’s goals are to enhance clinical assessment of comprehensive genomic profiling (CGP), increase access to clinical trials and improve therapeutic options for patients.

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!

OneOncology and Genentech partner to bring personalized cancer research to patients
"We are changing the face of community oncology," said Lee Schwartzberg, MD, Chief Medical Officer, OneOncology.

"This partnership is an important advancement to bring personalized cancer care to patients at practices across the OneOncology platform," said Lee Schwartzberg, MD, Chief Medical Officer, OneOncology and Medical Director, West Cancer Center. "By combining Genentech’s leadership in both scientific research and clinical development of personalized oncology medicines with OneOncology’s commitment to expanding access to world-class research, we are changing the face of community oncology."

Studies have shown that CGP can be crucial in determining the right treatment for cancer patients by testing tumors for genomic alterations. However, its use in community oncology remains limited. Genentech’s new clinical trial — Targeting Actionable Mutation Study in Cancer (MyTACTIC) — aims to match patient populations with a targetable genomic alteration to a specific investigational agent. OneR will participate in this multi-center, non-randomized phase II basket trial across its national network, along with other community oncology centers throughout the United States.

"We are very excited about the collaboration between Genentech and OneR which will enhance cancer research and cancer care for patients across the country," said Axel Grothey, MD, Medical Director, OneR, and Director, GI Cancer Research, West Cancer Center. "One of OneOncology’s key strengths is the ability to offer comprehensive molecular profiling to patients with advanced stage cancers. MyTACTIC realizes the promise of personalized cancer therapy by providing access to targeted treatment approaches to patients in a community oncology setting, where the vast majority of cancer patients in the United States are receiving care, while also advancing scientific discovery."

OneOncology and Genentech will also establish a joint committee that will design studies to evaluate the impact of personalized healthcare on outcomes for patients, the healthcare system and society. This group will design interventional and non-interventional studies to investigate the integration of CGP into routine practice and generate real-world evidence regarding utilization. The partnership will explore new methods for enabling just-in-time clinical research site start-up and patient identification across OneR.

"We are excited to collaborate with OneOncology to bring state-of-the-art cancer care to community oncology practices, where the diverse patient population creates a greater opportunity to advance inclusive research," said Jamie Freedman, MD, PhD, Head of U.S. Medical Affairs, Genentech. "The pandemic dramatically highlights the need to rethink how healthcare is delivered, and our goal is to enable a deeper understanding of each individual patient’s journey and to deliver the highest quality of research and evidence-based care."

On November 23, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, President and Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held on December 1-3, 2020 (Press release, Leap Therapeutics, NOV 23, 2020, View Source [SID1234571617]).

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 pre-recording of the fireside chat is currently available on the Investors page of the company’s website at View Source A replay of the event will be available for 90 days.

On November 23, 2020 ViewRay, Inc. (NASDAQ: VRAY) reported its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference (Press release, ViewRay, NOV 23, 2020, View Source [SID1234571615]).

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!

From November 23 to December 3, 2020, a fireside chat recording will be available for registered attendees via the Piper Sandler conference site. A recording will also be posted to the Company’s website at View Source

ViewRay will be participating in investor meetings on Tuesday, December 1st, which can be requested exclusively via Piper Sandler.