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Crinetics Pharmaceuticals to Participate in December Investor Conferences

On November 23, 2020  Crinetics Pharmaceuticals (Nasdaq: CRNX), reported that company management will participate in the following conferences in the month of December (Press release, Crinetics Pharmaceuticals, NOV 23, 2020, View Source [SID1234571633]). Please see additional details below:

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EVERCORE ISI 3RD ANNUAL HEALTHCONX CONFERENCE
Date: Thursday, December 3rd, 2020
Time: 1:00-1:45 pm ET in Track 1
Panel: Easy Pills to Swallow: Oral Drugs for Large Endo Markets
Presenter: Dr. Scott Struthers, Founder & CEO

PIPER SANDLER’S 32ND ANNUAL HEALTHCARE CONFERENCE
Date: Tuesday – Thursday, December 1st-3rd, 2020
Time: On demand
Presenter: Dr. Scott Struthers, Founder & CEO, and Dr. Alan Krasner, Chief Medical Officer

Webcast: Pre-recorded fireside chats will be available for viewing until the 3rd here 32nd annual Piper Sandler Healthcare Conference and the Piper Sandler conference website.

Immunocore’s tebentafusp demonstrates superior overall survival compared to investigator’s choice in a Phase 3 clinical trial of patients with previously untreated metastatic uveal melanoma

On November 23, 2020 Immunocore (the "Company"), a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune, reported that its Phase 3 IMCgp100-202 clinical trial of tebentafusp (IMCgp100) vs. investigator choice in metastatic uveal melanoma (mUM) has met the pre-defined boundaries for statistical significance of the primary endpoint of Overall Survival (OS) in its first pre-planned interim analysis conducted by the independent data monitoring committee (Press release, Immunocore, NOV 23, 2020, View Source [SID1234571630]). The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Although not yet mature, the Kaplan-Meier estimates suggest a 1-year OS rate of approximately 73% vs 58%, respectively. The efficacy data confirm the promising OS observed in the phase 2 study IMCgp100-102 in previously treated mUM which will be presented next month at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2020.

Bahija Jallal, Chief Executive Officer of Immunocore said: "A positive survival benefit for tebentafusp represents a major step towards bringing a potential new treatment for cancer patients with a high unmet need. If approved, tebentafusp would be the first new therapy to improve overall survival in 40 years and to be specifically indicated for metastatic uveal melanoma, a disease with poor survival and where new therapies are urgently needed. We look forward to sharing these data with the medical community and Health Authorities in the near future."

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector domain. It is engineered to specifically target gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. Tebentafusp has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) and has previously been granted orphan drug designation for uveal melanoma by the FDA and Promising Innovative Medicine designation under UK Early Access to Medicines Scheme.

"To our knowledge, this is the first survival benefit for any TCR therapeutic and for any bispecific in a solid tumor. The survival benefit observed in a randomized trial against checkpoint inhibitors validates our ImmTAC platform as we expand to study other cancers with high unmet need," said David Berman, Head of R&D, "Uveal melanoma has one of the lowest tumor mutational burdens (TMB) and these results suggest our ImmTAC platform should be evaluated in tumors with low or high TMB status."

The Phase 3 IMCgp100-202 clinical trial is designed to evaluate the OS of tebentafusp compared to investigator’s choice (either dacarbazine, ipilimumab or pembrolizumab) in patients with previously untreatedmUM. 378 patients were randomized in a 2:1 ratio to either tebentafusp or investigator’s choice. Final results from IMCgp100-202 are expected to be presented at an upcoming scientific conference and to be submitted for publication in a peer-reviewed journal.

Creation of a research partnership between Pierre Fabre and Y-Biologics for the development of new immunotherapies based on monoclonal antibodies

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.

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.

Ascentage Pharma Receives Approvals for Two Phase Ib/II Clinical Studies of the Bcl-2 Inhibitor APG-2575 for the Treatment of Waldenström Macroglobulinemia and Multiple Myeloma in China

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]).

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.

OneOncology Partners with Genentech to Bring Personalized Cancer Research to Patients at Community Oncology Sites

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.

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."