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]).

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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 ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, reported that L1 Capital Global Opportunities Master Fund ("L1") has converted $200,000 (plus accrued but unpaid interest) of the convertible security issued pursuant to the convertible security deed dated 10 June 2020, details of which were announced by the Company on 11 June 2020 (Press release, ImmuPharma, NOV 23, 2020, View Source [SID1234571559]). The conversion price is 11p per share resulting in the issue by the Company of 1,430,510 new ordinary shares of 10p each in the Company ("New Ordinary Shares").

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New Ordinary Shares and Admission

The New Ordinary Shares have been allotted today and are issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued ordinary shares.

An application will be made for the New Ordinary Shares to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") and Euronext Growth Brussels ("Admission"). It is anticipated that Admission to AIM will occur at 8.00am on or around Thursday 26 November 2020.

The New Ordinary Shares represent 0.58% of the Company’s enlarged issued share capital.

Total Shares in Issue

For the purposes of the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority ("DTR"), the Board of ImmuPharma hereby notifies the market that following Admission, the Company’s total issued share capital will consist of 247,716,315 Ordinary Shares with a nominal value of 10p each.

This figure may be used by Shareholders as the denominator for the calculations by which they may determine if they are required to notify their interest in, or a change to their interest in, the Company under the DTR.

The allotment of the New Ordinary Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s Annual General Meeting held on 18 June 2020.

On November 23, 2020 RGENIX, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that CEO Masoud Tavazoie, M.D., Ph.D., will present at the 32nd Annual Piper Sandler Virtual Healthcare Conference (Press release, Rgenix, NOV 23, 2020, View Source [SID1234571578]).

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This virtual presentation will be available online here from November 23, 2020 at 10:00 AM EST to December 3, 2020.

A link to an archived version of this presentation will also be available on RGENIX’s website within the News section.

Rgenix will also be participating in one-on-one meetings with investors on November 30 and December 1, meetings may be requested exclusively via Piper Sandler.

On November 23, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of a second abstract at the San Antonio Breast Cancer Symposium (SABCS), jointly authored by Professor Mothaffar F. Rimawi, the Global Principal Investigator of the GP2 Phase III clinical trial, and the Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, and Professor C. Kent Osborne, Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine (Press release, Greenwich LifeSciences, NOV 23, 2020, View Source [SID1234571595]). The abstract will be displayed as the Company’s second poster on Wednesday, December 9, 2020 in a virtual format with an introductory audio track.

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The abstract highlights the design of the planned Phase III clinical trial. The trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by submission of a Biologics Licensing Application. The Phase III clinical trial aims to reproduce the Phase IIb study which concluded that completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "The participation of Baylor College of Medicine as the Phase III clinical trial lead site further validates the significance of our Phase IIb data. Reducing the recurrence of breast cancer rates to 0% gives us great confidence as we try to reproduce this data in the Phase III clinical trial. We are addressing a potential market of up to $5 billion in a disease that affects 1 in 8 women, who if recur, will likely face metastatic breast cancer."

"We are very excited to be working with such prominent key opinion leaders. Professor Rimawi’s leadership of our Phase III clinical trial will complement the positive Phase IIb clinical trial results with the research and clinical expertise of Baylor College of Medicine. Due to GP2’s efficacy and safety profile, GP2 immunotherapy may provide clinicians with an option to reduce the use of other toxic and expensive treatments. We look forward to sharing our Phase IIb clinical trial data and Phase III clinical trial design with breast cancer leaders attending SABCS and to discussing the participation of their clinical sites in our trial," Patel concluded.

The Phase III clinical trial will explore the use of GP2 + GM-CSF as adjuvant therapy to prevent the recurrence of breast cancer in HER2/neu positive and HLA 2+ patients, post-surgery and following the first year of treatment with any trastuzumab-based therapy.

The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy or an approved biosimilar, treatment with GP2 + GM-CSF or placebo will be administered intradermally for the 6 primary immunization series over the first 6 months and 5 subsequent boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years of treatment plus 2 years of follow-up for a total of 5 years following the first year of treatment with trastuzumab-based therapy or approved biosimilar. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.

The majority of breast cancer patients will be HER2/neu positive and HLA 2+, disease-free, conventionally treated node-positive, post breast tumor removal surgery and following the first year of treatment with trastuzumab-based therapy.

Abstract OT-13-03 is entitled: A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer. The full abstract can be viewed here on page 912.

About SABCS

The 43rd annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research (AACR) (Free AACR Whitepaper) began collaborations with SABCS in 2007. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

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.

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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.