On December 16, 2024 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines to treat serious diseases by correcting abnormal gene expression, reported that it has made the decision to discontinue the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia (AML) (Press release, Foghorn Therapeutics, DEC 16, 2024, View Source [SID1234649122]). Foghorn is evaluating partnerships and ISTs (Investigator Sponsored Trials) to advance FHD-286. The Company will prioritize its proprietary pipeline and Lilly collaboration programs, including the clinical-stage selective SMARCA2 (BRM) inhibitor FHD-909 (LY4050784).

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As of September 30, 2024, the Company had $267.4 million in cash, cash equivalents and marketable securities. Its cash runway supports the Company into 2027.

In the Phase 1 dose escalation trial of FHD-286 in combination with decitabine in relapsed and/or refractory AML, objective clinical responses were observed by standard response criteria. However, the observed response rate did not meet the Company’s threshold to continue development by Foghorn alone. Foghorn expects to report the results at a medical conference in 2025.

"While clinical responses were observed for FHD-286, we will prioritize investment into our proprietary pipeline, including our Selective CBP program, Selective EP300 program, and ARID1B program, as well as our Lilly collaboration, including the clinical development of FHD-909." said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "Our pipeline of potential medicines represents significant opportunities in oncology with the potential for therapeutic expansion. We want to thank the clinical investigators, the patients, and their families for their participation in the FHD-286 clinical trial."

About FHD-286
FHD-286 is a highly potent, first-in-class, selective, allosteric, and orally available small-molecule, enzymatic inhibitor of SMARCA2 (BRM) and SMARCA4 (BRG1), two highly similar proteins that are the ATPases, or the catalytic engines, of the BAF complex, one of the key regulators within the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies, including both hematologic and solid tumors.

About AML
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

On December 16, 2024 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat cancers, reported it has extended its previously announced Research Funding Agreement (the "Agreement") with the University of Virginia ("UVA") to advance the development of its systemic DNase program through 2025 (Press release, Xenetic Biosciences, DEC 16, 2024, View Source [SID1234649139]).

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Xenetic’s DNase-based oncology platform is designed to target neutrophil extracellular traps (NETs), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. In cancer, NETs are expelled by activated neutrophils into the tumor microenvironment (TME) and blood, thereby promoting cancer spread, local and systemic immunosuppression, as well as cancer-associated thrombosis. Reduction of NETs burden via application of Xenetic’s proprietary recombinant human DNase I has been shown to improve efficacy of immunotherapy, adoptive cell therapy and chemotherapy in preclinical animal models.

"Allan Tsung, MD, and the team at UVA continue to be valued partners and we are pleased with the progress under the Agreement in evaluating the potential addition of DNase to available treatment options in areas of significant unmet need. The preclinical and translational data that UVA has accumulated under the initial Scope of Work to the Agreement further strengthens the scientific rationale for investigating combinations of DNase I with immunotherapies and chemotherapies. In the next phase of this partnership, UVA will continue to investigate combinations of DNase I with immunotherapies in models of primary and metastatic colorectal cancer. As a surgical oncologist and scientist, Dr. Tsung is internationally recognized for leading substantial research on the role of NETs in tumor growth, metastasis, and resistance to existing cancer therapies and we look forward to leveraging that expertise as we advance our technology toward the clinic," commented Reid P. Bissonnette, Ph.D., Executive Consultant for Translational Research and Development of Xenetic.

Under the terms of the Agreement, in addition to advancing Xenetic’s existing intellectual property, Xenetic has an option to acquire an exclusive license to any new intellectual property arising from the DNase research program. Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and Chair of the Department of Surgery at the UVA School of Medicine, will continue to oversee the research conducted under the Agreement. Xenetic is working toward its planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.

On December 16, 2024 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene, will present at the 43rd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco (Press release, Allogene, DEC 16, 2024, View Source [SID1234649124]).

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43rd Annual J.P. Morgan Healthcare Conference
Wednesday, January 15, 2025
3:00PM PT/ 6:00PM ET

A live audio webcast of the presentation will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section.

Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On December 16, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported the submission of its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for its MDG1015 program for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma in the phase 1 clinical trial EPITOME1015-I (Press release, MediGene, DEC 16, 2024, View Source [SID1234649140]). The CTA submission follows the Company’s receipt of the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for EPITOME1015-I earlier this year.

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EPITOME1015-I consists of a dose escalation followed by an expansion segment and aims to assess safety, feasibility and preliminary efficacy of MDG1015 in multiple solid tumor indications.

"We are delighted to announce the submission of the CTA for MDG1015. This milestone is a significant step forward in the development of our differentiated cell therapy. The extensive experience of European clinical sites provides an ideal environment for this trial. The robust infrastructure and strong network of clinical investigators will facilitate efficient patient recruitment once funding is secured, which will enable us to then rapidly progress toward bringing this potentially transformative therapy to patients in need," said Selwyn Ho, CEO at Medigene AG.

MDG1015 is a first-in-class, third generation T cell receptor engineered T cell (TCR-T) therapy targeting the cancer-testis antigen New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a (NY-ESO-1/LAGE-1a) in the context of human leukocyte antigen (HLA)-A*02 with a natural and optimal affinity 3S (specific, sensitive and safe) TCR. The TCR-T cells are further armored and enhanced by the addition of the proprietary costimulatory switch protein (CSP) PD1-41BB and have demonstrated significantly enhanced anti-tumor activities against tumor cells expressing varying levels of PD-L1, one of the most immunosuppressive signals emanating from the solid tumor microenvironment. Importantly, compared to first generation TCR-T therapies, MDG1015 will be manufactured with a short, 6-day cell expansion period, leading to younger, fitter cells, with the potential for a markedly reduced number of cells required during dosing and a shorter vein-to-vein time for patients of approximately 20 days. This has also resulted in a drug product with an almost pure CD8+ population and with a very high proportion of cells with stemness-like qualities (~95%) that could lead to improved durability of response, greater efficacy and reduced adverse events.

On December 16, 2024 SK Biopharmaceuticals, a biotech company focusing on the research, development and commercialization of treatments for disorders of the central nervous system and oncology worldwide, reported a research collaboration agreement with ProEn Therapeutics, a biotech company dedicated to advancing oncology treatments, to further extend its oncology research capability and expand its pipeline of radiopharmaceutical therapies (RPT) (Press release, SK biopharmaceuticals, DEC 16, 2024, View Source [SID1234649142]).

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Under this agreement, both sides seek to advance up to two preclinical candidates for the development of novel radiopharmaceutical drugs by 2027 – the year when SK Biopharmaceuticals aims to become a global leading RPT player, via strengthened internal and external resources.

This joint research builds on a series of SK Biopharmaceuticals’ global strategic partnerships, including the in-licensing of a radiopharmaceutical compound, and a supply agreement to secure actinium-225, an alpha-particle emitting radioisotope, since the company unveiled its "RPT Roadmap" to gain a competitive edge in the rapidly growing field of nuclear medicine.

SK Biopharmaceuticals will leverage ProEn Therapeutics’ ArtBody platform, a dual-target binding technology that incorporates small proteins[1] to identify and target specific tumor antigens – enhancing tumor selectivity – for the development of potential cancer treatments, while minimizing damage to healthy tissues. ArtBody, which has intrinsic advantages of high stability and structural robustness, can be mass-produced using bacteria, making it ideal for industrial applications.

Il-Han Lee, Chief Executive Officer of ProEn Therapeutics, said, "We are pleased to enter this joint research, and positive that the ArtBody platform will generate synergy with and complement SK Biopharmaceuticals’ radiopharmaceutical therapy business. ProEn Therapeutics will push to produce the best possible outcome that can meet not only the two companies’ expectations, but also patients’ needs."

Donghoon Lee, Chief Executive Officer of SK Biopharmaceuticals, said, "This collaboration with ProEn Therapeutics is significant as the platform technology will help overcome the limitations of existing therapies. We will aim to develop more effective, safer treatments, while leading global RPT research and development efforts."