EP300

CAMBRIDGE, United Kingdom, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, a pharmaceutical company based in Cambridge, UK, dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it will make five key data presentations at the 36th EORTC-NCI-AACR Symposium on molecular targets and cancer therapeutics, 23rd-25th October 2024, Barcelona, Spain. The Astex presentations will focus on its novel small-molecule CBP/p300 HAT domain inhibitor, ASTX528 in preclinical development and its Phase II-ready MDM2 antagonist, ASTX295. Astex data presentations at 36th EORTC-NCI-AACR Symposium, 23rd-25th October 2024, Barcelona TitlePresentationDate/Time/Session Title/PresenterPresentation numberA Novel Small-Molecule CBP/p300 HAT Domain Inhibitor Demonstrates PotentIn VivoActivity and a Favourable Safety Profile in Preclinical SpeciesPosterDate: Wed, 23rdOct 2024Time: 12:00 - 19:00Session Title: Molecular Targeted AgentsPresenter: Gianni Chessari, Astex Pharmaceuticals, UKCatalog #42Presentation #PB030Targeting the Catalytic HAT Domain of CBP/p300 for the Treatment of Hormone-Dependent Breast and Prostate CancersPosterDate: Wed, 23rdOct 2024Time: 12:00 - 19:00Session Title: Molecular Targeted AgentsPresenter: John Lyons, Astex Pharmaceuticals, UKCatalog #73Presentation #PB061From a Preclinical Therapeutic Concept to the Clinic. ASTX295: Discovery of a bone marrow sparing MDM2 antagonistOralDate: Wed, 23rdOct 2024Time: 16:55 -17:15Session Title:Optimising of preclinical models for drug developmentPresenter: Maria Ahn, Astex Pharmaceuticals, UKWorkshop 2Room 113+114Identification of Biomarkers Predictive of Response to ASTX295, a Next-Generation MDM2 Antagonist, in Solid Tumors Carrying Wild-type p53PosterDate: Wed, 23rdOct 2024Time: 12:00 - 19:00Session Title: Molecular Targeted AgentsPresenter: Maria Ahn, Astex Pharmaceuticals, UKCatalog #28Presentation #PB016Pulsatile Induction of the p53 Pathway by MDM2 Antagonist ASTX295 Shows an Enhanced Therapeutic Indexin vivoPosterDate: Thu, 24thOct 2024Time: 9:00 - 17:30Session Title: Translational StudiesPresenter: Andrea Biondo, Astex Pharmaceuticals, UKCatalog #289Presentation #PB277 ASTX528 - CBP/p300 HAT Domain Inhibitor - Preclinical ASTX528 is a novel small molecule CBP/p300 HAT domain inhibitor with potent in vivo activity and a favourable safety profile in preclinical species that was discovered by Astex using its proprietary fragment-based drug discovery approach. CREB binding protein (CBP) and its paralog, EP300 (p300), are lysine acetyltransferases and transcriptional cofactors implicated in human cancers. Dose-limiting tolerability issues have been observed with dual CBP/p300 bromodomain (BRD) inhibitors, which may limit their clinical utility. We hypothesised that a dual inhibitor targeting the histone acetyltransferase (HAT) domain may improve the therapeutic window. Our presentations will describe the effects of CBP/p300 HAT domain inhibition in preclinical models of AR- and ER-driven cancers and the characterisation of ASTX528, a potent, fragment-derived CBP/p300 HAT domain inhibitor with a low predicted human dose and promising preliminary toxicity evaluation. Astex is interested in discussing the further development of ASTX528 with potential partners. ASTX295 – Bone Marrow-Sparing MDM2 Antagonist, Phase II-ready ASTX295 is an oral, potent inhibitor of the p53-MDM2 protein-protein interaction that was discovered by Astex using its proprietary structure-based drug design approach. The compound was specifically designed to overcome the on-target toxicity seen in the first generation MDM2 antagonist compounds which have shown dose-limiting haematological toxicities in the clinic. In contrast, ASTX295 is a potent MDM2 antagonist with a clean CYP/hERG profile and a shorter human half-life allowing for pulsatile pathway modulation while avoiding myelosuppression. ASTX295 therefore has bone-marrow sparing characteristics which permit a differentiated safety profile. ASTX295 was discovered by Astex in collaboration with the Cancer Research UK Drug Discovery Unit at Newcastle University. Astex has an exclusive license to research, develop and commercialise ASTX295 under its drug discovery alliance agreement with Newcastle University and Cancer Research Technology Limited. About Astex Pharmaceuticals Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has several partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan. For more information about Astex Pharmaceuticals, please visit: http://www.astx.com For more information about Otsuka Pharmaceutical, please visit: https://www.otsuka.co.jp/en/ Contact At the Company:Jeremy CarmichaelSVP Corporate DevelopmentHead of Business DevelopmentTel: +44(0)1223 226289Email: jeremy.carmichael@astx.comFor Media Enquiries:Sue CharlesCharles ConsultantsTel : +44(0)7968 726585Email: sue@charles-consultants.com

– KB-7898, a p300 KAT inhibitor, is the Company's first development candidate for autoimmune diseases and originates from its proprietary discovery engine that decodes complex transcription factor regulatory networks – – Preclinical data for KB-7898 will be presented at ACR Convergence 2024 – Oct. 07, 2024 -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and autoimmune diseases driven by deregulated transcription, today announced the nomination of a development candidate, KB-7898, a p300 lysine acetyltransferase (KAT) inhibitor for the potential treatment of Sjögren’s disease, a chronic autoimmune disease that is characterized by the production of autoantibodies, chronic inflammation and lymphocytic infiltration of the exocrine glands that lead to uncomfortable dryness symptoms, known as sicca. Systemic effects are common and impact the lungs, kidneys and nervous system in addition to extensive dryness, profound fatigue and chronic pain. There are no approved treatments that target the underlying cause of Sjögren’s disease. Kronos Bio plans to initiate Investigational New Drug (IND)-enabling studies of KB-7898 in the fourth quarter of 2024. KB-7898 is being developed as an orally available therapy for people with Sjögren’s disease. p300 is an important cofactor for interferon regulatory factor 4 (IRF4) to enact immune responses across multiple cell types, including those that produce antibodies (B cells) and cytokines (T cells). Given this, Kronos Bio also intends to explore the utility of KB-7898 in other autoimmune diseases in the future. "Our proprietary discovery engine has enabled us to decode the multifaceted role of p300 across multiple cell types that drive inflammation and to create our second p300 KAT inhibitor—one that may treat autoimmune diseases,” said Nobert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “Sjögren’s disease symptomatology can significantly impact quality of life and even be life threatening, and patients do not currently have access to an approved therapy that addresses the underlying disease mechanism. KB-7898 has been shown preclinically to reduce antibody production in B cells and cytokine production in T cells, and we believe could impact the etiology of Sjögren’s disease.” The Company’s preclinical data that support the role of p300 in inflammatory indications, including Sjögren’s disease, will be presented at the American College of Rheumatology's annual meeting, ACR Convergence 2024, on November 18, 2024, in Washington, DC. The data are summarized as follows: Inhibition of the KAT activity of p300, a critical cofactor of proinflammatory transcription factors, resulted in selective downregulation of cytokines such as TNFα, IL-23, IL-17A as well as soluble IgG Selective gene expression changes occurred at doses corresponding to partial inhibition of p300 KAT activity p300 KAT inhibition also led to significantly decreased inflammation in the rat CIA model, as measured by joint swelling, clinical score and histopathology In addition, p300 KAT inhibition in vitro showed a reduction in IL-17 transcript and protein levels in Th17 cells and, in vivo, showed significant decreases in the secondary immune response (i.e. IgG production) in the KLH challenge model. The ACR Convergence 2024 presentation will be available under the Science & Pipeline section of the Kronos Bio website on November 14, 2024. The abstract can be found on the American College of Rheumatology’s website. Sjögren’s disease is a chronic autoimmune disease characterized by the production of autoantibodies, chronic inflammation and lymphocytic infiltration of the exocrine glands. Systemic effects are common and impact the lungs, kidneys and nervous system in addition to extensive dryness, profound fatigue and chronic pain. Complications can include pneumonia, bronchitis, kidney problems, hepatitis, cirrhosis, peripheral neuropathy and lymphomas, and lead to a 50% increase in all-cause mortality. It is estimated that there are two to four million people in the U.S. living with this disease, making it one of the most prevalent autoimmune diseases. However, given the heterogeneous symptomatology of Sjögren’s disease, it is estimated that only one million patients in the U.S. are diagnosed. The disease is significantly more common in women; most people are older than 40 when they are diagnosed. Currently there are no approved treatments that target the underlying cause of Sjögren’s disease. Kronos Bio is a clinical-stage biopharmaceutical company dedicated to developing small molecule therapeutics that address deregulated transcription, a hallmark of cancer and autoimmune disease. Our proprietary discovery engine decodes complex transcription factor regulatory networks to identify druggable cofactors. We screen for and optimize small molecules that target these cofactors in a disease-specific context. Kronos Bio has a pipeline of three drug candidates. Istisociclib (KB-0742) is currently enrolling ovarian cancer patients in a Phase 1/2 clinical trial. Preclinical candidate KB-9558 is being developed for multiple myeloma and HPV-driven tumors. KB-7898 is Kronos Bio’s first autoimmune development candidate and has a target indication of Sjögren’s disease. Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass. For more information, visit https://www.kronosbio.com or follow the Company on LinkedIn. 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USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 24, 2024 /PRNewswire/ -- USA News Group – Optimism is on the rise in fight against cancer, as researchers are making progress across the field of oncology. Helping to spur on the momentum, philanthropists recently gave a historic $150 million for pancreatic cancer research to City of Hope, while Stanford experts are calling for more massive federal funding increases to cancer research. According to the latest Cancer Progress Report from the American Association for Cancer Research, the USA has seen a 33% reduction in the overall cancer death rate from 1991 to 2021. Working behind the scenes are several biotech and biopharma companies who've recently made significant developments in the field of oncology, including O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Nurix Therapeutics, Inc. (NASDAQ: NRIX), Incyte Corporation (NASDAQ: INCY), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), and Foghorn Therapeutics Inc. (NASDAQ: FHTX). Building on the impressive momentum from its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) continues to advance its flagship therapy, pelareorep, toward a pivotal, registration-enabling study. The recent BRACELET-1 Phase 2 trial results have generated a surge of optimism, with over half of the patients in the pelareorep arm still alive at the study's end—a remarkable achievement that underscores the potential of this innovative cancer therapy. The median overall survival (OS) for patients treated with pelareorep combined with paclitaxel has not yet been reached, with estimates suggesting a 32-month survival benefit compared to just 18 months for the control arm. This outcome, along with a 64% two-year survival rate for the pelareorep group, highlights the therapy's potential to significantly improve patient outcomes in HR+/HER2- advanced or metastatic breast cancer. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." These promising results mirror the earlier success of the IND-213 study, which secured FDA Fast Track Designation for pelareorep in 2017. Combined, these two trials reinforce the growing belief in pelareorep's ability to make a substantial impact in oncology. Within the latest update on pelareorep's latest breast cancer study were plenty of reasons to build optimism, corroborating results of its previous randomized IND-213 breast cancer study that led to an FDA Fast Track Designation in 2017. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." As Oncolytics pushes forward, the stage is now set for the next chapter in pelareorep's journey—a registration-enabling study that could bring this promising therapy closer to becoming a vital tool in the fight against breast cancer. Clinical stage biopharma company Nurix Therapeutics, Inc. (NASDAQ: NRIX) is developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases. Recently, Nurix presented at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit in Boston, with a presentation titled Targeted Protein Degraders as Next Generation Antibody Payloads. Back in Q2 2024, Nurix also presented positive clinical data at the European Hematology Association Congress (EHA2024) supporting a potential best-in-class profile for NX-5948, its orally bioavailable degrader of Bruton's tyrosine kinase (BTK), for the treatment of chronic lymphocytic leukemia (CLL). NX-5948 demonstrated an objective response rate (ORR) of 69.2% in heavily pretreated chronic lymphocytic leukemia (CLL) patients, including in patients with Bruton's tyrosine kinase (BTK) inhibitor resistance mutations and patients with central nervous system (CNS) i "The data presented at EHA2024, reaffirm the best-in-class potential of our protein degradation platform to address the limitations of current inhibitors against challenging targets such as Bruton's tyrosine kinase," said Arthur T. Sands, M.D., Ph.D., President and CEO of Nurix. "We enter the second half of 2024 well positioned to develop our lead clinical program, NX-5948, into pivotal clinical trials in CLL in 2025 and to continue to advance our wholly owned pipeline of clinical assets, preclinical programs and strategic collaboration programs with Gilead, Sanofi and Pfizer." Recently at the ESMO 2024 Congress, Incyte Corporation (NASDAQ: INCY) gave a mini-oral presentation sharing promising results for its CDK2 inhibitor INCB123667 showing promising evidence of clinical activity in patients with advanced solid tumors, notably ovarian cancer. Of the 37 evaluable participants with platinum-resistant ovarian cancer, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer. "The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options. We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination." At both the ESMO 2024 Congress and IASLC 2024 World Conference on Lung Cancer (WCLC), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented progress across its differentiated oncology portfolio and pipeline. Regeneron first shared five-year survival data on Libtayo (PD-1 inhibitor) first-line monotherapy in advanced non-small cell lung cancer (NSCLC) at IASLC 2024, then shared longer-term results with investigational fianlimab (LAG-3 inhibitor) plus Libtayo from initial trial in advanced melanoma showing high clinical activity, including deepening responses, per a blinded independent central review. "The breadth of our presentations at ESMO and WCLC underscore our progress in advancing treatment approaches for cancer that have the potential to be among the best in their class," said Israel Lowy, MD, PhD, Clinical Development Unit Head, Oncology, at Regeneron. "At WCLC, five-year outcomes for Libtayo monotherapy in advanced NSCLC reinforce its position as the anti-PD-1 backbone of our oncology portfolio. At ESMO, the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients. As our portfolio and pipeline mature, the insights from these data are helping us advance our differentiated and novel combination approaches – all with the goal of transforming care for those living with cancer." Within its Q2 2024 financial and corporate update, Foghorn Therapeutics Inc. (NASDAQ: FHTX) stated it expects topline Phase 1 dose escalation data for its FHD-286 in combination with decitabine in relapsed and/or refractory AML patients to come in Q4 2024, and dosing of its first patient in a Phase 1 trial for FHD-909, a potential first-in-class SMARCA2 selective inhibitor for a primary target population in SMARCA4 mutated NSCLC to come in H2 2024. "We anticipate topline data from our Phase 1 combination trial with FHD-286 in patients with relapsed and/or refractory AML in the fourth quarter of 2024," said Adrian Gottschalk, President and CEO of Foghorn. "We believe FHD-286 has the potential to be a first-in-class, mutation-agnostic differentiation therapeutic. Additionally, the IND for FHD-909 cleared in May and we anticipate FHD-909 to be the first SMARCA2 selective inhibitor to enter the clinic. Dosing of the first patient in our Phase 1 trial, with primary target population in SMARCA4 mutated NSCLC, is planned for the second half of the year. We are also on track to initiate IND-enabling studies in the fourth quarter of 2024 for our Selective CBP degrader program targeting tumors harboring EP300 mutations including bladder, gastric and endometrial cancers." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. 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