On January 25, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), reported that the first patient has been dosed in its Phase I clinical trial evaluating BMF-219, the company’s irreversible covalent menin inhibitor, in patients with relapsed/refractory (r/r) acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations (Press release, Biomea Fusion, JAN 25, 2022, View Source [SID1234606765]).

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"We are honored and deeply humbled by this significant milestone, which marks our successful transition to a clinical stage company. Just over four years ago, we took the concept of designing a small molecule that targets menin and brought forward BMF-219 to the clinic to significantly improve the lives of patients," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "I’m incredibly proud of our team for their ability to execute on this aggressive timeline. This signals how we intend to operate as a drug discovery and development organization – advancing world-class science with rapid momentum and driven by an unwavering mission to improve patient outcomes and save lives. We are pursuing a novel approach to developing best-in-class molecules with our FUSION System across multiple indications and anticipate announcing our next pipeline candidate in the first half of 2022."

"Since 2017, we have focused on building a world-class discovery and development team at Biomea Fusion. We have internally developed our FUSION System, which allows us to expeditiously target validated cancer biology with breakthrough covalent chemistry. Our pipeline assets are designed to achieve higher selectivity, deeper target inactivation and thereby afford patients a greater therapeutic window. BMF-219 is just our first asset graduating now into clinical development. Our team has evolved significantly and is set up today not only to explore the full potential of BMF-219 and the inhibition of the menin pathway but also to advance several other programs into the clinic," said Ramses Erdtmann, President of Biomea Fusion. "We are an integrated biotech company engaged in all phases of drug discovery and clinical development. We have come a long way and are now set up to fully explore pre-clinically and clinically innovative therapies for the benefit of patients."

The current Phase I, open-label, multi-center, dose escalation and dose expansion study is designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of once daily oral dosing of BMF-219 in patients with r/r acute leukemias, including subpopulations where menin inhibition is expected to provide a therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). Additional information about the Phase I trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

Acute Myeloid Leukemia (AML) and Acute Lymphocytic Leukemia (ALL)

AML is the most common form of acute leukemia in adults and is responsible for the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 20,000 people in the U.S. are diagnosed with AML each year, and the five-year overall survival rate in adults is roughly 29% (Source: NCI SEER Data). Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (e.g., MLL1/KMT2A gene rearrangements or NPM1 mutations). ALL is a less common leukemia, with approximately 6,000 new cases in the U.S. each year and a higher five-year survival rate of nearly 70% (Source: NCI SEER Data). Between 10-15% of adult ALL patients and 60-70% of pediatric ALL patients have MLL1/KMT2A gene rearrangements.

On January 25, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the Japanese Patent Office has issued a Decision to Grant of a patent to Cleveland Clinic titled, "Ovarian Cancer Vaccines (Press release, Anixa Biosciences, JAN 25, 2022, View Source [SID1234606764])." The technology was invented by Drs. Vincent K. Tuohy, Suparna Mazumder and Justin M. Johnson at Cleveland Clinic. Anixa is the worldwide licensee for the vaccine technology. Patents for the technology were issued in the U.S. and Europe in 2021.

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"We’re pleased to announce this additional intellectual property protection of Anixa’s novel ovarian cancer vaccine, which was developed at Cleveland Clinic and is being studied at NCI. This unique technology has the potential to be the first vaccine to prevent ovarian cancer, which remains one of the most devastating and difficult-to-treat cancers," said Dr. Amit Kumar, CEO, President and Chairman of Anixa Biosciences. "If successful, this vaccine could prevent ovarian cancer from ever occurring and spare patients from undergoing chemotherapy and extensive surgical treatments, and potentially save lives. We look forward to continuing our preclinical work in the hope that this vaccine will add to the arsenal needed to target this challenging cancer and ultimately make a difference for many patients."

The ovarian cancer vaccine targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED), which is expressed in the ovaries but disappears as a woman reaches and advances through menopause. Of note, the majority of ovarian cancer diagnoses occur after menopause, and AMHR2-ED is expressed again in the majority of ovarian cancers. By receiving a vaccine such as Anixa’s that targets AMHR2-ED after reaching menopause, ovarian cancer, historically one of the most aggressive gynecological cancers, could be prevented from ever developing.

Preclinical work to advance the vaccine is ongoing through the PREVENT Program at the National Cancer Institute (NCI), which supports preclinical innovative interventions and biomarkers for cancer prevention and interception. Preclinical data published in Cancer Prevention Research in 2017 supports ongoing advancement toward clinical studies.

On January 25, 2022 48Hour Discovery and Fusion Pharmaceuticals to Develop Radiopharmaceuticals for the Treatment of Cancer Tumours (Press release, 48Hour Discovery, JAN 25, 2022, View Source [SID1234606763]).

48Hour Discovery Inc. (48HD), a biopharmaceutical company specializing in peptide-derived drug discovery reported that the company has entered into a strategic research collaboration with Fusion Pharmaceuticals. This is 48HD’s first collaboration with a Canadian company. The goal of the collaboration is to discover novel, peptide-based radiopharmaceuticals for the treatment of various solid tumours.

"We are excited to work with a dynamic oncology company like Fusion Pharmaceuticals" said Ratmir Derda, CEO of 48Hour Discovery "In this collaboration, 48Hour Discovery will identify potent ligands for targets selected by Fusion. This project will further validate the potential of our billion-scale molecular libraries and cloud-based discovery pipeline to accelerate the advance of peptide drug candidates in the radiopharmaceutical field."

"Fusion’s versatile platform, supported by our internal research capabilities, allows us to create targeted alpha therapies (TATs) using different classes of targeting molecules, tailoring the approach based upon the disease target," said Fusion Chief Executive Officer John Valliant, Ph.D. "With our antibody, bispecific, and small molecule programs in the clinic or progressing through investigational new drug-enabling studies, we are excited to announce our work with peptides. Partnering with a global leader like 48Hour Discovery in peptide discovery further diversifies our capabilities and assets needed to create differentiated TATs in multiple areas of high unmet medical need."

On January 25, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will be releasing its preliminary results for the full year ended 30 September 2021 on 27 January 2022 (Press release, Redx Pharma, JAN 25, 2022, View Source [SID1234606762]).

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A live webcast for analysts and investors will be held at1.00pm GMT (8.00am ET) on 27 January 2022. To join the webcast, please register in advance at https://bit.ly/3IobDLs

A recording of the webcast will be made available on Redx’s website following the results meeting.

On January 25, 2022 LUMICKS, a next generation life science tools company, reported that research findings from a consortium, led by researchers at Cancer Center Amsterdam, Amsterdam University Medical Centers, published in Science Translational Medicine, detailed a novel design strategy for preventing tumor escape through improved chimeric antigen receptor (CAR) T cell therapy for common blood cancers (Press release, LUMICKS, JAN 25, 2022, View Source;utm_medium=rss&utm_campaign=new-study-published-by-group-of-maria-themeli-cell-aviditys-power-as-a-functional-biomarker-for-improved-car-t-design-in-preventing-tumor-relapse [SID1234606761]).

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Using both cell avidity measurements, as provided by LUMICKS’ z-Movi Cell Avidity Analyzer, and traditional immuno-assays, the researchers successfully demonstrated that co-expression of costimulatory receptors (CCR) along with an FDA approved BCMA and CD19 CAR can improve both durability of potential treatments as well as sensitivity to recognize and lyse various variants of multiple myeloma and acute lymphoblastic leukemia with low antigen density. This innovative dual-targeting approach provides an exciting new avenue for next-generation therapies that may overcome many common problems of current approved therapies, including high rates of relapse. The study was published in the December 2021 issue of Science Translational Medicine.

In the study profiled, the researchers set out to characterize the dual targeting system through co-expression of high-affinity engagement of co-stimulatory molecules with a BCMA CAR. Using LUMICKS’ z-Movi Analyzer, the researchers were able to determine that dual targeting with CD38-binding CCR enhanced the cytotoxicity of BCMA-CAR-T cells by increasing their binding avidity. This increasing activity improved the overall sensitivity of these cells as compared to other approved therapies. The measurement of cell avidity’s power as a functional biomarker provided strong support for the mechanism of action underlying these results and a rational basis for ongoing efforts to improve next-generation CARs for enhanced therapeutic efficacy.

"The z-Movi platform’s distinct ability to measure and quantify avidity provides a powerful tool for immuno-oncologists," said Maria Themeli, M.D., Ph.D. Assistant Professor at Amsterdam UMC and corresponding author of the study. "The instrument provided an essential piece of evidence in our investigation, giving us critical insight into how these engineered cells work and what is ultimately responsible for their changes in behavior with this new dual-targeting strategy. Understanding mechanism of action is fundamentally important for any effective drug development study."

The LUMICKS z-Movi platform provides the unique ability to measure the avidity of hundreds of cells in parallel using an intuitive and convenient workflow based on the application of acoustic force. The strength of interaction between single targeting (first generation) and double-targeting T cells and MM1.S target cells was measured in the study. Statistically robust differences in avidity were measured between the two CAR designs, demonstrating the underlying cause of the enhanced cytotoxicity of the dual targeting system.

"This innovative new work, highlighting LUMICKS’ z-Movi as a critical tool to enable CAR-T developers to precisely understand fundamental principles of therapy design, is both exciting and important," said Andrea Candelli, Ph.D., Chief Scientific Officer and co-founder of LUMICKS. "This is the first step in our mission to demonstrate and validate the power of cell avidity as the biomarker for immuno-oncology research and development."