Month: January 2024

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel)in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma


Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, significantly improved progression-free survival and a well-established safety profile with mostly low-grade occurrences of cytokine release syndrome and neurotoxicity This is the first positive CHMP opinion in earlier lines of therapy for a chimeric antigen receptor (CAR) T…

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BPGbio Presents Updated Phase 2a Clinical Results Demonstrating Benefit of BPM31510 in Combination with Chemotherapy in Pancreatic Cancer at ASCO GI


Results show BPM31510 was well-tolerated, doubled progression free survival vs. chemotherapy alone BPGbio plans to further investigate BPM31510 as a first-line pancreatic cancer therapy with a phase 2b clinical trial Data validates BPM31510 mechanism of action and continues to show the success of BPGbio’s biology-first Bayesian AI-based approach to drug discovery Excerpt from the Press…

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Coherus Presents Positive Phase 2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2024 ASCO GI Cancers Symposium


– Data demonstrate early activity with casdozokitug/atezolizumab/bevacizumab; 38% objective response rate including three complete responses – – Data support casdozo as a promising novel immuno-oncology agent with clinical activity in liver cancer that may be associated with IL-27 pathway biomarkers – – Data support continued evaluation of casdozo with VEGF and PD-(L)1 blockade in HCC,…

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Strand Therapeutics Receives IND Clearance for Programmable mRNA Therapy STX-001 to Treat Solid Tumors


Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Strand Therapeutics, the programmable mRNA company developing breakthrough therapies for cancer and other diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1, first-in-human trial of STX-001, a multi-mechanistic synthetic self-replicating mRNA technology that expresses an…

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Prilenia Announces Clinical Data in Support of its Plans to Initiate Global Phase 3 Study in ALS


Excerpt from the Press Release: NAARDEN, Netherlands & WALTHAM, Mass.–(BUSINESS WIRE)–Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, will present clinical data supporting a future Phase 3 study in amyotrophic lateral sclerosis (ALS) during the 14th…

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Botensilimab/Balstilimab Breakthrough Data Presented at ASCO-GI Shows Unprecedented Tumor Shrinkage and Robust Biomarker Response in Prevalent Colorectal Cancer Population


Excerpt from the Press Release: LEXINGTON, Mass.–(BUSINESS WIRE)– Agenus Inc. (Nasdaq: AGEN), a leader in developing immunological cancer treatments, today announced results from the NEST-1 study, an investigator-sponsored trial (IST) evaluating the combination of botensilimab and balstilimab (BOT/BAL) in the neoadjuvant setting for colorectal cancer (CRC), both those with Microsatellite Stable (MSS) CRC and Microsatellite…

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Allurion Announces Publication of Randomized, Double-Blind Study Demonstrating Significant Improvement in Obesity-Related Co-Morbidities


Allurion Program led to resolution of type 2 diabetes, hypertension, and obstructive sleep apnea in just 4 months in over half of the patients treated Results improved with addition of oral GLP-1 agonist semaglutide Excerpt from the Press Release: NATICK, Mass.–(BUSINESS WIRE)–Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the…

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Xcell Biosciences Announces Collaboration with ElevateBio to Advance Technology Development for Cell and Gene Therapies


Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Xcell Biosciences, Inc. (Xcellbio), a platform technology company focused on cell and gene therapy applications, today announced a collaboration with ElevateBio, LLC (ElevateBio), through which the companies aim to explore novel approaches to improving therapeutic potency of cell and gene therapies. As part of this collaboration, ElevateBio becomes…

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Lykos Therapeutics (Formerly MAPS PBC) Announces Publication Examining the Effects of MDMA-Assisted Therapy on Emotional Coping Skills and Self-Experience in PTSD


Excerpt from the Press Release: SAN JOSE, Calif., Jan. 10, 2024 /PRNewswire/ — Lykos Therapeutics (formerly MAPS Public Benefit Corporation) (“Lykos”), a company dedicated to transforming mental healthcare, announced that PLOS ONE has published the first comparison of the effects of investigational MDMA-assisted therapy and therapy with placebo on emotional coping skills and self-experience in adults…

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Elicio Therapeutics Announces First Patient Dosed in Randomized Phase 2 Pancreatic Cancer Study


The 7-peptide formulation of ELI-002 is designed to stimulate an immune response against seven KRAS mutations that drive 25% of all solid tumors, potentially defeating resistance mechanismsElicio will present a Trial in Progressposter on the design of the AMPLIFY-7P trial at the ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 Excerpt from the Press…

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