Announcements

BMF-219 Enters the Clinic for KRAS Solid Tumors

10/20/2022

Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or pancreatic…

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Aligos Therapeutics Initiates Dosing In Healthy Volunteers With siRNA Drug Candidate ALG-125755

10/20/2022

Single ascending doses to be evaluated in healthy volunteers in Q4 2022 Single ascending doses to be evaluated in subjects with chronic hepatitis B beginning in Q1 2023 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 14, 2022 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on…

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New CPDC spinout company aims to become global leader in developing and distributing radiopharmaceuticals

10/19/2022

AtomVie Global Radiopharma is the latest company launched by the OICR-supported centre Excerpt from the Press Release: The Centre for Probe Development and Commercialization’s (CPDC) newest spinout company has now launched as AtomVie Global Radiopharma Inc. On August 24, the Hamilton-based radiopharmaceutical company announced it had closed Series A financing with healthcare investment firm Avego…

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Lyell Immunopharma Announces FDA Clearance of its IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors

10/19/2022

Autologous TIL therapy enhanced with Lyell’s Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function Phase 1 trial to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer Initial data presentation expected…

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Allogene Therapeutics Initiates Industry’s First Allogeneic CAR T Phase 2 Trial

10/19/2022

ALPHA2 Trial, Evaluating ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients, is Designed to Leverage the Ease and Convenience of a Single Dose of ALLO-501A Protocol Supported by Clinical and Translational Data from Phase 1 Trial Indicating Deep Responses are Achievable with a Single Dose of ALLO-501A When Used with a Lymphodepletion Regimen That Includes…

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Verastem Oncology Announces RAMP VS-6766 Clinical Trials and Corporate Update

10/18/2022

FDA Meeting Planned for Q4 to Discuss Regulatory Path Forward Based on Encouraging Results to Date in Ongoing RAMP 201 Trial in LGSOC Results of Part A of RAMP 202 Trial in KRAS G12V-Mutant NSCLC Show VS-6766 ± Defactinib Did Not Meet Criteria to Continue to Expansion Phase RAMP Trials with VS-6766 Combinations in KRAS…

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Elicio Therapeutics Announces Publication of Preclinical Data in Science Translational Medicine Demonstrating the AMP Platform Promotes Uptake of Intranasal Vaccine in the Mucosa Amplifying Immune Response

10/18/2022

AMP-protein-based vaccines administered intranasally to mice and nonhuman primates (NHPs) were transported across the epithelial lining to the nasal-associated lymphoid tissue (NALT) and persisted in the nasal mucosa eliciting immune responses at both local and distal mucosal sites Intranasal immunization with AMP-conjugated HIV Env gp120 or SARS-CoV-2 receptor binding domain (RBD) proteins elicited 100- to…

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Exelixis Expands Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Include the Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial

10/18/2022

— Agreement enables evaluation of XL092 in combination with an additional immune checkpoint inhibitor — Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced the expansion of its June 2021 Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb Company (NYSE: BMY) to include the use of the fixed-dose combination of…

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Myrtelle Completes Dosing of 8 Patients with Canavan Disease in Its Phase 1/2 Clinical Trial of the Investigational Gene Therapy rAAV-Olig001-ASPA

10/17/2022

Eight patients have been treated in the ongoing Phase 1/2 First-in-Human clinical trial with favorable safety and tolerability observed to date Assessments of the initial 3 patients reaching their six-month follow-up showed improvements on validated functional scales and increases in brain white matter and myelin content Encouraging efficacy and safety data support further development of…

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Abcuro Initiates Phase 1/2 Trial Evaluating ABC008 in Patients with T Cell Large Granular Lymphocytic Leukemi

10/17/2022

T-LGLL is an autoimmune disorder characterized by cytotoxic T lymphocytes which attack neutrophils and red blood cell precursors Excerpt from the Press Release: NEWTON, Mass.–(BUSINESS WIRE)–Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced initiation of a…

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