Cellevolve Bio Submits Investigational New Drug (IND) Application for Global Phase 2, Placebo-controlled Study of CE-VST01-JC for the Treatment of Progressive Multifocal Leukoencephalopathy (PML)


CE-VST-01-JC is a novel, allogeneic, off-the-shelf, T cell therapy that targets the JC Virus, the virus that causes progressive multifocal leukoencephalopathy (PML) ASCEND-JC is a randomized, double-blind, placebo-controlled, phase 2 study with sites planned across US, Europe, and Canada Licensed and developed in collaboration with QIMR Berghofer Medical Research Institute’s Professor Rajiv Khanna; NIH’s Irene…

Read More

Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes


Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes…

Read More

Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™


SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy Excerpt from the Press Release: CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™…

Read More

TRACON Pharmaceuticals Announces Submission of IND Application for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab


Excerpt from the Press Release: SAN DIEGO, Aug. 08, 2022 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced that the company submitted an Investigational…

Read More

Marengo Therapeutics Advances First-In-Class Selective T cell Activator, STAR0602, into Human Trials in Solid Tumors and Enters Cooperative Research and Development Agreement with the National Cancer Institute


Excerpt from the Press Release: CAMBRIDGE, Mass., Sept. 16, 2022 /PRNewswire/ — Marengo Therapeutics, a company pioneering novel therapeutics targeting the T cell receptor Vβ chain (TCR Vβ) to selectively activate the right T cell subsets to fight cancer, today announced it is advancing its lead TCR activator, STAR0602, into the clinic following clearance of its…

Read More

Larimar Therapeutics Announces FDA Clearance to Initiate the 25 mg Cohort of a Phase 2 Dose Exploration Trial of CTI-1601 in Friedreich’s Ataxia Patients


Initiation of the Phase 2 trial is expected in Q4 2022, with top-line data expected in 2H 2023 Company management hosting webcast and conference call today at 8:30 a.m. ET Excerpt from the Press Release: BALA CYNWYD, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused…

Read More

Atea to Advance Global Phase 3 Registrational Study of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with COVID-19


Novel Phase 3 Trial Design to Evaluate Bemnifosbuvir as Monotherapy and Combination Antiviral Therapy for COVID-19 Trial to Focus on High-Risk Patients at Greatest Risk for Disease Progression Trial Expected to Initiate in Fourth Quarter 2022 Conference Call at 8:30 a.m. ET Today Excerpt from the Press Release: BOSTON, Sept. 13, 2022 (GLOBE NEWSWIRE) —…

Read More

Vaxcyte Completes Enrollment of Phase 2 Study Evaluating Safety, Tolerability and Immunogenicity of VAX-24 in Adults 65 Years and Older


— Company Expects to Announce Topline Data from Study in Adults 65 Years and Older in the First Half of 2023 — — Vaxcyte Remains on Track to Announce Topline Data from the Phase 1 and Phase 2 Portions of the VAX-24 Proof-of-Concept Study in Adults Aged 18-64 in October or November 2022 — —…

Read More

2seventy bio Announces Plans to Initiate KarMMa-9 Study of Abecma (idecabtagene vicleucel) in Newly Diagnosed Multiple Myeloma Patients


This study will evaluate Abecma in patients with suboptimal response to transplant Data from KarMMa-3 and KarMMa-2 studies of Abecma will be presented at future medical meeting Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–2seventy bio, Inc. (Nasdaq: TSVT) today announced plans to initiate the KarMMa-9 study to evaluate Abecma (idecabtagene vicleucel) in newly diagnosed…

Read More

Moderna Completes Application To U.S. Food And Drug Administration For Emergency Use Authorization Of Omicron-Targeting Bivalent Covid-19 Booster Vaccine, mRNA-1273.222


mRNA-1273.222 Targets BA.4/BA.5 Strains of Omicron Variant Pending Authorization, Moderna Ready to Ship Bivalent Booster mRNA-1273.222 in September Clinical Data Available for Moderna’s Bivalent COVID-19 Booster Vaccines Have Met All Primary Endpoints and Support Request for Emergency Use Authorization Excerpt from the Press Release: CAMBRIDGE, MA / ACCESSWIRE / August 23, 2022 / Moderna, Inc.…

Read More