Month: December 2023

In a World First, a Patient’s Antibody Cells Were Just Genetically Engineered

12/27/2023

B cells are prolific producers of antibodies, but for the first time, scientists have modified them to make other proteins to counteract a serious genetic disease. Excerpt from the Press Release: Our B cells help prevent us from getting sick. Their job is to make antibodies, immune system proteins that fight off viruses and other…

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NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial

12/26/2023

Excerpt from the Press Release: CAMBRIDGE, Mass., Dec. 14, 2023 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today reported additional positive efficacy data from further evaluation of its Phase 2b trial (PARADIGM) with NeuroSense’s lead drug candidate for amyotrophic lateral sclerosis (“ALS”), PrimeC. Evaluation of the pre-specified…

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Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-617, a Novel Fusion Protein Uniquely Harnessing Both IL-2 and IL-12 Cytokines

12/25/2023

Excerpt from the Press Release: CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) — Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic, targeted oncology therapies, today announced that the first patient has been dosed with CLN-617 in a Phase 1 clinical trial. This is a first-in-human, multi-center, open label study designed to evaluate the…

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Maze Therapeutics Announces Initiation of Dosing in Phase 1 Trial Evaluating MZE829, a Novel Oral APOL1 Inhibitor, as a Potential Treatment for APOL1 Kidney Disease

12/22/2023

Maze Therapeutics Announces Initiation of Dosing in Phase 1 Trial Evaluating MZE829, a Novel Oral APOL1 Inhibitor, as a Potential Treatment for APOL1 Kidney Disease Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced the initiation of dosing in the company’s Phase…

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Immusoft Administers the First Engineered B Cell in a Human Clinical Trial

12/21/2023

Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Immusoft of CA, a wholly owned subsidiary of Immusoft Corporation (“Immusoft”), a clinical-stage cell therapy company dedicated to improving the lives of patients with rare diseases, today announced the first patient dosed with engineered B cell therapy ISP-001 in a Phase 1 trial in MPS I, at M…

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Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

12/20/2023

Excerpt from the Press Release: LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201). Based on the Company’s interactions with the U.S. Food and Drug Administration (FDA), the Company…

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Daré Bioscience Announces Funding Award Notice from the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to Support DARE-PTB1 Phase 1 Human Clinical Study

12/19/2023

DARE-PTB1 is being developed as a treatment to reduce the risk of preterm birth, for which there are no FDA-approved treatment options Up to approximately $2 million in grant funding to support DARE-PTB1 Phase 1 human clinical study Excerpt from the Press Release: SAN DIEGO, Dec. 13, 2023 (GLOBE NEWSWIRE) — DARÉ Bioscience, Inc. (NASDAQ: DARE),…

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SonALAsense Presents Preliminary Data From Clinical Study in Patients With Deadly Pediatric Brain Tumor

12/18/2023

Tumor Regression and Improved Patient Performance are Among the Early Findings Excerpt from the Press Release: OAKLAND, Calif.–(BUSINESS WIRE)–SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 (aminolevulinic acid HCl) in combination with Insightec’s Exablate 4000 Type-2 ultrasound device today announced the presentation of positive preliminary data from the ongoing Phase…

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Rezolute Completes Enrollment of its Phase 2 Study in Diabetic Macular Edema (“DME”)

12/15/2023

Plans to report topline data mid-second quarter 2024 Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced the completion of enrollment in its RZ402 Phase 2 study in diabetic macular…

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Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024

12/14/2023

— Caribou met with the FDA and reached alignment on a pivotal trial in 2L LBCL with CB-010 versus a comparator arm of immunochemotherapy followed by HDCT and ASCT — — ANTLER Phase 1 trial continues dose expansion enrollment; initial dose expansion data and RP2D expected Q2 2024 — — Caribou plans to initiate Phase…

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