Pharmaceutical

Gritstone bio Announces Publication of Interim Results from Phase 1 Study of Self-amplifying mRNA (samRNA) Vaccine Against COVID-19 in Nature Communications

06/20/2023

— Potent and durable immunogenicity achieved with low dose self-amplifying mRNA vaccine (samRNA) candidate — — Immunity boosted for at least 6 months in previously vaccinated-older adults (administration post-primary series of Vaxzevria®, Comirnaty® or Spikevax®) — — Data underscore the potential of Gritstone’s samRNA candidates to serve as next-generation vaccines against COVID-19 and other infectious…

Read More

Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1 Study of PIPE-791

06/19/2023

-Company on track to begin enrolling healthy volunteers in the second half of 2023- Excerpt from the Press Release: DIEGO–(BUSINESS WIRE)–Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to initiate its Phase 1 clinical trial of PIPE-791 in healthy volunteers. The…

Read More

Repare Therapeutics Reports Proof of Concept for Lunresertib (RP-6306) in Clinic, Initial Monotherapy Data from Phase 1 MYTHIC Clinical Trial and Early Insights from Ongoing Combination Trials

06/16/2023

Findings from the ongoing Phase 1 MYTHIC study demonstrated a favorable and distinctive tolerability profile for monotherapy lunresertib Monotherapy antitumor activity observed, including confirmed partial response and several patients with long stable disease Identified both intermittent and continuous schedules to enable combination studies Encouraging early responses across gemcitabine, camonsertib and FOLFIRI clinical combinations Repare to…

Read More

Epic Bio Presents Preclinical Data on EPI-321 for Facioscapulohumeral Muscular Dystrophy at ASGCT 26th Annual Meeting

05/24/2023

Oral presentation highlights EPI-321 effects on multiple clinically relevant markers – Excerpt from the Press Release: – Epic Bio, a biotechnology company developing therapies to modulate gene expression using compact, non-cutting dCas proteins, today presented promising preclinical data supporting development of EPI-321 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The data were shared in…

Read More

IntraOp Announces First Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients with Localized Carcinomas

05/23/2023

Study is the Second Clinical Human Trial Using Mobetron with Electron Excerpt from the Press Release: SUNNYVALE, Calif.–(BUSINESS WIRE)–IntraOp Medical Corporation announced the world’s first Phase II Electron FLASH Trial. It marks the first time a randomized trial will compare FLASH radiotherapy* to conventional radiotherapy in treating nonmelanoma skin cancer (NMSC). It is the second…

Read More

Palisade Bio Announces Enrollment and Dosing of First Patient in LB1148 Dose Optimization Study

05/18/2023

Study designed to determine if a different dosing protocol for all indications might enhance the risk profile of LB1148 while simultaneously providing efficacy Excerpt from the Press Release: Carlsbad, CA, May 11, 2023 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced…

Read More

Pieris Pharmaceuticals Announces Successful Completion of Safety Review for 10 mg Dose of Phase 2a Trial of Elarekibep (PRS-060/AZD1402)

05/11/2023

Excerpt from the Press Release: BOSTON, MA / ACCESSWIRE / May 4, 2023 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced the successful safety review of the 10 mg dry powder dose safety cohort from the…

Read More

Alnylam and Regeneron Report Positive Interim Phase 1 Clinical Data on ALN-APP, an Investigational RNAi Therapeutic for Alzheimer’s Disease and Cerebral Amyloid Angiopathy

05/08/2023

– Single Doses of ALN-APP Demonstrated Dose-Dependent, Rapid and Sustained Reduction of sAPPα and sAPPβ in Cerebrospinal Fluid, with Up to 90% at Highest Dose to Date – – Encouraging Clinical Safety and Tolerability Profile Observed with Single Dosing to Date – – Results Provide First Demonstration of Gene Silencing by RNAi Therapeutics in the…

Read More

Janux Therapeutics Announces First Patient Dosed with JANX008 in First-in-Human Phase 1 Clinical Trial in Patients with Solid Tumors

05/01/2023

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the first patient has been dosed at City of Hope…

Read More

First AML Patient Transplanted with Vor Bio’s Trem-cel Demonstrated Durable Engraftment through Multiple Mylotarg™ Cycles at Initial Dose Level

03/02/2023

Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 16, 2023 (GLOBE NEWSWIRE) — Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, presented clinical data from VBP101, its Phase 1/2a multicenter, open-label, first-in-human study of trem-cel (previously VOR33) in patients with acute myeloid leukemia (AML). In the first patient, trem-cel maintained hematopoiesis through three…

Read More