Industry News

TransCode Therapeutics Announces FDA Authorization to Proceed with First-In-Human Clinical Trial

01/10/2023

Excerpt from the Press Release: BOSTON, Dec. 29, 2022 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, announced today that it has received written authorization from the U.S. Food and Drug Administration (FDA) that it may proceed with its First-in-Human (FIH) Phase…

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Phio Pharmaceuticals Announces New Clinical Program to Study PH-762 for the Treatment of Cutaneous Squamous Cell Carcinoma

01/10/2023

Excerpt from the Press Release: MARLBOROUGH, Mass., Dec. 21, 2022 /PRNewswire/ — Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi…

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Minovia Therapeutics Reports First Clinical Data Demonstrating Disease-Modifying Efficacy and Safety of Mitochondrial Augmentation Therapy in Pediatric Patients with Primary Mitochondrial Diseases

01/10/2023

First in human clinical study provides proof-of-concept for mitochondrial augmentation therapy platform, which enables use of healthy mitochondria to improve mitochondrial function and mitigate effects of large-scale mitochondrial DNA (mtDNA) deletion syndromes Study showed improved quality of life measures in children with Pearson Syndrome and Kearns-Sayre Syndrome spectrum No treatment-related adverse effects reported in study…

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Kala Pharmaceuticals Announces FDA Acceptance of IND Application for KPI-012 for the Treatment of PCED

01/09/2023

— On-track to initiate Phase 2b trial in 1Q 2023; Topline data expected in 1Q 2024 — — Received remaining $25 million investment under previously announced private placement financing — Excerpt from the Press Release: ARLINGTON, Mass., Dec. 27, 2022 (GLOBE NEWSWIRE) — Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development…

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Alnylam Submits CTA Application for ALN-KHK, an Investigational RNAi Therapeutic for the Treatment of Type 2 Diabetes

01/09/2023

–Company Expects to Initiate a Phase 1/2 Study for ALN-KHK in Early 2023, with Initial Results Expected in Late 2023 – Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health…

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Erasca Announces First Patient Dosed in HERKULES-1 Phase 1b Trial Evaluating ERAS-007 and ERAS-601 MAPKlamp Combination in RAS/MAPK Pathway-Altered Solid Tumors

01/06/2023

Promising preliminary monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601 in advanced solid tumors, which had favorable safety, tolerability, and efficacy profiles that support combination development BRAF Class 2 and 3 alterations have no approved targeted therapies and represent up to 25% of all BRAF-driven tumors Excerpt from the Press Release: SAN DIEGO,…

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Guardant Health and Susan G. Komen® Partner to Develop Clinical Studies to Identify Early-Stage Breast Cancer Patients Who May Benefit From Additional Monitoring or Therapy

01/05/2023

Excerpt from the Press Release: PALO ALTO, Calif. & DALLAS–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Susan G. Komen®, the world’s leading breast cancer organization, announced today that they have entered into a partnership to bring the patient perspective to the development of clinical studies that help identify early-stage breast…

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Anti-TIGIT Domvanalimab-Containing Study Arms Improve Progression-Free Survival Compared to Anti-PD1 Alone in Phase 2 Non-Small Cell Lung Cancer Study

01/05/2023

– 35-45% Reduction in Risk of Progression or Death and a Doubling of mPFS Were Observed in the Domvanalimab-Containing Study Arms, Compared to Zimberelimab Monotherapy in First-Line, PD-L1-High NSCLC – – With Median Follow-Up of Approximately 12 Months, Both Domvanalimab-Containing Study Arms Also Improved ORR and Six-Month Landmark PFS Compared to Zimberelimab Monotherapy – –…

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Exelixis Announces Initiation of the STELLAR-304 Phase 3 Pivotal Trial Evaluating Zanzalintinib in Patients with Advanced Non-Clear Cell Kidney Cancer

01/05/2023

– STELLAR-304 is the second phase 3 pivotal trial evaluating zanzalintinib, a next-generation tyrosine kinase inhibitor in development for multiple advanced tumor types – Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-304, a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in…

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Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis

01/04/2023

– Similar clinical remission rates observed in patients receiving AMT-101 monotherapy compared to placebo at week 12 – AMT-101 was well-tolerated – Planned Phase 1b trial for the company’s second clinical asset, AMT-126, in UC patients – Exploring strategic partnership options to advance AMT-101 into Phase 3 in patients with chronic pouchitis – Strong cash…

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