Month: January 2023

QurAlis Announces First-in-Human Dose in Phase 1 Clinical Trial of QRL-101, a First-in-Class Kv7 Precision Therapy for ALS

01/11/2023

QRL-101 aims to reduce hyperexcitability-induced motor neuron degeneration Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 5, 2023 /PRNewswire/ — QurAlis Corporation, a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets, today announced that the company recently initiated dosing in a Phase 1…

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Surface Oncology Announces First Patient Dosed in a Phase 1/2 Study Evaluating SRF114, a Potential Best-In-Class Anti-CCR8 Antibody, in Patients with Advanced Solid Tumors

01/11/2023

SRF114 is designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment and has demonstrated highly specific CCR8-exclusive binding and reduced tumor growth in pre-clinical studies Initial clinical data anticipated in 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) — Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing…

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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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Janux Therapeutics Announces Submission of Investigational New Drug Application for JANX008, an EGFR-TRACTr for Solid Tumors

01/09/2023

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 that the Company has submitted the investigational new drug (IND)…

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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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Imago BioSciences Announces First Participant Dosed in Investigator-Sponsored Phase 2 Study of Bomedemstat in Combination with Ruxolitinib in Myelofibrosis

01/06/2023

Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 20, 2022 (GLOBE NEWSWIRE) — Imago BioSciences, Inc. (“Imago” or the “Company”) (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, today announced that the first participant has been dosed in an investigator-sponsored Phase…

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