Biotechnology

Septerna Announces Initiation of Phase 1 Clinical Trial with SEP-786, a Novel Oral Small Molecule PTH1R Agonist for the Treatment of Hypoparathyroidism

10/02/2024

Trial Initiation Marks Septerna’s Transition to a Clinical-Stage Company Developing a Portfolio of Oral Small Molecule GPCR-Targeted Medicines Phase 1 Clinical Trial Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SEP-786 in Healthy Volunteers Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Septerna, a clinical-stage biotechnology company pioneering a new era of…

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Oruka Therapeutics Announces Accelerated Clinical Timelines and Upcoming Presentation at EADV Supporting ORKA-001’s Profile as a Potentially Best-in-Class Half-Life Extended Antibody Targeting IL-23p19

09/27/2024

ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody (mAb), first-in-human dosing now expected first quarter 2025 ORKA-002, a novel half-life extended IL-17A/F mAb, first-in-human dosing now expected third quarter 2025 New preclinical data on ORKA-001 to be presented at EADV in September showing robust preclinical activity including a half-life in NHPs of over 30 days…

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ADI-001 Clinical Biomarker Data Demonstrate Robust Tissue Trafficking and Complete B Cell Depletion in Secondary Lymphoid Tissue

09/24/2024

-Results highlight ADI-001’s potential as a best-in-class allogeneic cell therapy for autoimmune disease- -Webcast featuring Dr. Blake Aftab with accompanying presentation available on Company website- Excerpt from the Press Release: REDWOOD CITY, Calif. & BOSTON–(BUSINESS WIRE)–Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for…

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Rigel Announces First Patient Enrolled in Phase 1b/2 Triplet Therapy Trial of REZLIDHIA® (olutasidenib) in mIDH1 AML

09/16/2024

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Sept. 5, 2024 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first patient has been enrolled in a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with REZLIDHIA® (olutasidenib) in patients…

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Ocugen Announces Completion of Dosing in Subjects with Stargardt Disease in High Dose Cohort of Phase 1/2 GARDian Clinical Trial of OCU410ST—A Modifier Gene Therapy

09/11/2024

Excerpt from the Press Release: MALVERN, Pa., Aug. 28, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 GARDian clinical trial for…

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NextPoint Therapeutics Announces First-in-class T Cell Engager NPX372 As New Drug Candidate Targeting B7-H7 in Solid Tumors

09/09/2024

CD3 bispecific antibody developed to redirect T cell-mediated immunity toward B7-H7 expressing tumors, expanding monotherapy treatment possibility for a new patient population Company’s precision immunotherapy approach enables prospective identification of patients most likely to benefit from NPX372 with a defined clinical biomarker Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–NextPoint Therapeutics, a clinical-stage biotechnology company…

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Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG990, its Novel Half-Life Extended OX40L Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

09/04/2024

Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases Excerpt from the Press Release: SAN FRANCISCO and WALTHAM, Mass., Aug. 19,…

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Stem Cell Therapy developers I Peace and iCamuno Biotherapeutics Start Natural Killer Cell Trial for Ovarian Cancer

08/29/2024

Excerpt from the Press Release: PALO ALTO, Calif., Aug. 22, 2024 /PRNewswire/ — I Peace, a pioneering CDMO in induced pluripotent stem (iPS) cells, and iCamuno Biotherapeutics, a biotech company developing iPS cell-based therapies, today announced a significant milestone with the dosing of the first patient in a clinical trial using iPS cell-derived natural killer (iNK) cells for ovarian…

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DermBiont Announces Treatment of Locally Advanced Basal Cell Carcinoma and Prevention of Basal Cell Carcinoma in Gorlin Syndrome Patients as New Lead Indications for SM-020 Following Positive Initial Phase 2a Data

08/27/2024

– 100% of 9 treated BCCs (1 superficial, 4 nodular, and 4 infiltrating) across 7 enrolled subjects to date demonstrate prompt, visible, and robust tumor responses during treatment with SM-020 1% BID for 28 days, resulting in partial or total reduction of clinically visible tumor. Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–DermBiont, a clinical-stage biotechnology…

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Turnstone Biologics Corp. Reports Positive Initial Data from Phase 1 Trial of TIDAL-01 in Metastatic Colorectal Cancer

08/22/2024

Excerpt from the Press Release: SAN DIEGO, Aug. 14, 2024 (GLOBE NEWSWIRE) — Turnstone Biologics Corp. (“Turnstone” or the “Company”) (Nasdaq: TSBX), a clinical-stage biotechnology company developing a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy, today reported positive initial data from its Phase 1…

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