Ukko Announces First Participant Dosed in Phase 1/2a Clinical Study Evaluating UKK-0018 for Peanut Allergy Treatment

Current approaches to peanut allergy remain burdensome and largely rely on strict avoidance, highlighting the significant unmet need for safer and more precise therapies that address the underlying immunological cause of disease,” said Uri Lopatin, M.D., Chief Executive Officer of Ukko. “By combining computational protein design with RNA/LNP delivery, UKK-0018 is designed to protect against peanut-induced anaphylaxis by promoting protective B and T cell immune responses. If successful, UKK-0018 has the potential to benefit patients faster, more safely, and with fewer treatments as compared to current approaches.

Immunome Announces U.S. FDA Acceptance of New Drug Application for Varegacestat for the Treatment of Adults with Desmoid Tumors

The FDA’s acceptance of our NDA for varegacestat is an important milestone for Immunome and for patients living with desmoid tumors,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. “We believe varegacestat has the potential to provide an important oral treatment option, supported by robust clinical data across all key efficacy endpoints. We look forward to working closely with the FDA throughout the review.

Vensica Medical Receives FDA IND Clearance to Initiate Phase 2 Study of ViXe, Its Needle-Free Xeomin® Delivery System for Overactive Bladder

NEW YORK–(BUSINESS WIRE)–Vensica Medical, a clinical-stage company developing needle-free therapeutic delivery solutions for urologic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to initiate a Phase 2 clinical trial of ViXe. The study will evaluate the Vibe® ultrasound-based, needle-free drug delivery system in combination with Xeomin® (incobotulinumtoxinA) for the treatment of overactive bladder (OAB).

SpliSense Secures Up to $13 Million from the Cystic Fibrosis Foundation to Advance Phase 2b Study of SPL84 for Cystic Fibrosis

Cystic Fibrosis Foundation funding follows positive SPL84 Phase 2a clinical results demonstrating clinical proof-of-concept for an inhaled antisense oligonucleotide therapy in a lung disease. Funding supports the ongoing global Phase 2b study evaluating SPL84 in people with cystic fibrosis carrying the 3849+10kb C-to-T mutation.

SpliSense Reports Positive Results from Phase 2 Study of SPL84 in Cystic Fibrosis

Results mark first evidence of potential clinical benefit of antisense oligonucleotide therapy in a pulmonary disease Encouraging safety profile with no identified safety signals to date Improvement in lung function observed in up to 70% of participants treated with SPL84 The readout validates SpliSense’ platform, supporting advancement of the Company’s additional pulmonary programs, for muco-obstructive …

OS Therapies Completes Acquisition of Advaxis Immunotherapies Clinical, Pre-clinical and IP Assets from Ayala Pharmaceuticals

OS Therapies Completes Acquisition of Advaxis Immunotherapies Clinical, Pre-clinical and IP Assets from Ayala Pharmaceuticals OS Therapies Completes Acquisition of Advaxis Immunotherapies Clinical, Pre-clinical and IP Assets from Ayala Pharmaceuticals KIRYAT ONO, ISRAEL and EDISON, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) — Pharma Two B Ltd. (“Pharma Two B”), a late-clinical stage company that is …

Nectin Therapeutics Licenses Novel Antibodies to Immunome

JERUSALEM, July 25, 2024 /PRNewswire/ — Nectin Therapeutics, Ltd., a biotechnology company developing novel immunotherapies and antibody drug conjugates (ADC) to address tumor resistance, today announced a global, exclusive license agreement with Immunome Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies. Under the terms of the license, Immunome received exclusive rights to …

MediWound Announces $25 Million Strategic Private Placement Financing

Mölnlycke Health Care, a global leader in innovative wound care solutions, leads the PIPE with a $15 million investment YAVNE, Israel, July 15, 2024 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), the world leader in next-generation enzymatic therapeutics for tissue repair, today announced it has entered into a definitive share purchase agreement with several new …

Biond Biologics Announces First Patient Dosed with BND-35 in Phase 1 Clinical Trial

MISGAV, Israel, June 24, 2024 /PRNewswire/ — Biond Biologics Ltd. (“Biond” or the “Company”), a private clinical-stage biopharmaceutical company developing novel immunotherapies for cancer and a platform for the intracellular delivery of biologics, today announced that the first patient has been dosed in a first-in-human clinical trial testing BND-35, a humanized ILT3/LILRB4 antagonist antibody. The first patient was administered BND-35 as a monotherapy …

CF Foundation Provides Up to $8.5M to SpliSense to Support a Clinical Trial for a Potential Treatment for Splicing Mutations

The additional funding will support a Phase 2 clinical trial for an inhaled antisense oligonucleotide drug for people with cystic fibrosis who have the splicing mutation 3849+10Kb C-to-T BETHESDA, Md.–(BUSINESS WIRE)–The Cystic Fibrosis Foundation is investing up to $8.5 million in additional funds in SpliSense to continue clinical trials for its inhaled antisense oligonucleotide (ASO) …