DANISH BIO – DANSK BIOTEK organizes four major plenary meetings for our members throughout the year to increase our members' knowledge regarding specific biotech topics and to facilitate networking. The events usually take place in February, May, September and November.

We also organize approximately four "saloon" meetings annually. They are small, intimate, "meet the expert" meetings with typically 6-20 participants advocating more in-depth discussion and knowledge-sharing on specific themes.

18 Oct 2023

Y-mAbs Therapeutics Announces U.S. FDA Clearance of Investigational New Drug Application for CD38-SADA

Clearance of CD38-SADA IND marks the second clinical development program utilizing the Company’s novel SADA technology platform

NEW YORK, Oct. 17, 2023 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for CD38-SADA, the Company’s second program within its Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy (“SADA Y-PRIT”) Theranostic Platform. The Phase 1 trial is a first-in-human, dose-escalation, open-label, single-arm, multi-center trial (Study 1201) investigating the safety and tolerability of the CD38-SADA: 177Lu-DOTA Drug Complex in patients with Relapsed or Refractory non-Hodgkin Lymphoma.

This trial will have two parts: Part A, CD38-SADA dose escalation with fixed 177Lu-DOTA payload doses to explore optimal CD38-SADA protein dose and interval between the SADA protein administration and the payload; and Part B, 177Lu-DOTA therapeutic dose escalation with the CD38-SADA dose determined in Part A. Patients will receive up to three cycles of therapy. The primary study outcome will evaluate safety and initial signals of efficacy using repeated dosing. Y-mAbs expects a total of approximately 30 patients and up to 12 U.S. sites to be included in the trial.

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