RARE Daily

Y-mAbs to Restructure and Reduce Workforce Following Complete Response Letter from FDA

January 5, 2023

One month after the U.S. Food and Drug Administration refused marketing approval for Y-mAbs Therapeutics’ experimental brain cancer therapy omburtamab, the company said it will cut an estimated 35 percent of its workforce as part of a restructuring plan.

Photo: Thomas Gad, founder, president and interim CEO of Y-mAbs

The plan is intended to extend Y-mAbs cash runway as it focuses on the commercialization and potential label extension of Danyelza and development of its SADA technology platform.

Y-mAbs expects the cuts to the workforce and its revised business plan will result in a reduction in operating expenses and extend its cash runway into the first quarter of 2026.

While Y-mAbs plans to discuss omburtamab at its upcoming Type A meeting with the FDA, it is deprioritizing the program, including all indications, in designing its restructuring plan and in its estimates for 2023. In addition, the company plans to deprioritize other pipeline programs, including activities relating to GD2-GD3 Vaccine and CD33 bispecific antibody constructs, as part of the restructuring plan.

“We believe that this restructuring of the organization aligns our resources to efficiently leverage both the Danyelza franchise and support development activities for our highly differentiated novel SADA platform, which we view as the key near and long-term potential growth drivers of Y-mAbs,” said Thomas Gad, founder, president and interim CEO of Y-mAbs. “We believe this sharpened focus should propel us through key anticipated milestones, including continuation and potential expansion of the commercialization of Danyelza for neuroblastoma patients and potential indication expansion.”

Danyelza is indicated, in combination with granulocyte-macrophage colony-stimulating factor, for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

In 2023, Y-mAbs said that besides expanding the markets and indications for Danyelza, it would seek initial validation of the tumor binding capability of the SADA platform in solid tumors in a multicenter trial through the collection of imaging data in patients with small-cell lung cancer, sarcoma, and malignant melanoma, targeting an IND submission in the second quarter for CD38-SADA construct against non-Hodgkin’s lymphoma to potentially validate SADA in blood cancers.

Author: Rare Daily Staff

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