FDA Fast Tracks Celgene Spinoff’s NK Cell Therapy for Treating Aggressive Brain Tumor

Celularity Inc. is a clinical-stage biotech specializing in developing off-the-shelf, allogeneic therapies derived from the postpartum human placenta. On March 18th, the New Jersey-based biotech announced that the FDA had granted Fast Track Designation to CYNK-001, its investigational NK cell therapy candidate for treating adults with recurrent glioblastoma multiforme (GBM), an aggressive form of brain tumor with no standard of care treatments.

“This designation marks a meaningful milestone for Celularity and validates the potential of our approach to change the cell therapy landscape and improve the lives of patients with GBM and beyond,” said Dr. Robert J. Hariri, M.D., Ph.D., Founder, Chairperson and CEO of Celularity.

Placental Cell-Derived NK Cell Therapy

Adoptive cell therapies have evolved rapidly over the years, offering cancer patients potent treatment alternatives. Natural Killer (NK) cell therapies being much safer and faster to manufacture than CAR T cell therapies, has propelled several companies to trial promising candidates against many hematological and solid tumors.

Celularity’s CYNK-001 is the only cryopreserved, allogeneic, off-the-shelf NK cell therapy that is being developed from placental CD34+ hematopoietic stem cells. It demonstrates cytolytic activity against hematological tumors and solid tumor cell lines and secretion of immunomodulatory cytokines such as IFN-γ in the presence of tumor cells.

After displaying promise in preclinical studies, CYNK-001 is currently being evaluated in Phase 1 trials as a treatment for recurrent GBM. After obtaining the IND clearance from the FDA in early 2020, Celularity announced dosing the first patient of the Phase 1 study (NCT04489420) in November. The study aims to determine the maximum safe dose (MSD) of the therapy. Besides GBM, CYNK-001 is also investigated to treat acute myeloid leukemia (AML), multiple myeloma (MM), and COVID-19.

“We believe the unique attributes of placental-derived cell therapies will allow us to not only overcome the challenges of NK cell proliferation and persistence, but also improve therapeutic availability as compared to adult bone marrow or peripheral blood approaches. We look forward to working more closely with the FDA to advance our clinical trials and, ultimately, to bringing a new potential treatment option to patients suffering from this historically challenging disease.” Dr. Hariri added.

This year, Celularity also plans to submit IND for CYNK-101, another off-the-shelf NK cell therapy candidate in its pipeline. The Phase 1/2a clinical trial will test CYNK-101 in combination with a monoclonal antibody to target HER2+ cancers, such as gastric cancer.

Celularity spun out of Celgene Corporation in 2018 with a $250 million investment. In January this year, the company entered a definitive merger agreement with GX Acquisition Corp. in a SPAC deal worth $372 million and gaining an opportunity to go public.

Related Article: Acepodia Raises $47 Million Funding to Nurture its Next-Gen, oNK Cell Therapy Assets

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Rajaneesh K. Gopinath