Around the Helix: Cell and Gene Therapy Company Updates – April 20, 2022

The cell and gene therapy sectors are growing exponentially, with new players emerging daily and much progress being made both in and out of the lab. CGTLive’s Around the Helix is your chance to catch up with the latest news in cell and gene therapies, including partnerships, pipeline updates, and more.

1. FDA Grants GCC19CART Fast Track Designation for Colorectal Cancer

The FDA has granted a Fast Track Designation to GCC19CART as a potential treatment for patients with relapsed and refractory metastatic colorectal cancer, according to a statement from Innovative Cellular Therapeutics, the developer of the guanylate cyclase 2C (GCC)-targeted autologous CAR T-cell therapy.

2. T Cell Therapy for Post-Transplant Virus Prevention Granted RMAT Designation

Investigational T cell therapy posoleucel has been granted regenerative medicine advanced therapy designation by the FDA for prevention of infection from 6 viruses that commonly affect people who have undergone allogeneic hematopoietic cell transplant.

3. Adicet Bio's ADI-001 Wins Fast Track in Non-Hodgkin Lymphoma

The off-the-shelf CD20 CAR-modified gamma and delta T cell therapy ADI-001 has been granted a Fast Track Designation by the FDA a potential treatment for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

4. Phase 1 Trial of Oral CRISPR Therapeutic Launched for E. coli Infection Prevention

SNIPR BIOME has dosed its first patients in a phase 1 clinical trial of SNIPR001, an orally administered CRISPR-based therapy designed to selectively target and eradicate E. coli in the gut in a high-risk population of patients with hematological cancer at risk for neutropenia.

5. Kite Expands CAR T-Cell Manufacturing Capacity With New Facility

The FDA has approved commercial production at Kite's new CAR T-cell manufacturing facility in Maryland, which will help boost production capacity by 50%.

6. FDA Releases New Guidance on Improving Diversity in Clinical Trials

Guidance issued by the Oncology Center of Excellence, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Office of the Commissioner, Office of Minority Health and Health Equity provides recommendations to sponsors on approaches to enrolling adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the US.

7. Cimeio Therapeutics Launches With Renewed Focus on Cell Therapies

Versant Ventures announced the launch of Cimeio Therapeutics, which will develop novel therapeutic approaches to hematopoietic stem cell transplants and adoptive cell therapy in rare genetic diseases, hematologic malignancies, and autoimmune disorders.