Around the Helix: Cell and Gene Therapy Company Updates – April 26, 2023

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. New Clinical Data Presented at ARVO 2023

Catch up on CGTLive’s coverage of the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting, held April 23-27, 2023, in New Orleans, Louisiana. Our coverage will continue throughout the week.

2. bluebird bio Submits BLA for Sickle Cell Gene-Edited Cell Therapy, Lovo-cel

bluebird bio has submitted a biologics license application to the FDA for lovotibeglogene autotemcel (lovo-cel) for the treatment of patients with sickle cell disease aged 12 or older who have a history of vaso-occlusive events.

3. Therapeutic Solutions International Seeks to Expand JadiCell Treatment to Broader ARDS Population

Therapeutic Solutions International has submitted an investigational new drug application to the FDA with the intention of initiating a new phase 3 clinical trial to evaluate JadiCell, an investigational mesenchymal stem cell product licensed by Therapeutic Solutions International, for the treatment of acute respiratory distress syndrome.

4. ASTCT’s Fundamentals of HCT Training Course: What to Know Ahead of the Meeting

The American Society for Transplantation and Cellular Therapy (ASTCT) is kicking off a 2-day virtual course to provide essential education around the process of using hematopoietic stem cell transplantation in the clinical care of patients. Beginning on Friday, April 28, 2023, the aptly titled 2023 Fundamentals of HCT Training Course will feature a variety of speakers and experts who will seek to help attendees develop or enhance their skills in the treatment of patients undergoing these procedures.

5. BASECAMP-1: Trial of Novel CAR T-Cell Agent Seeks Patients Eligible for Treatment

To date, impressive data have been published and presented showing the effects of chimeric antigen receptor T-cell therapies in patients with hematologic malignancies. Hoping to replicate this success in those with solid tumors, investigators have initiated the BASECAMP-1 trial (NCT04981119) with the hope of identifying individuals who may serve as suitable candidates for treatment in a subsequent trial evaluating the investigational agent A2B530 (A2 Biotherapeutics).

6. Coeptis Therapeutics Enters Term Sheet With Deverra Therapeutics for Potential Acquisition of Immuno-Oncology NK Platform and Associated Products

The allogeneic stem cell expansion and directed differentiation platform is intended to produce natural killer cells and other immune effector cell types for use in therapies. The agreement allows Coeptis Therapeutics the exclusive right to negotiate for the acquisition of specific products based on the platform from Deverra Therapeutics until August 31, 2023.

7. Teijen Limited, Japan Tissue Engineering Company, and Resilience US Join Forces to Expand Cell and Gene Therapy CDMO Capabilities

The 3 companies have entered into an agreement for a collaboration to expand the reach of the contract development and manufacturing organization services offered to their clients in the North America and Asia-Pacific regions. The companies are also discussing plans related to shared use of manufacturing platforms.

8. GenSight Biologics Pulls EMA Martketing Authorization Application for Lumevoq

Lumevoq (lenadogene nolparvovec) is an investigational gene therapy intended to treat Leber hereditary optic neuropathy. GenSight Biologics’ decision was based on an indication from the European Medicines Agency that the data submitted by the company would not be sufficient for approval.

9. OBiO Technology Opens New Gene Therapy “Super Factory”

The manufacturing facility, located in Shanghai, China’s Pilot Free Trade Zone, Lin-Gang Special Area, includes 29 GMP-grade production lines and encompasses 828,000 square feet. The company stated that the factory, referred to as OBiO Intelli-M, is among the world’s largest gene therapy manufacturing facilities.

10. AmerisourceBergen Announces Launch of System for Data Exchange in Path-to-Care Process for Patients Receiving Cell Therapies and Gene Therapies

The Cell and Gene Therapy Integration Hub is intended to streamline information exchange during the process of manufacture, transportation, and delivery of advanced therapeutics to patients. “Through the Cell and Gene Therapy Integration Hub, our goal is to increase connectivity and reduce potential barriers across the patient journey, simplifying the care coordination process and enabling an enhanced patient and provider experience,” Dale Hanna, the director of Cell & Gene Therapy Solutions at AmerisourceBergen, said in a statement.

11. Bristol Myers Squibb Acquires New Viral Vector Manufacturing Facility

The addition of the facility, which is located in Libertyville, Illinois, is the result of an agreement between Bristol Myers Squibb and Novartis. Bristol Myers Squibb stated that the facility is capable of manufacturing viral vectors for use in the production of its CAR-T products.

12. Enlivex Expects Issuance of Patent Related to Macrophage-Reprogramming Cell Therapy in 2023

The United States Patent and Trademark Office has issued a Notice of Allowance for Enlivex’s patent application number 16/076,026. The patent application is related to the use of Allocetra, an allogeneic cell therapy intended to reprogram macrophages, in combination with CAR-T therapies for the treatment of cancers.