GentiBio and Forge Biologics in viral vector contract development and GMP manufacturing partnership

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Aslan Alphan
© GettyImages/Aslan Alphan

Related tags: Viral vector, cell and gene therapy

Boston headquartered biotherapeutics company, GentiBio, Inc, and CGT focused CDMO, Forge Biologics, have set up a development and manufacturing partnership.

The alliance is aimed at advancing GentiBio’s immune tolerance platform; that company is developing engineered regulatory T cells (Tregs) that are programmed to treat autoimmune, alloimmune, autoinflammatory, and allergic diseases.

Forge, which is a contract and development manufacturing organization (CDMO) focused on accelerating cell and gene therapy (CGT) programs from preclinical through clinical and commercial stage manufacturing, is to provide adeno-associated viral (AAV) vector process and analytical development, scale-up engineering and GMP manufacturing services for GentiBio’s engineered Tregs therapeutic candidates.

The CDMO said its Blaze Vector production platform and HEK 293 Suspension Ignition Cells will be employed to facilitate GentiBio’s development process.

All development and GMP activities will occur Forge’s gene therapy GMP production facility in Columbus, Ohio.

Keeping the immune system in check 

GentiBio said its proprietary autologous and allogeneic EngTregs platform is designed to integrate complementary technologies aimed at restoring immune tolerance and to overcome the major limitations in existing Tregs cell-based therapeutics; it is looking to leverage a therapeutic modality that can be used to address the fundamental cause of many diseases that result from overactivity and/or malfunctioning of the immune system.

Tregs are said to play a central role in keeping the immune system in check by applying the brakes to maladaptive immune responses.

The emerging biotherapeutics player said its EngTregs are scalable. “Rather than isolating Tregs – a very rare population in the blood, we zero in on more abundant effector T cells to generate our EngTregs. Our technology stably converts the effector T cells into EngTregs and ensures our ability to scale manufacturing at very efficient costs.”

Once deployed to their target tissues, it said its EngTregs suppress the T cells that are actively attacking the body through a variety of mechanisms. “Extensive studies show that Tregs remain in the body for months and even years potentially providing an avenue to reset the immune system after limited dosing. Similarly, EngTregs are stable, potent and precise enough to prevent the immune system from turning against itself in select tissues, while allowing the body to continue to respond to other threats such as infections and cancer.”

The company added that it employs a fine-tuning system that can be used to tailor the performance and durability of EngTregs in the body to the needs of the patient.

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