FDA Grants Fast Track Status to Triumvira’s T-cell Therapy TAC01-CD19 for DLBCL

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Triumvira Immunulogics‘ investigational T-cell therapy TAC01-CD19 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The designation facilitates the development and review process of therapies that can treat severe conditions and fill an unmet clinical need, either because no treatments are currently available, or the new treatment offers significant benefits over approved therapies.

Treatments with fast track designation are eligible for benefits such as more frequent meetings with the FDA to discuss clinical trial design, as well as accelerated approval, priority review, and “rolling review,” meaning that the company can submit completed sections of its application for consideration by the FDA, rather than waiting for the full application to be completed before starting the review process.

“FDA’s decision to grant Fast Track designation to TAC01-CD19 is an important recognition of both Triumvira’s differentiated cell therapy technology and the critical need to develop new therapies to address the unmet medical need in the treatment of B-cell lymphomas,” Paul Lammers, MD, president and CEO of Triumvira, said in a press release.

Traditional T-cell therapies, such as CAR T-cell therapy, consist of collecting T-cells (a type of immune cell) from a cancer patient and modifying them in the lab, so that they specifically attack the patient’s tumor cells.

These therapies have proven effective for lymphomas and other blood cancers, but they are associated with side effects such as cytokine release syndrome and neurotoxicity, which can sometimes be life-threatening and limit the number of patients who can tolerate the treatment.

Triumvira’s novel T-cell Antigen Coupler (TAC) technology also extracts and modifies the patient’s T-cells, but instead of inserting a man-made receptor that becomes activated by binding to its target, the technology uses a protein, called an antigen coupler, that activates the natural T-cell receptor — the protein that regulates T-cell activation — once in contact with the target.

Because it keeps the natural control mechanisms of the T-cell intact, TAC technology has the potential to offer benefits similar to those of traditional CAR T-cell therapies while reducing the associated side effects.

“With our innovative TAC technology, we hope to significantly improve upon the limitations of existing cell therapies, including the risk of cytokine release syndrome and neurotoxicity, which would allow us to expand the number of patients eligible to receive this type of treatment,” said Lammers.

TAC01-CD19 is the first investigational therapy that uses TAC technology to target a protein called CD19, which is present in high amounts at the surface of lymphoma cells. Preclinical studies showed that TAC01-CD19 specifically targets tumor cells without causing unspecific responses or toxicity.

Triumvira plans to start the TACTIC-19 Phase 1/2 trial (NCT03880279) later this year, which will assess the safety and efficacy of TAC01-CD19. The study expects to recruit 36 participants with relapsed or refractory DLBCL and other B-cell lymphomas in the U. S. and Canada.