Tessa will investigate its TT11X in several subtypes of non-Hodgkin lymphoma. Credit: Ed Uthman / Flickr (Creative Commons)

Tessa Therapeutic has entered a cooperative research and development agreement (CRADA) with the National Institutes of Health’s (NIH) US National Cancer Institute (NCI) for investigating TT11X in several non-Hodgkin lymphoma subtypes.

TT11X is Tessa’s allogeneic ’off-the-shelf’ CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy.

Under the CRADA terms, Tessa will partner with NCI’s Division of Cancer Treatment and Diagnosis (DCTD) to identify potential opportunities to expand TT11X applicability as a non-Hodgkin lymphoma treatment.

In addition to working as the regulatory sponsor, the NCI Cancer Therapy Evaluation Program (CTEP) will be responsible for conducting mutually approved studies through NCI-backed clinical network groups as part of the partnership.

CTEP will conduct the trials using drug supply as well as with other necessary support from Tessa. 

Currently, Tessa is advancing a Phase I trial of TT11X in CD30-positive lymphomas in the US.

Findings from the Phase I trial showed that the allogeneic CD30 CAR EBVST therapy was well-tolerated at all dosing levels, with an overall response rate of 79% and a complete response rate of 43% in 14 heavily pre-treated CD30-positve Hodgkin lymphoma patients.

Tessa president and CEO Thomas Willemsen said: “The collaboration is a strong incentive and encouragement for us to continue developing our scientific platform and will significantly expand our ability to conduct clinical trials with TT11X in a wide number of indications.

“Based on compelling safety and efficacy data from the Phase I trial of TT11X in patients with CD30-positive Hodgkin lymphoma, we believe there is a substantial opportunity to direct our ‘off-the-shelf’ therapy to other CD30-positive subtypes of non-Hodgkin lymphoma, where there is high patient need.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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