On April 10, 2022 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported it will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 8-13, 2022 in New Orleans (Press release, Triumvira Immunologics, APR 10, 2022, View Source [SID1234611850]). The company will present an update from its ongoing TACTIC-2 clinical trial evaluating TAC01-HER2 in patients with HER2-positive solid tumors and new preclinical proof-of-concept data for its gastric cancer candidate, TAC-Claudin 18.2 (CLDN18.2).

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Triumvira’s TAC-T cell therapies feature TAC receptors that interact with the natural T cell receptor to uniquely help T cells recognize and eliminate cancer cells. They are designed to target specific cancer signatures, like HER2 and CLDN18.2. HER2 is commonly overexpressed in various solid tumors, including breast, ovarian and non-small cell lung cancers. CLDN18.2, by similar fashion, is a promising and reliable antigen selectively expressed on the surface of gastric tumor cells.

"We are very encouraged by the current progress of our clinical trial for TAC01-HER2, which has generated high levels of interest and momentum shown by the growing number of participating sites and noticeable increase in patient screening and enrollment by our investigators," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira. "This will enable us to discuss patient data over the coming months at major cancer conferences in the USA and Europe."

"Our new preclinical evidence bolsters the viability of targeting CLDN18.2 and further demonstrates the versatility of our TAC platform for difficult-to-treat cancers," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira. "We plan to build on this success through an eventual IND filing for CLDN18.2 and look forward to expanding our novel platform to address additional targets."

Update on TACTIC-2 study

Triumvira will provide an update on its ongoing TACTIC-2 Phase 1/2 multicenter, open-label trial designed to evaluate the safety, tolerability and efficacy of TAC01-HER2 in patients with HER2-positive solid tumors. Recruitment is ongoing across four sites in the U.S. and Canada as Triumvira plans to enroll approximately 135 participants in total. Patient cohort 1 dose level has completed enrollment and treatment with TAC-T cell therapy and met the requirements for evaluation of dose-limiting toxicities. In addition, the data safety monitoring committee completed its review of safety data from cohort 1, and recommended initiating enrollment for cohort 2.

Session: PO.CT01.04 – Phase I Trials in Progress 2
Presentation Title: CT247 / 8 – A phase I/II trial investigating safety and efficacy of autologous TAC T cells targeting HER2 in relapsed or refractory solid tumors (TACTIC-2)
Date: April 13, 2022, 9:00 AM – 12:30 PM CT
Location: Section 35

TAC-Claudin 18.2 demonstrates strong and specific activity against CLDN18.2-expressing solid tumor models

In the preclinical study of CLDN18.2, strong and specific activity of TAC-T cells targeted against CLDN18.2 was shown through a variety of in vitro assays, including demonstrated TAC-T cell activation in target cells expressing CLDN18.2. Lack of activity and increases in cytokine levels were observed in control settings, indicating that the T cell response is specific to the CLDN18.2 antigen. In addition to positive in vitro results, intravenous administration of CLDN18.2-TAC T cells led to sustained anti-tumor responses in various in vivo CLDN18.2 mouse models.

Session: PO.IM02.02 – Adoptive Cell Therapy 2
Presentation Title: 572 / 7 – Pre-clinical evaluation of Claudin 18.2 TAC T cells for the treatment of gastric cancer
Date: April 10, 2022, 1:30 – 5:00 PM CT
Location: Section 37