On January 5, 2023 Triumvira Immunologics, 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 a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada) (Press release, Triumvira Immunologics, JAN 5, 2023, View Source [SID1234625930]). Triumvira’s ongoing TACTIC-2 trial will evaluate the use of its novel autologous cell therapy TAC01-HER2 as a monotherapy but also in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of HER2-positive solid tumors.

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"We believe the addition of an immune checkpoint inhibitor, such as KEYTRUDA, to TAC01-HER2 will effectively release inhibitory PD-L1/PD1 signaling in T cells, potentially leading to improved and durable therapeutic responses, said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. We are pleased to work collaboratively with Merck to explore the potential of this approach to treat relapsed or refractory solid tumors and bring new drug therapies to patients who do not respond to existing treatments."

At the European Society for Medical Oncology 2022 Congress, Triumvira presented interim data from the ongoing TACTIC-2 Phase 1/2 trial that demonstrated the safety and preliminary efficacy of TAC01-HER2 in patients with HER2-positive solid tumors regardless of level of expression. TACTIC-2 is actively enrolling participants at five clinical trial sites across the U.S. and Canada. The expansion phase of the trial is expected to launch in 2023. The trial will enroll a monotherapy arm with TAC01-HER2 and a combination therapy arm with TAC01-HER2 and KEYTRUDA, in patients with HER2-positive solid tumors.

"We are encouraged by the interim preliminary safety and efficacy data to date from our TACTIC-2 trial, and this has the potential to drive a real breakthrough in the treatment of solid tumors that express HER2," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira. "Beyond TAC01-HER2 monotherapy, we hope to demonstrate the benefits of using TAC01-HER2 in combination with KEYTRUDA, and we look forward to collaborating with Merck on this trial."

Merck will supply Triumvira with KEYTRUDA for the trial and the two companies will form a Joint Development Committee to review the clinical trial results. More details on the Phase 1/2 TACTIC-2 trial can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04727151.