First Patient With Esophageal Cancer Receives TAC101-CLDN18.2 Cell Therapy

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The patient is doing well so far and may receive a booster dose of the TAC cell therapy.

Triumvira Immunologics has treated the first patient with Claudin 18.2+ solid tumors in its phase 1/2 TACTIC-3 trial (NCT05862324) investigating TAC101-CLDN18.2 cell therapy.1

“The patient has made good progress. We are going to, within the next couple of weeks, do the first scan to monitor for early evidence of clinical activity. So, we are very excited about it and we're looking forward to seeing the scans for the patient,” Deyaa Adib, MD, Chief Medical Officer, Triumvira Immunologics, told CGTLive®. “We are in fact being prepared that the patient may need a booster dose.”

Adib shared that the patient, who has esophageal cancer, had multiple prior lines of therapy, including chemotherapy and immune therapy. They were discharged the next day after dosing without any significant adverse events, cytokine release syndrome, or immune effector cell-associated neurotoxicity syndrome. Adib noted that preliminary scans will be conducted in the following weeks and the patient may receive a booster dose of TAC101-CLDN18.2 for the purpose of either deepening a response or prolonging the duration of response.

"Claudin 18.2 is a promising target for cell therapy," Andreas Bader, PhD, Chief Scientific Officer, Triumvira Immunologics, said in a statement.1 "Among normal tissues, it is restricted to the stomach and hidden between neighboring cells. In gastric cancer and a few other solid tumors, however, it is accessible and abundantly expressed on tumor cell surfaces and, therefore, it represents a significant tumor selective opportunity to address these types of cancers.

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TAC101-CLDN18.2 is an autologous cell therapy expressing a T-cell Antigen Coupler (TAC) that targets Claudin 18.2.TACTIC-3 is a first-in-human study aiming to evaluate the safety, recommended Phase II dose (RP2D), pharmacokinetics, and efficacy of the therapy inparticipants with CLDN18.2+ solid tumors who have been treated with at least 2 lines of prior therapy in Phase I and between 2-4 lines of prior therapy in Phase II (or pancreatic ductal adenocarcinoma with 1 line of prior antineoplastic therapy). Participants being treated with the current lines of therapy with no demonstrated benefit may also be eligible if no measurable disease was reported at baseline.

"We are delighted to initiate this study at such a pivotal moment for Triumvira as we advance an exciting clinical program aimed at addressing a substantial therapeutic gap for solid tumors," Adib added.1 "TAC101-CLDN18.2 represents a unique new therapy in our pipeline that has the potential to provide a new therapeutic solution for CLDN18.2 positive solid tumors including gastric, lung, ovarian and pancreatic cancers. There are currently no other approved treatment options against CLDN18.2, and novel therapeutics in development, such as TAC101-CLDN18.2, offer hope to a patient segment that constitutes ~40% of the gastric cancer population in the U.S. alone. Through our TAC technology, which harnesses the inherent signaling pathways of native TCRs, we aspire to bring forward innovative, chemotherapy-sparing therapeutic strategies for solid tumors."

Triumvira recently also presented data from a clinical trial (NCT04727151) of TAC01-HER2 in patients with HER2+ solid tumors at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium in San Francisco, California, from January 18-20, 2024. TAC01-HER2 showed some promising clinical activity, with a 68.8% disease control rate and a manageable safety profile.The recommended phase 2 dose was identified as dose level 4 (6-8 x 106 cells/kg).2

REFERENCES
1. Triumvira Immunologics Announces First Patient Dosed in Phase I/II Cell Therapy Trial of TAC101-CLDN18.2 for the Treatment of Claudin 18.2+ Solid Tumors. News release. Triumvira Immunologics. February 5, 2024. https://www.prnewswire.com/news-releases/triumvira-immunologics-announces-first-patient-dosed-in-phase-iii-cell-therapy-trial-of-tac101-cldn18-2-for-the-treatment-of-claudin-18-2-solid-tumors-302052750.html
2. Schlechter B, Dumbrava EE, George MA, et al. A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors. Presented at: 2024 ASCO GI, January 18-20; San Francisco, California. Abstract #747
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