TCR2 Therapeutics Announces Partnership with the National Cancer Institute for Phase 1/2 Trial of TC-210

CAMBRIDGE, MA, USA I July 31, 2019 I TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on the use of TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuCTM-T cells) as a cancer therapeutic agent against mesothelin in the Company’s ongoing Phase 1/2 trial of TC-210.

The collaboration with the Thoracic and GI Malignancies Branch (TGMB) at NCI, led by Raffit Hassan, M.D., provides TCR2 with access to Dr. Hassan and TGMB’s extensive laboratory and clinical expertise for treating patients with advanced mesothelin-expressing cancers. Studies by Dr. Hassan and his colleagues have validated mesothelin as a target for cancer therapy, characterized mesothelin expression in different tumor types, led to the development of diagnostic assays that measure shed mesothelin in serum, and further outlined the biological functions of mesothelin.

“The fundamental validation and use of mesothelin as a target in immunotherapy by Dr. Hassan and his colleagues was a major development in oncology and we are excited to collaborate with the National Cancer Institute on the first clinical trial of a TRuC-T cell against mesothelin,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “We look forward to providing an update on the safety, efficacy and translational studies occurring at several sites from the Phase 1 portion of the Phase 1/2 trial for TC-210.”

Under the terms of the agreement, NCI will participate in TCR2 Therapeutics’ first-in-human, multicenter, open-label, Phase 1/2 clinical trial and will conduct translational studies, measuring potential biomarkers in patients treated with TCR2 Therapeutics’ proprietary mesothelin-specific T cell-based therapy to better understand the pharmacodynamics of TC-210.

The Phase 1 portion of the trial will focus on patient safety and tolerability with the key objective to determine the recommended Phase 2 dose (RP2D). In addition to standard measures of safety and efficacy, translational work includes assessment of patients’ tissues for expansion, trafficking, and persistence of TC-210 T cells. The Phase 2 portion of the trial will evaluate the efficacy of TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: non-small cell lung cancer, ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. Additional details about the trial can be found using the identifier NCT03907852 at www.clinicaltrials.gov.

For patients interested in enrolling in this clinical trial, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615) and/or visit the Web site:  https://trials.cancer.gov.

About TCR2 Therapeutics

TCR2 Therapeutics Inc. is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuCTM-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while exhibiting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate, TC-210, is currently being studied at several sites in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. For more information about TCR2, please visit www.tcr2.com.

SOURCE: TCR2 Therapeutics

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