CAMBRIDGE, Mass., July 31, 2019 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (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.
This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the participation of NCI in TCR2’s Phase 1/2 clinical trial for TC-210.
The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other risks set forth under the caption “Risk Factors” in TCR2’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2 believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.
Moreover, except as required by law, neither TCR2 nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
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