TCR2 Therapeutics Announces Phase 2 Clinical Trial Collaboration with Bristol Myers Squibb to Evaluate Gavo-cel in Combination with Opdivo and Yervoy for Mesothelin-Expressing Solid Tumors

October 25, 2021 /BioonBIOON/ --T-cell therapy company TCR² Therapeutics recently announced a clinical trial collaboration agreement with Bristol-Myers Squibb (BMS), planning to conduct a Phase 2Clinical Trial, assessNovel cell therapy gavocabtagene autoleucel (gavo-cel, TC-210) in combination with anti-PD-1 therapy Opdivo (nivolumab) and anti-CTLA-4 therapy Yervoy (ipilimumab), for the treatment of refractory,Mesothelin-expressing solid tumors。

The primary objective of this Phase 2 trial is to evaluate the efficacy of gavo-cel in patients with unresectable, metastatic, or recurrent mesothelin-expressing solid tumors, including non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma (MPM), and cholangiocarcinoma. TCR² Therapeutics will sponsor this Phase 2 trial.

`Planned Phase 2`Clinical Trialwill evaluate anti-Tumoractivity, and to better characterize the safety of gavo-cel at the selected Recommended Phase 2 Dose (RP2D). Patients will receive gavo-cel at the RP2D, and based on their cancerDiagnosisEntered 4 different cohorts: NSCLC, ovarian cancer, MPM, and cholangiocarcinoma.

Specifically, patients with NSCLC, ovarian cancer, or cholangiocarcinoma will receive combination therapy with gavo-cel and Opdivo. Patients with MPM will be divided into three treatment groups: Group 1 will receive gavo-cel monotherapy, Group 2 will receive combination therapy with gavo-cel and Opdivo, and Group 3 will receive combination therapy with gavo-cel, Opdivo, and Yervoy.

Dr. Garry Menzel, President and Chief Executive Officer of TCR² Therapeutics, stated: “We are very pleased to partner with Bristol-Myers Squibb Company on our Phase 2Clinical Trial"…reached a collaboration agreement, as this enables us to evaluate the potential synergy between gavo-cel and immune checkpoint inhibitors. The new standard of care established by Opdivo for refractory diseases is of great importance to cancer patients worldwide, including the recent approval of the combination of Opdivo and Yervoy as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma. We look forward to determining whether gavo-cel can provide additional clinical benefit to these patients.”

gavo-cel is a novel TRuC (T cell receptor fusion construct) cell therapy consisting of autologous genetically engineered T cells expressing a fusion protein of a single-domain antibody and the CD3ε subunit, with the single-domain antibody recognizing human mesothelin. Upon expression, the single-domain antibody–CD3ε subunit fusion protein is integrated into the endogenous T cell receptor (TCR) complex, replacing the native CD3ε subunit.。In preclinical endothelin-positive tumor models, gavo-cel has shown anti-TumorActivity. Furthermore, compared with CAR-T cell therapies utilizing the same anti-mesothelin antibody, gavo-cel demonstrated superior efficacy.

gavo-cel is being developed for the treatment of mesothelin-positive solid tumors. Although mesothelin expression is low in normal tissues, it is highly expressed in various solid tumors, and in determiningTumorplays an active role in the malignancy and/or aggressiveness. Mesothelin overexpression is associated with a poorer prognosis in certain cancer types.

gavo-cel Phase 1/2Clinical TrialsFocuses on 4 indications: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma (MPM), and cholangiocarcinoma. In the United States alone, there are as many as 80,000 patients with these cancers.

in Phase 1/2Clinical TrialInterim data from the dose escalation portion have confirmed,gavo-cel demonstrated consistent clinical benefit, with nearly all patients experiencingTumorResponse (n=15/16, 94%), Disease Control Rate (DCR) of 81%。As of the data cutoff date of June 30, 2021, clinical activity was observed in the treatment of all 3 types of mesothelin-expressing solid tumors, among patients who received infusion of gavo cells following lymphodepletion,Overall Response Rate (ORR) 31%。 In terms of safety, gavo-cel remained generally well-tolerated overall, with manageable adverse events. (Bioon.com)

Source:TCR2 Therapeutics Announces Clinical Trial Collaboration Agreement with Bristol Myers Squibb to Evaluate Gavo-cel in Combination with Opdivo® and Yervoy® in Mesothelin-Expressing Solid Tumors