TCR² Therapeutics provided updates regarding the 2022 first quarter financial results and progress made towards regulatory approval for gavo-cel and TC-510.
TCR² Therapeutics provided updates Thursday regarding its 2022 first quarter financial results and progress made towards regulatory approval for therapeutic candidates gavo-cel and TC-510. The company specializes in the development of novel T-cell therapeutics for patients with solid tumors.
TCR² develops therapeutic candidates using its proprietary T-cell receptor (TCR) Fusion Construct T cells (TRuC-T cells). The company’s lead therapeutic candidate is gavo-cell. Potential indications include treatment of patients with cholangiocarcinoma, malignant pleural/peritoneal mesothelioma (MPM), ovarian cancer and mesothelin-positive non-small cell lung cancer (NSCLC). In 2021, the U.S. Food and Drug Administration granted Orphan Drug Designation for gavo-cell for treatment of cholangiocarcinoma.
A Phase-II study has been initiated to investigate gavo-cel’s efficacy, with 30 patients treated to date. TCR² anticipates releasing an updated data set in July for this trial. Participants in the study include 75 patients with MPM and twenty patients for each remaining diagnosis category: ovarian cancer and mesothelin-positive NSCLC.
The study design for patients with MPM includes combination dosing of gavo-cell with Opdivo (nivolumab). An additional subset of patients with MPM will also be dosed with Yervoy (ipilimumab), along with gavo-cell and Opdivo. Participants with ovarian cancer, NSCLC or cholangiocarcinoma will be given a combination therapy of gavo-cell with Opdivo.
Another of TCR²’s candidates, TC-510, is a mesothelin-targeted TRuC-T cell that provides a local costimulatory signal through the expression of a PD-1:CD28 chimeric switch receptor. A phase I/II trial is currently evaluating the efficacy of TC-510 in patients with mesothelin-expressing MPM, ovarian cancer, pancreatic cancer, triple-negative breast cancer and colorectal cancer. Data from one or more of the cohorts in the dose-escalation Phase-I study is expected by the end of 2022. The Phase II portion of the study will evaluate efficacy and safety at a dose.
TCR² President and CEO Garry Menzel, Ph.D. commented on the company’s progress.
“We are very pleased with the momentum generated in the last quarter as we initiated the next phases on two clinical programs and expect to present in July an expanded dataset on 30 patients treated with gavo-cel,” he noted.
The company ended the quarter with $232.2 million in cash and assets. This final amount comes after spending $31.1 million in Q1 2022 operational costs. For comparison, TCR² reported $23.9 million in operational costs in Q1 of 2021. Spending for the remainder of 2022 is expected to be between $115 million and $125 million, leaving remaining funds for operational expenses into 2024.
Research and development costs have also increased from last year, from $15.9 million to $22.9 million. The increase in spending is attributed to clinical trial costs, manufacturing, facility costs and personnel increases to facilitate the expansions. Net loss for Q1 of 2022 was $6.3 million, in comparison to $5.7 million in losses for Q1 of 2021.
Other upcoming milestones for TCR² include studies for TC-520 that will support an IND filing, as well as the selection of a lead candidate for the company’s allogeneic program.
