On November 8, 2022 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, reported that financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, TCR2 Therapeutics, NOV 8, 2022, View Source [SID1234623507]).

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"TCR2 continued to execute on its streamlined corporate priorities in the last quarter and stands poised to deliver multiple clinical catalysts over the next 12 months on our two core assets, gavo-cel and TC-510," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "In the Phase 1 trial for gavo-cel, we observed promising activity in ovarian cancer, leading us to place greater and earlier emphasis on this indication. We also established a baseline clinical profile which we believe positions gavo-cel as a first- and best-in-class anti-mesothelin monotherapy which we aim to further enhance with the addition of checkpoint inhibitors and redosing strategies in the Phase 2 portion of the trial. In addition, we have begun treating patients with our second product candidate, TC-510, a TRuC-T cell enhanced with a PD-1:CD28 chimeric switch receptor. These near-term focused activities will allow us to further maximize the number of cancer patients with access to our investigational therapies."

Recent Developments

gavo-cel:

TCR2 announced positive topline results from the complete Phase 1 dose escalation portion of the gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors. Twenty-eight of the 30 patients evaluable for efficacy experienced regression of their target lesions, including eight patients who achieved a partial response (PR) by target lesion assessment, six of whom met criteria for a PR according to RECIST 1.1 criteria. Following identification of a dose-limiting toxicity (DLT) in September 2021, the study proceeded to a dose de-escalation portion and subsequently declared dose level 3 (1×108 cells/m2 following lymphodepletion) the recommended Phase 2 dose (RP2D).

Enrollment and treatment in the Phase 2 expansion portion of the gavo-cel Phase 1/2 clinical trial is ongoing.

TCR2 presented new preclinical data at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting demonstrating gavo-cel maintained effector function to clear tumors and was not impaired, blocked or disrupted by functional suppression from supraphysiological levels of soluble mesothelin-related peptides.

TC-510:

Enrollment and treatment in the Phase 1 dose escalation portion of the TC-510 Phase 1/2 clinical trial is ongoing.

Financial Highlights

Cash Position: TCR2 ended the third quarter of 2022 with $176.0 million in cash, cash equivalents, and investments compared to $265.6 million as of December 31, 2021. Net cash used in operations was $25.8 million for the third quarter of 2022 compared to $19.4 million for the third quarter of 2021. TCR2 continues to project net cash use of $115-125 million for 2022. We expect cash on hand to support operations into 2024.

R&D Expenses: Research and development expenses were $24.8 million for the third quarter of 2022 compared to $20.3 million for the third quarter of 2021. The increase in R&D expenses was primarily due to an increase in clinical trial expenses associated with patient treatment and product manufacturing.

G&A Expenses: General and administrative expenses were $6.3 million for the third quarter of 2022 compared to $6.0 million for the third quarter of 2021. The slight increase in general and administrative expenses was due to an increase supporting corporate activities.

Net Loss: Net loss was $30.6 million for the third quarter of 2022 compared to $26.2 million for the third quarter of 2021.

Upcoming Events

TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.

Jefferies London Healthcare Conference: Garry Menzel, President and Chief Executive Officer of TCR2 Therapeutics, will present an update on Company progress on Tuesday, November 15, 2022 at 5:35pm GMT (12:35pm ET)

About TCR2 Therapeutics

TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for cancer patients suffering from solid tumors. The company is focused on the discovery and development of product candidates against novel and complex targets utilizing its proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC-T cells). The TRuC platform is designed to specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). For more information about TCR2, please visit www.tcr2.com.

About gavo-cel

Gavo-cel is a mesothelin-targeted TRuC-T cell. The ongoing gavo-cel Phase 1/2 clinical trial is evaluating the safety and efficacy of gavo-cel in patients with mesothelin-expressing malignant pleural/peritoneal mesothelioma (MPM), ovarian cancer, non-small cell lung cancer (NSCLC) and cholangiocarcinoma.

About TC-510

TC-510 is a mesothelin-targeted TRuC-T cell that co-expresses a PD-1:CD28 chimeric switch receptor to provide a local costimulatory signal by engaging with PD-L1 expressed in the hostile tumor microenvironment and converting the negative inhibitory signal into a positive costimulatory signal.