On August 8, 2019 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, TCR2 Therapeutics, AUG 8, 2019, View Source [SID1234538445]).
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"In the second quarter of 2019, we made significant progress with our two lead programs TC-210 and TC-110," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We began patient dosing in a Phase 1/2 clinical trial with TC-210 and partnered with the National Cancer Institute, an institution integral in the validation of targeting mesothelin, to further understand how our unique TRuC-T cells impact mesothelin-positive solid tumors. Additionally, we accelerated our ability to move programs toward and through the clinic by expanding our leadership team with experts that deepen our core competencies – manufacturing, IND enablement and innovation. We remain in a strong financial position with a cash runway into 2022 and look forward to providing updates on TC-210 as we progress through the clinic."
Recent Developments
TCR2 has begun dosing in its Phase 1/2 clinical trial of TC-210 to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma or cholangiocarcinoma.
TCR2 announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on the use of TCR2’s proprietary TRuC-T cells as a cancer therapeutic agent against mesothelin in the Company’s ongoing Phase 1/2 trial of TC-210.
TCR2 expanded its manufacturing and immuno-oncology expertise by hiring Vice Presidents Nigel Williams, Robert Tighe and Dario Gutierrez, Ph.D. The expansion of the leadership team strengthens the Company’s core competencies of manufacturing, IND enablement and innovation as it advances a broad portfolio of next generation TRuC-T cells.
The United States Patent and Trademark Office issued patents with claims covering TCR2’s T cell receptor (TCR) Fusion Construct T cells (TRuCTM-T cells) that express anti-B-cell maturation antigen (BCMA) and anti-CD19 TCR fusion proteins, including TC-110.
TC-210 Clinical Trial Design
The Phase 1/2 clinical trial (NCT03907852) is evaluating the safety and efficacy of TC-210, TCR2’s T-cell receptor fusion construct against mesothelin at Sarah Cannon Research Institute, MD Anderson Cancer Center and the NCI. The trial is enrolling patients with mesothelin expressing non-small cell lung cancer (NSCLC), ovarian cancer, cholangiocarcinoma or malignant pleural/peritoneal mesothelioma.
The Phase 1 portion of the clinical trial utilizes a 3+3 design with four escalating dose levels for TC-210. At each dose level, TC-210 is first administered without lymphodepletion and then following lymphodepleting chemotherapy. The primary objective for the study is patient safety with a key secondary objective to determine the recommended Phase 2 dose (RP2D). In addition to standard measures of safety and efficacy, translational work includes the assessment of TC-210 T cells for expansion, trafficking, persistence and phenotypic changes.
Under the terms of the CRADA, NCI 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.
In the Phase 2 portion of the clinical trial, approximately 50 patients are initially planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. Each cohort includes ten patients, except the NSCLC cohort which includes 20 patients with eight patients to receive TC-210 as single agent and 12 to receive TC-210 in combination with a programmed cell death 1 (PD-1) blocking antibody.
Financial Highlights
Cash Position: TCR2 ended the second quarter of 2019 with $180.7 million in cash, cash equivalents, and investments compared to $123.2 million as of December 31, 2018. Net cash used in operations was $21.0 million in the first half of 2019 compared to $7.7 million in the first half of 2018.
R&D Expenses: Research and development expenses were $8.8 million for the second quarter of 2019 compared to $5.2 million for the second quarter of 2018. The increase in R&D expenses is primarily related to increase in headcount and activities related to the start of the Phase 1/2 clinical trial of the Company’s lead solid tumor product candidate, TC-210.
G&A Expenses: General and administrative expenses were $3.3 million for the second quarter of 2019 compared to $1.6 million for the second quarter of 2018. The increase in general and administrative expenses was primarily due to an increase in personnel costs and cost associated with operations as a public company.
Net loss: Net loss was $11.1 million for the second quarter of 2019 compared to $6.2 million for the second quarter of 2018, driven predominantly by increased R&D expense in the quarter.
Upcoming Events
TCR2 Therapeutics management are scheduled to participate at the following upcoming conferences.
BTIG Biotechnology Conference 2019: Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will be available for one-on-one meetings on Monday, August 12, 2019 in New York, NY.
2019 Wedbush PacGrow Healthcare Conference: Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, will present on Tuesday, August 13, 2019 at 8:00am ET in New York, NY.