On March 23, 2023 TCR2 Therapeutics Inc. (Nasdaq: TCRR) (TCR2 or the Company), a clinical-stage cell therapy company with a pipeline of novel next-generation T cell therapies for patients suffering from solid tumors, reported fourth quarter and full-year 2022 financial results and provided a corporate update (Press release, TCR2 Therapeutics, MAR 23, 2023, View Source [SID1234629250]).
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"Focus and specialization are critical in the cell therapy space. The strategic combination with Adaptimmune and the operating benefits are highly compelling for both Adaptimmune and TCR² shareholders. Our complementary technology platforms are designed to treat solid tumors which represents a substantial market opportunity largely unaddressed by cell therapies. The combination of our two companies provides a strong foundation to commercialize curative therapies for people with cancer," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics.
Recent Developments
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TCR2 announced a strategic combination with Adaptimmune Therapeutics plc (Adaptimmune) to create a preeminent cell therapy company for solid tumors. The two companies entered into a definitive agreement under which Adaptimmune will combine with TCR² in an all-stock transaction. The transaction is expected to close in the second quarter of 2023, subject to shareholder approval and satisfaction or waiver of other closing conditions. Following the closing of the transaction, Adaptimmune shareholders will own approximately 75% and TCR² stockholders will own approximately 25% of the combined company. As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into 2026.
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TCR2 published preclinical gavo-cel data in OncoImmunology. Research showed that gavo-cel more rapidly infiltrated and eliminated mesothelin-positive tumors of various histologies while producing less pro-inflammatory cytokines than second-generation mesothelin-targeted CAR T cells.
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TCR2 reprioritized its pipeline to focus on gavo-cel in ovarian cancer and second-generation programs TC-510 and TC-520. In connection with the reprioritization, TCR2 reduced its workforce by approximately 40 percent.
Anticipated Milestones
gavo-cel:
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First readout from the ongoing Phase 2 portion of the gavo‑cel Phase 1/2 clinical trial in ovarian cancer in combination with checkpoint inhibitors and redosing strategies anticipated in the second half of 2023.
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Interim update, including key translational data, in patients with mesothelioma treated with gavo‑cel in combination with checkpoint inhibitors in the Phase 2 portion of the gavo-cel Phase 1/2 clinical trial before the focus was narrowed to ovarian cancer anticipated midyear 2023.
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Tumor regression has been observed in 93% of patients in the Phase 1 trial. The response rate was 29% in patients with ovarian cancer with a median progression free survival (PFS) of 5.8 months and a median overall survival (OS) of 8.1 months. The response rate in mesothelioma was 21% with a median PFS of 5.9 months and a median OS of 11.2 months.
TC-510:
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First data readout from the Phase 1 trial with TC-510 for patients with ovarian, malignant pleural mesothelioma, pancreatic, colorectal, or triple-negative breast cancer anticipated in the second half of 2023.
Financial Highlights
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Cash Position: TCR2 ended the fourth quarter of 2022 with $149.2 million in cash, cash equivalents, and investments compared to $265.6 million as of December 31, 2021. Net cash used in operations was $25.0 million for the fourth quarter of 2022 compared to $23.3 million for the fourth quarter of 2021.
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R&D Expenses: Research and development (R&D) expenses were $25.7 million for the fourth quarter of 2022 compared to $18.8 million for the fourth quarter of 2021. The increase in R&D expenses was primarily due to increased spending on clinical programs.
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Impairment and Restructuring Expenses: Impairment expenses were $29.9 million for the fourth quarter of 2022 compared to $3.7 million for the fourth quarter of 2021. The impairment charges during 2022 are primarily related to the Rockville manufacturing facility which have been reclassified as held for sale as of December 31, 2022.
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G&A Expenses: General and administrative (G&A) expenses were $5.8 million for the fourth quarter of 2022 compared to $5.2 million for the fourth quarter of 2021. The increase in G&A expenses was primarily due to an increase in personnel costs.
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Net Loss: Net loss was $60.5 million for the fourth quarter of 2022 compared to $27.7 million for the fourth quarter of 2021.
About gavo-cel, TC-510, and TC-520
Our most advanced program, gavo-cel, targets tumors that express the protein mesothelin.
TC-510 is an enhanced version of gavo-cel that co-expresses a PD-1:CD28 chimeric switch receptor that the Company believes may lead to deeper responses and more durable benefit.
TC-520 is the Company’s first TRuC-T cell targeting CD-70-expressing solid and liquid tumors which incorporates IL-15 pathway enhancements designed to improve T-cell persistence. TCR2 is currently advancing TC-520 to Investigational New Drug (IND) status.