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TCR2 Therapeutics Inc. (TCRR)
Chart Events
Performance Outlook
| Previous Close | 23.71 |
| Open | 23.89 |
| Bid | 23.39 x 2200 |
| Ask | 23.96 x 1400 |
| Day's Range | 23.42 - 24.19 |
| 52 Week Range | 8.63 - 35.86 |
| Volume | 558,883 |
| Avg. Volume | 571,661 |
| Market Cap | 905.763M |
| Beta (5Y Monthly) | 2.08 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.40 |
| Earnings Date | Mar 11, 2021 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 45.67 |
Fair Value
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- GlobeNewswire
TCR² Highlights Gavo-cel Translational Data and Emerging Solid Tumor Pipeline Preclinical Data at AACR Annual Meeting
CAMBRIDGE, Mass., April 10, 2021 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that clinical and translational data from the dose escalation portion of the Company’s Phase 1/2 clinical trial of gavo-cel in patients with treatment refractory mesothelin-expressing solid tumors will be presented today at the American Association for Cancer Research (AACR) Virtual Annual Meeting in an e-poster titled “Preliminary Safety and Efficacy of gavocabtagene autoleucel (gavo-cel, TC-210), a T Cell Receptor Fusion Construct (TRuC®), in Patients with Treatment Refractory Mesothelin Overexpressing Solid Tumors.” In addition, preclinical data from the Company’s autologous CD70 and allogeneic mesothelin TRuC-T cells will be highlighted in e-posters in the Adoptive Cell Therapy session at AACR. “We are excited to be sharing with the scientific community gavo-cel clinical and translational data, which we believe underscore the benefit gavo-cel could provide to treatment refractory solid tumor patients,” said Alfonso Quintás-Cardama, Chief Medical Officer of TCR2 Therapeutics. “The product attributes observed from our TRuC-T cell product candidate, such as transduction efficiency, the TRuC-T cell naïve content, as well as their expansion and persistence in vivo, are highly encouraging as this degree of manufacturing consistency and predictability will be critical to conduct the dose escalation portion of our study and to allow an accurate identification of the recommended Phase 2 dose. We are very pleased with the manageable toxicity profile and clinical benefit the initial gavo-cel dose levels have provided to patients with refractory solid tumors, in particular because they exhausted all available therapeutic options prior to enrolling in our study.” The data reported in gavo-cel poster presentation were from 8 treatment refractory mesothelin-expressing solid tumor patients, 7 mesothelioma and 1 ovarian, that received a single gavo-cel intravenous infusion at 5x107 cells/m2 or 1x108 cells/m2 either alone or following lymphodepletion with fludarabine (30mg/m2/day x4) and cyclophosphamide (600mg/m2/day x3). Translational data highlights from the poster include: Transduction Efficiency: Achieved a median transduction efficiency of 49% for gavo-cel T cell products (TCP).CD4:CD8 Ratio: The median CD4:CD8 ratio in the gavo-cel T cell products was 7.15.Memory Phenotype: The median percentage of naïve TRuCs in the TCPs was 30.45% (range, 14.1-56.2). The final TCPs show high TIM-3 positivity, variable PD-1 positivity and low LAG-3 positivity.Expansion and Persistence: Peak gavo-cel expansion (Cmax) occurred between days 7 and 23. Cmax increased when gavo-cel was administered following lymphodepletion. The median peak gavo-cel expansion was 811.9 copies/µg of genomic DNA (range, 520 to 5,901 copies/µg).Cytokines: Cytokine elevations were detected in all subjects, with minor changes in non-lymphodepleted patients. The highest cytokine levels were observed in patients who experienced grade 3 CRS (patients 2 and 7). The e-poster presentation titled “Engineering Off-the-shelf T Cell Receptor Fusion Construct (TRuC) T Cells” will highlight allogeneic (off-the-shelf) TRuC-T cells targeting mesothelin that utilized a CRISPR/Cas9 endonucleases approach, yielding fully functional TRuCs that lack alloreactivity and reduced risk of host rejection while maintaining upregulation of activation markers, secretion of cytokines and clearance of tumor cells comparable to autologous TRuC-T cells targeting mesothelin. The e-poster presentation titled “Discovery and Preclinical Characterization of Fratricide-resistant TRuC-T Cells Targeting CD70” will highlight fratricide-resistant CD70-directed TRuC-T cells, which demonstrated an improved memory phenotype and significant anti-tumor efficacy in multiple xenograft mouse models with no evidence of in vivo fratricide. “Our intent is to continue to build on the early success of gavo-cel by making a significant investment in our solid tumor pipeline,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “CD70 represents an excellent target for our technology and has a broad addressable patient population. In addition, we have also innovated an allogeneic TRuC-T cell targeting mesothelin that will complement our autologous programs. We look forward to providing further updates on our solid tumor pipeline throughout the year.” E-posters and poster videos presented at AACR are available in the Presentations section of the Investors page of the Company’s website at investors.tcr2.com. About TCR2 Therapeutics TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from solid tumors or hematological malignancies. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while secreting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Company’s lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visit www.tcr2.com. Forward-looking Statements This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the therapeutic potential of gavo-cel and other product candidates, timing for interim updates for the Company’s clinical trials and announcement of additional preclinical data, manufacturing timing and capacity for clinical trials and commercial operations, increased clinical trial demand, timing of future IND filings and clinical development plans, the development of the Company’s TRuC-T cells, their potential characteristics, applications and clinical utility, and the potential therapeutic applications of the Company’s TRuC-T cell platform. The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, including TCR2’s ability to secure additional manufacturing facilities; whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2’s ongoing operations; and other risks set forth under the caption "Risk Factors" in TCR2’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2 believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither TCR2 nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Investor and Media Contact: Carl MauchDirector, Investor Relations and Corporate CommunicationsTCR2 Therapeutics Inc.(617) 949-5667carl.mauch@tcr2.com
- GlobeNewswire
TCR² Therapeutics to Present at the Needham Healthcare Conference
CAMBRIDGE, Mass., April 08, 2021 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will present an update on Company progress at the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021 at 8:00am E.T. using a virtual platform. A live webcast of the presentation will be available on the Investors page of the Company’s website at www.investors.tcr2.com. An archived replay will be available for at least 30 days following the presentation. About TCR2 Therapeutics TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from solid tumors or hematological malignancies. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while secreting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Company’s lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visit www.tcr2.com. Investor and Media Contact: Carl MauchDirector, Investor Relations and Corporate CommunicationsTCR2 Therapeutics Inc.(617) 949-5667carl.mauch@tcr2.com
- GlobeNewswire
TCR² Therapeutics Establishes Commercial-Scale Cell Therapy Manufacturing Facility
85,000 square foot state-of-the-art facility being built in Rockville, MarylandAccelerates TCR2’s commercial-scale manufacturing timelines with production anticipated in 2023Aaron Vernon hired as Vice President of Technical Operations CAMBRIDGE, Mass., March 29, 2021 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. (NYSE: ARE) for an existing 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland which is ready for Current Good Manufacturing Practice (cGMP) build-out. The site will support clinical and commercial production of gavo-cel with a capacity to treat several thousand cancer patients annually. The facility is expected to accelerate the Company’s commercial-scale manufacturing timelines with production anticipated in 2023. “After observing the consistent early clinical benefit and manageable safety profile experienced by patients treated with gavo-cel, we committed to securing a dedicated U.S. manufacturing facility as the first step in building a regional network to supply cancer patients with our therapies,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “Leasing an existing manufacturing footprint is a substantial milestone for TCR2, saving us valuable time and capital so that we can be ready for commercial production in 2023. Our new state-of-the-art facility will allow us to directly leverage our cell therapy process development expertise and control our end-to-end production supply chain. We are very pleased to be building a world-class cell therapy production facility for gavo-cel that will bring new hope to cancer patients suffering from solid tumors.” The 85,000 square foot facility constructed by Alexandria Real Estate Equities will provide space for commercial and clinical manufacturing, quality control laboratories and offices upon completion. TCR2 is designing the state-of-the-art cell therapy facility to utilize semi-automated and functionally closed systems which aim to provide cGMP manufacturing while optimizing the reliability of our cell therapy products and reducing manufacturing costs and vein-to-vein time. The flexible layout will allow production of gavo-cel and other emerging cell therapies in the TRuC-T cell pipeline. “The hiring of Aaron Vernon to head technical operations for the Company comes at the right time as we expand our manufacturing capabilities in anticipation of commercial production. His prior leadership roles in building out commercial operations as well as his specific expertise in global supply chain management will offer vital insights to TCR2 as we continue to execute upon our clinical strategy for gavo-cel,” added Dr. Menzel. Aaron Vernon joins TCR2 as Vice President of Technical Operations. Most recently, he held senior positions including Vice President of Global Technical Operations and Vice President of Engineering & Supply Chain at Autolus Therapeutics, a clinical stage autologous CAR-T cell therapy company, where he held numerous responsibilities including manufacturing capacity expansion and overseeing internal and external manufacturing of plasmid, vector and cell therapy products. Previously, Aaron was Vice President of Global Supply Chain and Manufacturing at Sucampo Pharmaceuticals. Earlier in his career, served in various engineering and manufacturing operations roles at AstraZeneca, MedImmune and Johnson & Johnson. About TCR2 Therapeutics TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from solid tumors or hematological malignancies. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while secreting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Company’s lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visit www.tcr2.com. Forward-looking Statements This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the therapeutic potential of gavo-cel, timing for interim updates for the Company’s clinical trials and announcement of additional preclinical data, timing for the certification and operation of our manufacturing facilities, including the new facility in Rockville, Maryland, manufacturing timing and capacity for clinical trials and commercial operations, increased clinical trial demand, timing of future IND filings and clinical development plans, the development of the Company’s TRuC-T cells, their potential characteristics, applications and clinical utility, and the potential therapeutic applications of the Company’s TRuC-T cell platform. The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, including TCR2’s ability to secure additional manufacturing facilities; whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2’s ongoing operations; and other risks set forth under the caption "Risk Factors" in TCR2’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2 believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither TCR2 nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Investor and Media Contact: Carl MauchDirector, Investor Relations and Corporate CommunicationsTCR2 Therapeutics Inc.(617) 949-5667carl.mauch@tcr2.com
