Clinical-stage immunotherapy company TCR2 Therapeutics Inc. (TCRR:NASDAQ), which is focused on developing a novel T cell therapies for patients suffering from cancer and hematological malignancies, yesterday announced "positive interim data from the first five patients treated in the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for mesothelin-expressing solid tumors."
The firm stated that each of the five patients measured in the current phase of the study showed tumor regression including two RECIST unconfirmed partial responses. The company also advised that translational data demonstrated TRuC-T cell expansion and activation.
The company's President and CEO Garry Menzel, Ph.D., commented, "We are delighted that our very first dose of TC-210 induced consistent tumor regression and clinical benefit in heavily pre-treated cancer patients...There are very few options for patients with solid tumors and those expressing mesothelin represent a significant frontier of unmet medical need. While these are early data requiring further study, we are encouraged by the potential of our TRuC-T cells as we continue to enroll and treat patients with the goal of quickly finding a recommended Phase 2 dose for TC-210."
Alfonso Quintás-Cardama, M.D., Chief Medical Officer of TCR2 Therapeutics added, "Based on my prior experience working with both TCR-T and CAR-T cells, including the FDA approval of Kymriah, observing consistent clinical benefit in patients at presumably suboptimal T cell doses is quite meaningful...These early TC-210 data suggest our approach may overcome the challenges faced by many T cell therapies in the hostile solid tumor microenvironment. Our enrolled patients have failed multiple lines of therapy, including standard chemotherapy, checkpoint inhibitors and in some cases other mesothelin-directed approaches, in indications where survival has been historically shorter than six months."
The company listed that the main goal of this portion of the Phase 1 study are to define the safety profile of TC-210 in patients whose tumors overexpress mesothelin and to determine the recommended Phase 2 dose level (RP2D). The firm additionally reported that the clinical data from the first five patients treated with TRuC-T cells showed that TC-210 was safe and well tolerated and that there were no patients who experienced neurotoxicity or on-target, off-tumor toxicities.
The company outlined in greater detail that "the Phase 1/2 clinical trial (NCT03907852) is evaluating the safety and efficacy of TC-210, TCR2's T-cell receptor fusion construct directed against mesothelin and that the trial is enrolling patients with mesothelin expressing NSCLC, ovarian cancer, cholangiocarcinoma and malignant pleural/peritoneal mesothelioma." The Phase 1 portion is ongoing and the Phase 2 portion is planned to include around 50 patients who will be given TC-210 at the RP2D in four separate cohorts dependent upon their own specific cancer diagnosis of NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma or cholangiocarcinoma.
The company explained that "Mesothelin is a cell-surface glycoprotein highly expressed in a wide range of solid tumors, including malignant pleural/peritoneal mesothelioma, ovarian cancer, cholangiocarcinoma, breast cancer, pancreatic cancer and others."
TCR2 Therapeutics Inc. is a clinical-stage immunotherapy company based in Cambridge, Mass., that is engaged in developing novel T cell therapies for patients suffering from solid tumors or hematological malignancies. The firm indicated that "its 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."
TCR2 Therapeutics started the day with a market capitalization of around $315.4 million with approximately 24.1 million shares outstanding and a short interest of about 5.3%. TCRR shares opened 44% higher today at $18.92 (+$5.82, +44.43%) over Friday's $13.10 closing price. The stock has traded today between $15.21 and $19.85 per share and is currently trading at $17.14 (+$4.04, +30.84%).
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