TCRX - TScan Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update | Benzinga
Presented updated data from ongoing Phase 1 study of TSC-100 and TSC-101 for the treatment of heme malignancies at the Tandem Meetings of ASTCT and CIBMTR; 8/8 (100%) patients in treatment arms are relapse-free and show complete donor chimerism
Announced the clearance of two additional INDs for Solid Tumor Program: TSC-201-B0702 targeting MAGE-C2 on HLA-B*07:02 and TSC-204-A0101 targeting MAGE-A1 on HLA-A*01:01
Solid tumor clinical trial actively enrolling, with initial data for singleplex and multiplex cohorts anticipated in 2024
Expands leadership team with key appointments and promotions
Cash, cash equivalents, and marketable securities continues to fund operations into 2026
WALTHAM, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (NASDAQ:TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today reported financial results for the three months and full year ended December 31, 2023, and provided a business update.
"The advancements we made across our pipeline in 2023 have set the stage for a momentous year ahead as we continue to treat and follow patients in the heme malignancies study and commence patient dosing in the solid tumor program. We continue to make meaningful progress with our Phase 1 heme malignancies study, with updated data on eight treatment-arm patients and six control-arm patients presented at the Tandem Meetings of ASTCT and CIBMTR," said Gavin MacBeath, Ph.D., Chief Executive Officer. "We are encouraged to see that none of the patients in the treatment arms has relapsed following treatment with TSC-100 or TSC-101, including one high-risk TP53-mutated MDS patient who has now reached one year of follow-up. The one-year mark is a meaningful milestone for patients as the likelihood of relapse is now much lower, leading to an improved quality of life. We look forward to completing Phase 1 enrollment and reporting clinical and translational data in 2024 with two-year relapse-free survival data in 2025."
"We are on-track to treat the first patient in our Phase 1 solid tumor program this month, which will bring us one step closer to delivering customized, enhanced, multiplexed TCR-T therapies to patients with a variety of solid tumors," said Debora Barton, M.D., Chief Medical Officer. "Solid tumors are notoriously heterogenous, with tumors frequently expressing more than one target antigen. We believe the only way to eradicate solid tumors is through a multi-targeted approach. To make this a reality, we continue to prioritize expanding the ImmunoBank with additional TCRs to increase patient eligibility for multiplexed therapy. With recent FDA clearance of our INDs for TSC-201-B0702 and TSC-204-A0101, we now have six TCR-Ts cleared for clinical development. We look forward to continuing to advance the solid tumor program and sharing data on patients from singleplex and multiplex cohorts in 2024."
Recent Corporate Highlights
- In February 2024, the Company presented updated Phase 1 clinical results on lead TCR-T candidates TSC-100 and TSC-101 at the Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®).
- Data showed that all eight (100%) treatment-arm patients were free from relapse, including four patients with follow-up beyond ten months. Notably, one high-risk TP53-mutated MDS patient has now reached the one-year mark following treatment with TSC-101. Additionally, no patient-derived hematopoietic cells were detected in any of the eight treatment-arm patients, indicating complete elimination of target cells. One AML patient with detectable disease post-transplant converted to, and continues to show, no detectable disease following treatment with TSC-101, with the most recent measurement at day 180. Patients have now been enrolled up to the third and final dose level in both treatment arms with no dose limiting toxicities thus far, suggesting that the third dose level will likely become the recommended Phase 2 dose.
- Of the six patients enrolled in the control arm (transplant alone), two control-arm patients relapsed at day 161 and day 180, and one of them succumbed to the relapse on day 265 post-transplant. A third control-arm patient required clinical intervention on day 133 because of concerns of impending relapse, and only two of the control-arm patients achieved and maintained complete donor chimerism following transplantation.
- The Company hosted a virtual KOL event following the Tandem Meetings to discuss these data. A replay of the event can be found here.
- The Company recently received U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) applications for two additional TCR-Ts in their Solid Tumor Program:
- TSC-201-B0702, a TCR-T targeting melanoma-associated antigen C2 (MAGE-C2) on HLA -B*07:02
- TSC-204-A0101, a TCR-T targeting melanoma-associated antigen 1 (MAGE-A1) on HLA-A*01:01
With the clearance of these IND applications, TScan now has six enhanced TCR-Ts cleared for clinical development. The Company remains on-track to dose the first patient in its Phase 1 solid tumor program in the first quarter of 2024 and anticipates sharing initial data on patients from both the singleplex and multiplex cohorts in 2024.
- The Company will present two "Trials in Progress" poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024. Details for the posters include:
Title: Trial in progress: A phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation
Session Title: Phase I Clinical Trials in Progress 2
Session Date and Time: Monday April 8, 2024; 1:30 - 5:00 PM PDT
Location: Poster Section 50
Poster Board Number: 2
Abstract Presentation Number: CT151
Title: Trial in progress: A phase 1, first in human clinical trial for T-Plex, a multiplexed, enhanced T cell receptor-engineered T cell therapy (TCR-T) for solid tumors
Session Title: Phase I Clinical Trials in Progress 2
Session Date and Time: Monday April 8, 2024; 1:30 - 5:00 PM PDT
Location: Poster Section 50
Poster Board Number: 21
Abstract Presentation Number: CT170
- The Company continues to expand its leadership team with key appointments and promotions:
- Appointed Jason A. Amello as Chief Financial Officer
- Appointed Justin McCue, Ph.D., as Chief Technology Officer
- Promoted Zoran Zdraveski, J.D., Ph.D., to Chief Legal and Strategy Officer
- Appointed R. Keith Woods to its Board of Directors
- Promoted Cagan Gurer, Ph.D., to Senior Vice President, Discovery
- Promoted Jim Murray to Senior Vice President, Head of Development Operations
- Appointed Dawn Pinchasik, M.D., M.S., as Vice President, Clinical Development
- In November 2023, the Company was named a Top Place to Work by The Boston Globe for the second consecutive year.
Upcoming Anticipated Milestones
Heme Malignancies Program: TScan's two lead TCR-T cell therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), or myelodysplastic syndromes (MDS) undergoing hematopoietic cell transplantation (HCT) (NCT05473910).
- Plans to open expansion cohorts at the recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints in the third quarter of 2024.
- Plans to complete Phase 1 enrollment and report one-year clinical and translational data on initial patients in 2024.
- Expects to initiate registration trial and report two-year relapse data in 2025.
Solid Tumor Program: TScan continues to expand the ImmunoBank, a collection of therapeutic TCRs that target different cancer-associated antigens presented on diverse HLA types. TScan's strategy is to treat patients with multiple TCR-Ts to overcome tumor heterogeneity and prevent resistance that may arise from either target or HLA loss (screening protocol: NCT05812027) (treatment protocol: NCT05973487).
- Initiated Phase 1 solid tumor clinical study and expects to dose the first patient in the first quarter of 2024.
- Expects to share initial data on patients from both singleplex and multiplex cohorts in 2024.
- Plans to continue to expand the ImmunoBank with additional IND filings throughout 2024.
- Long-term duration of response data for multiplexed therapy anticipated in 2025.
Financial Results
Revenue: Revenue for the fourth quarter of 2023, was $7.2 million, compared to $3.1 million for the fourth quarter of 2022, and $21.0 million for the full-year 2023, compared to $13.5 million for the full-year 2022. The increase in both periods is primarily due to timing of research activities related to the collaboration agreement with Amgen which commenced in May 2023 compared to the collaboration and license agreement with Novartis which ended in March 2023.
R&D Expenses: Research and development expenses for the fourth quarter of 2023 were $22.4 million, compared to $15.6 million for the fourth quarter of 2022, and $88.2 million for the full-year 2023, compared to $59.8 million for the full-year 2022. The period over period increases were primarily driven by increased costs associated with clinical trial start-up fees and patient enrollment, increased personnel costs, and expansion of facilities.
G&A Expenses: General and administrative expenses for the fourth quarter of 2023, were $6.2 million, compared to $6.1 million for the fourth quarter of 2022, and $26.4 million for the full-year 2023, compared to $20.4 million for the full-year 2022. The full-year increase of $6.0 million was primarily driven by increased legal and professional fees and expansion of facilities.
Net Loss: Net loss was $19.6 million for the fourth quarter of 2023, compared to $18.7 million for the fourth quarter of 2022, and included net interest income of $1.7 million and $0, respectively. Net loss for the full-year 2023 was $89.2 million, compared to $66.2 million for the full-year 2022, and included net interest income of $4.2 million and $0.4 million, respectively.
Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2023 were $192.0 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into 2026.
Share Count: As of December 31, 2023, the Company had ...