WALTHAM, Mass., November 04, 2021 (GLOBE NEWSWIRE) – TScan Therapeutics, Inc. (Nasdaq: TCRX), a biopharmaceutical company focused on the development of T cell therapies modified by the T cell receptor (TCR) (TCR-T ) for the treatment of cancer patients, today announced that two abstracts related to its leading liquid tumor candidates TSC-100 and TSC-101 have been accepted for poster presentations at the upcoming annual meeting and exhibition of the American Society of Hematology (ASH), being held December 11-14, 2021. Abstracts are available on the ASH website at www.hematology.org. TSC-100 and TSC-101 are TCR-T cell products directed against the minor histocompatibility antigens HA-1 and HA-2, respectively, which are found only on blood cells. TScan is developing these products to prevent relapses after hematopoietic cell transplantation (HCT) in myeloid leukemia. The Company plans to file New Drug Investigation (IND) applications for both programs before the end of 2021.
The current standard of care for the treatment of myeloid leukemia is HCT, which can provide permanent cure but has a relapse rate of up to 50%, especially if the transplant uses reduced intensity conditioning (RIC), which is easier for patients to tolerate but does not usually completely eliminate their leukemia. TScan’s program is based on the well-established observation that patients who do not match their donors for minor histocompatibility antigens such as HA-1 or HA-2, and who naturally mount a T cell response against these. antigens, show significantly lower relapse rates after HCT. By developing TSC-100 and TSC-101, TScan aims to recreate this natural graft response to leukemia in order to prevent relapses in patients undergoing HCT.
“We are thrilled to bring TSC-100 and TSC-101 to patients who are at risk of a devastating relapse after suffering a demanding HCT,” said David Southwell, President and CEO of TScan Therapeutics. “We believe we are the only company advancing a T cell therapy product to safely reduce the risk of relapse, potentially filling an important gap in the current paradigm of leukemia treatment. “
As described in his Nayar R. et al. summary, TScan used its proprietary TCR discovery platform known as ReceptorScan to screen approximately 237 million CD8 + cells from five healthy HA-2-negative donors and identify approximately 1,302 natural TCRs that recognize HA-2 . These were then reduced to 15 TCRs with the highest surface expression and highest affinity for the HA-2 peptide. The company further evaluated the top five TCRs for off-target cross-reactivity against the entire human proteome using TScan’s proprietary TargetScan platform, identifying TCR-101 as the most active TCR with the lower off-target activity. TScan previously used the same process to identify TCR-100, an HA-1 specific TCR, for its TSC-100 program. The discovery of TCR-100 was presented at the 2020 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) and can be viewed here. Working together, ReceptorScan and TargetScan give TScan the ability to discover the most efficient and safe all-human TCR possible for any given antigen.
In Chattopadhyay et al. In summary, the Company describes the manufacturing process and Phase 1 clinical development plans for TSC-100 and TSC-101. TScan has developed a proprietary non-viral transposon / transposase delivery system known as T-Integrate, which enables cost-effective, rapid and consistent cell manufacture with short development times. This non-viral vector allows for a larger cargo size that TScan uses to further enhance the function of TSC-100 and TSC-101 by encoding both the alpha and beta chains of the CD8 co-receptor in the vector. In each case, the final cellular product is a mixture of cytotoxic and helper T cells, both of which have been engineered to recognize HA-1 or HA-2.
As described in Chattopadhyay et al. summary, TScan plans to launch a controlled, multi-arm phase 1/2 clinical trial to study the safety and efficacy of TSC-100 and TSC-101 in patients with acute myeloid leukemia (AML), lymphoblastic leukemia acute (ALL) and myelodysplastic syndromes (MDS) that undergo HCT after RIC. The donors in this study will be haplo-identical, which are typically family members who are half-matched on tissue HLA types. Such haplo-identical donors maximize the chances that patients and donors will not be matched for HA-1 or HA-2 minor antigens. HA-1-positive patients will be assigned to the TSC-100 treatment arm, while HA-2-positive patients will be assigned to the TSC-101 treatment arm. Patients who are negative for both antigens or who do not match their donor will be assigned to the standard care arm, which will serve as a control as historical data shows that antigen mismatch does not alone affect blood levels. relapse. Approximately 40% of patients are expected to be eligible for TSC-100 or TSC-101.
Primary endpoints of the study include safety and dose determination, and secondary and exploratory endpoints include relapse rate versus standard care as well as quantitative laboratory readings, including minimal residual disease and the kinetics of donor chimerism. Patient enrollment will begin in the first quarter of 2022. Once the recommended phase 2 dose is identified, the study will move to a phase 2 to assess relapse rates of treated patients compared to the standard care arm.
“The rapid advancement of our clinical liquid tumor programs demonstrates the value of our proprietary technology platform,” said Gavin MacBeath, Ph.D., Scientific Director of TScan Therapeutics. “With TargetScan and ReceptorScan, we were able to quickly identify natural high-affinity TCRs and reduce the risks of their clinical development by comprehensively screening for off-target effects. Using T-Integrate and our in-house GMP facility, we are able to efficiently manufacture genetically reprogrammed T cells with additional features that further enhance their function.
The details of the ASH 2021 poster presentations are as follows:
Title: Product Features and Multi-Arm Clinical Trial Design for TSC-100 and TSC-101, TCR-T Cells Targeting Leukemia After Hematopoietic Cell Transplantation Presenter: Shrikanta Chattopadhyay, MD, MBBS, TScan Therapeutics Author: Chattopadhyay et al. Abstract #: 153844 Session Type: Poster Presentation Session: Cellular Immunotherapies: Clinic Date and Time: Monday, December 13, 2021, 6 p.m. to 8 p.m. ET
Title: Discovery of TSC-101: A Natural First Class HA-2 Specific TCR to Treat Leukemia Following Hematopoietic Stem Cell Transplantation Therapy Presenter: Gavin MacBeath, Ph.D., TScan Therapeutics Author: Nayar et al. Abstract #: 151317 Session Type: Poster Presentation Session: Cellular Immunotherapies: Basic and Translational Date and Time: Saturday, December 11, 2021, 5:30 p.m. to 7:30 p.m. ET
Upon presentation, each poster will be available in the “Publications” section of the Company’s website at https://www.tscan.com/technology/publications/.
About TScan Therapeutics, Inc.
TScan is a biopharmaceutical company focused on the development of T cell modified T cell receptor (TCR) (TCR-T) therapies for the treatment of cancer patients. The Company’s primary candidates for TCR-T liquid tumor therapy, TSC-100 and TSC-101, are under development for the treatment of patients with hematologic malignancies to eliminate residual leukemia and prevent disease. relapses after hematopoietic stem cell transplantation. The company is also developing TCR-T multiplexed therapeutic candidates for the treatment of various solid tumors.
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