TScan Therapeutics Presents Promising Updated Phase 1 Clinical Results on TSC-100 and TSC-101 at the 2024 Tandem Meetings of ASTCT and CIBMTR
- All treated patients across TSC-100 and TSC-101 arms achieved complete donor chimerism with no relapse.
- One patient with high-risk, TP53-mutated MDS is relapse-free for over a year following treatment with TSC-101.
- Data suggests complete donor chimerism is a key indicator of treatment success.
- The company will host a virtual KOL event to discuss the updated data from the Phase 1 trial.
- None.
Insights
The recent clinical trial data for TScan Therapeutics' TSC-100 and TSC-101 therapies represent a significant development in the treatment of hematologic malignancies such as AML, ALL and MDS. The reported achievement of complete donor chimerism in all eight patients treated with these therapies is a promising indicator of efficacy, particularly in the context of preventing relapse post-hematopoietic cell transplantation (HCT). This is noteworthy as relapse rates post-HCT remain a critical challenge, with approximately 40% of patients experiencing a relapse.
From a research perspective, the sustained complete donor chimerism suggests that the patient's immune system is being adequately replaced by the donor's, which is a crucial step in ensuring the success of the HCT. Furthermore, the conversion of a patient from MRD-positive to MRD-negative status post-treatment with TSC-101 is a significant milestone, indicating the potential of these therapies to eradicate minimal residual disease, which is often a precursor to relapse.
The control arm data, which show a higher relapse rate, underscore the potential benefits of TSC-100 and TSC-101. However, it is important to consider that the sample size is relatively small and the follow-up period is limited. Long-term data will be essential to fully understand the efficacy and safety profile of these treatments.
The concept of donor chimerism is central to the success of allogeneic HCT, where a patient's diseased bone marrow is replaced with healthy donor cells. Achieving and maintaining complete donor chimerism, as reported in the TScan Therapeutics trial, is a critical factor in reducing the risk of relapse. It indicates that the transplanted donor cells have fully engrafted and are functionally active within the patient's body.
For patients with high-risk TP53-mutated MDS, the reported one-year relapse-free survival following treatment with TSC-101 is particularly encouraging. TP53 mutations are associated with poor prognosis and high relapse rates, thus the results may represent a significant advancement in the management of these patients. The use of TSC-100 and TSC-101 therapies in this context could potentially lead to improved outcomes, although further investigation in larger cohorts is necessary to validate these preliminary findings.
Additionally, the development of grade 1 skin graft-versus-host disease (GVHD) in one patient indicates the complexity of immune interactions post-transplant and the need for careful management of immunosuppression to balance the graft-versus-leukemia effect with the risk of GVHD.
The positive trial results for TScan Therapeutics could have a favorable impact on the company's financial outlook and market position. The biopharmaceutical sector is highly competitive and successful clinical outcomes can lead to increased investor confidence, potential partnerships and opportunities for accelerated regulatory pathways. The data presented could be an inflection point for TScan, positioning it as a leader in TCR-engineered T cell therapies for hematologic malignancies.
While the market for cancer treatments is vast, the high unmet need in AML, ALL and MDS provides a significant opportunity for TScan to capture market share. The company's focus on addressing relapse post-HCT could cater to a niche yet critical segment of the market. Additionally, the potential for these therapies to expand into other indications could further enhance their commercial prospects.
Investors will be closely monitoring the ongoing enrollment and long-term data from the study. As the company progresses through the clinical trial phases, the ability to maintain a strong cash position and manage operational costs will be crucial for sustaining momentum and ultimately bringing these therapies to market.
All eight (
Patient with high-risk, TP53-mutated MDS is relapse-free for over one year following treatment with TSC-101
Patient with AML converted from detectable to undetectable disease following treatment with TSC-101
Data presented at TANDEM meeting suggests complete donor chimerism is an early indicator of treatment success
Company to host virtual KOL event today, Monday, February 26, at 8:00 a.m. ET, to discuss the data presented at the 2024 Tandem Meetings
WALTHAM, Mass., Feb. 26, 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 announced an oral presentation at the 2024 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®). The oral presentation, selected for the plenary session as a Best Abstract, highlights updated data from the Phase 1 multi-arm clinical trial evaluating TSC-100 and TSC-101, designed to treat residual disease and prevent relapse following hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL) (NCT05473910).
“We are excited to report updated data from our heme program, with eight patients across our treatment arms and six patients in our control arm. We remain encouraged to see that no relapses have occurred to date in treated patients, four of whom have been on the study for over ten months. One patient with high-risk, TP53-mutated MDS has now reached the one-year mark following treatment with TSC-101, a meaningful milestone as the likelihood of relapse decreases significantly over time, leading to an improved quality of life,” said Debora Barton, M.D., Chief Medical Officer. “We have also enrolled six patients in the control arm, receiving transplant alone. To date, two control-arm patients relapsed following transplant, at days 161 and 180, and one of these patients succumbed to the relapse at day 265. A third patient required clinical intervention at day 133 because of concerns of impending relapse.”
“Sustained complete donor chimerism may be the most valuable indicator of treatment success,” added Gavin MacBeath, Ph.D., Chief Executive Officer. “HCT is currently the best treatment option for many patients suffering from AML, MDS, and ALL, as approximately
The Phase 1 trial is a multi-arm dose escalation study evaluating TSC-100 and TSC-101, which are designed to treat residual disease and prevent relapse following HCT in patients with AML, ALL or MDS undergoing haploidentical donor allogeneic HCT with reduced intensity conditioning. Primary endpoints include safety and dose-finding, and secondary and exploratory endpoints include relapse rates versus standard-of-care (HCT alone) as well as supportive surrogates of efficacy, including donor chimerism and minimal residual disease (MRD). MRD identifies any residual disease-related DNA present in a patient, and chimerism measures any remaining recipient-derived hematopoietic cells in a patient following HCT (NCT05473910).
Key Presentation Highlights Include:
TSC-100 treatment arm (N=4: T-ALL, AML, AML, MDS)
- 4/4 patients treated with TSC-100 achieved complete donor chimerism with no relapse.
TSC-101 treatment arm (N=4: TP53-mutated MDS, AML, B-ALL, B-ALL)
- 4/4 patients treated with TSC-101 achieved complete donor chimerism with no relapse, including a patient with high-risk, TP53-mutated MDS who has reached one year of follow-up.
- One patient with AML was MRD-positive following HCT and converted to and maintained MRD-negative status following treatment with TSC-101 (most recent measurement at day 180).
TSC-100 and TSC-101 persistence noted for prolonged periods:
- Persistence of TSC-100 and TSC-101 was observed at all time points after dosing, with the longest follow-up of over 9 months.
- Repeat dosing (dose levels 2 and 3) led to a 3-fold increase in circulating TSC-100 and TSC-101 levels compared to single dosing (dose level 1) at the same time points.
Six control arm patients (MDS, MDS, MDS, AML, AML, AML) have been enrolled and received standard of care HCT alone:
- One control-arm patient with high-risk, TP53-mutated MDS evolved with MRD positivity and worsening mixed chimerism, experienced clinical relapse approximately six months post-transplant, and succumbed to relapse approximately nine months post-transplant.
- One control-arm patient with MDS experienced clinical relapse approximately five months post-transplant.
- One control-arm patient with MDS developed worsening mixed chimerism requiring early termination of immunosuppression, resulting in complete donor chimerism but with grade 1 skin graft-versus-host disease.
- One control-arm patient never achieved complete donor chimerism, with more than four months follow-up post-transplant.
- 2/6 control-arm patients achieved complete donor chimerism following HCT.
Virtual KOL Event
The Company will host a virtual KOL event featuring:
- Monzr M. Al Malki, M.D., Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of the Unrelated Donor Bone Marrow Transplant and Haploidentical Transplant Programs at City of Hope
- Ran Reshef, M.D., M.Sc., Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center
The conference call will be held today, February 26, at 8:00 a.m. ET, to discuss the data presented at the Tandem Meetings. Details for attending the live event can be found here. A replay will be made available on the “Events and Presentations” section of the Company’s investor relations website at ir.tscan.com.
About TScan Therapeutics, Inc.
TScan is 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. The Company’s lead TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual disease and prevent relapse after allogeneic hematopoietic cell transplantation. The Company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized, enhanced, multiplexed TCR-T therapies for patients with a variety of cancers.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s hematologic malignancies program, including the potential implications of initial data from a large prospective clinical trial, presentation of additional data, and potential indicators of treatment success; the potential benefits of any of the Company’s current or future product candidates in treating patients; and the Company’s goals and strategy. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; the timing of the initiation, progress and expected results of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements and execute on upcoming anticipated milestones into 2026; and the effect of the COVID-19 pandemic, including mitigation efforts and political, economic, legal and social effects, on any of the foregoing or other aspects of TScan’s business or operations; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.
Contacts
Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
hsavelle@tscan.com
Joyce Allaire
LifeSci Advisors, LLC
Managing Director
617-435-6602
jallaire@lifesciadvisors.com
FAQ
How many patients achieved complete donor chimerism with no relapse in the TSC-100 and TSC-101 arms?
Which patient is relapse-free for over a year following treatment with TSC-101?
What is the key indicator of treatment success according to the data presented?
What event will the company host to discuss the updated data from the Phase 1 trial?
