TScan Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating TCR-T Therapy for the Treatment of Solid Tumors

Rhea-AI Summary

TScan Therapeutics announced the dosing of the first patient in a Phase 1 clinical trial for TCR-T therapy targeting solid tumors, with initial data expected in 2024. The company aims to expand its ImmunoBank to enhance multiplex TCR-T therapy for solid tumors.

Positive

• TScan Therapeutics successfully dosed the first patient in its Phase 1 clinical trial for TCR-T therapy targeting solid tumors.

• The company is on track to report initial data from the solid tumor clinical trial in 2024, showcasing progress in its clinical programs.

• TScan Therapeutics is manufacturing TCR-T products for additional patients and plans to file more IND applications for expanding the ImmunoBank to offer multiplex TCR-T therapy for solid tumors.

Negative

• Effective treatment of solid tumors is challenging due to their heterogeneity, which may impact the success of the multiplex TCR-T therapy.

• Despite the enthusiasm for the trial, the outcome of the Phase 1 trial and the effectiveness of TCR-T therapy in treating solid tumors remain to be seen.

Insights

Medical Research Analyst

The initiation of TScan Therapeutics' Phase 1 clinical trial with the first patient dosed marks a pivotal step in the development of its TCR-T therapy, potentially addressing a critical gap in oncological treatments for solid tumors. TSC-203-A0201 targets PRAME, a tumor antigen that is prevalently expressed in various malignancies, including melanoma. The specificity of TCR-T therapy to target antigens like PRAME offers a tailored approach potentially increasing efficacy and reducing off-target effects which are common in broader-spectrum cancer therapies. The mention of a multi-pronged approach acknowledges the complexity of solid tumors, which often require combinatorial or highly specific treatments to overcome the heterogeneity and resistance mechanisms. The clinical progress suggests a strategic move to expand the ImmunoBank, indicating a significant investment in diversifying treatment options for cancer patients. If the initial data, expected to be reported in 2024, show promising results, it could lead to increased investor confidence and a positive impact on the company's valuation. Looking ahead, the scalability of the TCR-T platform and its success in clinical trials will be critical in determining the company's long-term potential in the rapidly growing field of personalized cancer therapeutics.

Market Research Analyst

As TScan Therapeutics progresses into the clinical trial phase for its TCR-T therapy, the company appears to be capitalizing on the increasing demand for personalized cancer treatments. The biotechnology landscape has seen a surge in investment into cell therapy technologies and TScan's foray into this space could position them favorably against competitors. The market for targeted cancer treatments, especially those addressing solid tumors, represents a substantial opportunity given the high incidence and mortality associated with these cancers. The company's strategic focus on expanding its ImmunoBank to cover diverse targets and HLA types could be a move to capture a broader patient demographic and cater to individual patient needs, which is a trend gaining traction in precision medicine. The company's stock might experience volatility around the anticipated data release in 2024, with potential spikes if the data is favorable or drops if it fails to meet expectations. Investors are likely to monitor the trial's progress closely, considering its future implications on the company's product pipeline and market position.

Patient dosed with TSC-203-A0201 targeting cancer-associated antigen PRAME

On-track to report initial data from the solid tumor clinical trial in 2024

WALTHAM, Mass., May 09, 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 (TCR-T) therapies for the treatment of patients with cancer, today announced that the first patient has been dosed in the Company’s Phase 1 trial evaluating TCR-T therapy for the treatment of solid tumors. The patient, diagnosed with metastatic melanoma, was dosed with TSC-203-A0201 targeting the cancer-associated antigen PReferentially expressed Antigen in MElanoma (PRAME).

“Dosing the first patient in our solid tumor program is a significant milestone for us, as we are now well underway with both of our core clinical programs,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “There is a lot of enthusiasm for this trial, and we are already manufacturing TCR-T products for three more patients. We have six TCR-Ts cleared under existing IND applications for patient dosing in this program, and we plan to file additional IND applications to further expand the ImmunoBank across diverse targets and HLA types to broaden the reach of multiplex TCR-T therapy for solid tumors.”

“Solid tumors are notoriously heterogeneous, and we believe that an effective way to treat solid tumors is through a multi-pronged approach,” added Chrystal U. Louis, M.D., Chief Medical Officer. “Customized multiplex TCR-T therapy is designed to achieve durable responses by overcoming tumor heterogeneity and resistance that develops from either target or HLA loss. We look forward to sharing initial data from our solid tumor trial later this year.”

About TScan’s Solid Tumor Program

TScan’s Phase 1 clinical trial is designed to assess the safety and feasibility of T-Plex, autologous customized TCR-T therapy targeting multiple peptide/human leukocyte antigens (HLA) targets in participants with antigen-positive, locally advanced, unresectable or metastatic solid tumors. Multiplex TCR-T therapy has the potential to overcome tumor heterogeneity and HLA loss of heterozygosity, commonly observed resistance mechanisms in solid tumors. First generation TCR-T therapies, targeting single antigens, have shown encouraging response rates in patients, but have often shown limited duration of response.

TScan believes that its approach of dosing patients with more than one TCR-T targeting different cancer-associated antigens will result in increased response rates and increased duration of response. To make this possible, TScan is screening patients (screening protocol: NCT05812027) with melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, cervical cancer, ovarian cancer, anogenital cancers, and other solid tumors for target expression and the presence of intact HLA genes in their tumor cells. Eligible patients are then enrolled in the study treatment protocol (NCT05973487) and administered one or more investigational TCR-T products that are matched to cancer-associated antigens expressed in their tumors. This is made possible by the Company’s ImmunoBank, its repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types. Currently, the ImmunoBank includes six TCR-T clinical candidates in Phase 1 development: TSC-203-A0201 (PRAME, HLA-A*02:01); TSC-200-A0201 (HPV16, HLA-A*02:01); TSC-201-B0702 (MAGE-C2, HLA-B*07:02); TSC-204-A0201 (MAGE-A1, HLA-A*02:01); TSC-204-C0702 (MAGE-A1, HLA-C*07:02); and TSC-204-A0101 (MAGE-A1, HLA-A*01:01). TScan intends to continue to expand the ImmunoBank with TCR-Ts for additional targets and HLA types, thereby increasing the number of patients that are eligible to receive multiplex therapy.

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 candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation. The Company is also developing multiplexed TCR-T 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 multiplex therapeutic TCR-Ts 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 solid tumor program, including dosing of patients, reporting of data, and filing of INDs; the Company’s current and future research and development plans or expectations; the structure, timing and success of the Company’s planned preclinical development, submission of INDs, and clinical trials; the potential benefits of any of the Company’s proprietary platforms, multiplexing, or 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; the progress of the solid tumor Phase 1 clinical program being indicative or predictive of the success of such program; 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 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 

Maghan Meyers
Argot Partners
212-600-1902
TScan@argotpartners.com

FAQ

<p>What is the Phase 1 clinical trial announced by TScan Therapeutics?</p>

TScan Therapeutics announced the dosing of the first patient in a Phase 1 clinical trial evaluating TCR-T therapy for the treatment of solid tumors.

<p>Which cancer-associated antigen is targeted in the Phase 1 trial by TScan Therapeutics?</p>

The Phase 1 trial targets the cancer-associated antigen PRAME with TSC-203-A0201 in solid tumors.

<p>When is TScan Therapeutics expected to report initial data from the solid tumor clinical trial?</p>

Initial data from the solid tumor clinical trial is expected to be reported in 2024 by TScan Therapeutics.

<p>How does TScan Therapeutics plan to enhance multiplex TCR-T therapy for solid tumors?</p>

TScan Therapeutics aims to expand its ImmunoBank to offer multiplex TCR-T therapy for solid tumors by filing additional IND applications and manufacturing TCR-T products for more patients.