Marker Therapeutics Announces First Lymphoma Patient Treated with MT-601 in Phase 1 Clinical Trial
Adoptive T cell transfer, such as genetically modified T cells expressing anti-CD19 chimeric antigen receptors (CARs) targeting CD19 antigens, is a therapeutic modality that has recently demonstrated impressive clinical impact in patients with large B-cell malignancies who have failed more than two lines of treatment. Administration of anti-CD19 CAR T cells to patients with relapsed/refractory B-cell lymphomas have been a transformative treatment paradigm because of their significant benefit relative to the standard of care. However, for various reasons, including low antigen levels and loss of CD19 antigen expression, anti-CD19 CAR T cell therapy is associated with relapse rates of up to 60%, within one year (Chong et al, N Engl J Med, 2021). In addition, a number of patients with relapsed/refractory B-cell lymphomas are ineligible for anti-CD19 CAR T cell therapy due to the associated toxicities.
A recent Phase 1 study conducted by
Marker is developing MT-601, an autologous T cell product that is directed against six tumor associated antigens for the treatment of patients with relapsed/refractory lymphoma who are either ineligible to receive or have failed anti-CD19 CAR T cell therapy. Given the positive TACTAL trial results, which targeted five tumor associated antigens, Marker believes broadening its multiTAA-specific T cell product to target six antigens could result in better and more durable responses due to its ability to overcome antigen loss by targeting more than one antigen.
The recent press release issued by Marker on
The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) sponsored by Marker is assessing MT-601 in patients with lymphoma who have either relapsed after anti-CD19 CAR T cell therapy or were ineligible to receive it. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of MT-601 in patients with various lymphoma subtypes. Data from the APOLLO trial will guide
The first patient in the APOLLO trial recently received MT-601 at the 200 million cell dose level. This patient was monitored for 18 days after being dosed and showed no treatment-related adverse events, indicating that the therapy was well tolerated. This observation is consistent with the favorable safety profile and tolerability previously reported for lymphoma patients in the TACTAL study. Under the APOLLO trial, eight clinical sites across
"The initiation of clinical treatment under the APOLLO trial represents not just a major achievement for our team at Marker, but a beacon of hope for countless individuals with lymphoma who are confronting the reality of disease progression,” said
"Phase 1 of the clinical trial is a critical period," continued
"We are grateful to our dedicated team of scientists, clinicians, and trial participants who have made this significant step possible," said
“The initiation of clinical treatment under the Phase 1 trial of MT-601 is a major step in our mission to bring forward transformative advancements in lymphoma treatment, with the goal of significantly improving patient outcomes. We are committed to diligently monitoring and analyzing the data from this Phase 1 clinical trial to ensure we continue making informed decisions that prioritize patient safety and therapeutic effectiveness," concluded
About multiTAA-specific T cells
The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's blood capable of recognizing a broad range of tumor antigens. Clinical trials that enrolled more than 180 patients with various hematological malignancies and solid tumors showed that the multiTAA-specific T cell product was well tolerated, demonstrated durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables the patient's own T cells to expand, potentially contributing to a lasting anti-tumor effect. Unlike other cell therapies which require hospitalization and close monitoring, multiTAA-specific T cells are designed to be administered in an outpatient setting.
To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials of our product candidates, including MT-601 for the treatment of patients with relapsed non-Hodgkin lymphoma. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Source: Marker Therapeutics