Full Press Release Details
Marker Therapeutics Announces FDA Clearance
of IND for MT-601, the six-antigen targeted T Cell Therapy for the treatment of relapsed/refractory Non-Hodgkin Lymphoma
Company expects to initiate Phase 1 trial of
MT-601 in r/r NHL in 2023
Houston, TX-August 4, 2022-Marker
Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation
T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the U.S.
Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for MT-601, a multi-tumor-associated
antigen (multiTAA)-specific T cell product targeting six antigens, for the treatment of patients with relapsed/refractory non-Hodgkin
lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment.
"This new clinical trial will build upon results that were observed
in the Phase I/II TACTAL study conducted by BCM, which assessed the safety and efficacy of five-antigen-directed multiTAA-specific T cell
product," stated Dr. Mythili Koneru, Marker's Chief Medical Officer. "In the TACTAL study, BCM observed long-term
CR rates that were comparable to recently approved CD19 CAR-T therapies, even at very low cell doses. Unlike CD19 CAR-T cell therapies,
patients receiving multiTAA-specific T cell product had superior durability of response, without the severe toxicities that commonly occur
with other adoptive cell therapies, such as cytokine release syndrome or neurotoxicity. Based on these results, we believe that multiTAA-specific
T cell products can be easily administered in an outpatient setting without hospitalization."
In the TACTAL study, patients were treated with five-antigen-directed multiTAA-T cell product. Based upon the safety profile observed with multiTAA-specific T cell therapies containing WT-1 in multiple cancer
indications, the FDA cleared in the IND the addition of WT-1 as the sixth tumor-associated antigen to the MT-601 product that will be
used to treat patients in the Marker sponsored study. In addition, the FDA has cleared Marker to initiate its study at a dose level of
200 million cells per infusion, versus the dose range of 10-40 million cells per infusion used in the TACTAL study. This increase in the
cell dose will be possible due to Marker's development and adoption of a 9-day manufacturing process, which also accelerates the
Dr. Koneru continued: "We believe that the most important
finding of the TACTAL study was that the administration of multiTAA therapy consistently drove an enhanced immunological response from
the patient's own immune system, which we believe was due to the lack of lymphodepletion which allowed the patient's own immune
system to play a part. We believe that this phenomenon, known as epitope spreading, was critical in driving more durable responses than
have been observed with other cell therapies like TCRs and CAR-Ts. It is notable that none of the patients who developed a CR in the TACTAL
study relapsed during the follow up period, and several patients have been in CR for over five years at their last follow-up. This contrasts
strongly with the experience of CD-19 CAR-Ts, where up to 40% of patients are expected to relapse within 12 months of developing a complete
Marker's MT-601 Phase 1 trial will focus on r/r NHL patients
who have failed CD19 CAR-T therapy, or those who are ineligible for treatment with those therapies. MT-601 targets a series of tumor
antigens other than CD19, offering patients a therapeutic alternative even if their tumor has escaped by downregulating the expression
of CD19. For patients who cannot access CD19 therapies, MT-601 has the potential to generate objective responses, with tolerability and
potentially longer duration of response.
"FDA clearance of our IND for MT-601
is a significant milestone as we advance our pipeline in a number of Company-sponsored trials," said Peter L. Hoang, Marker's
President and Chief Executive Officer. "We believe that MT-601, which targets six tumor-associated antigens highly expressed
in lymphoma, has the potential to build upon results of the TACTAL study. We look forward to initiating our Company-sponsored Phase 1
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology
company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies
and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific
T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of
T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system
to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our
product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and
TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell
therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.
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Forward-Looking Statements
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, including MT-601; 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, including the Phase 1 trial
of MT-601. 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.
Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global economy. 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.
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