Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601

Rhea-AI Summary

Marker Therapeutics, Inc. (MRKR) announced the approval of 'neldaleucel' as the nonproprietary name for MT-601, a T cell product candidate for the treatment of lymphoma. The approval signifies a significant milestone in the development of multiTAA therapies, following positive clinical safety and durability results in the Phase 1 study. Juan Vera, M.D., President and CEO of Marker Therapeutics, expressed the importance of the approval in advancing potential treatments for patients with lymphoma.

Oncology Doctor

The approval of the nonproprietary name 'neldaleucel' for MT-601 by the USAN Council and WHO INN is a noteworthy development in the field of immuno-oncology. This signifies that the drug candidate has undergone rigorous evaluation and has met certain standards. From a clinical perspective, the designation of a universal name is crucial as it facilitates clear communication among healthcare professionals and ensures that the drug can be accurately identified in various stages of treatment, from prescription to administration.

Moreover, the clinical update regarding MT-601's safety and efficacy in a Phase 1 study provides promising insights into its potential as a therapeutic option for lymphoma patients, particularly those with CAR T-cell therapy relapse. As an oncologist, the durability of response and safety profile observed in the study are key factors when considering new treatments, as they directly impact patient outcomes and quality of life.

Medical Research Analyst

The adoption of 'neldaleucel' as the INN for Marker Therapeutics' MT-601 marks a significant transition from clinical research to potential commercialization. The INN system is designed to provide a unique and universally accepted name to active pharmaceutical ingredients, which is essential for the clear identification and global communication about the drug. This step is often indicative of a product's progression through the regulatory pathway and can be seen as a precursor to further clinical development and potential marketing authorization.

From a research analyst's viewpoint, the clinical update indicating a positive safety profile and clinical benefit in the first study participant is a key factor in assessing the drug candidate's viability. It suggests that the company's multiTAA-specific T cell approach may offer a valuable alternative treatment modality in the immuno-oncology space, which is a highly competitive and rapidly evolving field.

Market Research Analyst

Marker Therapeutics' announcement regarding the INN naming and clinical study update could have implications for its market position and investor perceptions. The immuno-oncology market is characterized by high growth potential and significant investment interest. The assignment of an INN not only streamlines future marketing and regulatory processes but also serves as a signal to the market of the drug's advancing maturity in the development pipeline. Investors often monitor such milestones closely as they can influence the company's valuation and the stock's performance.

Furthermore, the positive clinical safety and durability data contribute to the company's narrative of innovation and therapeutic promise. If subsequent data continues to support MT-601's efficacy and safety, the impact on business could be substantial, potentially leading to partnerships, increased funding opportunities, or favorable stock market reactions.

HOUSTON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, announced today that the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved “neldaleucel” as the nonproprietary (generic) name for MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product candidate for the treatment of patients with lymphoma.

The USAN Council in close collaboration with the WHO established INN expert committee select and assign a single unique name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical, ensuring clear identification, safe prescription and dispensing of medicines to patients. Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by national and international legislations. The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing. The Company recently provided a clinical update on the Phase 1 study investigating MT-601 in CAR relapse patients with lymphoma, demonstrating clinical safety and durability in the first study participant, suggesting the clinical benefit of neldaleucel (Press Release, Dec 11, 2023).

“The assignment of the nonproprietary name to MT-601 represents a significant milestone as we advance this potential treatment for patients with lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “The INN and USAN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. The USAN and WHO INN approval of neldaleucel allows us to establish a universally recognized and conflict-free nonproprietary drug name for MT-601 and represents an important step in our path to ultimately market the drug.”

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/donor’s blood capable of recognizing a broad range of tumor antigens. Clinical trials that enrolled more than 200 patients with various hematological malignancies and solid tumors showed that autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables the potential contribution to a lasting anti-tumor effect.

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. The T cell therapy technology developed by Marker 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 the T cells, Marker believes that its 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; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the timing, conduct and success of our clinical trials of our product candidates, including MT-401 for the treatment of patients with AML and MT-601 for the treatment of patients with 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 its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.

Contacts
TIBEREND STRATEGIC ADVISORS, INC.
Investors
Daniel Kontoh-Boateng
(862) 213-1398
dboateng@tiberend.com

Media
Casey McDonald
(646) 577-8520
cmcdonald@tiberend.com

What is the nonproprietary name approved for MT-601 by the USAN and WHO INN?

The nonproprietary name approved for MT-601 is 'neldaleucel'.

What is Marker Therapeutics' ticker symbol?

Marker Therapeutics' ticker symbol is MRKR.

What type of products is Marker Therapeutics developing?

Marker Therapeutics is developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors.

When was the clinical update on the Phase 1 study investigating MT-601 provided?

The clinical update on the Phase 1 study investigating MT-601 was provided on December 11, 2023.

Who is the President and CEO of Marker Therapeutics?

Juan Vera, M.D., is the President and CEO of Marker Therapeutics.