Marker Therapeutics Awarded $2 Million Grant from NIH in Support of Phase 1 Study Investigating MT-601 in CAR-Relapsed Patients with Non-Hodgkin’s Lymphoma
Marker Therapeutics (Nasdaq: MRKR) has been awarded a $2 million grant from the NIH Small Business Innovation Research program to support the clinical investigation of MT-601 in patients with non-Hodgkin's lymphoma (NHL) who have relapsed following anti-CD19 CAR T cell therapy. The grant will fund the nationwide multi-center Phase 1 APOLLO study, evaluating the safety and efficacy of MT-601, a multi-tumor associated antigen-specific T cell product.
The company has now received over $19 million in non-dilutive funding. Preliminary results from the APOLLO study show objective responses in all three study participants treated at City of Hope, with no cytokine release syndrome or immune effector cell associated neurotoxicity syndrome observed. This grant supports Marker's efforts to address the unmet medical need for patients who relapse after CD19-targeting CAR-T cell therapy.
Marker Therapeutics (Nasdaq: MRKR) ha ricevuto un finanziamento di 2 milioni di dollari dal programma NIH Small Business Innovation Research per supportare l'indagine clinica di MT-601 in pazienti con linfoma non-Hodgkin (NHL) che sono recidivati dopo la terapia con cellule T CAR anti-CD19. Il finanziamento sarà utilizzato per lo studio multi-centro di Fase 1 APOLLO a livello nazionale, volto a valutare la sicurezza e l'efficacia di MT-601, un prodotto a base di cellule T specifiche per antigeni associati a più tumori.
La società ha ora ricevuto oltre 19 milioni di dollari in finanziamenti non diluitivi. I risultati preliminari dello studio APOLLO mostrano risposte oggettive in tutti e tre i partecipanti allo studio trattati presso il City of Hope, senza osservare sindrome da rilascio di citochine o sindrome neurotossica associata a cellule effettrici immunitarie. Questo finanziamento supporta gli sforzi di Marker per affrontare il bisogno medico insoddisfatto dei pazienti che recidivano dopo la terapia con cellule CAR-T mirate a CD19.
Marker Therapeutics (Nasdaq: MRKR) ha recibido una del programa NIH Small Business Innovation Research para apoyar la investigación clínica de MT-601 en pacientes con linfoma no Hodgkin (NHL) que han recaído tras la terapia con células T CAR anti-CD19. La subvención financiará el estudio multicéntrico Fase 1 APOLLO, que evalúa la seguridad y eficacia de MT-601, un producto de células T específicas para antígenos asociados a múltiples tumores.
La compañía ha recibido más de 19 millones de dólares en financiamiento no dilutivo. Los resultados preliminares del estudio APOLLO muestran respuestas objetivas en los tres participantes del estudio tratados en City of Hope, sin que se hayan observado síndrome de liberación de citoquinas o síndrome neurotóxico asociado a células efectoras inmunitarias. Esta subvención apoya los esfuerzos de Marker para abordar la necesidad médica no satisfecha de los pacientes que recaen después de la terapia con células CAR-T dirigidas al CD19.
Marker Therapeutics (Nasdaq: MRKR)는 200만 달러의 보조금을 NIH 소규모 기업 혁신 연구 프로그램에서 수여받아 CD19 CAR T 세포 요법 후 재발한 비호지킨 림프종(NHL) 환자에 대한 MT-601의 임상 조사를 지원합니다. 이 보조금은 MT-601의 안전성 및 유효성을 평가하는 국가 멀티 센터 1상 APOLLO 연구에 사용될 것입니다.
회사는 현재 1900만 달러 이상의 비희석 자금을 받았습니다. APOLLO 연구의 예비 결과는 City of Hope에서 치료받은 세 명의 연구 참여자 모두에게서 객관적인 반응을 보여주며, 세포 사이토카인 방출 증후군이나 면역 효과 세포 관련 신경독성 증후군은 관찰되지 않았습니다. 이 보조금은 CD19 표적 CAR-T 세포 요법 후 재발하는 환자들을 위한 충족되지 않은 의료 수요를 해결하려는 Marker의 노력을 지원합니다.
Marker Therapeutics (Nasdaq: MRKR) a reçu une subvention de 2 millions de dollars du programme NIH Small Business Innovation Research pour soutenir l'investigation clinique de MT-601 chez des patients atteints de lymphome non hodgkinien (NHL) ayant rechuté après une thérapie CAR T-cell anti-CD19. La subvention financera l'étude APOLLO de Phase 1 à plusieurs centres à l'échelle nationale, évaluant la sécurité et l'efficacité de MT-601, un produit de cellules T spécifiques aux antigènes associés à plusieurs types de tumeurs.
La société a maintenant reçu plus de 19 millions de dollars de financements non dilutifs. Les résultats préliminaires de l'étude APOLLO montrent des réponses objectives chez les trois participants de l'étude traités au City of Hope, sans que l'on ait observé de syndrome de libération de cytokines ou de syndrome neurotoxique associé aux cellules effectrices immunitaires. Cette subvention soutient les efforts de Marker pour répondre aux besoins médicaux non satisfaits des patients qui rechutent après une thérapie CAR-T ciblant le CD19.
Marker Therapeutics (Nasdaq: MRKR) hat eine Förderung von 2 Millionen Dollar aus dem NIH Small Business Innovation Research-Programm erhalten, um die klinische Untersuchung von MT-601 bei Patienten mit non-Hodgkin-Lymphom (NHL), die nach einer anti-CD19 CAR-T-Zelltherapie einen Rückfall erlitten haben, zu unterstützen. Die Förderung wird die landesweite multizentrische Phase-1-APOLLO-Studie finanzieren, die die Sicherheit und Wirksamkeit von MT-601, einem spezifischen T-Zell-Produkt für mehrere Tumorassoziierte Antigene, bewertet.
Das Unternehmen hat nun über 19 Millionen Dollar an nicht verwässernden Mitteln erhalten. Vorläufige Ergebnisse der APOLLO-Studie zeigen, dass alle drei Studienteilnehmer, die in der City of Hope behandelt wurden, objektive Reaktionen zeigen, ohne dass ein Zytokinfreisetzungssyndrom oder ein syndrombezogenes neurotoxisches Syndrom beobachtet wurde. Diese Förderung unterstützt die Bemühungen von Marker, den unerfüllten medizinischen Bedarf von Patienten, die nach CD19-gerichteter CAR-T-Zelltherapie zurückfallen, zu decken.
- Awarded $2 million NIH grant for Phase 1 APOLLO study
- Received over $19 million in total non-dilutive funding
- Preliminary results show objective responses in all three study participants
- No cytokine release syndrome or neurotoxicity observed in initial patients
- None.
Insights
This
The preliminary clinical data showing objective responses in all three initial study participants, coupled with the absence of severe side effects like CRS or ICANS, is particularly promising. However, it's important to note that these are early results and long-term efficacy and safety data are still pending. The multi-tumor associated antigen approach of MT-601 could potentially offer a more robust treatment option, especially for patients who have developed resistance to single-target therapies.
The
However, investors should note that while this grant supports ongoing research, it doesn't guarantee commercial success. The company's focus on securing non-dilutive funding is a prudent strategy, particularly for a clinical-stage biotech firm. This approach helps conserve cash and extend the runway for clinical development, which is important given the long and expensive process of bringing new therapies to market.
Marker Therapeutics to receive non-dilutive funding from NIH Small Business Innovation Research Program based on preliminary clinical results and non-clinical data in lymphoma
HOUSTON, Aug. 12, 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 tumor indications, today announced that the Company has been awarded a
The SBIR grant has been awarded based in part on Marker’s preliminary clinical data in patients with lymphoma (Press Release, September 11, 2023) as well as non-clinical data demonstrating the anti-tumor activity of MT-601 on anti-CD19 CAR resistant lymphoma cells (Press Release, May 31, 2023). The proceeds of the grant will support the nationwide multi-center Phase 1 APOLLO study (ClinicalTrials.gov identifier: NCT05798897), evaluating the safety and efficacy of MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, in patients with relapsed NHL including those previously treated with anti-CD19 CAR-T cell therapy. Including this SBIR grant, the Company has been awarded over
“We are pleased to receive the SBIR grant from the NIH to support our clinical Phase 1 study in CAR-relapsed patients with non-Hodgkin’s lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “Although anti-CD19 CAR-T cells are rapidly expanding as a treatment option in patients with hematological malignancies, approximately 40
Dr. Vera continued: “While our results of the APOLLO study are preliminary, as we move through the dose escalation part of the study, we are encouraged by the objective responses observed in all three study participants treated at City of Hope (Press Release, April 8, 2024) and the lack of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) observed. We will continue to closely monitor all patients for long-term treatment effects and durability of response, and with the non-dilutive funding support from NIH we look forward to treating additional participants in this Phase 1 study.”
“This grant award is a testimony of our continued commitment to apply for non-dilutive funding and allows us to leverage our data to drive innovation and growth while maximizing shareholder value. Obtaining non-dilutive funding is an ongoing effort, and we are actively applying for additional opportunities as they become available,” concluded Dr. Vera.
About the NIH SBIR Program
The NIH Small Business Innovation Research (SBIR) Program sets aside more than
About MT-601
The Company’s lead product, MT-601, is a multi-tumor associated antigen (multiTAA)-specific T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGE-A4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of lymphoma patients who are relapsed after or where CD19 CAR-T cell therapy is not an option.About APOLLO
The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with lymphoma who relapsed after anti-CD19 CAR-T cell therapy or where anti-CD19 CAR-T cell therapy is not an option. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the safety and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. Under the APOLLO trial, it is anticipated that nine clinical sites across the United States will cumulatively enroll up to approximately 30 participants during the dose escalation phase.
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. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research.
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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-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.
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