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Marker Therapeutics Provides a Clinical Update on MT-601 in Patients with Lymphoma

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Marker Therapeutics (MRKR) reported positive clinical updates from its Phase 1 APOLLO study of MT-601 in lymphoma patients. The study showed 78% objective response rates with 44.4% complete response in patients who relapsed after anti-CD19 CAR-T therapy or where CAR-T wasn't an option. Out of 10 treated patients, data is available for 9 participants from 5 U.S. clinical sites.

MT-601 demonstrated strong safety profile with no immune-effector cell associated neurotoxicity syndrome (ICANS) and only one Grade 1 cytokine release syndrome case. Long-term follow-up data of 6-12 months is available for three patients, with ongoing monitoring for response durability. The treatment showed efficacy in heavily pre-treated patients who had received 3-12 prior lines of therapy.

Marker Therapeutics (MRKR) ha riportato aggiornamenti clinici positivi dal suo studio di Fase 1 APOLLO di MT-601 su pazienti affetti da linfoma. Lo studio ha mostrato un tasso di risposta obiettivo del 78% con un tasso di risposta completa del 44,4% nei pazienti che hanno recidivato dopo la terapia CAR-T anti-CD19 o per i quali la CAR-T non era un'opzione. Su 10 pazienti trattati, sono disponibili dati per 9 partecipanti provenienti da 5 siti clinici negli Stati Uniti.

MT-601 ha dimostrato un forte profilo di sicurezza senza sindrome di neurotossicità associata alle cellule effettrici immunitarie (ICANS) e solo un caso di sindrome da rilascio di citochine di Grade 1. I dati di follow-up a lungo termine di 6-12 mesi sono disponibili per tre pazienti, con monitoraggio in corso per la durata della risposta. Il trattamento ha mostrato efficacia in pazienti pesantemente pre-trattati che avevano ricevuto da 3 a 12 linee terapeutiche precedenti.

Marker Therapeutics (MRKR) informó actualizaciones clínicas positivas de su estudio de Fase 1 APOLLO sobre MT-601 en pacientes con linfoma. El estudio mostró una tasa de respuesta objetiva del 78% con una tasa de respuesta completa del 44,4% en pacientes que habían recaído después de la terapia CAR-T anti-CD19 o donde CAR-T no era una opción. De 10 pacientes tratados, hay datos disponibles para 9 participantes de 5 sitios clínicos en EE. UU.

MT-601 demostró un fuerte perfil de seguridad sin síndrome de neurotoxicidad asociado a células efectoras inmunitarias (ICANS) y solo un caso de síndrome de liberación de citoquinas de Grado 1. Los datos de seguimiento a largo plazo de 6 a 12 meses están disponibles para tres pacientes, con monitoreo continuo para la durabilidad de la respuesta. El tratamiento mostró eficacia en pacientes con tratamiento previo intenso que habían recibido de 3 a 12 líneas de terapia.

Marker Therapeutics (MRKR)는 림프종 환자를 대상으로 한 MT-601의 1상 APOLLO 연구에서 긍정적인 임상 업데이트를 보고했습니다. 이 연구는 78%의 객관적 반응률44.4%의 완전 반응률을 보여주었으며, 이는 항-CD19 CAR-T 치료 후 재발한 환자 또는 CAR-T가 옵션이 아닌 환자에게 해당됩니다. 치료를 받은 10명의 환자 중 5곳의 미국 임상 센터에서 9명의 참가자에 대한 데이터가 제공됩니다.

MT-601은 면역 효과 세포와 관련된 신경독성 증후군(ICANS)이 없고 1단계의 사이토카인 방출 증후군 사례가 단 1건만 발생하여 안전한 프로필을 나타냈습니다. 6-12개월의 장기 추적 데이터는 3명의 환자에게서 이용 가능하며, 반응 지속성에 대한 지속적인 모니터링이 진행 중입니다. 이 치료는 3-12차의 사전 치료를 받은 환자들에게도 효능을 보여주었습니다.

Marker Therapeutics (MRKR) a rapporté des mises à jour cliniques positives de son étude de Phase 1 APOLLO sur MT-601 chez des patients atteints de lymphome. L'étude a montré un taux de réponse objective de 78% avec un taux de réponse complète de 44,4% chez les patients ayant rechuté après une thérapie CAR-T anti-CD19 ou pour qui la CAR-T n'était pas une option. Sur 10 patients traités, des données sont disponibles pour 9 participants provenant de 5 sites cliniques aux États-Unis.

MT-601 a démontré un solide profil de sécurité sans syndrome de neurotoxicité associé aux cellules effectrices immunitaires (ICANS) et seulement un cas de syndrome de libération de cytokines de Grade 1. Des données de suivi à long terme de 6 à 12 mois sont disponibles pour trois patients, avec un suivi continu de la durabilité de la réponse. Le traitement a montré son efficacité chez des patients lourdement prétraités ayant reçu de 3 à 12 lignes de thérapie précédentes.

Marker Therapeutics (MRKR) berichtete über positive klinische Aktualisierungen aus seiner Phase-1-Studie APOLLO zu MT-601 bei Lymphom-Patienten. Die Studie zeigte eine objektive Ansprechrate von 78% mit einer vollständigen Ansprechrate von 44,4% bei Patienten, die nach einer anti-CD19 CAR-T-Therapie zurückgefallen sind oder bei denen CAR-T keine Option war. Von 10 behandelten Patienten sind Daten für 9 Teilnehmer aus 5 klinischen Standorten in den USA verfügbar.

MT-601 zeigte ein starkes Sicherheitsprofil ohne neurotoxisches Syndrom im Zusammenhang mit Immunwirkungseffekten (ICANS) und nur einen Fall von Zytokinausschüttungssyndrom Grad 1. Langfristige Nachbeobachtungsdaten von 6 bis 12 Monaten sind für drei Patienten verfügbar, wobei die Reaktionshaltbarkeit weiterhin überwacht wird. Die Behandlung zeigte Wirksamkeit bei stark vorbehandelten Patienten, die zuvor 3 bis 12 Therapieansätze erhalten hatten.

Positive
  • 78% objective response rate in first dose cohort
  • 44.4% complete response rate in treated patients
  • Strong safety profile with no ICANS and minimal side effects
  • Effective in heavily pre-treated patients (3-12 prior therapies)
  • Addresses unmet need in post-CAR-T relapsed patients with no current standard treatment
Negative
  • patient data (only 9 patients analyzed)
  • Early-stage Phase 1 trial with long-term follow-up data

Insights

The Phase 1 APOLLO study results for MT-601 represent a significant breakthrough in treating relapsed lymphoma patients. The 78% objective response rate and 44.4% complete response rate in heavily pre-treated patients are remarkably high for this patient population. Most notably, these responses were achieved in patients who had failed 3-12 prior therapies, including CAR-T cell treatment.

The safety profile is particularly impressive - minimal cytokine release syndrome (Grade 1) and no immune-effector cell associated neurotoxicity syndrome (ICANS) represents a substantial improvement over current CAR-T therapies, which often cause severe side effects. This favorable safety profile could position MT-601 as a preferred treatment option, especially for frailer patients who may not tolerate traditional CAR-T therapy.

The multi-antigen recognizing (MAR) T cell approach addresses a key limitation of current CAR-T therapies by targeting multiple tumor antigens, potentially reducing the risk of resistance development. Early data suggesting enhanced expansion and persistence of MAR-T cells with lymphodepletion provides valuable insights for optimizing the treatment protocol.

The clinical significance of these results cannot be overstated. With 40-60% of lymphoma patients relapsing within a year of CD19 CAR-T therapy and no approved standard of care for this population, MT-601 addresses a critical unmet need. The durability data, though early, shows promising signs with sustained responses at 6-12 months in the initial patient cohort.

The non-engineered MAR-T cell approach represents a paradigm shift in cellular therapy. By expanding natural tumor-specific T cells that can recognize multiple antigens, this technology may offer better long-term efficacy and reduced risk of secondary malignancies compared to engineered CAR-T cells. The ability to achieve responses both with and without lymphodepletion provides valuable treatment flexibility for different patient populations.

For Marker Therapeutics (market cap: $36M), these results could be transformative. The addressable market is substantial and growing, considering the increasing use of CAR-T therapy and subsequent relapse rates. MT-601's superior safety profile and promising efficacy position it favorably for potential accelerated approval pathways, given the high unmet need in post-CAR-T relapsed patients.

The technology's scalability and potentially lower manufacturing costs compared to traditional CAR-T products could provide significant competitive advantages. The stock appears significantly undervalued given these clinical results and market opportunity, though investors should note that additional validation through larger trials will be important for regulatory approval and commercial success.

APOLLO study investigating MT-601 in patients with relapsed lymphoma: 78% of patients achieved objective response rates, with 44.4% demonstrating complete response (CR)

MT-601 was observed to be well tolerated in all study participants with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS)

HOUSTON, Dec. 19, 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 provided an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of September 10.

The Company’s Phase 1 APOLLO study is investigating MT-601, a multi-antigen recognizing (MAR) T cell product (formerly known as multi-tumor associated antigen-specific T cells, or multiTAA), in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR) T cell therapy or where anti-CD19 CAR-T cells are not an option. A total of 10 patients have been treated in the study, for which clinical data is currently available for 9 patients from 5 clinical sites across the United States. Study participants showed early objective responses with and without lymphodepletion. However, immunomonitoring data confirmed that lymphodepletion enhanced the expansion and persistence of MAR-T cell clones in vivo.

Key findings from the APOLLO study include:

  • Safety
    Infusion of MT-601 was well tolerated in all study participants, with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) and one reported Grade 1 cytokine release syndrome (CRS). No dose limiting toxicities (DLTs) have been reported to date.
  • Efficacy
    In the first dose cohort, 7 out of 9 patients achieved objective responses (78%) at first response assessment, with 4 patients demonstrating complete response (CR; 44.4%) (Table 1).
  • Time in Follow-Up
    Long-term follow-up of 6 to 12 months is currently available for three patients (Table 2). Ongoing follow-up visits are being conducted to assess the durability of responses. All study participants are monitored closely to ensure comprehensive data collection and patient safety.

Table 1: MT-601 shows objective responses at first disease assessment.

No. of Patients
Treated*
No. Prior Lines
of Therapy
Response Rate at
First Assessment
CR at First
Assessment
93 - 1278%44.4%

CR, Complete Response. Data as of September 10, 2024.

Table 2: Duration of patient follow-up in Phase 1 APOLLO study.

Longest Follow-UpNo. of PatientsClinical Response
≥ 12 months1CR
≥ 6 months2CR, PR
1-4 months4CR, PR

CR, Complete Response; PR, Partial Response. Data as of September 10, 2024.

“We are encouraged by the positive clinical outcomes we are observing in our Phase 1 APOLLO study,” said Monic Stuart, M.D., CMO of Marker Therapeutics. “Observing objective responses at the first response assessment in patients who have been heavily pre-treated and have relapsed after 3 to 12 prior lines of therapy, including CAR-T cells and bispecific antibodies, is a tremendous achievement and we are encouraged by the benefit and hope our therapy may provide to patients and their families. We will continue to monitor long-term treatment effects and durability of response and look forward to enrolling additional participants in this study.”

Although CD19-targeting CAR-T cell therapies have gained acceptance as treatment for patients with lymphoma, 40-60% of patients relapse within the first year of treatment (Chong et al, N Engl J Med, 2021; Neelapu et al, Blood, 2023.). These post-CD19 CAR-T relapsed patients currently have no approved standard of care, illustrating a high unmet medical need and urgency for new therapies. In addition, CAR-T cells are associated with severe side effects such as CRS or ICANS and may increase the risk for secondary malignancies (U.S. Food and Drug Administration, November 28, 2023). Data from clinical trials to date have demonstrated that MAR-T cells are well tolerated with no evidence of ICANS. In addition, Marker’s non-engineered MAR-T cell approach selectively expands natural tumor-specific T cells from a patient’s blood that can recognize a broad range of tumor antigens, minimizing the risk of mutagenesis.

“We are enthusiastic about the progress we have made with MT-601 and our study in patients with lymphoma who have relapsed after CD19 CAR-T cell therapy and for whom there is currently no approved drug on the market,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “We believe that MT-601 can address this unmet medical need in a large and growing patient population. We will continue to treat additional participants in this Phase 1 study to validate our observations and to gather comprehensive safety and durability data to identify the best developmental strategy for MT-601 development in patients with lymphoma.”

About MT-601
The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) 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, MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who relapsed after or are ineligible for anti-CD19 CAR-T cell therapies.

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 relapsed or refractory lymphoma who either failed anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are ineligible for anti-CD19 CAR-T cell therapy. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, 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 MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) 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, MAR-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 MAR-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. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-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, interim results announcements and outcomes 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.

Contacts
Investors
TIBEREND STRATEGIC ADVISORS, INC.
Jonathan Nugent
205-566-3026
jnugent@tiberend.com


FAQ

What are the response rates for MRKR's MT-601 in lymphoma patients?

In the Phase 1 APOLLO study, MT-601 achieved 78% objective response rates, with 44.4% of patients demonstrating complete response (CR) at first assessment.

How safe is MRKR's MT-601 compared to CAR-T cell therapy?

MT-601 showed a strong safety profile with no ICANS and only one Grade 1 cytokine release syndrome case, compared to CAR-T therapies which can cause severe side effects.

What is the current follow-up data for MRKR's MT-601 APOLLO study?

As of September 2024, long-term follow-up data of 6-12 months is available for three patients, with one patient followed for ≥12 months and two patients for ≥6 months.

How many patients were treated in MRKR's Phase 1 APOLLO study?

A total of 10 patients were treated in the study, with clinical data currently available for 9 patients from 5 clinical sites across the United States.

What patient population does MRKR's MT-601 target?

MT-601 targets lymphoma patients who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T cells are not an option, addressing an unmet medical need.

Marker Therapeutics, Inc.

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