On March 22, 2023 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, reported fiscal year 2022 financial results and provided updates for its clinical development programs (Press release, Marker Therapeutics, MAR 22, 2023, View Source [SID1234629162]).

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"2022 was a critical year for Marker Therapeutics as we advanced the company on several fronts, including key enhancements to our multiTAA clinical development pipeline and strategic initiatives, including with Wilson Wolf, to leverage our differentiated manufacturing capabilities to generate alternative sources of funding for our clinical programs," said Peter L. Hoang, President and Chief Executive Officer at Marker Therapeutics. "We believe these initiatives will unlock multiple value building opportunities for Marker throughout 2023. We continue to advance our MT-401 Phase 2 ARTEMIS clinical trial and are encouraged by recent data involving measurable residual disease (MRD) positive patients, which suggest MT-401 produced with our new T cell manufacturing process could be well suited for this underserved subset of patients with AML. We anticipate reporting a more expansive data readout from the MRD positive group in the second half of 2023.

Mr. Hoang continued: "We also made considerable progress with our MT-601 program, securing FDA clearance for INDs in non-Hodgkin lymphoma and pancreatic cancer. We have initiated enrollment for the lymphoma Phase 1 clinical study of MT-601 and expect to report topline data in early 2024 and expect to initiate enrollment for the pancreatic study by the fourth quarter of 2023. We continue to be energized by the manufacturing services agreement with Wilson Wolf and believe we are on track to earn the additional $1 million bonus provided for in the agreement. Additionally, we see the potential to build on the success of this project with additional revenue-generating opportunities whereby we leverage our unique expertise in technical operations to provide the company with non-dilutive capital to fund our clinical programs

MT-401 PHASE 2 ARTEMIS (AML)

New manufacturing process for MT-401:

· In 2022, Marker implemented an improved manufacturing process that reduced production time to 9 days (compared to the original process of >30 days).
· This new process enabled a >90% reduction in the number of operator interventions during production and an improved final T cell product candidate compared to the original product candidate that was used in the ongoing ARTEMIS trial.
· These process improvements have yielded an MT-401 product candidate that has five times the measurable specificity and four times the potency in terms of tumor killing as compared to the prior manufacturing process. Marker has now treated 12 patients with MT-401 manufactured using the Company’s improved process, with 16 patients treated with MT-401 manufactured using the original process, for a total of 28 patients.

Adjuvant Patients:

· To date, a total of 11 patients in the adjuvant arm of the ARTEMIS study have been randomized to treatment with MT-401 using a new manufacturing process or to standard-of-care.
· All patients are too early for evaluation, but the Data Monitoring Committee has reviewed the existing safety data and has not identified any concerns.

Marker continues to see promising data with MRD+ patients:

· A total of four patients with measurable residual disease (MRD+) have been treated and are currently evaluable.
o Two MRD+ patients were treated with MT-401 manufactured using the original manufacturing process and showed elimination of detectable disease.
· In this update, Marker can report on the status of two additional MRD+ patients that were treated with MT-401 manufactured with the improved process:
o The first MRD+ patient was treated at 100 x 106 cells per infusion and was able to remain in stable disease for six months, allowing the patient to bridge to a second allogeneic transplant.
o The second MRD+ patient was dosed at 200 x 106 cells per infusion and the PCR value, which proved to be a valuable tool for detecting MRD, has decreased by 70% only four weeks after the last infusion. This patient’s disease status will continue to be closely monitored and evaluated.
· Marker also treated one additional MRD+ patient with product manufactured using the improved process. This patient is too early for evaluation. Additional MRD+ patients have been enrolled and are awaiting treatment.
· Marker anticipates reporting a data readout of the MRD+ patient subset in the second half of 2023.

Measurable residual disease is an important biomarker in hematological malignancies, such as AML, that is used for prognostic, predictive and monitoring assessments. This term refers to a small number of malignant cancer cells remaining in a patient’s body after completion of therapy, despite the absence of clinical and radiological evidence of disease. MRD detection relies on highly sensitive laboratory techniques, such as next-generation sequencing, polymerase chain reaction (PCR), or flow cytometry. The assessment is crucial in AML management as it can provide prognostic information and guide therapeutic decisions, such as the need for additional treatment or close surveillance. Importantly, MRD is a transitional phase prior to development of frank relapse and considered a negative prognostic factor. Thus, the achievement of MRD negativity, defined as the absence of detectable malignant cells, is a favorable prognostic factor and an important treatment goal in AML

The standard first-line treatment for the last decade had been combination chemotherapy using cytarabine and an anthracycline. However, approximately half of the patients eventually relapse. Eligible patients subsequently proceed to hematopoietic stem cell transplantation (HSCT), but disease relapse after transplant is frequent and remains a major cause of death. To date, there is no approved therapy for post-transplant MRD+ patients, highlighting the need for novel therapies. Therefore, the positive clinical responses observed in MRD+ patients treated with MT-401 may provide a more effective approach to treatment.

"Our ARTEMIS trial showed promising clinical responses in post-transplant MRD positive patients highlighting the potential benefit of our multiTAA-specific T cell therapy in patients where no treatments have been approved," said Dr. Juan F. Vera, Chief Scientific Officer and Chief Operating Officer of Marker Therapeutics. "We will continue to track the patients’ disease status and look forward to investigating MT-401 in a larger patient population."

Dr. Vera continued: "Our improved T cell manufacturing process used for multiTAA-specific T cells enables a 9-day ex vivo T cell production, providing a fast turnaround for patient treatment to reach MRD positive patients before relapse."

Frank Relapse Patients:

· To date, a total of 15 frank relapse patients have been treated.
· In addition to the 11 patients previously reported, who were treated with MT-401 manufactured using the original manufacturing process, four additional patients with frank relapse have been treated with MT-401 manufactured using the improved manufacturing process:
o Of the four patients treated with the improved manufacturing process, one of these patients received a dose of 100 x 106 cells per infusion, while the other three patients were dosed at 200 x 106 cells per infusion.
o None of the frank relapse patients showed an objective response to therapy.
· Marker has suspended further enrollment of frank relapse patients while re-evaluating additional modifications for this patient cohort, including potentially higher cell doses.

MT-601 (Lymphoma)

· IND cleared by FDA for the multicenter Phase 1 trial of MT-601 for the treatment of patients with non-Hodgkin lymphoma
· Phase 1 clinical trial initiated in Q1 2023 with a clinical readout expected in the first quarter of 2024

MT-601 (Pancreatic):

· IND cleared by FDA for the multicenter Phase 1 trial of MT-601 for the treatment of patients with metastatic pancreatic cancer in combination with front-line chemotherapy
· Phase 1 clinical trial expected to initiate by Q4 2023.

FISCAL YEAR 2022 FINANCIAL RESULTS

Cash Position and Guidance: At December 31, 2022, Marker had cash and cash equivalents of $11.8 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

R&D Expenses: Research and development expenses were $26.1 million for the year ended December 31, 2022, compared to $27.8 million for the year ended December 31, 2021.

G&A Expenses: General and administrative expenses were $12.8 million for the year ended December 31, 2022, compared to $12.9 million for the year ended December 31, 2021.

Net Loss: Marker reported a net loss of $29.9 million for the year ended December 31, 2022, compared to a net loss of $41.9 million for the year ended December 31, 2021.

About Marker’s Phase 2 ARTEMIS Trial

The multicenter Phase 2 AML study is evaluating the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease setting. In the adjuvant setting, approximately 150 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus standard-of-care observation, while approximately 40 patients with active disease will receive MT-401 as part of the single-arm group.

The primary objectives of the trial are to evaluate relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease patients. Additional objectives include, for the adjuvant group, overall survival and graft-versus-host disease relapse-free survival while additional objectives for the active disease group include overall response rate, duration of response, progression-free survival, and overall survival.