Marker Therapeut Stock Price, News & Analysis

Marker Therapeutics, Inc. (NASDAQ:MRKR) has announced the initiation of its Phase 2 trial for MT-401, a MultiTAA-specific T cell therapy aimed at treating patients with acute myeloid leukemia (AML) post-stem cell transplant. The trial, enrolling 160 patients across 20 cancer centers, will assess the therapy's effectiveness in both adjuvant and active disease settings. The primary goal for the adjuvant group is relapse-free survival, while the active group focuses on complete response rates. Topline results for the active group are expected in Q1 2022, addressing a significant unmet need for AML patients.

Marker Therapeutics (NASDAQ:MRKR) announced the completion of its cGMP manufacturing facility in Houston, TX, designed for scalable production of MultiTAA-specific T cell products. This facility will support the timely manufacture of MT-401, targeting acute myeloid leukemia (AML), particularly after the initiation of a Phase 2 study. The technology transfer process has begun, with operations expected in the first half of 2021. Marker’s MultiTAA platform is notable for its non-genetic modification approach, enhancing tumor-destroying capabilities while potentially allowing outpatient administration.

Marker Therapeutics (Nasdaq: MRKR) announced that the FDA has lifted the partial clinical hold on its Phase 2 trial for MT-401, a T cell therapy aimed at treating post-transplant acute myeloid leukemia (AML). This decision allows for the continued enrollment of patients in the trial, which evaluates MT-401's safety and efficacy compared to standard care. The trial, which includes approximately 120 patients in the adjuvant setting and 40 with active disease, aims to assess various survival metrics and remission rates. MT-401 has previously received Orphan Drug designation from the FDA.

Marker Therapeutics, Inc. (Nasdaq:MRKR) reported significant progress in its Phase 2 trial of MT-401 for acute myeloid leukemia (AML) in Q3 2020. The company enrolled its first patient for the safety lead-in portion and plans to activate approximately 20 clinical sites. Manufacturing improvements resulted in a 50% reduction in production time. Financially, Marker had cash and equivalents of $27.0 million, with a net loss of $7.4 million for the quarter, up from $5.5 million in Q3 2019. The new cGMP facility is on track for completion by year-end.

Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company, will host a conference call on November 9, 2020, at 5:00 p.m. Eastern Time to discuss its third quarter 2020 financial and operating results. The call will be accessible via the company’s website, and a replay will be available afterwards. Marker Therapeutics focuses on developing next-generation T cell-based immunotherapies for hematological and solid tumors, utilizing non-engineered, tumor-specific T cells to target multiple tumor antigens.

Marker Therapeutics (NASDAQ:MRKR), a leader in immuno-oncology, announced that CEO Peter L. Hoang will present at the Virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, from 1:40 to 2:20 p.m. ET. The event will showcase the company's innovative T cell-based therapies targeting hematological malignancies and solid tumors. Live webcasts of the presentation will be available on the Investors section of their website and can be replayed afterward.

Marker Therapeutics (Nasdaq:MRKR) provided a corporate update and reported financial results for Q2 2020. The company continues to advance its Phase 2 trial for MultiTAA-specific T cell therapy targeting acute myeloid leukemia (AML) despite COVID-19 challenges. Marker has cash reserves of $32.1 million, expected to fund operations into Q2 2021. R&D expenses rose to $4.3 million, while general and administrative costs decreased to $2.5 million. The net loss for the quarter was $6.3 million, compared to $5.6 million in Q2 2019.

Marker Therapeutics (MRKR) has announced a new lease agreement for a cGMP manufacturing facility in Houston, TX, expected to be operational by 2021. This facility will enhance the company's capacity to produce its MultiTAA-specific T cell therapies according to FDA standards, enabling clinical trials for hematological malignancies and solid tumors. The facility spans approximately 48,500 square feet and reinforces Marker’s strategic plans as it advances its AML trial. The company continues to manufacture its therapies at Baylor College of Medicine until the new facility is operational.

Marker Therapeutics, Inc. (Nasdaq: MRKR) announced that the USAN Council has approved "zelenoleucel" as the generic name for MT-401, a T cell therapy targeting acute myeloid leukemia (AML) after stem cell transplants. The therapy, which received Orphan Drug designation in April, has shown clinical benefits in trials. CEO Peter L. Hoang highlighted the significance of this approval as it marks progress in their clinical development and anticipates starting a Phase 2 study for AML patients.