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Marker Therapeutics, Inc. (MRKR) is a clinical-stage immuno-oncology company focused on the development and commercialization of innovative T cell-based immunotherapies and peptide-based vaccines. Specializing in treating both hematological malignancies and solid tumor indications, Marker Therapeutics employs its proprietary MultiTAA T cell technology to cultivate non-engineered, tumor-specific T cells. These T cells target tumor-associated antigens (TAAs) to effectively eliminate cancer cells.
The company’s promising pipeline includes advanced T cell vaccine candidates currently undergoing clinical trials for ovarian and breast cancers. Marker Therapeutics' therapies aim to stimulate both killer and helper T cells, enhancing the immune response in up to 80% of patients. The company's off-the-shelf products are designed for easy integration with other immunotherapeutics, such as checkpoint inhibitors, either as standalone treatments or part of combination regimens.
Marker Therapeutics is actively pursuing multiple clinical trials, including Phase Ib/IIa and Phase II studies, with some programs benefiting from FDA fast track and orphan disease designation. The company's innovative approach aims to overcome the limitations of earlier cancer vaccine technologies, positioning it as a key player in the immuno-oncology space.
In addition to its T cell therapies, Marker Therapeutics is developing peptide-based immunotherapeutic vaccines for metastatic solid tumors and other difficult-to-treat cancers. One of its most notable programs is PolyStart, which seeks to harness and amplify the body's immune response to cancer.
Recent updates from Marker Therapeutics highlight significant advancements in its clinical programs. For example, a study participant with Non-Hodgkin’s Lymphoma, who relapsed after anti-CD19 CAR T cell therapy, tolerated an initial dose of MT-601 well and has remained in complete response for six months.
Marker Therapeutics also reported third-quarter financial highlights and upcoming milestones for its key programs, MT-401 (Acute Myeloid Leukemia) and MT-601 (Lymphoma and Pancreatic Cancer).
Marker Therapeutics (Nasdaq: MRKR) announced a Common Stock Purchase Agreement with Lincoln Park Capital Fund for up to $25 million. This agreement allows Marker to sell shares at its discretion over a 24-month period, subject to the effectiveness of a registration statement with the SEC. The proceeds will support the Phase 2 ARTEMIS trial of its lead candidate, MT-401, and other clinical programs. CEO Peter Hoang emphasized the importance of this deal for flexible capital access post-restructuring.
Marker Therapeutics, Inc. (Nasdaq: MRKR) announced FDA clearance for its Investigational New Drug (IND) application for MT-601, a T cell product targeting six antigens for patients with advanced pancreatic cancer. The IND approval marks a significant milestone as the company prepares to initiate a Phase 1 clinical trial in 2023. The new manufacturing process for MT-601 allows production in 9 days with a 90% reduction in interventions, improving the final T cell product. The clinical trial follows encouraging results from the Phase 1 TACTOPS study conducted at Baylor College of Medicine.
Marker Therapeutics, Inc. (Nasdaq: MRKR) has been awarded a $2 million U.S. FDA Orphan Products Grant for its Phase 2 ARTEMIS trial of MT-401, targeting post-transplant AML patients. The company has successfully treated six patients using a new T cell manufacturing process, which enhances potency against tumor antigens. Financial results for Q3 2022 show a net loss of $6.9 million, an improvement from $12.4 million the previous year. Cash and equivalents stand at $18.1 million, with R&D expenses rising to $7.3 million. Marker aims to initiate further trials in 2023.
Marker Therapeutics has received a $2 million grant from the FDA's Orphan Products Grants program to support its Phase 2 ARTEMIS trial of the multi-antigen targeted T cell therapy, MT-401, in patients with post-transplant acute myeloid leukemia (AML). This grant will fund the evaluation of MT-401 in patients with minimal residual disease after stem cell transplant. The trial aims to assess relapse-free survival and treatment efficacy, with promising initial results suggesting potential benefits for patients facing limited treatment options.
Marker Therapeutics (Nasdaq: MRKR), a clinical-stage immuno-oncology company, announced that its President and CEO, Peter L. Hoang, will participate in a panel discussion titled, “CAR-T and Beyond: What Are the Next Generation Cell Therapies?” at the Cantor Fitzgerald Cell and Genetic Medicines Conference in New York on September 15, 2022 at 9:20 a.m. ET. This participation highlights the company’s focus on developing innovative T cell-based immunotherapies for treating hematological malignancies and solid tumors, showcasing their commitment to advancing cancer treatment.
Marker Therapeutics (MRKR) reported its Q2 2022 financial results and corporate updates, highlighting progress in its clinical programs for AML and lymphoma. The company received an $8 million upfront payment from Wilson Wolf, aiding its efforts. MT-401, a treatment for AML, continues to show promise with recent patient results. Additionally, the FDA cleared IND applications for MT-601 targeting lymphoma and pancreatic cancer. However, the company implemented a restructuring plan, reducing its workforce by 23.5% to conserve capital. As of June 30, 2022, cash reserves stood at $25.8 million.
Marker Therapeutics (Nasdaq: MRKR) has received FDA clearance for its IND application of MT-601, a novel T cell therapy targeting six tumor-associated antigens. The upcoming Phase 1 trial will focus on patients with relapsed/refractory non-Hodgkin lymphoma who have failed anti-CD19 CAR T therapies. The therapy aims to offer significant advantages, including enhanced durability and reduced severe toxicities compared to traditional CAR-T therapies. The trial highlights a manufacturing process enabling a higher cell dose, which could accelerate treatment timelines and improve patient outcomes.
Marker Therapeutics, Inc. (MRKR) provided a corporate update and Q1 2022 financial results. The company anticipates topline data from its Phase 2 AML trial's Group 2 in Q2 2022. Initial results from the trial showed MRD elimination in one patient. Marker plans to file INDs for its second T cell therapy candidate, MT-601, in lymphoma and pancreatic cancer by the end of 2022, with trials to begin in 2023. As of March 31, 2022, cash reserves were $28.8 million, while R&D expenses rose to $7.0 million, and net loss increased to $9.9 million.
Marker Therapeutics, Inc. (Nasdaq: MRKR) announced the presentation of four posters on its Multi-Tumor-Associated Antigen (MultiTAA)-specific T cell therapies at the 2022 ISCT Annual Meeting in San Francisco from May 4-7, 2022. CEO Peter L. Hoang highlighted improvements in manufacturing processes leading to faster production and enhanced potency, particularly for MT-401 in Phase 2 trials for post-transplant AML. The posters will cover topics including the clinical results from the Phase 2 AML trial and advances in T cell manufacturing technology.
Marker Therapeutics (MRKR) announced a services agreement with Wilson Wolf Manufacturing, featuring an $8 million upfront payment and a potential additional $1 million. This partnership highlights Marker’s expertise in cell therapy manufacturing, allowing it to maintain control and reduce costs. CEO Peter Hoang emphasized the benefits of having in-house production capabilities. The deal is expected to enhance Marker’s operations, particularly in treating hematological and solid tumors, while showcasing Wilson Wolf's confidence in Marker’s technology.