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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 (MRKR) provided a corporate update and financial results for Q2 2021, reporting a net loss of $10.9 million, up from $6.3 million in Q2 2020. The company completed the safety lead-in for its Phase 2 trial on MultiTAA-specific T cell therapy for AML and is enrolling patients for the main trial. Marker opened a new cGMP manufacturing facility in Houston, expected to lower costs and improve patient access. With $57.2 million in cash, the company anticipates funding through Q1 2023.
Marker Therapeutics (Nasdaq: MRKR) announces the opening of its new cGMP manufacturing facility in Houston, TX. This facility will support the Phase 2 acute myeloid leukemia (AML) trial, aiming to enroll 160 patients. The modular facility, spanning 48,500 square feet and currently utilizing a third of its space, represents a strategic goal to enhance therapy access and reduce manufacturing costs. This development is crucial for the company's MultiTAA-specific T cell products, aiming to facilitate future clinical trials and potential commercialization of approved products.
Marker Therapeutics, Inc. (Nasdaq:MRKR) announced the completion of the six-patient safety lead-in phase of its Phase 2 trial for MT-401, targeting post-transplant acute myeloid leukemia (AML). All participants met safety endpoints following treatment with the MultiTAA-specific T cell therapy. The ongoing trial aims to evaluate MT-401's efficacy against AML in both adjuvant and active disease settings, with a total of approximately 160 patients involved. The FDA previously granted Orphan Drug designation to MT-401, highlighting its potential in addressing unmet needs in AML treatment.
Marker Therapeutics, Inc. (NASDAQ: MRKR) announced that Chief Financial Officer Anthony H. Kim will present at the virtual Raymond James Human Health Innovation Conference on June 21, 2021, at 9:20 a.m. ET. Marker Therapeutics is focused on developing next-generation T cell-based immunotherapies for treating hematological malignancies and solid tumors. The presentation will be available via a live webcast on their website and can be replayed afterward. The company's innovative approach emphasizes non-engineered, tumor-specific T cells, potentially reducing manufacturing costs and toxicities while enhancing patient outcomes.
Marker Therapeutics, Inc. (Nasdaq:MRKR) reported its Q1 2021 financial results, highlighting a net loss of $8.8 million compared to $6.5 million in Q1 2020. The company closed a public offering raising approximately $56.5 million, strengthening its cash position to $64.5 million, sufficient to fund operations into Q1 2023. Significant advancements include dosing the first patient in a Phase 2 trial for AML and the operationalization of a new cGMP facility. Expected milestones include initiating the main trial phase in Q3 2021 and completing patient enrollment by Q4 2021.
Marker Therapeutics, Inc. (Nasdaq:MRKR) will host a conference call and webcast on May 12, 2021, at 5:00 p.m. ET to discuss its first quarter 2021 financial results and provide a corporate update. Participants can join via the company's website or by calling 877-407-8913 (domestic) or 201-689-8201 (international). After the event, the archived webcast will be available for replay. Marker Therapeutics specializes in developing T cell-based immunotherapies for hematological malignancies and solid tumors, claiming advantages over current engineered therapies.
Marker Therapeutics (Nasdaq:MRKR) announced the presentation of new robotics technology for manufacturing multi-tumor-associated antigen (mTAA)-specific T cell therapies at the ASGCT Annual Meeting from May 11-14, 2021. Lead author Anastasiya Smith, Ph.D., will discuss a robotic assistant prototype, co-designed with ABB Robotics, which demonstrated superior precision in liquid handling compared to human operators. This innovation aims to simplify processes and enhance the availability of cell therapies to a broader patient population, particularly for treating hematological cancers like acute myeloid leukemia (AML).
Marker Therapeutics, Inc. (Nasdaq: MRKR) has completed an underwritten public offering of 32,282,857 shares of common stock at a price of $1.75 per share, generating approximately $56.5 million in gross proceeds. The offering, managed by Piper Sandler & Co., Cantor Fitzgerald & Co., and Oppenheimer & Co. Inc., was conducted under a shelf registration statement declared effective by the SEC on June 25, 2019. The funds raised are expected to support the company’s development of T cell-based immunotherapies for hematological malignancies and solid tumors.
Marker Therapeutics, Inc. (NASDAQ:MRKR) announced that President and CEO Peter L. Hoang will present at the Virtual Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 3:10 p.m. ET. This clinical-stage immuno-oncology company focuses on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors. A live webcast of the presentation will be accessible on Marker’s website, with a replay available afterwards.
Marker Therapeutics, Inc. (Nasdaq: MRKR) has announced the pricing of an underwritten public offering of 28,572,000 shares at $1.75 each, aiming to raise approximately $50 million before expenses. A 30-day option for underwriters to purchase an additional 4,285,800 shares has been granted. The offering, managed by Piper Sandler & Co. and Cantor Fitzgerald & Co., is expected to close around March 16, 2021, subject to customary conditions. This transaction is part of a shelf registration statement effective since June 25, 2019.