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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) has secured a $16.1 million private placement through the sale of 5,031,250 shares of common stock and accompanying warrants. The financing, priced at $3.20 per share, includes participation from Blue Owl Healthcare Opportunities, NEA, and Aisling Capital.
The proceeds will primarily support the clinical advancement of the company's Phase 1 APOLLO study investigating MT-601, a multi-antigen recognizing T cell product, in lymphoma patients who have relapsed after anti-CD19 CAR-T cell therapy or where such therapy isn't an option.
The warrants will be exercisable upon shareholder approval with a five-year term and an exercise price of $4.03 per share. Canaccord Genuity leads the placement with Brookline Capital Markets as co-placement agent.
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) has been awarded a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support clinical investigation of MT-601 in metastatic pancreatic cancer patients. The grant will fund the Phase 1 PANACEA study evaluating safety and tolerability of their multi-tumor associated antigen T cell product.
MT-601 is currently being studied in CD19-CAR relapsed lymphoma patients, with preliminary data showing sustained objective responses in three participants. The therapy targets six tumor-specific antigens and shows promise beyond lymphoma. Previous studies at Baylor College of Medicine using similar technology showed favorable results in pancreatic cancer patients, with 1 complete response, 3 partial responses, and 6 stable disease cases out of 13 patients.
Including this grant, MRKR has secured over $30 million in non-dilutive funding, including an additional $2 million NIH SBIR grant for pancreatic cancer research. The company plans to initiate the pancreatic cancer clinical program in 2025.
Marker Therapeutics (MRKR), a clinical-stage immuno-oncology company, announced its participation in the 2024 Ladenburg Thalmann & Co. Virtual Oncology Innovators & Investors Symposium. Juan Vera, M.D., President and CEO, will present on December 12, 2024, at 1:30 PM EST.
The presentation will showcase Marker's technology and clinical developments in T cell-based immunotherapies for treating hematological malignancies and solid tumor indications. Registered participants can access the presentation through the event portal, and a replay will be available on the Company's IR website under Events & Presentations.
Marker Therapeutics (Nasdaq: MRKR), a clinical-stage immuno-oncology company, announced its participation in the upcoming Citizens JMP Hematology and Oncology Summit on December 2, 2024. CEO Juan Vera will present the company's technology and clinical developments at 11 AM EST during this virtual event.
The presentation will showcase Marker's focus on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumor treatments. Following the presentation, a replay will be available on the company's IR website. The management team will also conduct one-on-one meetings with registered investors to discuss business and clinical development strategies.
Marker Therapeutics (MRKR) reported Q3 2024 financial results and business updates. The company received two $2 million NIH SBIR grants to support MT-601 clinical trials in lymphoma and pancreatic cancer patients. The ongoing Phase 1 APOLLO study for MT-601 in lymphoma patients shows promising activity, with preliminary data expected by year-end. Financial highlights include $9 million in cash and cash equivalents, expected to fund operations into October 2025. Q3 2024 showed R&D expenses of $3.5 million, G&A expenses of $0.9 million, and a net loss of $2.3 million.
Marker Therapeutics (Nasdaq: MRKR) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Preliminary safety and efficacy data from the Phase 1 APOLLO study of MT-601 in lymphoma patients showed objective responses in 3 out of 3 participants.
2. MT-601 was well-tolerated with no cytokine release syndrome or neurotoxicity observed.
3. Marker received a $2 million NIH SBIR grant to support MT-601 clinical investigation.
4. Q2 2024 financial results: $7.8 million in cash and cash equivalents, $2.3 million in R&D expenses, $1.1 million in G&A expenses, and a net loss of $2.2 million.
5. The company expects its cash to fund operations into Q4 2025.
Marker Therapeutics (Nasdaq: MRKR) has been awarded a $2 million grant from the NIH Small Business Innovation Research program to support the clinical investigation of MT-601 in patients with non-Hodgkin's lymphoma (NHL) who have relapsed following anti-CD19 CAR T cell therapy. The grant will fund the nationwide multi-center Phase 1 APOLLO study, evaluating the safety and efficacy of MT-601, a multi-tumor associated antigen-specific T cell product.
The company has now received over $19 million in non-dilutive funding. Preliminary results from the APOLLO study show objective responses in all three study participants treated at City of Hope, with no cytokine release syndrome or immune effector cell associated neurotoxicity syndrome observed. This grant supports Marker's efforts to address the unmet medical need for patients who relapse after CD19-targeting CAR-T cell therapy.
Marker Therapeutics (Nasdaq: MRKR) reported first quarter 2024 financial results and business updates. The company highlighted continued clinical progress, noting promising results in its Phase 1 APOLLO study of MT-601 for lymphoma. Significant milestones include sustained complete responses in study participants and an official nonproprietary name 'neldaleucel' for MT-601. Financially, Marker saw a reduction in R&D and G&A expenses, narrowing its net loss to $2.4 million from $4.9 million year-over-year. Cash and cash equivalents stood at $11.3 million, expected to fund operations into Q4 2025.
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