On November 17, 2023 March Biosciences (March Bio), a clinical stage biotechnology company committed to combating challenging cancers unresponsive to existing immunotherapies, reported that it has received a notice of award for a major competitive grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to help support continued clinical development of its innovative chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed and refractory CD5 positive T-cell cancers (Press release, March Biosciences, NOV 17, 2023, View Source [SID1234637786]). The approximately $13.4 million product development award is intended to support March Bio’s upcoming Phase 2 clinical trial of MB-105 for the treatment of relapsed and refractory T-cell lymphomas.
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MB-105 is currently being assessed in a Phase 1 clinical trial in patients with relapsed and refractory T-cell malignancies at Baylor College of Medicine. This grant follows a $4.8 million investment from the Cancer Focus Fund announced earlier this month also to support the MB-105 Phase 2 trial.
"We are committed to advancing MB-105 and creating a best and first-in-class therapy for patients with these difficult cancers," commented Sarah Hein, cofounder and CEO of March Biosciences. "We expect that receipt of this substantial non-dilutive award from CPRIT will serve as a catalyst to our current financing activities and allow us to continue to move quickly to advance MB-105 as a novel treatment for patients seeking better options."
Patients with T-cell malignancies face a dismal prognosis once their disease becomes relapsed or refractory to first-line therapies and have extremely limited continuing treatment options, resulting in just 15% survival over about 3 years. The development of specific therapies for these indications is difficult due to the fact that many potential targets, including the CD5 receptor targeted by MB-105, are present on both normal and malignant T-cells, which means that therapies targeting malignant T-cells risk damaging the healthy T-cells needed for normal immunity.
Since CD5 is widely expressed by both normal and malignant T-cells, the MB-105 CD5 CAR-T cell therapy has been specifically engineered to preserve many healthy T-cells while maintaining potency against CD5 positive tumor T-cells. In an ongoing Phase 1 trial conducted at the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital, and Texas Chidren’s Hospital, MB-105 has demonstrated a favorable safety profile and encouraging early efficacy results in patients with both relapsed and refractory T-cell lymphoma and T-cell acute lymphoblastic leukemia.
March Biosciences was cofounded with inventors Drs. Max Mamonkin and Malcolm Brenner, leading scientists from the Center for Cell and Gene Therapy who are both recipients of CPRIT research awards. Dr. Mamonkin is an Associate Professor at Baylor and serves as Chief Scientific Officer at March Biosciences. He was recently awarded the Outstanding New Innovator Award by the American Society for Cell and Gene Therapy. Dr. Brenner is a renowned leader in the field, with an extensive history of technology invention contributing to the launch of both private and public biotechnology companies. He serves as an advisor to cell therapy companies across the industry.
Dr. Mamonkin commented, "The treatment of T-cell lymphomas and leukemias has been particularly challenging, which led us to focus on the development of this new approach early on. We have been highly encouraged by the clinical results we have already seen, and I am pleased that CPRIT has recognized the potential importance of these efforts to patients and will support the continued development of the CD5 CAR-T approach."
March Bio is currently preparing for its Phase 2 trials of MB-105 with a development collaboration with recent CPRIT awardee, CTMC, a joint venture between MD Anderson Cancer Center and National Resilience.