On January 8, 2021 MANA Therapeutics, a clinical-stage company creating nonengineered, off-the-shelf allogeneic cell therapies that target multiple cancer antigens, reported a $35 million Series A financing (Press release, MANA Therapeutics, JAN 8, 2021, View Source [SID1234573712]). The financing was led by Cobro Ventures and Lightchain Capital, with participation from LifeSci Venture Partners and other undisclosed investors. MANA is using its EDIFY platform to develop a pipeline of proprietary and partnered off-the-shelf cell therapies for cancer patients across a broad range of liquid and solid tumors, with an initial focus on relapsed acute myeloid leukemia (AML).
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MANA’s EDIFY platform leverages natural immune system pathways to educate T-cells to target multiple cell surface and intracellular tumor-associated antigens. The multi-antigen targeting is uniquely achieved without the need for viral or non-viral delivery systems or genetic modifications. MANA was founded based on the research and human proof-of-concept clinical trials conducted by Catherine Bollard, M.D., MBChB and her team at Children’s National Hospital (CNH) along with colleagues at Johns Hopkins Medical Center. The initial CNH and Hopkins-led clinical trials in solid and hematologic tumors supported a strong safety profile, showed immunological anti-tumor activity and validated MANA’s initial set of tumor antigens. The product candidates used in these trials formed the basis of the Phase 1 candidate, MANA-312, an allogeneic donor-derived cell therapy for the treatment of AML in the relapsed/refractory post-hematopoietic stem cell transplant (HSCT) setting, and MANA-412, a preclinical off-the-shelf allogeneic cell therapy being developed for the treatment of transplant-ineligible AML and solid tumors.
"I co-founded MANA with Dr. Bollard and her colleagues from Children’s National Hospital because we believe off-the-shelf, allogeneic approaches are the future of cell therapy that will enable more patients to benefit from this breakthrough in cancer treatment," said Marc Cohen, Co-founder of Cobro Ventures and Co-founder and Executive Chairman of MANA Therapeutics. "MANA is building upon the strong foundational science established at CNH with a unique approach that promises to produce off-the-shelf allogeneic therapies that do not compromise on safety or efficacy. I look forward to continuing to support the MANA team as they advance their internal pipeline for the treatment of AML and select solid tumors, and expand the potential of EDIFY through strategic partnerships focused on new target antigens and cancer types."
MANA’s goal is to develop an inventory of off-the-shelf allogeneic products that will be able to treat the majority of patients in targeted cancer indications based on a simplified HLA matching protocol. Through multiple antigen targeting, MANA’s product candidates are designed to prevent immune escape and could provide superior efficacy to single antigen and other cell therapy approaches. MANA uses a simplified scalable manufacturing process that does not require genetic modification and has a high product yield, with the potential to generate tens of billions of cells from a single partial HLA-matched donor. The high safety profile supported by academic clinical trials and the nonengineered approach may also permit for repeat dosing of patients.
"Over the past decade we have seen tremendous progress in cancer research and treatment and are beginning to unlock the potential of cell therapy for a variety of tumor types," said Dr. Bollard, who chairs MANA’s Scientific Advisory Board. "The human proof-of-concept trials conducted by my team and colleagues showed potential for a nonengineered approach to educating T-cells to attack multiple tumor antigens, which MANA is expanding even further through refinement of the manufacturing process for an allogeneic product and application to a broader set of antigens in a variety of clinical indications and settings."
"This Series A funding is enabling rapid progress with our programs," said Martin Silverstein, M.D., President and CEO of MANA Therapeutics. "We recently initiated our Phase 1 clinical trial for MANA-312 in relapsed/refractory AML with the goal of establishing single-agent activity and safety of higher and multiple doses along with the assessment of key efficacy biomarkers in the post-transplant setting. This important study with an allogeneic donor-derived cell therapy is designed to inform and accelerate trials for our off-the-shelf allogeneic candidate, MANA-412, for which we plan to file an IND in late-2021."
As part of the financing, Drew Dennison of Lightchain Capital has joined the MANA Board of Directors. Locust Walk served as exclusive transaction advisor to MANA.
About EDIFY
MANA Therapeutics’ EDIFY platform constitutes the next-generation cell therapy approach by leveraging natural immune system pathways to educate T-cells to target the unique sets of antigens expressed by tumors, without the need for genetic modification. The EDIFY platform uses dendritic cells as antigen presenting cells. The dendritic cells are loaded with ManaMix antigens and stimulate and expand T-cells to generate product candidates. Product candidates developed from the EDIFY platform are designed to increase efficacy through multiple antigen targeting and to support a strong safety profile by utilizing a nonengineered approach that could permit for repeat dosing of patients. The EDIFY platform uses a simplified, high-yield manufacturing process.