Mana Therapeutics, Inc.

The hunt for effective therapies for solid tumors has heated up in early 2021 with a string of biotechs touting big investor checks and name-brand collaborations to chase those hard-to-treat lumps. Now, with one of its candidates already in the clinic for leukemia, Mana Therapeutics is taking a new round of funding to join the fray. On Friday, Mana unveiled a $35 million Series A financing round that will help push the Boston-area biotech’s lead candidate through a Phase I trial and could help the company secure an IND for an off-the-shelf allogeneic molecule targeting transplant-ineligible AML and solid tumors within the year. The biotech’s leading molecule, dubbed MANA-312, is already engaged in the Phase I study of patients with acute myeloid leukemia, myelodysplastic syndrome after undergoing an allogenic hematopoietic stem cell transplantation. Mana’s goal is to use its technology to create an inventory of off-the-shelf allogeneic products that can treat the majority of patients with certain targeted cancer indications using what’s called a human leukocyte antigen matching system. It’s a different take on a similar line of attack for solid tumors: using the body’s natural immune system to educate healthy cells already in the body to target antigens on the surface of the tumor’s cancer cells without damaging the otherwise healthy cells. To do this, Mana uses an in-house platform called EDIFY, which it says leverages natural immune system pathways to educate T cells to target multiple cell surfaces and intracellular tumor-associated antigens. Through multiple antigen targeting processes, the company’s technology is designed to prevent the tumor’s immune escape, and it says the allogeneic method — which uses healthy donor cells to create a master cell bank and is then used for specific therapies — of attacking the solid cancer tumors could provide superior efficacy to single antigen and other cell therapy approaches. MANA-312 also isn’t the biotech’s only candidate in the works. MANA-412 is a preclinical off-the-shelf allogeneic cell therapy for treating transplant-ineligible acute myeloid leukemia and solid tumors and could be ready for an IND filing by the end of the year, Mana said. The Series A round will help fund preclinical development for that candidate as well. Mana was founded based on research and human proof-of-concept clinical trials conducted by Catherine Bollard of Children’s National Hospital and her colleagues at Johns Hopkins Medical Center. Those trials, in both solid and hematologic tumors, “supported a strong safety profile, showed immunological anti-tumor activity and validated MANA’s initial set of tumor antigens,” the company said. Then Bollard co-founded the company with industry vet Marc Cohen. Ex-Gilead exec Martin Silverstein is the CEO. “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,” Bollard said in a statement. MANA’s $35 million financing round was led by Cobro Ventures and Lightchain Capital and joined by LifeSci Venture Partners with other undisclosed investors.

Mana Therapeutics takes aim at solid tumors with allogenic cell therapies and Aulos Bioscience sees a new path for IL-2 monoclonal antibodies. Ahead of the J.P. Morgan Healthcare Conference, two companies launched with goals of improving treatment for cancer patients with two different approaches. Mana Therapeutics takes aim at solid tumors with allogenic cell therapies and Aulos Bioscience sees a new path for IL-2 monoclonal antibodies. Mana Therapeutics – Off-the-shelf allogenic cell therapies against solid tumors have become an increasingly popular approach in the fight against cancer. Joining the effort is startup Waltham, Mass.-based Mana Therapeutics, which raised $35 million in a Series A financing round to support its efforts. Mana will use the funds to support the Phase I development of MANA-312 in patients with acute myeloid leukemia (AML) in the relapsed/refractory post-hematopoietic stem cell transplant (HSCT) setting. Martin Silverstein, who will helm Mana as chief executive officer, said the goal of the Phase I study is to establish single-agent activity and safety of higher and multiple doses if MANA-312, along with the assessment of key efficacy biomarkers in the post-transplant setting. Additionally, the funds will be used to accelerate preclinical development of the company’s off-the-shelf allogenic programs, which includes MANA-412, a preclinical off-the-shelf allogeneic cell therapy being developed for the treatment of transplant-ineligible AML and solid tumors. If all goes well, the company intends to Investigational New Drug application for MANA-412 later this year. Mana’s approach involves its EDIFY platform, which harnesses natural immune system pathways to educate T-cells to target multiple cell surface and intracellular tumor-associated antigens. The company said the multi-antigen targeting is achieved without the need for viral or non-viral delivery systems or genetic modifications. The company’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. Mana was founded by Catherine Bollard, Conrad Russell Y. Cruz and Patrick Hanley and other colleagues at Children’s National Hospital. The teams investigated the approach in clinical studies in solid and hematologic tumors. The results of those studies supported a strong safety profile, showed immunological anti-tumor activity and validated MANA’s initial set of tumor antigens, the company said. Bollard, who is the scientific advisory committee chair for Mana, pointed to the advances in cancer research made over the past 10 years. Cell therapies are becoming increasingly important in the treatment of cancer. “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,” Bollard said in a statement. The Series A was led by Cobro Ventures and Lightchain Capital, with participation from LifeSci Venture Partners and other undisclosed investors. Aulos Bioscience – Also out of the gate this morning is Aulos Bioscience , a company launched by life sciences venture capital group ATP and biotech Biolojic Design. Aulos is developing highly differentiated interleukin-2 (IL-2)-binding monoclonal antibodies as therapeutics against solid tumors. Aulos was formed to develop antibodies with unique properties that hold best-in-class promise among IL-2 targeted therapies, Michael Ehlers, chief scientific officer of ATP said in a statement. “Biolojic has designed elegant and impressively simple molecules that redirect IL-2 to low-affinity effector T-cells away from high-affinity regulatory T-cells by binding to the body’s own IL-2, steering it away from immune suppression and towards immune activation. Other drug candidates that redirect IL-2 fail to target naturally occurring IL-2 and introduce complex, modified, exogenous versions of IL-2 that are often difficult to manufacture and can have unfavorable pharmacokinetic properties. We think that the advantages of the Aulos approach could enable us to deliver a new mainstay in fighting multiple cancers,” Ehlers said in a statement. Yanay Ofran, CEO of Biolojic Design and acting CEO of Aulos, said they see the approach taking by Aulos as a chance to disrupt the cancer treatment landscape. To support its program, Aulos secured $40 million from ATP in a Series A financing round that will help the company advance its lead molecule through preclinical development and into the clinic later this year. The new company will unveil more of its approach to oncology during this year’s virtual J.P. Morgan Healthcare Conference. The company’s presentation is scheduled for Jan. 14.

Jan. 8, 2021 11:00 UTC MANA’s next-generation EDIFY™ platform expands the potential of cell therapies with off-the-shelf allogeneic approaches to liquid and solid tumors Financing to support the MANA-312 Phase 1 study, now underway in patients with AML/MDS after allogeneic HSCT, and accelerate preclinical development of off-the-shelf allogeneic programs WALTHAM, Mass.--(BUSINESS WIRE)-- MANA Therapeutics, a clinical-stage company creating nonengineered, off-the-shelf allogeneic cell therapies that target multiple cancer antigens, today announced a $35 million Series A financing. 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). 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 pro 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 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 pro utilizing a nonengineered approach that could permit for repeat dosing of patients. The EDIFY platform uses a simplified, high-yield manufacturing process. About MANA Therapeutics MANA Therapeutics is harnessing the natural immune system to develop broadly accessible, ready-to-use cellular therapies to improve outcomes for cancer patients. By educating T-cells to target multiple tumor associated antigens without the need for genetic modification, MANA’s EDIFY™ platform provides the opportunity to deliver safe, effective, and repeatable therapies. Our journey began with acute myeloid leukemia (AML) and we are advancing the science to develop additional proprietary and partnered programs for additional hematologic and solid tumors. View source version on businesswire.com: Contacts MacDougall Amanda Houlihan ahoulihan@macbiocom.com or (781) 235-3060 Source: MANA Therapeutics View this news release online at: