Two Companies Launch with Diverse Approaches for Improving Cancer Treatments


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 file an 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.

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