Batu Biologics Receives FDA Clearance for First Multi-Pronged Immunotherapy Targeting the Blood Vessels That Feed Cancer

SAN DIEGO--(BUSINESS WIRE)-- Batu Biologics, an immuno-oncology company dedicated to the development of its tumor-angiogenesis targeting immune therapy, ValloVax™, has received an Investigational New Drug (IND) approval from the U.S. FDA allowing Batu to proceed with Phase 1 clinical trials. To the company’s knowledge, this is the first polyvalent immunotherapy cleared by the FDA that targets the blood vessels that feed cancer. ValloVax was inspired by the original research of Dr. Valentin Ivanovich Govallo who observed tumor regression of advanced cancer patients subsequent to placental immunization. ValloVax is a defined, off the shelf, cellular therapy that specifically induces immune responses against the tumor vasculature.

“It has been my honor to lead the clinical development and manufacturing of the ValloVax vaccine, which is comprised of placental stem cell-like cells generated under Good Manufacturing Practices (GMP) at the University of Miami,” said Dr. Amit Patel, Director of Biologic Innovation in the Department of Surgery at University of Miami and National Principal Investigator of the Batu clinical trial. “We believe that leveraging of the immune system to block angiogenesis, or new blood vessel growth, is a highly promising approach.”

Batu Biologics has previously published in peer reviewed literature that ValloVax is effective in treating lung, colon, breast, brain and skin cancer in animal models.^1,2

“It is our hope that ValloVax, our novel immune therapy, will treat cancer by training the immune system to kill tumor-associated blood vessels,” said Dr. Alan Lewis, Chairman of Batu Biologics. “Blood vessel formation is associated with malignancy and metastatic activity in established tumors, and ValloVax may have clinical benefit in treating multiple cancers.”

Lewis continued, “With the recent IND approval, our 25-year old president and CEO, Samuel Wagner, has become one of the youngest CEOs to ever lead a life science company through a successful IND filing with the FDA. I am very excited to guide the Company through the drug development process in the next steps for the company.”

ValloVax is a polyvalent cancer vaccine that stimulates an immune response against the tumor-associated blood vessels, seeking to cut off the blood supply required for sustainable tumor growth. Mechanistic studies have indicated that ValloVax triggers both a cell-mediated and antibody-mediated response that is specific to cancer blood vessels and not healthy blood vessels.² Batu Biologics has also previously published three case study reports of end stage cancer patients treated with ValloVax in an Investigator-initiated, compassionate use setting where safety and demonstration of cancer blood vessel specific immune response was observed.³

“Our team of collaborators and investors have worked tirelessly in bringing the first ‘multivalent angiogenesis targeted cancer immunotherapy’ to patients in the U.S.,” said Wagner. “While current advances in immunotherapy have improved prognosis in specific types of cancers, at present only 20 percent of patients respond to conventional immunotherapy, such as checkpoint inhibitors. The fact that ValloVax possesses potent anticancer activity when used alone in mouse models, combined with the demonstrated synergy with checkpoint inhibitors², means to us that ValloVax could be another potent weapon in our fight against cancer.”

References:

1. “Induction of tumor inhibitory anti-angiogenic response through immunization with interferon Gamma primed placental endothelial cells: ValloVax™,” Ichim TE, Li S, Ma H, et al. J Transl Med. 2015;13:90.
2. “Induction and characterization of anti-tumor endothelium immunity elicited by ValloVax therapeutic cancer vaccine,” Oncotarget, Wagner SC, Ichim TE, Bogin V, et al. 2017;8(17):28595-28613.
3. “Safety of targeting tumor endothelial cell antigens,” J Transl Med., Wagner SC, Riordan NH, Ichim TE, et al. 2016;14:90.

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