FDA OKs Batu Biologics’ ValloVax for Clinical Investigation in Certain Solid Tumors

FDA OKs Batu Biologics’ ValloVax for Clinical Investigation in Certain Solid Tumors

The U.S. Food and Drug Administration (FDA) has cleared Batu Biologics to advance its immunotherapy, ValloVax, into clinical trials for certain solid tumors, the company announced.

This is the first immunotherapy targeting the blood vessels feeding tumors to receive an investigational new drug (IND) approval from the FDA. The decision will allow the company to initiate Phase 1 clinical trials testing the drug.

“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,” Amit Patel, MD, director of Biologic Innovation in the Department of Surgery at University of Miami and lead U.S. investigator of the Batu clinical trial, said in a press release.

“We believe that leveraging the immune system to block angiogenesis, or new blood vessel growth, is a highly promising approach,” added Patel.

In previous preclinical studies with animal models, Batu showed that ValloVax effectively treats lung, colon, breast, brain, and skin cancer.

“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 Alan Lewis, PhD, 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.”

“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,” Lewis said.

ValloVax works by inducing a comprehensive immune response (mediated by both immune cells and antibodies) against the cancer blood vessels, while leaving healthy blood vessels unharmed.

In fact, early clinical data using ValloVax in cancer patients showed the immunotherapy was not only well-tolerated, but elicited an effective and specific immune response against tumor blood vessels. These findings were reported in the study “Safety of targeting tumor endothelial cell antigens” published in the Journal of Translational Medicine.

“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, CEO of Batu Biologics.

“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 inhibitors, means to us that ValloVax could be another potent weapon in our fight against cancer,” he said.

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