Oragenics is bidding adieu to its lead program, a treatment designed to ward off inflammatory side effects from cancer treatments like chemotherapy and radiation. It’s halting a phase 2 study of the drug and yanking its Investigational New Drug application. The company will pivot its resources to developing a COVID-19 vaccine.
The Tampa, Florida-based company made the call after “further review of new data and other factors” related to the phase 2 trial. It had been developing the treatment, AG013, for oral mucositis, a condition in which the cells lining the gastrointestinal tract break down. This opens the mucus membranes to ulceration and infection, which can make it difficult or impossible for patients to eat.
“Although the Phase 2 AG013 clinical trial demonstrated activity in certain patient populations, the overall lack of efficacy along with other factors, inclusive of strategic product portfolio considerations, led us to the decision to discontinue further development of AG013 under the ECC [Exclusive Channel Collaboration],” said Oragenics CEO and President Alan Joslyn, Ph.D., in a statement.
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In ending the program, Oragenics will also exit a partnership with Precigen—previously Intrexon—which developed the treatment.
Its “portfolio considerations” include work on a COVID-19 vaccine, dubbed TerraCoV2, picked up in its acquisition of Noachis Terra. To get its hands on the candidate, Oragenics ponied up $1.9 million in cash and 9.2 million shares as well as the option for Noachis Terra’s shareholders to buy another 9.2 million shares at $1.25 apiece.
“As we await Biomedical Advanced Research and Development Authority (“BARDA”) and other federal and state non-dilutive grant decisions, we expect to use our available cash to continue development of TerraCoV2, with the goal of bringing this COVID-19 vaccine candidate into human clinical trials by early 2021,” said Joslyn.