Anixa Biosciences has delayed a planned IND filing by 12 months to buy time to improve its CAR-T candidate. The delay will enable Anixa to perform additional genetic engineering intended to boost the efficacy of the treatment in ovarian cancer.
California-based Anixa had planned to file its IND by the end of 2019, setting it up to start a clinical trial of its CAR-T candidate next year. That plan is now on the scrapheap. Anixa now plans to file its IND in late 2020 and start testing the treatment in humans in 2021, putting it a full 12 months behind its original timeline.
Anixa framed the delay as a consequence of new results from the laboratory of Jose Conejo-Garcia, the Moffitt Cancer Center researcher who invented its CAR-T technology. According to Anixa, the results pointed to a way to “greatly” improve the efficacy of its treatment in ovarian cancer patients.
The plan is still to take T cells from a patient, use a viral vector to get the cells to express the follicle stimulating hormone and administer them back into the patient. However, Anixa will now perform “additional engineering” on the cells to equip them to express “much higher” levels of the hormone. The work will require the creation and testing of a new viral vector.
Amit Kumar, president and CEO of Anixa, presented the work as a way to increase the likelihood of the CAR-T working in solid tumors, a set of indications that has so far proved fairly resistant to cell therapy.
“While this new development may be disappointing to shareholders, we have decided that we want to go into the clinic with the best possible therapy. CAR-T technology has not worked in a clinically meaningful way for solid tumors. Making this change would result in a radically superior therapy and give us a dramatically greater chance of success against ovarian cancer, a solid tumor," Kumar said in a statement.
That bet may pay off in the long term, but in the near term it could create some difficulties. As of September, Anixa had $4.4 million in cash, a sum that, when viewed in light of other financial factors, it anticipated would see it through the next 12 months.