Just six weeks after taking the helm of biotech Advaxis, CEO Ken Berlin has launched a search for a partner for its stalled lead axalimogene filolisbac (AXAL) and will scale back trials of the immunotherapy in order to bring earlier stage programs forward. It will also eliminate almost a quarter of its workforce.
Berlin joined the company from Rosetta Genomics in April shortly after the FDA placed a clinical hold on a phase 1/2 study of AXAL in human papillomavirus-associated cancers—in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab)—after a patient fatality. The trial was enrolling patients with both cervical and head-and-neck cancers, and the death was in a cervical cancer patient.
Advaxis says it will spend “a limited period of time” looking for a U.S. or European partner but, if it can’t find one, it will wind down an ongoing study in high-risk, locally advanced cervical cancer patients as well as a second planned trial in metastatic cervical cancer.
It will press ahead with head-and-neck cancer studies if it can find a cost-effective way to do so, but the net effect will be “a significant reduction in our spend on the HPV program,” according to Berlin. Advaxis will respond to the FDA’s concerns about the HPV trial shortly, he added.
That reduction means the company can accelerate plans to start clinical testing for two earlier-stage immunotherapies—ADXS-HOT and Amgen-partnered ADXS-NEO—which both target cancer neoantigens and are designed to stimulate T cells to attack tumor cells. Advaxis reckons they have potential applications across multiple tumor types, but the first ADXS-HOT candidate will be tested in non-small cell lung cancer. Trials of both will get underway this year and will generate data beginning in 2019.
“It is important that we allocate capital to invest in these programs in order to realize their potential, but this also requires us to reduce investments in other programs,” said Berlin on a conference call. “The HPV program is important to us, but we must be realistic about what we can and cannot develop on our own.”
Advaxis reported data from another immunotherapy candidate, ADXS-PSA, in prostate cancer at ASCO this year and says that the combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) is worthy of “further evaluation.” It will follow patients for another six to nine months before deciding on a path forward.
The ASCO trial showed evidence of “an early clinical signal in extending survival among patients,” according to Advaxis new chief medical officer Andres Gutierrez, M.D., Ph.D., who joined the firm at the same time as Berlin.
Shares in the company rose 11% in the wake of the announcement, which coincided with Advaxis’ second-quarter results statement, suggesting investors were happy with Berlin’s decisions. The company posted a net loss of just over $13 million in the three-month period, ending it with cash reserves of around $59 million.
The headcount reduction and rejigged R&D portfolio means that Advaxis has operating funds for at least one year, according to the company.