|U. of Cincinnati's Tom Herzog|
After rounding up a long lineup of collaborations for its cancer vaccine axalimogene filolisbac (ADXS-HPV), Advaxis says that a small study for cervical cancer produced promising outcomes for a significant number of the 26 patients involved.
That assessment was initially spurned by the market, with the stock ($ADXS) plunging close to 30% before immediately bouncing back and hovering around even Thursday afternoon.
The therapeutic vaccine was put through its paces among patients who had already failed at least one treatment. On average, says the Princeton, NJ-based biotech, these patients would have around 4 to 7 months to live, with no viable treatment options. But after 12 months of therapy in the single arm study--where there was no comparator arm--the investigators tracked a 38.5% survival rate.
The data come from the first stage of a two-step Phase II study, which the biotech says should open a path to establishing a special protocol assessment for a Phase III study.
There were some serious signs of toxicity. One of the patients experienced a serious grade 4 lung infection and sepsis, four (15%) had grade 3 hypotension and cytokine release syndrome--a dangerous response. And 19 had a grade 1 or 2 reaction, usually fatigue, chills and fever.
Typically, though, for dying patients with nowhere to turn, regulators will allow for serious reactions, with developers expected to look to find ways to ameliorate the dangers involved.
"The Stage 1 results for axalimogene filolisbac, which show 12-month survival, are a meaningful step forward in meeting the needs of women who require second-line treatment for PRmCC," says Tom Herzog, clinical director at the University of Cincinnati Cancer Institute.
A year ago Advaxis partnered with Merck ($MRK) on Keytruda in a no-money-down collaboration. That followed a separate pact with AstraZeneca ($AZN) on the PD-L1 checkpoint inhibitor MEDI4736 and preceded another tie-up with Incyte ($INCY).
The sudden gyrations may have created some uncertainty in the market. Advaxis shares were fluctuating between red and green not long after the biotech posted the numbers.
- here's the release