Dive Brief:
- Immunotherapy-focused biotech Advaxis will lay off about a quarter of its workforce, cutting costs amid a restructuring announced Thursday that seeks to reduce spending on the company's lead candidate in favor of three earlier compounds.
- Under newly installed CEO Ken Berlin, the company conducted a review of its clinical development efforts aimed at deciding which candidates it could better develop in house or through partnering.
- Advaxis anticipates the job cuts and reduced clinical expenditures will lower its annual cash burn by about 38% to $50 million. As of Oct. 31, the company listed 108 employees on its payroll, and as of April 30 it reported $58.8 million in cash, equivalents and short-term investments.
Dive Insight:
Advaxis' stock fell sharply in March this year, when the Food and Drug Administration put a clinical hold on a Phase 1/2 trial of its immunotherapy drug axalimogene filolisbac. The agent was being tested in combination with AstraZeneca's Imfinzi (durvalumab) in patients with advanced HPV-associated cancers, and the hold followed a patient death after nine months of therapy.
In its most recent update, Advaxis said it plans to submit a response to the FDA on the hold "shortly".
But the hold appears to have diminished Advaxis' interest in investing more to develop the asset. It will search for partners for the drug in human papillomavirus (HPV)-associated cancers, including cervical.
If none are found, Advaxis says it will wind down the ongoing AIM2CERV trial in high-risk locally advanced cervical cancer, and won't conduct the ADVANCE PD-1 combination trial in metastatic cervical cancer.
Advaxis will, however, continue development in HPV-positive head-and-neck cancer through what it describes as "cost-effective clinical studies".
"We continue to believe in HPV as a target, and are evaluating cost-effective studies for AXAL in head-and-neck cancer. We hope to secure a partner to continue the development of AXAL in cervical cancer," said CEO Ken Berlin in a June 7 statement.
Berlin, who was announced as the new CEO in April, focused the pipeline review on, among other things, identifying "rapid and cost-effective" paths to generating proof-of-concept data.
ADXS-NEO and ADXS-HOT, which target tumor neoantigens, rose to the top.
"We are dedicating more resources to the HOT program because these assets scored very high when we conducted our portfolio review," said Berlin.
"This program, along with our NEO program which is partnered with Amgen, hold great potential in the exciting and fast-developing field of neoantigens and have application across multiple tumor types in high-value indications."
ADXS-PSA, a combination trial with Merck & Co.'s Keytruda (pembrolizumab), could prove another area of interest if early data presented this past week hold up over the next six to nine months, Advaxis said.