Back in October, the FDA slammed the brakes on four studies involving Advaxis' cervical cancer vaccine, axalimogene filolisbac, dubbed ADXS-HPV. The Princeton, NJ-based company announced on Wednesday that the FDA has lifted the clinical hold, allowing it to carry on with its clinical trials and sending its shares up 38%.
One month after a European safety review raised no issues with the blockbuster-to-be HPV vaccine Gardasil 9, Merck received another boost for its jab this week.
GamaMabs Pharma has raised €15 million ($16.4 million) to advance a monoclonal antibody against gynecological cancers into the clinic and up to proof-of-concept. Edmond de Rothschild Investment Partners' BioDiscovery 4 came on board to lead the Series B round.
On Sept. 18, Advaxis reported "encouraging" data from a Phase II trial of its cervical cancer vaccine, axalimogene filolisbac, dubbed ADXS-HPV. Now, the biotech is reporting an FDA clinical hold on the candidate--5 days after the FDA placed the hold.
Operating in a field that can leave patients with few options, Advaxis rolled out data for its cervical cancer vaccine this week that represent a "meaningful step" for those afflicted, according to one expert.
Following behind a blockbuster is no easy task, but with a European Commission decision on Wednesday in favor of the vaccine, Merck's Gardasil 9 may just be up to the challenge of succeeding Gardasil.
The recommended schedule for HPV vaccination is two or three doses, but some patients never make it back for all of the shots. This may cease to be a concern if future trials prove what scientists reported on Wednesday: A single dose of GlaxoSmithKline's Cervarix could work as well as the recommended two- or three-dose regimens at preventing the majority of cervical cancers.
Femasys raises $10.2M in Series B for female sterilization device trial and to market diagnostic tools
Women's health startup Femasys has raised $10.2 million in a Series B round. The financing will go to support pivotal testing for its FemBloc non-surgical female sterilization device and to marketing the company's two commercial diagnostics tools, one for female infertility and the other for cervical cancer.
An Israeli company, Biop Medical, is developing the Biop diagnostic medical device to detect cervical cancer.
Advaxis, on a partnering spree after joining with Merck and AstraZeneca to test its cancer vaccine candidates in immunotherapy combos, has teamed up with Incyte to trial one of its prospects in cervical cancer.