Amgen does preclinical I/O tie-up with small cap Advaxis for up to $540M

Amgen

Small cap Advaxis ($ADXS) has been through a lot of ups and downs in the nearly 15 years since it was founded. But it’s struck a recent high note in a new deal with industry giant Amgen ($AMGN). The preclinical partnership includes an upfront of $40 million alongside a $25 million investment, giving the cash-poor small cap plenty of runway to keep moving forward.

The deal is for preclinical cancer immunotherapy candidate ADXS-NEO, which is intended to activate an individual patient’s immune system to respond to unique mutations, or neoepitopes. Clinical testing of the candidate is slated to start next year.

“Amgen’s collaboration with Advaxis leverages and enhances our development and commercialization expertise in novel immuno-oncology treatments,” said EVP of R&D at Amgen Dr. Sean Harper in a statement. “We look forward to partnering with Advaxis to advance this highly targeted and patient-specific treatment option for patients.”

ADXS-NEO is based on an analysis of a patient’s normal and tumor cells that is then used to engineer listeriolysin O vectors to correspond to a patient’s particular cancer-related genetic mutations. These are intended to be used to immunize the patient against neoepitopes that are specific to their cancer. The candidate is part of Advaxis’ MINE (My Immunotherapy Neo-Epitopes) program.

This deal could help give more value to Advaxis' existing clinical candidates, which include Phase II candidate axalimogene filolisbac or AXAL, that targets human papillomavirus (HPV)-associated cancers and is being tested in cervical, head and neck, and anal cancer. It is slated to start a Phase III trial in high risk locally advanced cervical cancer this summer.

Advaxis also has another candidate in Phase I/II testing for prostate cancer that's partnered with Merck ($MRK) and, finally, one in Phase I for HER2-positive solid tumors.

In addition to the upfront payment and investment, the ADXS-NEO deal includes development, regulatory and sales milestones of up to $475 million with a high-single digit to mid-double digit royalty based on worldwide sales.

Advaxis will lead clinical development of the candidate through proof-of-concept, as well as be responsible for manufacturing. It had $44.9 million in cash at the end of the most recent quarter with an operating loss of $15.6 million, so the Amgen upfront and investment amounts to roughly a year’s worth of runway.

"This agreement allows us to advance ADXS-NEO with Amgen bearing all the clinical development and commercialization costs," Advaxis President and CEO Daniel O'Connor told FierceBiotech. "This, along with the economic benefits, puts Advaxis on solid footing to further advance our lead product candidate AXAL and our clinical pipeline."

- here is the release

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