Advaxis gets green light for trial of Amgen-partnered neoantigen cancer vaccine

The Investigational New Drug (IND) is believed to be the third granted by FDA for a neoantigen-based cancer therapy

Neoantigen cancer immunotherapies are a hot topic at the moment and gained a big biotech backer when Amgen licensed rights to Advaxis' lead candidate last year. Now, that candidate is heading for its first test in a clinical trial.

The FDA has given approval for a trial of ADXS-NEO in multiple cancers later this year, say the two partners, which joined forces on the drug in a deal valued at up to $540 million—including $65 million upfront—last August.

Advaxis and Amgen's Investigational New Drug (IND) application is believed to be only the third granted by the regulator for a neoantigen cancer therapy, coming after Fierce 15 company Neon Therapeutics got the go-ahead for a trial pairing its NEO-PV-01 candidate with Bristol-Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) and Aduro's green light for a therapy for advanced gastrointestinal cancers.

Neoantigen vaccines are a new form of personalized immunotherapy in which antigens that are found in diseased tissues but not normally in healthy patients are used to develop tailored vaccines.

Advaxis' approach to this is based on the use of an antigen delivery technology that uses a bacteria carrier to present multiple neoantigens to the immune system, which the company says stimulates both cell and antibody responses against tumor cells.

"Tumors can accumulate up to 100 or more mutations that can generate neoantigens, and each patient has a set of mutations that are unique to his or her own tumors," says the biotech. "ADXS-NEO is designed to hit multiple targets at once to improve the likelihood of a benefit."

Interest in the use of the approach in cancer has accelerated in the last couple of years with a string of deals involving companies with active neoantigen programs.

Moderna and biotech billionaire Patrick Soon-Shiong's made one of the first plays in the category with the acquisition of Precision Biologics for $50 million, and this was followed by $102 million in venture backing for star-up Gritstone Oncology, and last year by the launch of UK start-up Achilles Therapeutics, with backing from Syncona and Cancer Research UK.

Meantime, in December the sector saw the creation of a public-private partnership—the Tumor Neoantigen Selection Alliance (TESLA)—to help coordinate these efforts. Bringing together dozens of academic institutions and biotechs, TESLA has been set up to try to discover new neoantigens that can hopefully lead to more effective cancer vaccines with fewer side effects.

Amgen looking to beef up its immuno-oncology portfolio and catch up with the leaders in the fast-growing sector. Its already a player in the category with its bispecific antibody Blincyto (blinatumomab) for acute lymphoblastic leukemia (ALL), and recently added to its portfolio by licensing technology from Immatics and Xencor.

"Over the past several years, the field of cancer immunotherapy has brought promising new treatments with meaningful benefits to cancer patients," said the biotech major's senior vice president for translational sciences David Reese.

"Amgen remains committed to a multi-modality approach in immunotherapy, and our collaboration with Advaxis adds to the toolkit of cancer-fighting options available for patients."

Barclays analysts said they "view this as positive for shares, as ADX-NEO can now proceed to the clinical stage. While details on the planned phase 1 trial in multiple tumor types have not yet been released, the My Immunotherapy Neo-Epitopes (MINE) technology should in principle be a scalable and essentially commercial-stage platform for generating individualized, patient-specific immunotherapies. 

"We look for NEO to be applied in the phase 1 in both earlier lines of therapy and in patients whose disease has progressed despite treatment with an anti-PD1. We continue to like Advaxis shares ahead of upcoming catalysts as an attractive way to garner exposure to immunotherapies."