- Amgen on Tuesday acquired global rights to a preclinical cancer immunotherapy developed by Advaxis, paying the New Jersey-based biotech $40 million upfront along with a $25 million equity investment, the companies said.
- Advaxis, long focused on immuno-oncology, is eligible to receive an additional $475 million in development, regulatory and sales milestones for its ADXS-NEO investigational treatment.
- Clinical trials for ADXS-NEO are expected to begin in 2017. Amgen will fund clinical and commercial activities while Advaxis takes the lead on development through proof-of-concept.
With ADXS-NEO, Amgen and Advaxis hope to develop a more personalized cancer immunotherapy, one that triggers an immune response specifically tailored to attack the unique mutations, or neoepitopes, of an individual patient's tumor.
Current cancer immunotherapies such as Bristol-Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) or Merck's Keytruda (pembrolizumab) have shown extraordinarily promising results in some patients. Yet, the drugs are far from a cure and some subsets of patients don't see a substantial improvement or even a response at all.
Both Opdivo and Keytruda work by inhibiting PD-1, but are being tested in patients with both low and high levels of the PD-L1 protein. Varied responses amongst the groups have left the industry searching for combination therapies that can help fill the gaps.
Advaxis has developed a pair of proprietary technologies it hopes can tailor treatment to the genetic mutations of a patient's tumor. One, which Advaxis calls MINE (My Immunotherapy Neo-Epitopes), enables exome sequencing of a patient's tumors along with healthy cells; the other, bio-engineered Listeria monocytogenes (Lm), is used to create stronger immune cells. By mapping tumors, Advaxis believes it can pinpoint cancer mutations that will respond well to immuno-oncology combination drugs.
Advaxis already has collaborations in place with MedImmune (part of Pfizer) and Merck evaluating its Lm technology in combination with both big pharma's PD-1 inhibitors.
But its partnership with Amgen is the first to use the parallel sequencing of MINE to target neoepitopes in conjunction with Advaxis' Lm technology.
Advaxis teamed up with Memorial Sloan Kettering Cancer Center to launch MINE last October. In a statement at the time, Jedd Wolchok, chief of melanoma and immunotherapeutics service at Memorial Sloan Kettering pointed to the opportunities unlocked by genome sequencing in developing personalized cancer treatments.
"Existing immunotherapies have been shown to very effectively augment tumor immunity in a subset of patients, leading to durable responses," Wolchok said. "However, recent advances in genome sequencing have made it possible to investigate the role of neoepitopes, or unique mutations, in an individual patient’s cancer."
Investors certainly seemed cheered by the news of the Amgen partnership, sending Advaxis stock soaring by over 25% in Tuesday trading.