Advaxis says Amgen’s withdrawal from a 2016 personalized immuno-oncology partnership is due to portfolio rationalization, high cost of goods, and the high-risk of commercialization.
In 2016, Amgen teamed up with New Jersey-based Advaxis to co-develop and commercialize Advaxis’ investigational cancer immunotherapy ADXS-NEO in a deal worth up to $540 million (€475 million).
But after paying out $78 million, Amgen sent written notice last month alerting Advaxis it is terminating the partnership, effective from February 8, said Advexis in an SEC filing.
Amgen will end its partnership with Advaxis on February 8. Image: iStock/Ivan-balvan
Ken Berlin, CEO of Advaxis, told investors during the firm’s fourth quarter financial call last week that there were three reasons why Amgen is ending the deal, the first being portfolio rationalization.
“Based on their internal portfolio review they did not feel our program was in-line with the direction they were taking,” he said.
“Second was cost of goods. Our Advaxis-NEO product is personalized to each patient. Therefore, it inherently has a higher cost of goods to manufacture then other non-personalized cancer therapies such as checkpoint inhibitors.
“And the third reason they provided was that it is high-risk and far from commercialization. We are still early in the development cycle for Advaxis-NEO and therefore by definition it’s a high-risk proposition, which we are working to de-risk. And it will be several years before products from our Advaxis-NEO program can be launched.”
While a blow to Advaxis, Berlin said there are some elements of the termination which will benefit the firm. This includes the freedom to present data generated from the candidate’s study where and when appropriate.
“As a result, we are now in the process of gathering and reviewing the safety, immune correlative and early clinical information from our first cohort and anticipate releasing these data within the next two months.”
Personalized vs off-the shelf
ADXS-NEO is based on the Advaxis Lm Technology, which uses bioengineered live attenuated Listeria monocytogenes (Lm) bioengineered to produce and deliver tumor antigen/adjuvant fusion proteins. A patient’s DNA is sequenced and compared to identify mutations in genes coding for potential neo-antigens in the cancer, and then Advaxis engineers and manufactures patient-specific listeriolysin O vectors capable of immunizing them against neoepitopes exclusive to their cancer.
As part of Advaxis’ personalized therapy pipeline, Berlin said that one of Amgen’s issues with ADXS-NEO, the high cost of goods, is due to making a bespoke product for each individual patient. “By definition it is more expensive than a one-size-fits-all approach.”
Advaxis is also developing off-the-shelf cancer therapies through its HOT program, with candidates expressing public or shared antigens and other tumor associated antigens to treat numerous patients across multiple cancer types.
“Our HOT programs address one of the issues raised by Amgen cost of goods,” Berlin said. “While we’ve made good progress on identifying ways to reduce the cost of manufacture our Advaxis NEO constructs, a significant enhancement of our Advaxis-HOT drug construct is that it is off-the-shelf, meaning the drug construct for each cancer type is universal to all patients with that type of cancer, and therefore the cost to manufacture is a fraction of what it cost to manufacture Advaxis-NEO, plus there is no waiting time. The drug is ready when the patient is ready to be dosed.”