Advaxis has three cancer molecules in clinical development, and speaking at its investor and analyst day on Wednesday, CEO Daniel O'Connor said completion of a new flex suite for GMP clinical production and an additional facility expansion currently underway will expedite bringing these products to market.
“These are important steps for the company and these new capabilities will provide us with both a very competitive cost structure and the flexibility to respond quickly to the needs of our clinical programs,” he told stakeholders (transcript here).
“From my point of view next to safety and efficacy, manufacturing is probably the most important other element for cancer immunotherapies and for product candidates moving from the clinic and into the commercial setting.”
In 2014, the firm paired up with Dutch contract manufacturing organisation (CMO) SynCo Bio Partners to help commercialise its lead candidate, human papillomavirus (HPV)-associated cancer drug Axalimogene Filolisbac.
O’Connor said, however, that over the past year the firm has been evaluating a number of options for its supply chain.
“In particular we analysed whether to make or to buy and concluded that building our own internal manufacturing capability made the most sense,” he said.
“We have designed and implemented a simple robust process to manufacture our own product candidates. We also continue to evolve the process with the ultimate goal of delivering commercial process that’s reliable, compliant and highly cost effective.”
Meanwhile, Biopharma-Reporter.com contacted SynCo Bio and a spokesperson confirmed that Advaxis remains a customer of the CMO, but only for commercial production.
Advaxis’s pipeline is based on its platform Lm Technology which uses live, attenuated bioengineered Listeria monocytogenes (Lm) bacteria to stimulate the immune system to view tumour cells as bacterial infected cells and target them for elimination.
“[This] naturally triggers many post defense mechanisms by engineering the bacteria to express tumour-associated antigens, such as the prostate specific antigen, the human papilloma virus, HER2 and now Neo antigens [which] we can educate the immune system to direct and attack against the cancer,” O’Connor told investors.
“This is the common denominator to all of our product candidates and in fact is at the heart of our company.”