Per the agreement, Pfizer will gain exclusive rights to develop the immunotherapeutic and will be responsible for optimization and potential commercialization.
The exercised option stems from a Series A funding agreement between the two companies in June 2016. This agreement also included Orion Equity and Juvenile Diabetes Research Foundation (JDRF) in which the funding parties provided $4m (€3.5m) to fund research for AnTolRx’s targeted nanoparticle tolerance therapeutics for immune disorders including type 1 diabetes (T1D).
Mark Carthy, CEO of AnTolRx, told us that the original agreement was set up with a series of milestones and the company has “marched through those milestones” and is able to identify a candidate that would be suitable for preclinical work. With those achievements, Pfizer was able to exercise its option and license the drug candidate.
“It seems to us, that Pfizer has developed a strong interest in this area over those two years [since the original agreement],” Carthy told us. He added that with the data package the company has been able to draw together and the increasing interest in the immunotherapeutic market, there seems to be a clear path to Pfizer expressing its option.
Michael Vincent, CSO of Inflammation & Immunology at Pfizer, said in a statement that his department, which will take on the development of this drug candidate, sees AnTolRx’s approach to “re-educate the immune response as one potentially promising strategy” to achieve its goal of advancing cures for autoimmune disease.
Immunotherapeutic re-establishes tolerance
Jessica Kenison, senior scientist at AnTolRx, told us, that the immune tolerance therapy works through the aryl hydrocarbon receptor (AhR) pathway. AhR is a receptor known to induce tolerance pathways. When used in combination with AnTolRx’s platform AhR can be used to induce antigen-specific tolerance.
“In T1D, you have T-cells that are incorrectly targeting antigens that are presented on beta cells in your pancreas. The immune cells are going in and attacking the pancreas and destroying it,” Kenison explained.
“What we’re doing is shutting off that pathway, re-establishing tolerance, re-educating the immune system so that the immune cells that were attacking the pancreas, no longer do that,” she continued.
Immune tolerance market
According to Kenison, the market for antigen-specific therapies is a “hot area right now”, as the need for therapeutic options outside of general immunosuppressant therapy area, which are often the first line of treatment, can have significant side effects.
“We plan to overcome the problems caused by raw immunosuppressant products which are currently used in the field,” Carthy said.
Antigen-specific therapies, according to AnTolRx, can be used to treat early-stage diseases, especially in patients without severe effects of disease but who still demonstrate biomarkers.
“In T1D in particular, researchers have been developing some strong biomarkers like the recognition of autoantibodies that are produced in patients, and they have been able to recognize a pretty high probability of disease in patients, and therefore we can go in with an early intervention type product like the one we’re developing and prevent the disease from even happening in the first place,” said Kenison.
With AnTolRx’s approach showing a strong safety profile, physicians may be more interested in antigen-specific therapies for early-stage patients and, “that would create a big new market for treating diseases like early stage T1D,” concluded Carthy.