Startup Applied Molecular Transport is aiming to mimic the systems used by naturally occurring microbes in the gastrointestinal tract to develop oral biologics that can cross the organ's barriers. Johnson & Johnson ($JNJ) demonstrated its interest in the drug delivery paradigm by making the company one of the 10 first occupants of its just opened 30,000-square-foot life science incubator in South San Francisco.
Currently, no oral biologics are on the market; drugs in this new class are generally injected. That's because the "systemic bioavailability of oral proteins and peptides is unacceptably low," said AMT's founder and chief business officer, Tahir Mahmood, in an interview with FierceDrugDelivery. "Our GI tract is a barrier. It's been designed to keep things out, not let them in."
Mahmood said AMT has solved that drug delivery problem by creating microbe-derived proteins that are based on a new understanding of microbial genomics and the way in which some bacteria are able to shuttle proteins across the intestinal epithelia.
"We are working with nature, not against it," Mahmood said, although he declined to specify the species of bacteria being used as the model.
Another problem facing oral biologics is that antibodies and other biologically derived components degrade when exposed to the digestive system, but Mahmood said AMT's candidate is stable in the intestinal lumen. He wouldn't disclose the drug being delivered, but said it belonged to a class of proteins known as cytokines.
J&J's decision to let AMT use office space in the new incubator means "one or more of their companies has some interest in keeping abreast of what's going on," Mahmood said.
In fact, unlike most of the other incubator companies, AMT had a previous relationship with J&J. In December, the startup launched a collaboration with the industry bigwig granting J&J's Janssen Biotech an exclusive, worldwide license for an oral candidate to treat inflammatory bowel diseases (IBD).
J&J has been active in the IBD space as it scrambles to replace megablockbuster Remicade, which earns more than $8 billion per year. The injectable is approved to treat various IBDs including Crohn's disease and ulcerative colitis, but biosimilar competition from Celltrion's Remsima is looming in the U.S. Remsima is already available internationally.
Around the same time as the AMT collaboration, J&J licensed Vedanta Biosciences' microbiome pharmaceutical candidate for IBD. And in December, J&J canceled a collaboration with Belgium's Galapagos in the IBD space.
The oral biologics being developed can also enter systemic circulation via the bloodstream after crossing the GI tract, Mahmood said. AMT is open to future partnerships in the immune-mediated inflammation, metabolic diseases and RNAi arenas.
"We get to leverage all of the resources that J&J is building for the incubator, which is just world class," the CBO said, mentioning tissue culture facilities, mass spectrometers and other analytical equipment for proteins.
Founded in 2010, AMT moved into the Silicon Valley incubator when it opened in January, giving the company its first centralized office space. Mahmood said the company is expanding and should soon have 10 employees.