In Conversation: Gary Fanger, Ph.D., Founder, President, and CEO of Rise Therapeutics

Rise Therapeutics is taking on immunotherapy from a slightly different pathway – the gut microbiome.

In the context of normal human biology, the microbiome is a collection of microorganisms, including bacteria, fungi, viruses, and other microbes, that reside in various bodily habitats, including our gut. Gary Fanger, Founder, President and Chief Executive Officer of Rockville-based Rise Therapeutics, explains that the microbiome needs to be seen in light of a new organ in the body.

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“These organisms impact virtually every element of our biology. The microbiome is critical for us to live, and regulates everything from gut and immune health to our mood and psychology,” Fanger said.

The organisms in the microbiome can regulate key immune pathways, he said. Fanger, who previously served as Chief Operating Officer of Amplimmune, then explained that, for example, some cancer patients respond well to immunotherapy drugs that have a certain bacteria reservoir, which makes the immunotherapy work better. Building on this understanding is the basis of Rise Therapeutics’ approach to treating disease.

“We are redesigning microbiome products and using synthetic biology to direct functionality of living medicines to treat human diseases,” Fanger said.

Using its proprietary TriPartite X (TPX) oral drug delivery platform approach, Rise Therapeutics has taken a more traditional pharmaceutical approach, packaging their investigational drugs into probiotics in order to target specific immune pathways regulated microbiome. The TPX platform enables biological therapy to be delivered orally. This targeted immunology approach provides Rise a competitive drug development advantage, Fanger said. Fanger noted that these are living medicines that ultimately act as miniature pumps that secrete and produce drugs within the body. Using this approach, we can correct disease conditions at an earlier stage than traditional injected or infused biological therapies, Fanger added.

“Based upon our targeted biologics approach, we have a strong mechanistic understanding of how our drugs work,” he said.

In its pipeline, the company has three assets it’s preparing to begin clinical development within the next year. The first, R-3750, is an oral immune therapy being assessed as a potential treatment for the underlying basis of gastrointestinal-associated inflammatory disease by inducing immune homeostasis of the intestinal tract. According to company data, R-3750 has the ability to enhance gut barrier integrity, a key mechanism to resolving inflammatory disease of the gut. Rise Therapeutics is developing R-3750 for inflammatory bowel disease.

Rise’s second clinical asset is R-2487, a targeted oral immune therapy that has the ability to induce T regulatory cell populations. It is designed to engage specific microbiome-associated immune pathways that regulate tolerance in order to reset T regulatory deficiencies that will then reduce specific inflammatory cytokines that contribute to autoimmune disease. Initially, Rise is developing R-2487 for the treatment of Sjogren’s syndrome, an immune disorder characterized by dry eyes and dry mouth, as well as other autoimmune diseases.

R-5780 is Rise Therapeutics’ lead oncology drug candidate. The oral treatment has demonstrated what Fanger called a pronounced ability to enhance immune checkpoint activity. Fanger said R-5780 is building on the growing understanding of how the microbiome can boost the efficacy of immuno-oncology medicines. R-5780 is a targeted drug product that engages selective immune pathways that can drive robust anti-tumor responses. The company believes that with R-5780, they can take patients who won’t respond to checkpoint inhibitors like Merck’s Keytruda and make them respond to it.

Additionally, Rise Therapeutics has multiple live cell therapy products that are still in the early stages of development.

2022 has been an exciting year for Rise thus far. Earlier this year, the company initiated operations of its clinical GMP manufacturing facility. The infrastructure buildout was supported by the National Institute of Health’s Commercialization Readiness Pilot program, as well as funds from Montgomery County. Fanger touted the financial assistance provided by these government organizations, as well as funds provided by the state of Maryland.

“They have been tremendous partners to us,” Fanger said.

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With its new facility now online, Fanger said it will allow the company to carry out strain engineering, process development, analytical characterization, and clinical GMP manufacturing of microbial-based products, including Live Biotherapeutic Products and microbiome-based medical food products. 

Even as Rise works toward its own microbiome-based drug development, Fanger said the company has developed the capabilities to assist other companies in preparing for product development as well. Not only does this partnership capability benefit Rise, it also benefits smaller companies and the overall industry, Fanger said.

Fanger said Rise hopes to spur innovation in treating disease. The company is “taking on the challenge” to drive innovation forward, particularly with the use of synthetic biology-derived living drugs.

“There’s a tremendous need for synthetic biology to design and direct the functionality of living drugs in appropriate ways,” Fanger added.