Novome Biotechnologies and Genentech Enter into a Strategic Collaboration

November 10, 2021

SOUTH SAN FRANCISCO, Calif. – Novome Biotechnologies, a clinicalstage biotechnology company developing engineered cellular therapies for the gut, announced a multi-year research collaboration and licensing agreement with Genentech, a member of the Roche Group to use Novome’s proprietary Genetically Engineered Microbial Medicines (GEMMs) platform to discover, engineer and develop bacterial strains that express and deliver specific therapeutically relevant molecules to targets in the human intestinal tract to treat diseases
such as Inflammatory Bowel Disease (IBD).

Novome is focused on treating chronic diseases with the first platform for the controlled and robust colonization of the human gut with engineered bacteria to deliver targeted therapeutic cargos and functions. The IBD program is the third program to advance in the Company’s pipeline; its lead program targeting enteric hyperoxaluria (EH), a common cause of kidney stone formation, entered into a Phase 1 clinical trial earlier this year.

Under the terms of the agreement, Novome will have responsibility for research activities up to initiation of IND-enabling preclinical studies for this multi-target collaboration. Genentech will be responsible for clinical development of candidates and commercialization of potential medicines resulting from the collaboration.

Novome will receive an upfront payment of $15 million. The Company is also eligible to receive up to $590 million in potential milestone payments based on the achievement of prespecified development and commercial milestones, as well as tiered royalties on sales resulting from the agreement. Additionally, Novome retains rights to develop its own, wholly-owned IBD candidates utilizing targets outside of those included in the collaboration.

“We are extremely pleased to establish this strategic collaboration with Genentech, a recognized global leader in therapeutic innovation, which will serve to accelerate preclinical research into a new disease area for us,” said Blake Wise, CEO of Novome. “Our unique platform for colonizing the gut with engineered microbes capable of delivering novel and validated cargo has great potential to help people suffering from IBD. It is our hope that, with access to the deep research expertise of Genentech’s scientific teams, we can advance this exciting science more rapidly and deliver a truly needed therapy to people living with IBD.”

“We believe Novome’s GEMMs platform could be an important approach for developing oral cellbased therapeutics,” said James Sabry, MD, PhD, global head of Pharma Partnering, Roche. “This partnership, which combines Novome’s unique platform and our research expertise, complements our efforts to discover and accelerate new treatments for patients with inflammatory bowel diseases.”

Inflammatory bowel disease (IBD) is the common name used to describe both Crohn’s disease and ulcerative colitis. According to the Crohn’s and Colitis Foundation, as many as 1.6 million Americans have been diagnosed with IBD, most before age 35, with 70,000 new cases diagnosed each year.  While different diseases, Crohn’s disease and ulcerative colitis both involve inflammation of the colon.

About Novome
Novome Biotechnologies, Inc. is a clinical-stage biotechnology company developing engineered cellular therapies for the gut to treat chronic diseases. The Company has developed the first platform for the controlled colonization of the gut with engineered bacteria to deliver targeted therapeutic cargos and functions, enabling first-in-class living therapeutics: Genetically Engineered Microbial Medicines (GEMMs). Novome is utilizing its proprietary GEMMs platform in its lead program in enteric hyperoxaluria, which is focused on the development of a therapeutic strain of bacteria that degrades oxalate to decrease the risk of kidney stone formation. Efforts are also directed toward advancing pipeline indications in ulcerative colitis, irritable bowel syndrome and immuno-oncology.