Johnson & Johnson’s Janssen Biotech will partner with enGene to develop and commercialize new therapies for inflammatory bowel disease (IBD), the companies said today, in a deal that could generate more than C$441 million (nearly $340 million) for the gene therapy developer.

Janssen will have the option to exclusively license enGene's lead product candidate, EG-12, for gut-localized expression of the anti-inflammatory cytokine IL-10. enGene and Janssen will jointly develop EG-12 through to clinical proof of mechanism in patients with IBD.

If it agrees to exercise its option, Janssen will take over further clinical development and commercialization of EG-12 for all indications worldwide. The collaboration also allows Janssen to explore the therapeutic potential of enGene's platform to deliver one additional undisclosed target.

The strategic alliance will use enGene's non-viral vector platform for gene delivery to cells lining the intestine. enGene's vector system can be administered to the intestine via the oral or enema route.

“This strategic collaboration will also accelerate the development of enGene's gene delivery platform into an orally available 'Gene Pill', which offers the potential of being a game-changer by making oral delivery of protein drugs a reality,” Anthony Cheung, Ph.D, CEO and a co-founder of enGene, said in a statement. “This alliance represents a significant opportunity for us to develop an entirely new class of transformative therapies for IBD and other diseases.”

Dr. Cheung also cited Janssen’s experience and success in immunology and developing drugs for IBD. Janssen markets REMICADE® (infliximab), a tumor necrosis factor (TNF) blocker whose numerous indications include Crohn’s disease in children and adults; as well as ulcerative colitis in children and adults. Yesterday, J&J reported REMICADE sales of $4.881 billion for the first three quarters of this year, down 6.1% from the year-ago period.

enGene said the partnership was facilitated by Johnson & Johnson Innovation, which offers funding, R&D expertise, business model development, and facilities and operational support to areas of strategic importance in J&J’s pharmaceutical, diagnostic, consumer and medical device businesses.

enGene said it will receive an upfront payment, equity investment through J&J’s venture capital arm Johnson & Johnson Innovation–JJDC, and R&D funding. The gene therapy developer is also eligible to receive up to a total C$441 million (nearly $340 million) in payments tied to preclinical, clinical, regulatory and commercialization milestones, plus tiered royalties on potential net sales of products.








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