Clinical development of guselkumab expands into UC
PLANEGG, Germany—MorphoSys AG announced in mid-January that its licensee Janssen Research & Development LLC (Janssen) has further expanded the clinical development of guselkumab (Tremfya) into ulcerative colitis (UC). Janssen has initiated a proof-of-concept Phase 2a clinical trial in patients with moderately to severely active UC, a chronic inflammatory bowel disease. This randomized, double-blind study will evaluate the efficacy and safety of guselkumab in combination with golimumab compared to guselkumab or golimumab monotherapy in approximately 210 patients with moderately to severely active UC. Guselkumab is a human anti-IL-23 monoclonal antibody developed by Janssen that was generated utilizing MorphoSys’s proprietary HuCAL antibody technology.
Dr. Markus Enzelberger, chief scientific officer of MorphoSys AG, said: “We are very pleased that our licensee Janssen has further expanded the clinical development program of guselkumab by initiating a clinical study in ulcerative colitis. We see a high medical need to investigate new treatment options for patients suffering from this inflammatory disease of the gastrointestinal tract.”
Biomunex signs licensing agreement for bi- and multi-specific antibodies
PARIS—Biomunex Pharmaceuticals recently announced a licensing agreement with Sanofi that will allow the latter company to have access to Biomunex’s proprietary technology to generate and optimize bi- and multi-specific antibody therapeutics. Sanofi will be solely responsible for the research, development, manufacturing and global commercialization activities. This agreement, the first of its kind for Biomunex, is in line with the company’s business model, which is to establish licensing or collaboration agreements and to become a clinical-stage company in the short term.
Biomunex will receive an initial upfront payment and will be eligible to receive further clinical, regulatory and commercial milestone payments. Further financial details were not disclosed.
“This licensing agreement is a major milestone for Biomunex. It demonstrates the high value of the BiXAb technology and is the starting point for our collaboration strategy with pharmaceutical companies to discover and develop cutting-edge bi- and multi-specific antibodies, giving patients new treatment options,” said Dr. Pierre-Emmanuel Gerard, founder and CEO of Biomunex.
Oculis in-licenses anti-TNF alpha antibody fragment
LAUSANNE, Switzerland—In early January, Oculis SA, a clinical-stage biopharmaceutical company developing next-generation topical ophthalmic treatments, entered into an agreement to in-license a novel topical anti-TNF alpha antibody from Novartis. No financial details were disclosed.
The compound, named LME 636, is based on a proprietary single-chain antibody fragment technology specifically designed for topical delivery. Efficacy and safety were evaluated in three clinical trials, which demonstrated a promising profile for treating inflammatory conditions of the anterior segment of the eye, including dry eye disease.
The in-licensing of LME 636, which will be renamed OCS-02, expands Oculis’ portfolio of novel topical therapies for major ophthalmic diseases, and offers Oculis the opportunity to address unmet medical needs of patients with potentially the first topical anti-TNF alpha therapy for ophthalmic indications.