V ClinBio, a biopharmaceutical company focused on transforming existing compounds into differentiated new therapeutics, has acquired a 49.98% equity stake in Cellix Bio, a drug design and development company. 

This transaction strengthens the companies’ existing collaboration focused on advancing best in class therapies across multiple drug categories promising to accelerate clinical success and fulfil unmet needs. Later this year V ClinBio expects to file an Investigation New Drug Application (NDA) with the U.S. FDA for CLX-106 and CLX-103 to treat relapsing-remitting multiple sclerosis (RRMS) and ulcerative colitis (UC) respectively.

Both CLX-106 and CLX-103 were generated from Cellix Bio’s proprietary Synergix drug delivery platform, which unlocks the clinical and regulatory potential of existing therapies across multiple drug categories and disease indications. Synergix offers biopharma companies the potential to shorten development times and reduce the risk of clinical failure. The new molecular entities allow for flexible regulatory paths, including 505(b)(1) and 505(b)(2).

“Many promising new molecules fail in the clinic due to poor activity or bioavailability, unacceptable toxicity or suboptimal efficacy or pharmacology,” said Bob Oliver, president, V ClinBio. “I personally feel that this incremental innovation can be transformative by yielding significant improvements in a compound’s therapeutic window and measurably increasing the probability of development success.”

The Synergix platform uses a rational drug design process to modify molecules with demonstrated activity against a specific target to achieve specific efficacy and pharmacology profiles. This is achieved by generating novel prodrugs of approved therapies and conjugating them with long chain fatty acids. Synergix also enables the development of dual-action therapies containing two bioactive molecules, providing a synergistic approach for targeting two critical points in a disease-related pathway more efficiently than can be achieved by co-administration or independent dosing of multiple therapies.

“The power of Synergix is its ability to alter molecules that are known to be active against a specific target through a rationale design process to achieve specific safety, efficacy and pharmacology profiles,” said Mahesh Kandula, managing director and chief executive officer, Cellix Bio. “Through our expanded collaboration with V ClinBio, CLX-106 and CLX-103 are the beginning of a growing portfolio of product candidates that offer clear clinical and market benefits compared with their unmodified counterparts.”

“Patients and physicians need rapid access to new therapies and every stakeholder in the healthcare system is under pressure to reduce costs,” said Mr. Oliver. “Synergix has tremendous potential to achieve both of these critical needs, and we believe that greater access to Synergix through our equity position in Cellix Bio will allow us to advance our product pipeline and create multiple opportunities for high-value collaboration and licensing transactions with leading biopharmaceutical companies.”