V ClinBio Acquires 49.98% Stake in Cellix to Advance Synergix, a Transformative Pro-drug Technology Platform

- Lead compounds for the treatment of relapsing-remitting multiple sclerosis and ulcerative colitis on target to enter clinic in 2018 -

PRINCETON, N.J., Feb. 06, 2018 -- V ClinBio Inc., an innovative biopharmaceutical company focused on transforming existing compounds into differentiated new therapeutics, today announced that it has acquired a 49.98% equity stake in Cellix Bio, an innovative 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. Food and Drug Administration (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 of 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 CEO, 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,” he added.

“Patients and physicians need rapid access to new therapies and every stakeholder in the healthcare system is under pressure to reduce costs,” continued 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.”

About CLX-106 & CLX-103
CLX-106, a novel formulation of MMF conjugated to icosapentaenoic acid for the treatment of RRMS and psoriasis, has demonstrated a highly differentiated profile compared with other MMF prodrugs in development. MMF is an approved RRMS therapy that achieved global sales of over $4 billion in 2016.

CLX-103 is a novel, patented prodrug molecular conjugate of mesalamine, eicosapentaenoic acid and caprylic acid designed to offer incremental benefits over the currently approved 5-ASA formulations for the treatment of ulcerative colitis.  In 2016, mesalamine therapeutics generated more than $4.8 billion in annual sales globally.

About V ClinBio
V ClinBio is an innovative biopharmaceutical company, spearheaded by former Otsuka president and J&J senior executive, Bob Oliver, which is driving the development of novel drug products for treatment of immune and other related diseases. V ClinBio develops New Molecular Entities (NMEs) using incremental innovation and prodrug technology targeted to provide better pharmacokinetic, pharmacodynamics, physicochemical properties, and to enable the development of known agents for both existing and new indications. With our expanded collaboration with Cellix Bio, we have access to the group’s entire portfolio of asset development and patents. Our technology has the potential to increase efficacy, tissue distribution, safety, compliance and synergic/additive pharmacology of conjugate components. Our focus is to develop a robust pipeline of new medicines addressing unmet medical needs across diverse therapeutic areas including neurology, inflammation and metabolic diseases.

About Cellix Bio
Cellix is an innovative drug design and development biopharmaceutical company, founded by Mahesh Kandula, a prolific inventor focused on designing and developing best-in-class therapies for the treatment of Neurological, Inflammatory and Metabolic Diseases.  With 143 Global Patents, 64 issued U.S Patents and a robust pipeline of pending patents using our proprietary technologies and strong scientific platform “Synergix”; new and effective medicines are being developed that modulate more than one target in the disease pathway while minimizing as much risk as possible from the discovery and development process. We select drugs known for their demonstrated efficacy and clinical safety along the targeted biological pathway, and use our proprietary Synergix technology platform to produce new medicines that modulate the disease pathway with enhanced safety and efficacy profile.

For information:
Chantal Beaudry, Lazar Partners
[email protected]
646-871-8480

Amy Feldman, Lazar Partners
[email protected]
212-867-1779