V ClinBio forges clear path to FDA

Acquires equity stake in Cellix Bio and its Synergix drug delivery program; partners with Camargo

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PRINCETON, N.J.—Taking a giant step toward controlling its own destiny, biopharmaceutical V ClinBio Inc. has acquired a 49.98-percent equity stake in India-based Cellix Bio, a drug design and development company—and its vital Synergix drug delivery platform, which has the potential to shorten development times and reduce the risk of clinical failure.
V ClinBio has further paved its path to U.S. Food and Drug Administration (FDA) approval of its candidate drugs—CLX-106 for the treatment of relapsing-remitting multiple sclerosis (RRMS) and CLX-103 for treating ulcerative colitis—by entering into service agreements with Camargo Pharmaceutical Services LLC, based in Cincinnati, to provide end-to-end regulatory consulting and strategic development services. This includes pre-Investigational New Drug preparations through New Drug Applications submissions. V ClinBio plans to file with the FDA later this year.
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.
“Many promising new molecules fail in the clinic due to poor activity or bioavailability, unacceptable toxicity or suboptimal efficacy or pharmacology,” states 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.”
“With our expanded collaboration with Cellix Bio, we have access to the group’s entire portfolio of asset development and patents,” Oliver adds. “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.”
The Synergix platform uses a rational drug design process to modify molecules with demonstrated activity against a specific target, with the goal to achieve specific efficacy and pharmacology profiles. This is achieved by generating new prodrugs of already-approved therapies and conjugating them with long chain fatty acids.
A prodrug is defined as a medication or compound that is converted within the body into a pharmacologically active drug. Inactive prodrugs are pharmacologically inactive medications that are metabolized into an active form within the body.
Instead of administering a drug directly, a corresponding prodrug might be used to improve how a medicine is absorbed, distributed, metabolized and excreted. Prodrugs are often designed to improve bioavailability when the original drug itself is poorly absorbed from the gastrointestinal tract. A prodrug also may be used to improve how selectively the drug interacts with cells or processes that are not its intended target, thus reducing adverse or unintended effects of a drug—which is especially important in treatments like chemotherapy that can have severe unintended and undesirable side effects.
CLX-106 is a new formulation of 5-(methoxymethyl)furan-2-carbaldehyde (MMF) conjugated to icosapentaenoic acid for treating RRMS and psoriasis. It has demonstrated a significantly 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, according to V ClinBio.
CLX-103 is a new patented prodrug molecular conjugate of mesalamine, eicosapentaenoic acid and caprylic acid, designed to offer incremental benefits over the currently approved 5-aminosalicylic acid formulations for treating ulcerative colitis. In 2016, mesalamine therapeutics generated more than $4.8 billion in annual sales globally, V ClinBio reports.
Mahesh Kandula, managing director and CEO of Cellix Bio states, “The power of Synergix is its ability to alter molecules that are known to be active against a specific target through a rational design process to achieve specific safety, efficacy and pharmacology profiles.”
The technology also enables the development of dual-action therapies containing two bioactive molecules, which provides 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.
“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,” Kandula adds.
Oliver states, “Patients and physicians need rapid access to new therapies and every stakeholder in the healthcare system is under pressure to reduce costs. 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.”

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