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The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.
On Feb. 06, 2018, V ClinBio, a biopharmaceutical company focused on converting existing compounds into new therapeutics for treating immune and other related diseases, announced the acquisition of a 49.98% equity stake in Cellix Bio, a drug design and development biopharmaceutical company.
The acquisition strengthens the companies' existing collaboration focused on advancing best-in-class therapies across multiple drug categories and is expected to accelerate clinical development. Later in 2018, V ClinBio expects to file an investigational new drug application with FDA for the lead compounds, CLX-106 and CLX-103, to treat relapsing-remitting multiple sclerosis (RRMS) and ulcerative colitis (UC), respectively.
The two lead compounds were generated from Cellix Bio's proprietary Synergix drug delivery platform. The technology advances the clinical and regulatory potential of existing therapies across multiple drug categories and disease indications, according to the companies. The technology also offers biopharma companies the potential to shorten development times and reduce the risk of clinical failure. The generation of new molecular entities using this technology allows for flexible regulatory paths, including 505(b)(1) and 505(b)(2), as stated by the companies.
"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, in a company press release. "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, 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. 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, according to the companies.
"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, in the press release. "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," Oliver said in the release. "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."
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. It is 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, according to V ClinBio.
Source: V ClinBio