CRO roundup of recent trial wins for LabCorp, inVentiv, Evotec
Kicking off the week is a long-term partnership between China’s Shandong XuanZhu Pharma, an R&D subsidiary of Sihuan Pharmaceutical Holdings, and LabCorp’s Covance to support the global development of Sihuan Pharmaceutical’s drug candidate pipeline consisting of multiple compounds that address unmet needs across a range of therapeutic areas, including cardiovascular, metabolic, infectious disease, oncology and urology.
More specifically, Covance will provide Sihuan Pharmaceutical with global drug development and regulatory expertise, particularly in efforts to achieve dual or multiple filings for regulatory approvals such as investigational new drug (IND) applications and new drug applications (NDA) in China and internationally.
“This agreement is the first of its kind signed with a partner in the Asia Pacific region, and Covance looks forward to collaborating with Sihuan Pharmaceutical in its efforts to potentially bring global filing strategies to realization,” said Honggang Bi, VP and General Manager of China at Covance. “With multiple compounds in its development pipeline, Sihuan Pharmaceutical is a promising pharmaceutical company to watch for ground-breaking new therapies.”
The partnership also comes as LabCorp recently highlighted its recent clinical research efforts in oncology and viral hepatitis. A study published in the February 1st issue of Clinical Cancer Research shows how LabCorp’s HERmark Breast Cancer Assay (HERmark) can identify certain breast cancers that over-express HER2 and that are most likely to provide patients with increased clinical benefit from dual agent HER2 therapy, compared to single agents alone.
LabCorp is also collaborating with the US Centers for Disease Control and Prevention (CDC) through a three year deal that will provide the agency access to LabCorp’s extensive data stores of viral hepatitis test results. The agreement will enable the CDC to use de-identified test results to evaluate trends and patterns in hepatitis virus test results to enhance patient care.
inVentiv Deal
Meanwhile, Canada’s Portage Biotech subsidiary Biohaven Pharmaceutical Holding Company, which Portage holds 54% equity, has entered into an agreement with CRO inVentiv Health to execute Biohaven's first clinical trial with their lead compound (BHV-0223).
Biohaven is engaged in the identification and development of clinical stage neuroscience compounds targeting the glutamatergic system. Clinical drug supply manufacturing has begun for BHV-0223, and Biohaven plans to begin a Phase 1 pharmacokinetic and biomarker study by Q3 of this year to confirm optimized drug exposure levels of its novel formulation. inVentiv Health will oversee the study execution of this clinical trial.
BHV-0223 is a glutamate modulating agent being developed using Section 505(b)(2) of FDA guidelines, which permits approval of new drug applications based, in part, upon prior findings of safety and/or effectiveness from a previously approved drug product.
Evotec Partnership
And finally, Germany’s Evotec has entered into a multi-target screening collaboration on several ion channel targets, with Asahi Kasei Pharma Corporation, a wholly owned subsidiary of Asahi Kasei of Japan.
Under the terms of the agreement, Evotec will use its ion channel platform to identify inhibitors of multiple ion channel targets. Financial terms were not disclosed.
