CytoDyn Inc. (OTCMKST:CYDY) announced Tuesday two new additions to its management team as it seeks regulatory approval of its flagship drug leronlimab (PRO 140) to treat cancer and HIV.
The Vancouver, Washington-based biotech company said in a statement that it has named Brendan Rae as senior vice president of Business Development and George Bitar as executive director, head of quality.
News of the appointments comes as the Food and Drug Administration has granted fast-track status to leronlimab for use in combination with carboplatin for the treatment of patients with triple negative breast cancer (mTNBC).
The FDA also has fast-tracked leronlimab in combination with HAART, or highly active antiretroviral therapy, for HIV treatment. And CytoDyn on Monday announced that it would test the drug to prevent fatty liver disease in mice.
Given the potential of leronimab, CEO Nader Pourhassan said the “timing is ideal to have Brendan’s and George’s deep experience on the team, as we implement our commercialization plan and pursue new potential strategic agreements.”
Rae will lead CytoDyn’s business development initiatives, including all potential partnering and licensing opportunities for leronlimab, the company said, which added that Rae is an accomplished licensing and business development executive with a proven track record of deal-making.
Rae comes to CytoDyn from Serina Therapeutics, a private company, where he was chief business officer, responsible for partnering, out licensing and overall company strategy. Previously, Rae was the executive director of NPS Pharmaceuticals and head of GI and Endocrinology Business Development until the acquisition by Shire Pharmaceuticals for $5.2 billion in 2015.
Prior to NPS, Rae held the role of chief business officer at Arrowhead Research and Vivaldi Biosciences, as well as senior leadership roles at VIA Pharmaceuticals Inc (OTCMKS:VIAP), Purdue Pharma and Hoffman-La Roche, according to the statement.
Rae was an attorney specializing in biopharmaceutical intellectual property law and earlier in his career was a research scientist focusing on metastasis and the molecular basis of cellular transformation, the company said.
CytoDyn said Bitar will be responsible for overseeing all facets of the company’s quality systems, quality assurance, and compliance operations to ensure that the product is manufactured consistently to meet FDA standards.
READ: CytoDyn secures fast track FDA designation for leronlimab in treating metastatic triple negative breast cancer
As CytoDyn enters into a new era of manufacturing partnerships with contract manufacturing organizations (CMOs) in preparation for post-approval product launch of leronlimab, a knowledgeable head of quality is a critical component of the approval and the commercialization process, the company said.
Bitar brings over 25 years in quality management, technical operations, pharmaceutical manufacturing and R&D, to CytoDyn, most recently as the global head of quality at Hitachi Chemical Advanced Therapeutics Solutions, a cellular and gene therapy contract development and manufacturing organization.
Previously, Bitar led Pfizer’s (NYSE:PFE) generic oncology and biosimilars manufacturing through the approval process and was the site head of quality for Pfizer’s specialty injectable and biologic drug products.
Prior to Pfizer, Bitar was vice President – head of quality at InnoPharma Inc., which was acquired by Pfizer.
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