CytoDyn Inc (OTCMKTS:CYDY), said Friday that it had executed an exclusive worldwide licensing agreement with cell diagnostic company IncellDX to sell non-commercial grade quantities of its PA-14 antibody for use in the development of immunoassays for measuring CCR5 levels in human cells.
The Vancouver, Washington-based late-stage biotechnology company’s PA-14 antibody is the diagnostic designation of the murine version of its flagship leronlimab (PRO 140) drug.
In the HIV and AIDS setting, leronlimab acts as a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.
Shares in CytoDyn were up 2.3% to $0.45 before the opening bell.
READ: CytoDyn eyes revenue in August from deal to supply IncellDX with its non-commercial grade PRO 140
Under the terms of the agreement, IncellDX will be responsible, at its sole expense, for all aspects of assay development, regulatory clearance, including PA-14 or PRO140 labeling, packaging and commercialization.
At the end of each month during the term of the agreement, IncellDX will provide CytoDyn with forecasts for PA-14 or PRO 140 for the upcoming three-month period.
On pace to generate revenue
“The execution of the definitive agreement with IncellDX marks an important milestone for CytoDyn as it puts us firmly on pace to generate our first revenues over the course of the next several months,” said CytoDyn CEO Nader Pourhassan said in a statement.
The company said the collaboration represents an “immediate revenue opportunity” as a diagnostic test for receptor occupancy and the existence of CCR5 on cancer tissue and in HIV.
“IncellDX is very excited to license the exclusive worldwide diagnostic rights to CytoDyn’s CCR5 antibody that binds to the same site as PRO 140, an exciting therapeutic in trials for HIV and cancer,” said IncellDx founder CEO Bruce Patterson. “This agreement fits with our strategy to develop companion diagnostics for powerful new classes of drugs.”
IncellDX said it expects the new product line to be a “major growth driver” for the company in the second half of 2019.
“We are thankful to Dr Patterson for recognizing the value of PA-14 and PRO 140 as a potent and valuable asset as a diagnostic test to measure CCR5 expression on human cells,” said Dr Pourhassan.
Earlier this month, CytoDyn which is developing leronlimab (PRO 140) as a monotherapy for HIV patients, and IncellDx said that they had successfully developed a screening test to assess whether a HIV patient would respond effectively to leronlimab as a single treatment.
CytoDyn is also evaluating the safety and potency of flagship drug leronlimab in multiple indications including cancer, GvHD and fatty liver disease, or NASH.
Contact Uttara Choudhury at [email protected]