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Revenue on the horizon
VANCOUVER, Wash.—Biotechnology company CytoDyn Inc. is moving into the commercial space with the announcement of an exclusive licensing agreement with IncellDX to sell non-commercial grade quantities of PA-14 or PRO 140 (humanized PA-14) for use in developing and commercializing immunoassays for quantitative measurement of CCR5 levels on human cells. Per the terms of the agreement, IncellDX will be responsible for all aspects of assay development, regulatory clearance, and PA-14 or PRO 140 labeling, packaging and commercialization. At the end of each month for the duration of the deal, IncellDX will provide CytoDyn with demand forecasts for the two compounds for the upcoming three-month period. Specific financial terms were not disclosed.
“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,” Dr. Nader Pourhassan, CytoDyn’s president and CEO, said in a press release. “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.”
PRO 140 (leronlimab) is an investigational humanized IgG4 monoclonal antibody (mAb) that blocks CCR5. To date, leronlimab has been evaluated in nine clinical trials in more than 800 people, and the U.S. Food and Drug Administration has granted a Fast Track designation for leronlimab in two potential indications: as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and for metastatic triple-negative breast cancer.
“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,” stated Dr. Bruce Patterson, founder and CEO of IncellDX. “This agreement fits with our strategy to develop companion diagnostics for powerful new classes of drugs. We expect this new product line will be a major growth driver for IncellDX in the second half of 2019 and beyond.”
As for what made IncellDX stand out as a partner for this work, Pourhassan explains that they have worked together before.
“We have a special diagnostic test that we had IncellDX develop for us that we need in order to commercialize our monotherapy trial. That assay could use our own antibody as a staining,” he says, adding that “IncellDX has done substantial work in the CCR5 space, and they indicated they can purchase our product for other companies they do different projects for. Therefore, as a ‘diagnostic use’ and not therapeutic use, this made a lot of sense for us.”
While the companies are optimistic about leronlimab’s potential as a diagnostic, Pourhassan tells DDNews that as a therapeutic, its market potential is even greater. He notes that some reports estimate a market value of $1 billion to $2 billion for a combination therapy for HIV, and more than $7 billion as a monotherapy.
Beyond HIV, Pourhassan notes that CCR5 antagonists are also being explored in triple-negative breast cancer, colon cancer, nonalcoholic steatohepatitis, multiple sclerosis and graft-versus-host disease.
CCR5 plays a role in all of those diseases to some degree, and as such, offers a new target. In HIV/AIDS, leronlimab masks CCR5, which protects healthy T cells from infection by blocking the predominant HIV (R5) subtype from entering the cells. In addition, leronlimab is a self-injectable, subcutaneous injection—the world’s first such option for HIV, according to CytoDyn. Unlike HAART, it causes no serious side effects or serious adverse events, the company states, and also offers better compliance and a longer half-life. Beyond that, “76 percent of patients have resistance to at least one drug with HAART. There has been no drug resistance in patients identified in patients taking Leronlimab in monotherapy for over four years,” CytoDyn reports on its website.
In cancer, CCR5 is implicated in tumor invasion and metastasis, with increased expression serving as an indicator of disease status in many cancer types. By blocking CCR5, researchers have shown they can reduce tumor metastases in lab and animal models of breast and prostate cancer—and leronlimab reduced human breast cancer metastasis by more than 98 percent in a mouse xenograft model.
There is also support for this receptor as a culprit in graft-versus-host disease. Studies have shown that blocking CCR5 can reduce the impact of acute graft-versus-host disease without significant impact on the engraftment of transplanted bone marrow stem cells.
And CytoDyn is looking into leronlimab’s potential in all of these indications. When asked what the next development step is for PRO 140, Pourhassan says “First, BLA submission and initiate our commercialization of leronlimab for combination therapy [in HIV]. Then we will have revenue to chose which indications we will explore next.”