CytoDyn Inc (OTCMKTS:CYDY), a late-stage biotechnology company developing leronlimab (PRO 140) as a monotherapy for HIV patients, and cell diagnostic company IncellDx said Tuesday that they had successfully developed a screening test to assess whether a HIV patient would respond effectively to leronlimab as a single treatment.
The Vancouver, Washington-based biotech said the assay could “predict in two hours the responder’s rate for a monotherapy" and the appropriate dose for each patient at the time of screening.
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.
Currently, all new patients in CytoDyn’s monotherapy trial are being evaluated with this newly developed screening test with the objective of identifying patients expected to respond to a monotherapy versus those not expected to respond due to CCR5 density.
Test accurately identifes responders
“The development and implementation of an assay that can rapidly and accurately identify potential responders to leronlimab offers a tremendous technical advancement with the potential to more precisely target leronlimab on patients most likely to respond to treatment,” said CytoDyn CEO Nader Pourhassan. “We are excited about our partnership with IncellDx to provide the technical support to explore the power and potential of CCR5 inhibition.”
Dr Pourhassan said that with over 110 HIV active patients on leronlimab monotherapy for almost one year and five patients from the company’s original Phase 2 monotherapy extension now reaching almost five years on monotherapy without viral breakthroughs, the company is “very excited” with its collaboration with IncellDx, which is led by Dr Bruce Patterson, former medical director of virology at Stanford University Hospitals and Clinics.
“With Dr Patterson’s expertise, we are confident that we will be able to much more efficiently identify responders in HIV, and potentially in many other indications, including our ongoing cancer research,” said Dr Pourhassan. “The continued clinical success of leronlimab in HIV underpins our soon to begin partnership with Thai Red Cross AIDS Research Centre for the PrEP clinical trial that will exclusively utilize leronlimab as a monotherapy.”
Busy spell for the company
It’s been a busy spell for the company as the FDA has requested an in-person meeting to discuss and potentially finalize the protocol for a trial of leronlimab as a single treatment for HIV patients.
Dr Pourhassan says a monotherapy with leronlimab, if approved, may allow patients with 'pill fatigue to maintain a disciplined compliance regimen.'
Furthermore, the company is evaluating the safety and potency of flagship drug leronlimab in multiple indications including cancer, GvHD and fatty liver disease, or NASH.
“The HIV-co-receptor CCR5 has both genotypic differences in patients, as well as being a highly regulated receptor with different amounts expressed on different cells under certain conditions such as inflammation,” said IncellDx CEO Patterson. “The development of a portfolio of assays, including CCR5 genotyping and the assay being reported today that reliably and timely identifies a patient’s CCR5 status, offers a leap in the understanding of potential response to treatment with leronlimab.”
Dr Patterson said his company was happy to partner with CytoDyn to potentially help bring “leronlimab to the right patients at the right time.”
Contact Uttara Choudhury at [email protected]