Regnum Corp., and SevenScore Pharmaceuticals, LLC (“SevenScore”), announced the assignment of the Commercialization and License Agreement (“CLA”) and a related Supply Agreement to commercialize leronlimab (PRO 140) in the U.S. for the treatment of HIV from SevenScore to Regnum. The CLA was signed between Vyera Pharmaceuticals, LLC (“Vyera”) and CytoDyn on December 17, 2019 and assigned to SevenScore on October 29, 2020.
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Under the terms of the CLA, Regnum has been granted an exclusive license to market and distribute leronlimab in the U.S. for the treatment of HIV and CytoDyn will maintain responsibility for the development and FDA approval of leronlimab for all HIV-related and other indications. In exchange for such exclusive license, Regnum has agreed to pay regulatory and sales-based milestone payments, as well as a royalty of 50 percent on net sales.
“CytoDyn expects to file the BLA for leronlimab for the treatment of HIV with FDA in the first quarter of 2022,” stated Dr. Nader Pourhassan, President and CEO of CytoDyn. “We look forward to working closely with the Regnum team to launch leronlimab and bring this important new treatment option to patients infected with HIV.”
Anne Kirby, Chief Executive Officer of Regnum Corp., noted: “This is an important step towards Regnum’s evolution into a fully integrated biopharmaceutical company. Our partnership with CytoDyn aligns with our commitment to bringing novel therapies to patient populations in need of new treatment options or refined care plans.”
About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in Highly Treatment Experienced (HTE) Multi-Drug Resistant (MDR) HIV Patients).
In the setting of HIV/AIDS, leronlimab is 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. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.