Regnum Corp., CytoDyn Inc., and SevenScore Pharmaceuticals, LLC, announced the assignment of the Commercialization and License Agreement and a related Supply Agreement to commercialize leronlimab in the U.S. for the treatment of HIV from SevenScore to Regnum.
In exchange for the exclusive right to market and distribute leronlimab in the U.S. for HIV-related indications, SevenScore will receive 4,094,023 shares of Regnum Corp.
NEW YORK, Jan. 10, 2022 /PRNewswire/ -- Regnum Corp. (OTCMKT: RGMP) (“Regnum”), CytoDyn Inc. (OTC.QB: CYDY) (“CytoDyn”), and SevenScore Pharmaceuticals, LLC (“SevenScore”), today 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.
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.
In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98 percent in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of graft-versus-host disease (GvHD).
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH. CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options. CytoDyn is working diligently to resubmit its Biologics License Application (“BLA”) for this HIV combination therapy since receiving a Refusal to File in July 2020. In July 2021, CytoDyn announced that it had submitted a dose justification report to the FDA, and in November 2021 resubmitted the non-clinical and manufacturing sections of the BLA, all integral steps in the BLA resubmission process, which it expects to complete by the end of the first quarter of calendar 2022. CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label expansion approval. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a sub-population of R5 HIV patients who chose to switch from their daily pills regimen to once-a-week subcutaneous dose of leronlimab. Several patients on leronlimab’s Phase 2b extension arm have remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigative trial are passing two and some four years of monotherapy with suppressed viral load. CytoDyn is also conducting a Phase 2 clinical trial with leronlimab in mTNBC, a Phase 2 basket trial in solid tumor cancers (22 different cancer indications), Phase 2 investigative trial for post-acute sequelae of SARS COV-2, also known as COVID-19 long haulers, and a Phase 2 clinical trial for NASH. CytoDyn has already completed a Phase 2 and Phase 3 trial for mild-to-moderate and severe-to-critical COVID-19 patients, respectively, for which CytoDyn did not meet its primary or secondary endpoints except for the secondary endpoint in the critically ill subpopulation. More information is at www.cytodyn.com.
About Regnum
Regnum is a biopharmaceutical company focused on late-stage commercial and clinical development programs. Built around the core values of innovation, collaboration, integrity, and empathy, Regnum is committed to bringing relevant therapies to patient populations in need of new treatment options or refined care plans. We address the needs of our patient populations through the development of novel therapeutics and dedicated patient service programs.
Forward-Looking Statements
This press release contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, that involve risks, uncertainties, and assumptions that are difficult to predict. Regnum, CytoDyn, and SevenScore (collectively, the “Companies”) intend that such forward-looking statements be subject to the safe harbors created thereby. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companies’ forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companies’ cash position, (ii) the Companies’ ability to raise additional capital to fund its operations, (iii) the Companies’ ability to meet its debt obligations, if any, (iv) the Companies’ ability to enter into partnership or licensing arrangements with third parties, (v) the Companies’ ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companies’ ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companies’ clinical trials, (viii) the results of the Companies’ clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companies’ products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companies’ control. CytoDyn urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, neither Company the Company undertakes any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
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Company Codes: OTC-PINK:CYDY, OTC-PINK:RGMP, OtherOTC:CYDY, OtherOTC:RGMP
