VANCOUVER, Washington, Jan 27, 2020 — The poster and oral presentation will highlight the role of the CCR5 antibody in preventing macaques from intrarectal Simian-Human Immunodeficiency Virus (SHIV)
Based on these strong results, CytoDyn has partnered with the Thai Red Cross AIDS Research Centre (TRCARC) to conduct clinical trials evaluating the potential of leronlimab to prevent HIV; trial could begin this year
VANCOUVER, Washington, Jan. 27, 2020 — CytoDyn Inc. (otc.qb:CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the acceptance of an abstract detailing the advantages of the CCR5 antibody, leronlimab, to prevent macaques from intrarectal Simian-Human Immunodeficiency Virus (SHIV) at the Keystone Symposia on HIV Pathogenesis and Cure in Keystone, Colorado from March 22-26, 2020.
Details of the oral presentation are as follows:
Presentation Title: Antibody-Mediated CCR5 Blockade Recapitulates the CCR5 Deficiency-Mediated Protection from Sexual HIV Acquisition
Presenter: Xiao Lan Chang, Oregon Health & Science University
Presentation Date and Time: Thursday, March 26, 2020 from 2:30 p.m. MT – 4:30 p.m. MT
Additional details can be found on the conference website.
Dr. Jonah Sacha, Ph.D., Professor at the Vaccine and Gene Therapy Institute at the Oregon Health & Science University and senior science advisor to CytoDyn, commented, “In the absence of a prophylactic vaccine, the use of antiretroviral medications as pre-exposure prophylaxis (PrEP) to prevent HIV acquisition by uninfected individuals is a promising approach to slowing the epidemic. Unfortunately, negative side effects, viral resistance, and regimen adherence severely limit PrEP efficacy. Therefore, the development of new, highly effective, and long-acting PrEP modalities with high patient uptake is urgently needed. The scientific premise for leronlimab-based PrEP is founded on the long-standing observation that CCR5-deficient individuals are extremely resistant to HIV infection. The results presented here demonstrate that leronlimab treatment is able to prevent sexual transmission of HIV. Given leronlimab’s excellent safety profile, this finding paves the way for a new, patient-friendly PrEP regimen.”
“Over the past 15 years, HIV therapies have advanced significantly, however, there has been minimal prevention of HIV in the U.S. According to the CDC (Centers for Disease Control and Prevention), about 38,000 new infections occur annually the in U.S. alone. The potential for a once-monthly leronlimab injection for HIV prevention could be a significant step in eradicating HIV in the U.S. given its remarkable safety profile,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. Over 840 HIV patients have received leronlimab with zero drug-related SAEs. Its success as a HIV monotherapy (single-agent therapy) has been outstanding, with 5 patients exceeding 5 years of successful once-weekly, self-injections of leronlimab as a monotherapy. Additionally, approximately 150 patients in our ongoing Phase 2b/3 investigative monotherapy trial have maintained viral suppression with leronlimab for almost a year. A paradigm shift in HIV prevention could be significant with once-a-month injection of leronlimab,” added Dr. Pourhassan.
About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) have 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. 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 antiretroviral therapies in HIV-infected treatment-experienced 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% in a murine xenograft model. CytoDyn is therefore conducting a Phase 1b/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 GvHD.
CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. 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 Company’s 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 Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s 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 Company’s 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 Company’s control. The Company 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, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.