CytoDyn Announces CROI’s Acceptance of Late-Breaking Abstract by Dr. Jonah Sacha for use of Leronlimab as PrEP

Acceptance underscores the scientific community’s recognition of leronlimab as a potential HIV prophylactic

CytoDyn is currently partnered with the Thai Red Cross AIDS Research Centre (TRCARC) to develop and conduct clinical trials evaluating the potential of leronlimab to prevent HIV; trial could begin this year

VANCOUVER, Washington, Jan. 27, 2020 (GLOBE NEWSWIRE) -- 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 clinical indications in HIV, cancer, GvHD and NASH, announced today the acceptance of a late-breaking abstract that will be presented at the Conference on Retroviruses and Opportunistic Infections (CROI) to be held on March 8-11, 2020 in Boston. Poster presentations will detail the results from a preclinical study demonstrating that leronlimab prevented intrarectal transmission of Simian-Human Immunodeficiency Virus (SHIV) in macaques. These data support the potential of leronlimab as a pre-exposure prophylaxis (PrEP) treatment option.

Details of the presentation are as follows:

Presentation Title: CCR5 antibody blockade protects macaques from intrarectal SHIV acquisition
Presenter: 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
Presentation Date and Time: March 9, 2020 from 2:30 p.m. ET – 4:00 p.m. ET
Location: Hynes Convention Center, Boston, MA

Additional details can be found on the conference website.

Dr. Jonah Sacha stated, “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 positive results reported here in the pre-clinical macaque model of HIV sexual transmission are exciting given the potential for immediate clinical translation.”

“The acceptance of Dr. Sacha’s late-breaking abstract describing leronlimab’s utility in HIV prevention underscores the potential of leronlimab for treatments beyond suppression of established HIV infection. Current PrEP options require a continued daily dosing regimen in order to be effective and are inherently difficult to maintain in the long-term,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Leronlimab could offer a much needed, simple and long-lasting preventative treatment option for people at risk of HIV infection. The results from this study are extremely promising and further support our efforts to begin clinical trials for leronlimab as a PrEP treatment. The eradication of HIV could get a boost with the use of leronlimab as a once monthly 700 mg injection to prevent HIV. This could be a powerful paradigm shift in the world of HIV prevention.”

CytoDyn is currently embarking on a joint venture with the Thai Red Cross AIDS Research Centre (TRCARC) to conduct a PrEP clinical trial examining leronlimab in people at high risk of HIV infection.

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.

About CytoDyn
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.

Forward-Looking Statements 
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,” 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.

CONTACTS
Media:
Grace Fotiades
LifeSci Communications
[email protected]
(646) 876-5026

Investors:
Nader Pourhassan, Ph.D.
President & CEO
[email protected]