CytoDyn Anticipates Revenue Commencing in August 2019 from Use of PA-14 and/or PRO 140 in Diagnostic Test
CytoDyn Signs Non-binding Agreement for Diagnostic License
and Supply Agreement with IncellDX for PA-14 and/or
PRO 140 (non-commercial grade)
Collaboration represents an immediate revenue opportunity as a diagnostic test for
receptor occupancy and the existence of CCR5 on cancer tissue and in HIV
VANCOUVER, Washington, July 01, 2019 (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 multiple therapeutic indications today announced a non-binding agreement with IncellDX, Inc. for a diagnostic license and supply agreement for the PA-14 antibody (the diagnostic designation of the murine version of PRO 140) and PRO 140, which is humanized PA-14. Assays to determine the existence of CCR5 on cancer tissue and the receptor occupancy level for HIV patients are believed to be integral for the effective introduction of leronlimab for therapeutic benefits in this patient population.
“Our non-binding agreement with IncellDX, subject to execution of a definitive agreement, which is expected to be finalized in July 2019, may lead to our first ever product revenues,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “Importantly, the PRO 140 used for the PA-14 diagnostic test is non-commercial grade product in storage. As such, this transaction allows CytoDyn to potentially realize significant value from product that would have very likely been discarded,” continued Dr. Pourhassan. “Each diagnostic test may use 20 micro mg (mcg) of PRO 140 (1 mg = 1,000 mcg), implying significant revenue opportunity for CytoDyn, since any use of leronlimab for commercial purposes will require this diagnostic test. Bottom line, this is a small first step in realizing full value from PRO 140,” concluded Dr. Pourhassan.
Bruce Patterson, M.D., CEO and Founder of IncellDx added, “We are excited about the potential to utilize the PA-14 and/or PRO 140 diagnostic test throughout our franchise, including in diagnostic tests that we will be conducting for major pharmaceutical and life science companies.” Dr. Patterson added that, “it is important to note that the diagnostic test using PA-14 and/or PRO 140 is performed in vitro.”
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. 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 700 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral 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 >98% 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).
CytoDyn Signs Non-binding Agreement for Diagnostic License
and Supply Agreement with IncellDX for PA-14 and/or
PRO 140 (non-commercial grade)
Collaboration represents an immediate revenue opportunity as a diagnostic test for
receptor occupancy and the existence of CCR5 on cancer tissue and in HIV
VANCOUVER, Washington, July 01, 2019 (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 multiple therapeutic indications today announced a non-binding agreement with IncellDX, Inc. for a diagnostic license and supply agreement for the PA-14 antibody (the diagnostic designation of the murine version of PRO 140) and PRO 140, which is humanized PA-14. Assays to determine the existence of CCR5 on cancer tissue and the receptor occupancy level for HIV patients are believed to be integral for the effective introduction of leronlimab for therapeutic benefits in this patient population.
“Our non-binding agreement with IncellDX, subject to execution of a definitive agreement, which is expected to be finalized in July 2019, may lead to our first ever product revenues,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “Importantly, the PRO 140 used for the PA-14 diagnostic test is non-commercial grade product in storage. As such, this transaction allows CytoDyn to potentially realize significant value from product that would have very likely been discarded,” continued Dr. Pourhassan. “Each diagnostic test may use 20 micro mg (mcg) of PRO 140 (1 mg = 1,000 mcg), implying significant revenue opportunity for CytoDyn, since any use of leronlimab for commercial purposes will require this diagnostic test. Bottom line, this is a small first step in realizing full value from PRO 140,” concluded Dr. Pourhassan.
Bruce Patterson, M.D., CEO and Founder of IncellDx added, “We are excited about the potential to utilize the PA-14 and/or PRO 140 diagnostic test throughout our franchise, including in diagnostic tests that we will be conducting for major pharmaceutical and life science companies.” Dr. Patterson added that, “it is important to note that the diagnostic test using PA-14 and/or PRO 140 is performed in vitro.”
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. 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 700 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral 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 >98% 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).
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