One might want to take note of the fact that CytoDyn Inc (OTCMKTS:CYDY) just announced that the Company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19).
Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn explains: “Leronlimab inhibits migration of Tregs, which can inhibit the innate immune response against pathogens, into areas of inflammation. Most importantly, the migration of macrophages and the release of inflammatory cytokines including TNF and IL-6 (cytokine storm) is what causes the profound damage in the lungs in some patients. Leronlimab binding to CCR5 changes the macrophages migration and cytokine production. Taken together, these activities may reduce the morbidity and mortality in moderate to severe cases of COVID-19. IncellDx has developed a suite of diagnostics to monitor these effects of leronlimab on the immune system in these critical patients.”
CytoDyn Inc (OTCMKTS:CYDY) promulgates itself as a late-stage biotechnology company that focuses on the clinical development and commercialization of humanized monoclonal antibodies to treat human immunodeficiency virus (HIV) infection.
Its lead product is PRO 140, a therapeutic anti-viral agent, which is in Phase IIb extension study for HIV as monotherapy, rollover study for HIV as a combination therapy, Phase IIb/III investigative trial for HIV, Phase Ib/II trial for triple-negative breast cancer, and Phase II trial for graft-versus-host disease.
CytoDyn Inc. has strategic agreement with Samsung BioLogics Co. Ltd. for the clinical and commercial manufacturing of leronlimab. The company was formerly known as RexRay Corporation. CytoDyn Inc. was incorporated in 2002 and is based in Vancouver, Washington.
According to company materials, “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 anti-retroviral 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.”
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As noted above, CYDY just announced that the Company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19).
While this is a clear factor, it has been incorporated into a trading tape characterized by a pretty dominant offer, which hasn’t been the type of action CYDY shareholders really want to see. In total, over the past five days, shares of the stock have dropped by roughly -9% on above average trading volume. All in all, not a particularly friendly tape, but one that may ultimately present some new opportunities. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -15%. What’s more, the name has registered increased average transaction volume recently, with the past month seeing 60% beyond what we have been seeing over the larger time frame.
“Coronavirus deaths are linked to patients’ immune systems that have an inflammatory response to the virus causing Acute Respiratory Distress Syndrome (ARDS). With ARDS, the entire lung is affected, unlike pneumonia where often only part of the lung is affected,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Our scientists believe that our data in cancer patients indicated that leronlimab’s role in blocking Tregs and macrophages demonstrates that leronlimab modulates the inflammatory response to more effectively provide effector function. With more than 840 patients treated with leronlimab in our clinical trials, we believe leronlimab could reduce the inflammation which contributes to ARDS, thereby potentially reducing morbidity and mortality rates in coronavirus patients. If we can show a similar response in our current Phase 2 trial, then leronlimab could have a powerful impact on improving the prognosis for coronavirus patients. With leronlimab’s Fast Track designation from the FDA for the treatment of HIV and mTNBC (triple-negative breast cancer), we are expediting the initiation of this trial to address the rapid spread of this disease and are eager to test this proof of concept in clinical trials as a potential treatment for coronavirus,” added Dr. Pourhassan.
Now commanding a market cap of $468M, CYDY has a chunk ($1.2M) of cash on the books, which compares with about $29.7M in total current liabilities. One should also note that debt has been growing over recent quarters. The company is pre-revenue at this point. This may be a very interesting story and we will look forward to updating it again soon. Sign-up for continuing coverage on shares of $CYDY stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $CYDY, either long or short, and we have not been compensated for this article.