Cytodyn Inc - CYDY stock

Overview

CytoDyn Inc., a biotechnology company in the clinical stage, focuses on developing treatments for various therapeutic indications. The company's primary focus lies in the clinical development of leronlimab, a unique humanized monoclonal antibody designed to target the C-C chemokine receptor type 5 receptor. Leronlimab is being investigated across several areas including COVID-19, human immunodeficiency virus (HIV), Metabolic dysfunction-associated steatohepatitis (MASH), and certain solid tumors in oncology, such as metastatic triple-negative breast cancer. Currently, leronlimab is undergoing phase 2 development for the treatment of NASH, HIV-NASH, and solid tumors, while also undergoing pre-clinical development for the treatment of HIV-PrEP and HIV-Cure. Previously known as RexRay Corporation, CytoDyn Inc. was established in 2002 and operates out of Vancouver, Washington.

Pipeline

CytoDyn has a multi-product pipeline in various stages of development. Monoclonal Antibodies, or MABs, are the name given to these cloned or replicated antibodies. A vaccination, as opposed to MABs, tries to stimulate or strengthen one's immune system to produce antibodies that are efficient in combating the foreign antigen. MAB is an inorganic strategy, whereas vaccination is an organic one. A special humanized monoclonal antibody is leronlimab. Preclinical research has also demonstrated that leronlimab suppresses calcium channel signaling of the CCR5 receptor when present on the surface of cancer cells, preventing HIV from exploiting the CCR5 receptor as an entrance gateway for healthy cells. It is thought that a key factor in the development of metastatic cancer is the calcium channel signaling of the CCR5 receptor.

Monoclonal Antibodies

Letronlimab (PRO 140), a monoclonal antibody from CytoDyn, is an experimental humanized IgG4 mAb that inhibits CCR5, a cellular receptor with potential implications for HIV infection, tumor metastasis, and immunological signaling. Nine Phase 1/2/3 clinical studies with more than 800 patients have been completed with leronlimab (PRO 140), including a major Phase 3 trial in conjunction with conventional anti-retroviral medicines in HIV-infected patients with prior treatment experience.

NASH

Continued inflammation and liver injury associated with steatosis can lead to liver fibrosis. Individuals with non-alcoholic steatohepatitis (NASH) and fibrosis face an increased risk of progressing to cirrhosis, advanced liver disease, and hepatocellular carcinoma. While there is presently no approved treatment specifically targeting NASH fibrosis, it is feasible for NASH to be reversible. Current therapeutic strategies primarily aim at reducing both steatosis and fibrosis. In an initial investigation of NASH, a 350mg dosage of leronlimab demonstrated a reduction in both steatosis and fibrosis.

NASH/HIV

Non-alcoholic steatohepatitis (NASH) and liver-related fibrosis tend to be more prevalent among individuals living with HIV. This heightened occurrence could be attributed to an increase in metabolic comorbidities, the hepatotoxic effects associated with antiviral therapy, and the chronic nature of HIV infection. Liver disease ranks among the primary causes of non-AIDS-related mortality. A significant portion of HIV patients are typically excluded from clinical trials focusing on NASH, underscoring the unmet medical need in addressing HIV/NASH. Cytodyn posits that leronlimab possesses a unique potential to manage HIV viral load while also potentially reducing steatosis and fibrosis. Moreover, they suggest that the CCR5 receptor's involvement is crucial in macrophage-mediated inflammation and hepatic stellate cell activation, both of which serve as pivotal factors driving progression at various stages of NASH.

Oncology

There is a potential for CCR5 could have a significant impact on tumor advancement across various cancer types. Overexpression of CCR5 has been observed in breast cancer, prostate cancer, colorectal carcinoma, melanoma, head and neck cancer, gastric cancer, esophageal cancer, pancreatic cancer, and other tumor types. Elevated CCR5 expression serves as an indicator of disease severity in several cancers. Studies have revealed several crucial aspects of CCR5's involvement in cancer progression.

HIV

Cytodyn holds the view that leronlimab exhibits promise as a potent antiviral agent, requiring less frequent dosing compared to certain daily drug regimens currently utilized in HIV treatment. While combination antiretroviral therapy has significantly enhanced survival rates and extended life expectancy among individuals with HIV, it is not curative and necessitates daily adherence indefinitely. Cytodyn envisions the future of HIV treatment revolving around long-acting injectables, and the company is actively pursuing the development of a long-acting version of leronlimab. This formulation could potentially complement standard-of-care therapies for treating HIV patients and may also prove beneficial in HIV pre-exposure prophylaxis (PrEP). In the absence of prophylactic vaccination, PrEP remains a promising strategy for controlling transmission and slowing the spread of the HIV epidemic.

In March, 2022, the FDA placed a hold on clinical trials. A revised revised HIV clinical trial protocol was provided to the FDA in early 2024.

Covid-19

Cytodyn has also been developing a Covid-19 treatment. In March, 2022, the FDA placed a hold on leronlimab.

Milestones

On 10/25/21 the company announced that its first patient in Brazil has begun treatment with leronlimab for COVID -19 in its Phase 3 trial (CD16). They had previously announced the first patient in another Phase 3 trial in Brazil (CD17) on 9/9/21. According to the release, "This new pivotal Phase 3 clinical trial (CD16) will focus on hospitalized critically ill COVID-19 patients who require mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation (ECMO)."

Activist Group

Paul Rosenbaum, CEO and chairman of specialty chemical business SWR Corporation organized a group of 28 shareholders which subsequently nominated 5 directors for election to the company’s board. on June 30, 2021. The activist shareholders believed that the board had done a poor job managing leronlimab.

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OTC Symbol: CYDY | OTC Tier: OTCQB