If CytoDyn can’t get Leronlimab approved, these shareholders have a bold plan to tap into big pharma

If CytoDyn’s leadership cannot get their lead treatment approved, a group of very optimistic investors would like to give it a try.

After weeks of public power struggles (PDF) at the biotech company in Vancouver, Washington, a group of shareholders presented a strategic plan to get Leronlimab approved in a cancer indication.

To quickly sum up the CytoDyn drama, the FDA beat the company in May for promoting Leronlimab as a promising COVID-19 treatment, despite the failure of a late-stage study. A public meltdown ensued, with the CEO pleading with investors to spare the regulator that holds the key to the pharmaceutical market. The therapy is also being developed against cancer and HIV.

The COVID-19 battles have pushed the company and its shareholders into a public battle, complete with lawsuits from activists, attempts to oust board members and settlements. The effectiveness claims even called for a review by the Justice Department and the Securities and Exchange Commission.

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Now, through a website called Advancing Leronlimab, a group of shareholders involved in the failed litigation is taking a different approach to propose a path for the CCR5 antagonist.

The plan provides that Leronlimab could be combined with checkpoint inhibitors such as Keytruda from Merck & Co., Opdivo from Bristol Myers Squibb or Tecentriq from Roche. The plan compares Leronlimab to Bristol Myers’ Yervoy, which is often combined with Opdivo. Big Pharma collects about $ 1.5 billion annually from combination drug approvals.

These partner therapies, called immune control point (ICI) inhibitors, work when the tumor begins to withstand the main treatment and reactivate the immune system to prolong the anti-tumor response.

CytoDyn could benefit from the popularity of combination treatment studies that are currently on everyone’s lips in oncology, the group argues. They suggest that leronlimab would do the same job as an ICI, basing their argument on data from previous COVID-19 and HIV studies that suggest the drug can reverse T-cell depletion.

RELATED: CytoDyn Catches SEC and DOJ Examination Over Public Claims About COVID-19 Drug Viability

“Leronlimab has the potential to be an important replacement option for ICIs due to toxicity concerns,” the shareholders said.

The therapy is planned to avoid the serious side effects associated with this type of treatment, such as pituitary disorders and organ dysfunction. Leronlimab could have chances in lung, breast, pancreatic, urothelial and colon cancers, shareholders believe.

Under the plan, CytoDyn will seek partnerships with Bristol Myers, Roche, AstraZeneca, Pfizer and Regeneron to negotiate possible combinations of clinical trials.

“These companies should be open to clinical testing of the Leronlimab combination as soon as Leronlimab has demonstrated its effectiveness as a CCR5 inhibitor,” the plan says.

Leronlimab is already being tested in a clinical phase 2 study on 22 solid tumors.

At the time of publication, CytoDyn representatives did not submit a request for comments on the proposal for a combination therapy.