CytoDyn advances to Phase 2 trial with leronlimab for mTNBC metastatic breast cancer treatment

CytoDyn Inc (OTCQB:CYDY) has announced that a clinical trial for its flagship drug candidate, leronlimab, has advanced from Phase 1b to a Phase 2 study.

The leronlimab trial is being carried out in combination with carboplatin for the treatment of metastatic triple-negative breast cancer (mTNBC).

The late-stage biotechnology company said the positive advancement confirms leronlimab will be administered with a 700 mg dosage for patients in the mTNBC trial and Basket trial for 22 solid tumor cancers, as well as compassionate use, emergency investigational new drug (eIND) and “right-to-try” patients. The trial has demonstrated safety with 350 mg, 525 mg and 700 mg dosages. 

READ: CytoDyn granted important US patent for methods of treating coronavirus infection with leronlimab

“In April of this year, we shared our early findings with the medical and scientific communities at the Triple Negative Breast Cancer Drug Development Digital Summit and the continued progress of our drug candidate, leronlimab,” CytoDyn chief medical officer and chairman Scott Kelly said in a statement.

“We believe these safety findings are a tremendous step forward for CytoDyn’s oncology program for all tumors that have the potential to be treated with leronlimab,” he added.

The US Food and Drug Administration (FDA) has granted CytoDyn fast track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for mTNBC.

Leronlimab is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including nonalcoholic steatohepatitis (NASH). It has been studied in 16 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial, which saw it combined with HIV standard care in patients with multi-drug resistance to current available classes of HIV drugs.

“Over the past seven years, we have been working with the FDA to advance our potential indications in an effort to provide our drug to patients as soon as the regulatory process allows,” said CytoDyn president and CEO Dr Nader Pourhassan.

“Navigating through this tough (and rightfully so) path towards approval (which typically takes 10-15 years) while managing many other issues, including raising capital, has been a challenge.”

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Story by ProactiveInvestors