CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer
VANCOUVER, Washington, Jan. 27, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), today announced that a compassionate benefactor has formally committed funding to support the Company’s Expanded Access Program (EAP) for patients with triple-negative breast cancer.
The benefactor, who has chosen to remain anonymous, has a longstanding interest in patient access initiatives, the potential of leronlimab, and how the Company’s recent data and mechanism of action theories might serve to offer experimental avenues to patients who have exhausted all approved treatment options. This strategic funding initiative will enable CytoDyn to set up and administer a program to expand access to leronlimab for a group of eligible patients, as determined by the U.S. Food and Drug Administration (FDA) guidelines, with advanced disease but who do not otherwise meet the enrollment criteria for the Company’s ongoing clinical trials.
“We are honored by this benefactor’s commitment to accelerating patient access to promising cancer therapies such as leronlimab,” said Jacob Lalezari, M.D., CEO of CytoDyn. “This support allows us to responsibly broaden the availability of leronlimab while continuing to advance our promising clinical programs as we generate data to inform future regulatory pathways.”
(WEP Clinical) has been engaged to serve as the clinical research organization (CRO) for the EAP, and the Company expects to formally open the program for patient referral in March 2026, assuming FDA’s allowance of the Company's revised protocol submission. In addition to providing compassionate access to patients who have exhausted other treatment options and are otherwise unable to participate in the Company's upcoming Phase 2 trial, the EAP program will serve as another potential avenue to observe PD-L1 induction following treatment with leronlimab, and thereby – in theory – opening a treatment pathway towards sustained remission when combined with an immune checkpoint inhibitor (“ICI”). The EAP will operate under applicable FDA guidelines, and additional information for physicians and eligible patients will be available on the Company’s website () as the program is rolled out in the coming weeks.
About CytoDyn
CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.
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Note Regarding Forward-Looking Statements
This news release may contain forward-looking statements relating to, among other things, mechanism of action, clinical development programs, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.
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