Data from 10 Patients with Stage Four Cancer Treated with Leronlimab for Nearly One Year Will Serve as Basis for Pre-Breakthrough Therapy Designation Meeting with FDA
CytoDyn Inc. (OTC.QB: CYDY) has announced plans for a pre-Breakthrough Therapy designation meeting to expedite preparations for a Phase 3 clinical trial involving leronlimab for 22 solid tumor cancer indications. Encouraging results from preliminary trials suggest potential for a reduced trial size. The company is optimistic about leronlimab's ability to control cancer metastasis and its role in immunotherapy. Additionally, CytoDyn is preparing to resubmit its Biologics License Application (BLA) for HIV treatment, following previous setbacks.
- Preparing for a pre-Breakthrough Therapy designation meeting for leronlimab in solid tumors.
- Positive preliminary indications from current clinical trials could support a smaller Phase 3 trial.
- Leronlimab has met primary endpoints in previous HIV clinical trials, showing its efficacy.
- Previously received a Refusal to File letter for the BLA submission, indicating past regulatory hurdles.
- Potential challenges in executing Phase 3 trials and securing regulatory approvals.
VANCOUVER, Washington, May 03, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it is preparing a request for a pre-Breakthrough Therapy designation (BTD) meeting ahead of preparing a Phase 3 clinical trial protocol for 22 solid tumor cancer indications. The Company is extremely encouraged about the prospects of a Phase 3 trial and BTD based on preliminary indications of patients in the Company’s current Phase 2 basket trial, compassionate use study and a patient treated under an eIND, which may support a smaller trial.
Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, stated, “We are very encouraged by leronlimab’s potential to control metastasis by blocking CCR5 overexpression in cells that undergo malignant transformation. We also believe in the potential of leronlimab in the tumor microenvironment, including decreased angiogenesis, macrophage polarization, and blocking T regulatory cells that turn off the immune system’s ability to fight cancer.”
Dr. Kelly recently presented “The Role of Leronlimab to Treat TNBC” at the Triple Negative Breast Cancer Drug Development Digital Summit 2021 and added, “We appreciate the warm reception of our oncology colleagues at the TNBC digital summit, and the recognition of the potential of leronlimab’s role in the future of immunotherapy.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer, commented, “Our multi-pathway approach to exploring all potential indications for leronlimab is proving to be very encouraging. We look forward to accelerating our efforts in the oncology field with leronlimab. We are equally excited to update our stockholders on Wednesday, especially concerning the potential use of leronlimab in treating COVID-19 in severe, critical, and long-hauler populations.”
About Leronlimab (PRO 140)
Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies.
CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to resubmit its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File letter in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the submission. CytoDyn expects to resubmit its BLA via a rolling submission starting in the third quarter of calendar 2021.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to provide positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
mmulholland@cytodyn.com
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