CytoDyn Inc. reports developments for leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor. The company is a clinical-stage oncology issuer focused on CCR5 biology in difficult-to-treat cancers, including metastatic triple-negative breast cancer and metastatic colorectal cancer.
Recurring news includes clinical and translational data presentations, Phase 2 colorectal cancer study updates, expanded access activity for triple-negative breast cancer, and preclinical work in glioblastoma. Company updates also cover financing actions used to support leronlimab development and corporate webcasts addressing scientific, operational, clinical, and financial progress.
CytoDyn Inc. (OTCQB: CYDY) announced that Brazil’s regulatory authority ANVISA has approved its clinical trial protocol to begin patient enrollment in the CD17 trial for severe COVID-19 patients. This Phase 3 trial, to be conducted by Albert Einstein Israelite Hospital, aims to enroll up to 612 hospitalized patients needing oxygen support to prevent disease progression. An interim analysis will occur after 245 patients are enrolled. CytoDyn’s CEO expressed gratitude for the approval, highlighting the significance of leronlimab in treating COVID-19 and outlining expectations for interim analysis results in 3-4 months.
CytoDyn (OTCQB: CYDY) announced that the director nominations from the Rosenbaum/Patterson Group were invalid due to significant deficiencies in their submission. The group aimed to replace current board members, but their nomination notice failed to comply with company bylaws. Notably, the notice did not disclose the group's past affiliations or conflicts of interest. Consequently, their nominations will not be recognized at the upcoming Annual Meeting on October 28, 2021. CytoDyn is committed to engaging with shareholders and advancing its treatment, leronlimab, for various indications.
CytoDyn Inc. (OTCQB: CYDY) announced a webcast on July 22, 2021, hosted by CEO Nader Pourhassan and other executives to discuss recent clinical trial results for leronlimab, their CCR5 antagonist. The webcast will cover updates on mTNBC, COVID-19, and NASH trials, as well as the status of the BLA resubmission for HIV. Participants can submit questions online before and during the event. The archived webcast will be available for 30 days post-event.
CytoDyn Inc. (OTCQB: CYDY) announced plans to seek FDA guidance on an expedited regulatory path for leronlimab, which has received Fast Track designation for metastatic triple-negative breast cancer (mTNBC). Preliminary Phase 1b/2 trial results show that 72% of treated patients experienced a decrease in CAMLs after a month, correlating with increased progression-free survival by ~300% and overall survival by ~450%. CytoDyn aims to further discuss the regulatory process based on these promising outcomes.
CytoDyn Inc. (OTCQB: CYDY) announced its advancement in the clinical trial of leronlimab for metastatic triple-negative breast cancer, moving from Phase 1b to Phase 2. The trial will administer a 700 mg dosage in combination with carboplatin, with preliminary efficacy data expected in about two weeks. Leronlimab, targeting CCR5, has strong potential across various cancers and has previously achieved primary endpoints in HIV trials. The FDA has granted it Fast Track designation for both HIV and metastatic cancer indications, signaling regulatory support for CytoDyn's innovative approach.
CytoDyn Inc. (OTCQB: CYDY) announced the granting of U.S. Patent No. 11,045,546 for its drug candidate leronlimab, designed to treat coronavirus infections, particularly targeting hyperinflammation caused by SARS-CoV-2. This patent, expected to last until June 15, 2040, reflects the rapid approval process under the USPTO's COVID-19 Prioritized Examination Pilot Program. The patent claims methods for normalizing CD4/CD8 T cell ratios and enhancing CD8 T cell frequency in infected subjects. CytoDyn is advancing several clinical trials for leronlimab, including indications for HIV, COVID-19 long-haulers, and NASH.
CytoDyn (OTCQB: CYDY) announced the submission of a dose justification report to the FDA as part of its Biologics License Application (BLA) for leronlimab, aimed at HIV patients resistant to standard therapies. This report will guide the optimal dosage for the drug. CytoDyn plans to begin BLA module submissions following FDA feedback. The company is also progressing with clinical trials for COVID-19, NASH, and various cancers, with hopes for expanded therapeutic indications and ongoing evaluations. CEO Nader Pourhassan expresses optimism about leronlimab's future, highlighting its potential across multiple diseases.
A group of long-time stockholders in CytoDyn Inc. (CYDY) has nominated five candidates for the Company’s Board of Directors, citing ineffective leadership and failures regarding the Leronlimab drug. The nominees, who include medical professionals and business leaders, aim to replace the current management team to secure FDA approval for Leronlimab and enhance shareholder value. The Nominating Stockholders have also launched a dedicated website for updates and plans to file a proxy statement with the SEC for the solicitation of proxies from other stockholders.
CytoDyn Inc. (OTCQB: CYDY) has released preliminary results from its clinical trial assessing the efficacy of leronlimab for COVID-19 long-haulers. In this trial, 56 patients reported improvements in 18 of 24 COVID-19 symptoms, with no significant safety issues noted. However, the study's small sample size limits statistical validity. The company aims to discuss future regulatory steps with the FDA, seeking Breakthrough Therapy designation for further trials. Leronlimab has previously received FDA Fast Track designation for HIV and metastatic cancer treatments, demonstrating its potential in multiple therapeutic areas.
CytoDyn Inc. (OTCQB: CYDY) announced an upcoming investment community webcast scheduled for June 21, 2021. CEO Nader Pourhassan, CMO Scott Kelly, and COO Christopher Recknor will discuss results from the recently unblinded COVID-19 long-haulers trial data. The presentation will also include updates on global COVID-19 trials, ongoing trials for NASH, cancer, and recent regulatory developments. The webcast is a 'listen only' format and will be archived for 30 days, providing a platform for analysts and investors to submit pre-webcast questions.