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 the acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract highlights research on combining early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab, a CCR5 antagonist, in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV).
Key findings include:
- The study aimed to assess if this combination could provide sustained viral control without continuous ART
- 18 infant rhesus macaques were treated with various combinations of ART, bNAbs, and leronlimab
- No virus rebound was observed in treated animals over a 27-week period
- Results suggest potential for durable viral control and reduced need for ongoing ART
The study, funded by an NIH grant to OHSU, will be presented by Dr. Jonah B. Sacha at the conference in Lima, Peru on October 10, 2024.
CytoDyn Inc. (OTCQB: CYDY) has engaged Syneos Health as the contract research organization (CRO) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (CRC). Syneos Health is a leading biopharmaceutical solutions organization with advanced data analytics and AI/ML capabilities.
Dr. Jacob Lalezari, CEO of CytoDyn, stated that investigating leronlimab in oncology remains their top priority. The company expects to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. CytoDyn submitted the final study protocol to the FDA for approval in September 2024 and anticipates starting patient screening in early 2025.
CytoDyn Inc. (OTCQB: CYDY) has announced preliminary findings from a preclinical study conducted by SMC Laboratories on leronlimab, its CCR5 antagonist. The study assessed optimal dosing for MASH (Metabolic dysfunction-Associated Steatohepatitis) and potential synergies with Resmetirom. Key findings include:
1. Leronlimab monotherapy (700 mg) showed statistically significant fibrosis reversal compared to control (p<0.01).
2. Dose-dependent antifibrotic activity was observed, with 700 mg performing better than 350 mg.
3. Leronlimab (700 mg) appeared to have better anti-fibrotic activity than Resmetirom (p=0.057).
Dr. Jacob Lalezari, CEO of CytoDyn, expressed excitement about the results, stating they confirm leronlimab's potential to benefit patients with various medical concerns. The company is in discussions with SMC Laboratories regarding next steps, including supplemental studies to expand on these findings and advance their clinical pipeline.
CytoDyn Inc. (CYDY) has made significant progress in 2024, as outlined in the September shareholder letter. Key developments include:
- FDA lifting the clinical hold on leronlimab in March 2024
- Submission of two clinical trial protocols to the FDA
- Settlement with Amarex, resulting in a $10 million cash influx
- Initiation of pre-clinical and clinical leronlimab trials
- Progress on developing a longer-acting therapeutic with an AI partner
The company is focusing on oncology, with a Phase II study in colorectal cancer and exploration of triple-negative breast cancer and glioblastoma. In inflammation, CytoDyn is evaluating leronlimab for HIV-related chronic inflammation, Alzheimer's Disease, and chronic fatigue syndrome. Other areas include MASH and HIV cure research. The company believes it has sufficient cash to commence clinical trials and advance development initiatives into 2025.
CytoDyn Inc. (OTCQB: CYDY) has announced the engagement of Syneos Health as the contract research organization (CRO) for its upcoming Phase II study on leronlimab's effects on chronic inflammation. Syneos Health is a leading biopharmaceutical solutions provider with a strong track record, having contributed to the development or commercialization of 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.
Dr. Jacob Lalezari, CEO of CytoDyn, expressed optimism about the collaboration, stating that their goal is to generate clinical data that will affirm leronlimab's utility in addressing various medical concerns impacting patients globally.
CytoDyn Inc. (OTCQB: CYDY) has completed a meeting with the FDA regarding its planned Phase II study of leronlimab in relapsed/refractory microsatellite stable colorectal cancer patients. The study will investigate leronlimab's safety and activity in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. The trial will be an open-label, randomized (1:1), multicenter study evaluating leronlimab doses of 350 mg and 700 mg in approximately 60 patients with CCR5+, microsatellite stable metastatic CRC (mCRC). Patients must have measurable disease and prior treatment with specific chemotherapies. The company plans to submit its final study protocol to the FDA and engage a clinical research organization (CRO) to initiate the trial in the coming months.
CytoDyn has settled its lawsuit with Amarex Clinical Research, resulting in a $12 million cash payment to CytoDyn and the elimination of a $14 million accounts payable liability. This settlement was reached to resolve all legal claims between the parties, with no additional payment required from CytoDyn. The settlement also includes the release of a $6.5 million surety bond to CytoDyn. The company believes this outcome substantially strengthens its balance sheet, providing immediate non-dilutive cash and eliminating a significant liability. CytoDyn plans to utilize these resources to further its clinical trials and research initiatives.
CytoDyn, a biotechnology company working on leronlimab, announced the start of a preclinical MASH study with SMC Laboratories. The study aims to clarify optimal dosing and evaluate combination therapy potential, with results expected in Fall 2024. The study will assess leronlimab's effectiveness in preventing or reversing liver fibrosis at 350 and 700 mg doses, alone and combined with Resmetirom. CytoDyn's CEO, Dr. Jacob Lalezari, emphasized this study's importance for future partnerships in the MASH space, even as the company focuses on oncology and inflammation therapies.
CytoDyn, a biotechnology company developing the CCR5 antagonist leronlimab, announced a webcast scheduled for May 30, 2024. The event, led by CEO Dr. Jacob P. Lalezari, will feature updates on clinical trials, research collaborations, and development opportunities. Key executives including Tanya Urbach, Mitch Cohen, Tyler Blok, and Scott Hansen will join. The webcast is accessible online, and a replay will be available until June 30, 2024. No Q&A session will occur, but questions can be submitted via email.
CytoDyn's CEO, Dr. Jay Lalezari, updates shareholders on key 2024 fiscal year achievements, including the lifting of the FDA clinical hold in February 2024. The company is working towards initiating clinical trials for leronlimab, focusing on relapsed/refractory microsatellite stable colorectal cancer and its anti-inflammatory effects.
Partnerships and research initiatives, such as studies on Alzheimer's and HIV, are in progress. The company has submitted multiple leronlimab manuscripts for peer review and continues to explore new research and development partnerships. Dr. Lalezari emphasizes the company's commitment to shareholders and the potential of leronlimab as a breakthrough therapeutic.