CytoDyn Inc. is making strides in its clinical development pipeline, focusing on oncology, inflammation, and HIV, following the FDA's lifting of the clinical hold on leronlimab in March 2024. The company is initiating new trials and pursuing strategic collaborations to explore the therapeutic potential of leronlimab across multiple indications. CEO Dr. Jacob Lalezari expressed optimism about the company's prospects and commitment to advancing leronlimab as a life-changing therapeutic. "We are unwavering in our belief that by continuing to take the best next step, one after another, we will continue to hit key milestones in the coming year and, in the process, drive significant potential value for our shareholders."
Oncology Focus: Colorectal Cancer, TNBC, and Glioblastoma
CytoDyn's primary focus remains on oncology, with a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (CRC) slated to begin screening patients in early 2025. The final protocol is being submitted to the FDA this week, following a review meeting in August. In addition to CRC, CytoDyn is exploring the role of leronlimab in triple-negative breast cancer (TNBC) through collaborations with institutions such as the University of Hawaii Cancer Center, MD Anderson Cancer Center, and the Pennsylvania Cancer and Regenerative Medicine Research Center. A preclinical TNBC study will aim to confirm the mechanism of action of leronlimab in oncology and assess potential synergies with antibody-drug conjugates and immune checkpoint inhibitors. Results from a preclinical glioblastoma study in mice, conducted by the Albert Einstein College of Medicine, are expected in the coming months.
Inflammation Studies: HIV, Alzheimer's, and Chronic Fatigue Syndrome
In the realm of inflammation, CytoDyn has selected Syneos Health as its clinical research organization (CRO) to implement an FDA-approved protocol evaluating leronlimab in treating HIV and chronic inflammation. This trial aims to elucidate leronlimab's mechanism of action on biomarkers during the treatment of chronic inflammation. Patient screening is expected to commence in December 2024. Furthermore, CytoDyn is planning a pilot study of leronlimab in mild to moderate Alzheimer's Disease, evaluating a neuroradiology primary endpoint to determine efficacy. A foundation has tentatively agreed to fund this study. Additionally, a pilot study is being organized for patients with chronic fatigue syndrome who exhibit elevated markers of chronic inflammation.
Other Areas of Investigation: MASH and HIV Cure Research
CytoDyn is also investigating leronlimab in other areas, including MASH (metabolic dysfunction-associated steatohepatitis) and HIV cure research. Preclinical study results of leronlimab in a mouse model of MASH are anticipated soon, aiming to clarify dosing and potential synergy with Resmetirom, the only approved therapy for MASH. CytoDyn is partnering with the American Foundation for AIDS Research (amfAR) to sponsor the HIV LATCH study, which will use leronlimab to protect CCR5+ donor immune cells from HIV infection during bone marrow transplantation in HIV+ recipients. Recent success in HIV cure research using stem cells from donors heterozygous for the CCR5 delta-32 mutation has heightened optimism for the LATCH program.
Publication of Clinical Data
CytoDyn continues to pursue publication of existing clinical data. The CD10 manuscript, detailing the leronlimab trial in patients with mild to moderate COVID-19, has been accepted for publication by Clinical Therapeutics. Manuscripts on the CD02 HIV paper, the CD12 manuscript on severe/critical COVID-19, TNBC study results, and the MASH manuscript are pending final review and data confirmation before submission.
