Draft:Jacob Lalezari

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Jacob P. Lalezari
EducationB.A., University of Rochester
M.A., University of Virginia
M.D., University of Pennsylvania
OccupationsPhysician, clinical researcher
Employer(s)Quest Clinical Research, CytoDyn Inc.
Known forAntiviral drug development, clinical trials, HIV and COVID-19 research
WebsiteQuest Clinical Research

Jacob Paul Lalezari (Jay Lalezari) is an American physician and clinical researcher specializing in infectious diseases and oncology.[1] NP2 His work has focused on clinical trials for HIV/AIDS, viral infections, and investigational cancer therapies.[2][3]

Early life and education

Lalezari studied at the University of Rochester, where he earned a Bachelor of Arts degree, and later received a Master of Arts from the University of Virginia. He completed his medical degree at the University of Pennsylvania before pursuing residency training at Mount Zion Hospital in San Francisco in internal medicine.[4][5]

Career

Lalezari began his career in clinical research by founding the Mount Zion HIV Clinical Research Center in June of 1989, participating in early antiretroviral trials. In 1996, he established Quest Clinical Research, an independent trial center in San Francisco that has conducted studies in HIV, cytomegalovirus, herpes simplex virus, human papillomavirus, hepatitis B and hepatitis C, influenza, fatty liver disease, gene therapy, and oncology.[6] His work at Quest has been cited in independent coverage of clinical research and biotechnology developments.[7]

In November 2023, Lalezari was appointed interim chief executive officer of CytoDyn, Inc., and was named permanent CEO in January 2024,[8][9] a biotechnology company developing leronlimab, a monoclonal antibody directed toward a key immune cell receptor called CCR5.[10][11] Under his leadership, the company has pursued clinical and preclinical trials of leronlimab in a variety of solid tumors[12] including Colorectal Cancer, Triple-Negative Breast Cancer, and Glioblastoma.[13][14]

He is also a co‑founder and Vice President of NP2,[15] a nonprofit pharmaceutical company launched in 2019 to provide generic intravenous chemotherapy at reduced prices to cancer centers across the United States (NP2.org). Lalezari has also served as Medical Director of Siempre Unidos,[16] a Honduran HIV/AIDS organization, since the early 2000s, contributing to international efforts in HIV care and treatment.

Research Contributions

Lalezari has authored or co‑authored more than 140 peer‑reviewed publications. His early work included studies on cidofovir for cytomegalovirus retinitis in patients with AIDS, published in The New England Journal of Medicine in 1995. He later contributed to clinical trials of CCR5 antagonists[17], including PRO 140, reported in the Journal of Infectious Diseases in 2009.[18] More recently, he was a co‑author of a randomized trial of leronlimab for multidrug‑resistant HIV, published in the Journal of Acquired Immune Deficiency Syndromes in 2025. His publications have been cited in independent scientific literature and reflect a sustained contribution to clinical research in infectious diseases and oncology.

Public Engagement

Lalezari has participated in interviews and discussions in medical and biotechnology outlets.[19] He has spoken about investigational therapies for HIV and cancer in podcasts and conference presentations,[20] including appearances on the Empowered Patient Podcast and interviews on research platforms.[21] His work has been covered in independent media sources such as The Scientist, BioSpace, and TrialSiteNews, which have reported on his involvement in clinical trials and leadership in biotechnology.

Selected publications

  • Lalezari, Jacob P. (1995). "Safety and efficacy of cidofovir in the treatment of cytomegalovirus retinitis in patients with AIDS". New England Journal of Medicine. 333 (1): 10–16. doi:10.1056/NEJM199507063330103. PMID 7791814.[22]
  • Lalezari, J. et al. “Cidofovir for CMV Retinitis in Patients with AIDS.” New England Journal of Medicine (1995).
  • Lalezari, J. et al. “Safety and Efficacy of PRO 140, a CCR5 Antagonist, in HIV Infection.” Journal of Infectious Diseases (2009).[23]
  • Lalezari, Jacob P. (2009). "A phase II clinical trial of the CCR5 antagonist PRO 140 in HIV-infected adults". Journal of Infectious Diseases. 200 (1): 163–168. doi:10.1086/599364. PMID 19432545.[18]
  • Lalezari, J. et al. “Leronlimab Treatment for Multidrug‑Resistant HIV‑1 (OPTIMIZE): a Randomized, Double‑Blind, Placebo‑Controlled Trial.” Journal of Acquired Immune Deficiency Syndromes (2025).[24]

References

  1. "Dr. JAY". Quest Clinical. Retrieved May 21, 2026.
  2. "CytoDyn Appoints Jacob Lalezari M.D. as CEO, Mitchell Cohen as Interim CFO". CytoDyn Inc. January 29, 2024. Retrieved May 21, 2026.
  3. Wire, Globe News (January 29, 2024). "CytoDyn Appoints Jacob Lalezari M.D. as CEO, Mitchell Cohen as Interim CFO". GlobeNewswire News Room (Press release). Retrieved May 21, 2026.
  4. "Dr. Jacob Lalezari - Internal Medicine in Western Addition , San Francisco - Book Appointment, View Fees & Reviews | Practo". www.practo.com. Retrieved May 21, 2026.
  5. "Jacob P. Lalezari MD - Executive Bio, Work History, and Contacts - Equilar ExecAtlas". people.equilar.com. Retrieved May 21, 2026.
  6. AIDS, 1 Min ReadInternational Foundation for Alternative Research in (July 24, 2012). "Jacob Lalezari: In HIV/AIDS, "Cure Is a Four-Letter Word" (Video)". TheBody Pro. Retrieved May 21, 2026.{{cite web}}: CS1 maint: numeric names: authors list (link)
  7. Read, 5 Min (April 22, 2026). "CytoDyn Completes Enrollment in Phase 2 Metastatic Colorectal Cancer Study". BioSpace. Retrieved May 21, 2026.{{cite web}}: CS1 maint: numeric names: authors list (link)
  8. "Vancouver-based biotech firm CytoDyn gets new interim CEO". The Columbian. May 2, 2026. Retrieved May 21, 2026.
  9. "CytoDyn Appoints Jacob Lalezari M.D. as CEO, Mitchell Cohen as Interim CFO". markets.financialcontent.com. Retrieved May 21, 2026.
  10. Gathe, Joseph C.; Dejesus, Edwin; Ramgopal, Moti N.; Rolle, Charlotte-Paige; Yang, Otto O.; Sanchez, William E.; Lalezari, Jacob P.; Krishen, Alok; Sacha, Jonah B.; Hansen, Scott G.; Meidling, Joseph (June 1, 2025). "Leronlimab Treatment for Multidrug-Resistant HIV-1 (OPTIMIZE): A Randomized, Double-Blind, Placebo-Controlled Trial". Journal of Acquired Immune Deficiency Syndromes (1999). 99 (2): 185–194. doi:10.1097/QAI.0000000000003648. ISSN 1944-7884. PMID 39972543.
  11. CytoDyn, The Scientist. "A Novel CCR5 Antagonist for Multiple Therapeutic Applications". The Scientist. Retrieved May 21, 2026.
  12. "Empowered Patient Podcast: Turning Cold Tumors Hot to Effectively Treat Triple-Negative Breast Cancer with Dr. Jay Lalezari CytoDyn". empoweredpatientradio.com. Retrieved June 11, 2026.
  13. Sava, Jordyn (May 21, 2026). "FDA Clears Phase 2 Trial of Leronlimab for Microsatellite-Stable CRC | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways". www.targetedonc.com. Retrieved May 21, 2026.
  14. Baron, A.; Arman, C.; Joseph, M.; Adams, D.; Weinberg, B. A.; Lalezari, J. P. (July 1, 2025). "134eP Observed survival following treatment with leronlimab in patients with metastatic colorectal cancer". Annals of Oncology. 36: S58–S59. doi:10.1016/j.annonc.2025.05.146. ISSN 0923-7534.
  15. "Our Leadership Team". NP2 - Pharma Reimagined. Retrieved May 21, 2026.
  16. "Our Team". Siempre Unidos. Retrieved May 21, 2026.
  17. Jacobus, Nicholas; PhD, Jay Lalezari (June 11, 2026). "The Influence of Targeting CCR5 Receptors | PharmExec". www.pharmexec.com. Retrieved June 11, 2026.
  18. Jacobson, Jeffrey M.; Lalezari, Jacob P.; Thompson, Melanie A.; Fichtenbaum, Carl J.; Saag, Michael S.; Zingman, Barry S.; D'Ambrosio, Paul; Stambler, Nancy; Rotshteyn, Yakov; Marozsan, Andre J.; Maddon, Paul J.; Morris, Stephen A.; Olson, William C. (October 1, 2010). "Phase 2a Study of the CCR5 Monoclonal Antibody PRO 140 Administered Intravenously to HIV-Infected Adults". Antimicrobial Agents and Chemotherapy. 54 (10): 4137–4142. doi:10.1128/aac.00086-10. PMC 2944554. PMID 20660677.
  19. AIDS, 1 Min ReadInternational Foundation for Alternative Research in (July 24, 2012). "Jacob Lalezari: In HIV/AIDS, "Cure Is a Four-Letter Word" (Video)". TheBody Pro. Retrieved June 9, 2026.{{cite web}}: CS1 maint: numeric names: authors list (link)
  20. Chaudhry, Samena (July 13, 2002). "GPs should use nurses more to lighten their load". BMJ (Clinical research ed.). 325 (7355): 62B. doi:10.1136/bmj.325.7355.62/b. ISSN 1756-1833. PMC 1123628. PMID 12114228.
  21. "Dr. Jacob Lalezari, MD - CEO, CytoDyn - Next Generation of Monoclonal Antibody Therapeutics". Apple Podcasts. Retrieved June 9, 2026.
  22. Lalezari, J. P.; Holland, G. N.; Kramer, F.; McKinley, G. F.; Kemper, C. A.; Ives, D. V.; Nelson, R.; Hardy, W. D.; Kuppermann, B. D.; Northfelt, D. W.; Youle, M.; Johnson, M.; Lewis, R. A.; Weinberg, D. V.; Simon, G. L. (April 1, 1998). "Randomized, controlled study of the safety and efficacy of intravenous cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with AIDS". Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology: Official Publication of the International Retrovirology Association. 17 (4): 339–344. doi:10.1097/00042560-199804010-00008. ISSN 1077-9450. PMID 9525435.
  23. Jacobson, Jeffrey M.; Thompson, Melanie A.; Lalezari, Jacob P.; Saag, Michael S.; Zingman, Barry S.; D'Ambrosio, Paul; Stambler, Nancy; Rotshteyn, Yakov; Marozsan, Andre J.; Maddon, Paul J.; Morris, Stephen A.; Olson, William C. (May 15, 2010). "Anti-HIV-1 activity of weekly or biweekly treatment with subcutaneous PRO 140, a CCR5 monoclonal antibody". The Journal of Infectious Diseases. 201 (10): 1481–1487. doi:10.1086/652190. ISSN 1537-6613. PMC 2856743. PMID 20377413.
  24. Gathe, Joseph C.; Dejesus, Edwin; Ramgopal, Moti N.; Rolle, Charlotte-Paige; Yang, Otto O.; Sanchez, William E.; Lalezari, Jacob P.; Krishen, Alok; Sacha, Jonah B.; Hansen, Scott G.; Meidling, Joseph (June 1, 2025). "Leronlimab Treatment for Multidrug-Resistant HIV-1 (OPTIMIZE): A Randomized, Double-Blind, Placebo-Controlled Trial". Journal of Acquired Immune Deficiency Syndromes (1999). 99 (2): 185–194. doi:10.1097/QAI.0000000000003648. ISSN 1944-7884. PMID 39972543.