Aneel Paulus is a distinguished physician-scientist and consultant with over 15 years of experience in translational oncology, clinical trials, and drug development from pre-clinical to early-stage clinical phases. During his tenure at the Mayo Clinic in Florida, Dr. Paulus spearheaded the laboratory research program focused on mature B-cell cancers, leading to significant advancements in the treatment of multiple myeloma, chronic lymphocytic leukemia, and rare lymphomas. His innovative research included the discovery of new drug indications and therapeutic combinations, notably utilizing the unique properties of the Neem plant and Curcumin. More recently, his work has expanded to explore the intersection of aging, immunology, cancer neuroscience, neuromodulation, and psychedelic-assisted therapies.
Dr. Paulus was the Co-Founder and Chief Scientific Officer of Alpha2 Pharmaceuticals. This clinical-stage company is dedicated to developing personalized therapeutics to combat cancer drug resistance and prevent relapse. In his role, he oversaw all facets of drug design, manufacturing, production, strategic acquisitions, and product pipeline development, positioning Alpha2 Pharmaceuticals at the forefront of innovative cancer treatment.
Dr. Paulus’ extensive experience at the Mayo Clinic included leading a multi-disciplinary malignant hematology research team composed of physicians, nurses, clinical coordinators, and laboratory scientists. His work has covered a wide range of therapeutic areas, including small molecules, natural products, proteasome inhibitors, B-cell receptor pathway inhibitors, therapeutic antibodies, and nanotherapeutics. He has contributed to the development of several key drugs such as Lenalidomide, Venetoclax, and Ibrutinib, and has been involved in the design and execution of multiple Phase I and II clinical trials, providing a critical bridge between pre-clinical research and clinical application.
Educationally, Dr. Paulus holds an MD from Windsor University and an MS in translational oncology from the State University of New York at Buffalo/Roswell Park Cancer Institute. His expertise is recognized globally, having served on international grant review committees and disease-focused think tanks. He has also consulted for leading Fortune 500 biopharmaceutical companies including GSK, BMS, AstraZeneca, Janssen, and Takeda, as well as smaller companies like Natera, Ascentage, Affimed AB, and Vivolux AB.
Beyond his professional achievements, Dr. Paulus is an active community member, coaching youth soccer and promoting exercise and wellness. His contributions to cancer medicine, his patents in novel treatment strategies and individualized cancer vaccines underscore his commitment to advancing medical science and improving patient outcomes- mind, body and spirit.
Profile
Consultant and Physician-Scientist with 15+ years experience in translational oncology, clinical trials and pre-clinical to early-stage clinical drug development. While at Mayo Clinic in Florida, I designed and led the laboratory research program in mature B-cell cancers. My team identified new drug indications and novel therapeutic combinations for use in multiple myeloma, chronic lymphocytic leukemia and rare lymphomas, some of which were based on the unique properties of the Neem plant and Curcumin. More recent work in the aging process and associated immunological changes led me to study cancer neuroscience, neuromodulation and psychedelic-assisted therapies.
Experience
Co-Founder | Chief Scientific Officer
Alpha2 Pharmaceuticals
2019 – Present
Inventor of a novel multivalent cancer vaccine at Alpha2 Pharmaceuticals- a clinical-stage company focused on developing personalized therapeutics to protect against cancer drug resistance and prevent relapse. I oversee all aspects of drug design, manufacturing, production, strategic acquisitions and product pipeline development.
Head of Translational Research in Mature B-Cell Cancers
Associate Professor of Medicine
Mayo Clinic Florida
2012 – 2023
Led a multi-disciplinary malignant hematology research team consisting of physicians, nurses, advanced nurse practitioners, clinical coordinators, laboratory scientists and research technologists/technicians.
Pre-Clinical —> Clinical Stage Drug Development Experience
Small Molecules
- Immunomodulating agents (IMiDs).
- Lenalidomide (Celgene Corp. PMID: 24236538, 22010965, 22171982, 29105343)
- Bcl-2 inhibitors.
- AT-101 (Ascentage. PMID: 24467634, 22171982)
- Venetoclax/ABT-199 (Abbvie. PMID: 28548645; ASH Abstract; Blood (2014) 124 (21): 1689.
- Lisaftoclax/APG-2575 (Ascentage. PMID: 37074726, 36048524)
- Research funding, Scientific Advisory board
- Natural products.
- Neem leaf extract (PMID: 23721511, 25382610, NCT01251250)
- Curcumin (PMID: 30079563)
- Proteasome inhibitors/Deubiquitinating enzyme (DUB) inhibitors.
- b-AP15 / VLX1570 (Vivolux AB: PMID: 27264969, 25854145, 25691154)
- Ixazomib citrate (Millenium Pharmaceuticals. PMID: 24467634, 38286472)
- B-cell receptor / PI3K pathway inhibitors.
- Ibrutinib (Pharmacyclics, PMID: 28548645, 30940652, 38286472, 30080238, 35488778)
- Copanlisib (Bayer Pharma; Presented at 10th International Workshop on Waldenstrom Macroglobulinemia, NY, 2018)
- Research funding, Scientific Advisory board
Therapeutic Antibodies / Biologics
- Anti-CD38 monoclonal antibodies.
- Daratumumab (Jaansen Pharma. PMID: 32421811, 30940652, 30080238)
- Research Funding
- Isatuximab (PMID: 27914971, 27570087)
- Daratumumab (Jaansen Pharma. PMID: 32421811, 30940652, 30080238)
- Anti-CD20 monoclonal antibodies.
- Rituximab (Genentech. PMID: 22162923, 22171982; Hematol Leuk. 2015; 3:2. http://dx.doi.org/10.7243/2052-434X-3-2)
- Obinutuzumab (Roche. ASH Abstract Blood (2018) 132 (Supplement 1): 5558)
- Anti-CS1/SLAMF7 antibody.
- Elotuzumab (Bristol Myers Squib. PMID: 31415286)
- Research funding, Scientific Advisory board
- Bispecifc antibodies/engagers.
- AFM13 (CD16a x CD30; Affimed AG.; J Immunol May 1, 2019, 202 (1 Supplement) 71.12)
- XmAb®13676 (CD3 x CD20; Xencor. PMID: 34781809)
Nanotherapeutics
- Drug-bearing lipid nanoparticles (PMID: 32558607)
- D1XB (Proteasome inhibitor nanoparticle; Sagitraxx Therapeutics)
- D1XN (MDM2 inhibitor nanoparticle; Sagitraxx Therapeutics)
Clinical Trial Experience
Phase I trials
Designed and developed preclinical rational, co-designed clinical study and correlatives for following studies:
- NCT03537482. A Phase I Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Property of Orally Administered APG-2575 in Patients with Hematologic Malignancies
- NCT03015792. Phase I/II Trial of Ibrutinib, Dexamethasone, and Lenalidomide as Initial Therapy for Transplant Ineligible Multiple Myeloma Patients
- NCT02697344. R-(-)-Gossypol Acetic Acid With Lenalidomide and Dexamethasone in Treating Patients With Relapsed Symptomatic Multiple Myeloma (Phase I/II)
- NCT01003769. Phase I/II Study of Lenalidomide in Combination with AT-101 for Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
- NCT04260217. Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab
Phase II trials
- NCT04230304. Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT
- Developed preclinical rationale, designed trial arms and endpoints, correlative studies.
- NCT03477539. Daratumumab in Treating Transplant-Eligible Participants With Multiple Myeloma
- Co-designed and wrote trial protocol, obtained funding for correlative studies.
- NCT03713294. Phase II study of Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients with Refractory Multiple Myeloma
- Co-designed study protocol; designed and obtained funding for correlative studies.
- NCT02649387. Minimal Residual Disease Eradication with Ibrutinib Therapy (MERIT) in Patients with Chronic Lymphocytic Leukemia After Frontline Therapy
- Co-designed and wrote trial protocol, conducting single-cell correlative analyses
Education
Windsor University, St. Kitts — BS/MD, 2008
State University of New York at Buffalo/Roswell Park Cancer Institute, Buffalo NY — MS, 2010
Skills
My training encompasses laboratory and clinical sciences; Ive served as head of an academic translational laboratory, spearheading biology-driven clinical trials and Chief Scientific Officer of a pharmaceutical company. I am a subject matter expert on Bcl-2 and CD38-targeting drugs. My other work includes studying the role of CD38 and NAD on cellular aging and rejuvenation. Ive served on international grant review committees and disease-focused think tanks. Consulting experience for Fortune 500 biopharma companies such as GSK, BMS, Astra-Zeneca, Jaansen, Takeda as well as smaller cap companies such as Natera, Ascentage, Affimed AB, Vivolux AB.
Patents
- Methods and materials for identifying and treating mammals resistant to proteasome inhibitor treatments. (US20170128518A1)
- Individualized vaccines for cancer treatment and prevention. (PCT/ US2020/067237)
- Novel proteasome inhibitors. (PCT/US20/55010)
- Design and development of novel CKL-BPi series of compounds (Dual BTKPI3K inhibitors) for treatment of cancer. (Filed/Patent pending).
Musings
- U10 JFC Soccer coach
- EMS exercise
- Cancer Neuroscience
