Preamble: Cancer immunotherapy is demonstrating impressive clinical benefit in different malignancies and clinical oncologists are increasingly turning their attention to immune-oncology. Despite recent achievements, there remain a number of unresolved issues in order to successfully implement cancer immunotherapy in many cancers. Achieving the vision to create a collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer and better outcomes for patients with cancer.
Current:
Kaumaya has been shepherding compounds from discovery into 3-first-in-human trials at OSU. Continuing this process at IU CCC would be a priority with implementing novel clinical trial paradigm.
1. HER-2 (B-Vaxx): PK is holder of FDA approved IND and have gram quantities of GMP peptides and adjuvant materials in house for additional clinical trials. Phase 1 clinical trial concluded successfully without toxicity at OSU and published with Phase II trial at OBD ongoing at OSU James.
2. HER-2 Phase I trial in Neoadjuvant setting will open at IU with Dr Miller as PI and Kaumaya as sponsor. Protocol from OSU has been transferred to IU obtain IUCCC-IRB approval.
3. PD-1 (PD1-Vaxx): Imugene has FDA approved IND and Kaumaya has GMP peptides in house and at Imugene delivery location in USA. Phase 1 trial completed successfully. Phase 1b trial with Atezolizumab has begun at OSU James. Same trial can start at IU with Imugene paying for Clinical trial costs. Drs Hanna and Jalal will serve as PIs. Imugene needs to be in contact with IUCCC-CTO to facilitate implementation
4. CTLA-4 (CTLA-4-Vaxx). Preclinical studies completed. Epitope identified and Phase 1 ready. Manuscript in preparation for submission
5. TIGIT-Vaxx. Epitopes identified, Ongoing studies to develop further
6. LAG3-Vaxx. Epitope identified Ongoing studies to develop further
7. ADJUVANT STUDIES. ISA720 versus ISA 51 partly completed; Adju-Phos +CpG ongoing
8. Combination immunotherapy B-Vaxx + PD1-Vaxx; B-vaxx +PDL1-Vaxx completed preclinical studies
Future:
1. Phase 1 clinical trial B-Vaxx (Combo HER-2) + PD1-Vaxx: (GMP materials for both B-Vaxx and PD1-Vaxx available and in stock and ready to be deployed in clinical trials at IU).
2. Phase 1 clinical trial B-Vaxx + PDL1-Vaxx. B-Vaxx trial completed and GMP material available in house. Preclinical data on combination completed successfully with synergistic efficacy (published Onco-Immunology 2021). Must apply for funds (ISP or otherwise) to GMP manufacture PDL1-Vaxx. Kaumaya to apply for IND and FDA approval for Phase 1 clinical trial for PDL1-Vaxx as well as for the combined vaccines.
3. Novel Clinical Trial Paradigm: to efficiently evaluate the safety and effectiveness of immuno-oncology therapeutics, including combination regimens (HER-2, PD-1, PD-L1, CTLA-4).
4. Combination TIGIT-Vaxx and PDL1-Vaxx in TNBC. Need to start studies in syngeneic models BALB/c/4T1
5. POTENTIAL COMBINATION IMMUNOTHERAPIES: Continuing studies are ongoing and to be finalized:
(i) LAG-3
(ii) TIGIT
(iii) TIM-3
• Additional Checkpoint molecules that need exploration
(i) Vista,
(ii) BTLA,
(iii) 4-1BB
• Potential New Phase 1 clinical trials could be planned. All preclinical efficacy completed
(i) VEGF
(ii) HER-3
(iii) HER-1
(iv) IGF-1R
• Development of new Peptide mimics/therapeutics and peptide small-molecule inhibitors in collaboration with Florida Atlantic University (Stephane Roche) and Galore TX (Sasikumar). New NIH applications being planned.
• Hoping to have IU help spin new companies and startups based on technologies I have developed and new ones being developed to demonstrate the breath and depth of our checkpoint inhibitor vaccines in cancer. IU may have the ability to attract startup -individuals, investors and aspiring entrepreneurs to impact cancer with other IU innovations.
• To establish additional SYNGENEIC CANCER MOUSE MODELS: Lung, Melanoma, TNBC
• To establish a Peptide/Protein Engineering/Neoantigen CORE in IUCCC
Post-doctoral Fellowship - University of Texas, Austin, TX 1981-1984
Ph.D. - University of Portsmouth, Hants, UK 1981
