TapImmune (TPIV) is developing immunotherapies for a variety of cancers designed to target both tumors and metastatic disease. The company’s next-generation technology has been engineered to overcome the deficiencies of earlier cancer vaccine approaches and has the potential to be a powerful standalone therapy or part of a leading combination regimen by complementing other approved or development-stage immunotherapeutics (i.e. checkpoint inhibitors). The company’s off-the-shelf vaccines boost patients’ immune systems to comprehensively stimulate both killer T-cells and helper T-cells to destroy cancer cells.
TapImmune is advancing two clinical stage T-cell vaccine candidates in multiple Phase II and Phase Ib/IIa clinical trials for treating ovarian and breast cancers, including programs in ovarian cancer that will benefit from FDA Fast Track and Orphan Disease Designation. The company is working in collaboration with industry and clinical leaders including Mayo Clinic, Memorial Sloan Kettering Cancer Center, and AstraZeneca.
On May 1st, TapImmune announced Richard Kenney, MD, FACP, was joining TapImmune to lead the Clinical Development Program. Dr. Kenney will manage TapImmune’s ongoing and planned clinical programs for its next-generation T-cell vaccine candidates, which currently include multiple Phase 2 trials in advanced breast and ovarian cancer.
Prior to joining TapImmune, Dr. Kenney served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, where he established and led the clinical development, pharmacovigilance and regulatory affairs groups to advance the development and commercialization of the company’s cancer prime-boost immunotherapeutic and vaccines. Previously, Dr. Kenney served as Chief Medical Officer of Crucell Holland, BV, where he directed clinical development of a broad platform of vaccines. He also served as Senior Vice President, Clinical Development for Vical Incorporated, where he led the clinical development of DNA vaccines for cancer immunotherapy and infectious diseases. Dr. Kenney held key positions in vaccine development at GSK Biologicals from 2005 to 2009, most recently as Senior Director of Global Clinical R&D, Vaccines for Viral Diseases. He earned his M.D. degree at Harvard Medical School, completed his residency in Internal Medicine at Duke University Medical Center, and a fellowship in Infectious Diseases at the National Institute of Allergy and Infectious Diseases.
MR: Congratulations on your new position as Medical Director for TapImmune.
What are your responsibilities in this role?
RK: I am responsible for the clinical development of our products. Once a compound is shown to be promising in the research lab, it needs to be tested in human trials that show its safety and effectiveness. Few patients are exposed at first, when the risks are not fully known. When it is clear that more patients can be tested, larger populations are used to show whether a benefit can be expected from that product in various indications. I manage the design of future trials and help with the operational aspects of ongoing trial oversight.
MR: What prior experience do you have with clinical development programs in immunotherapy that will expedite TapImmune’s T-cell vaccine candidates as they progress through clinical trials?
RK: My career has been focused on the induction of immunity in human populations, using vaccines for infectious diseases as well as for different tumors. I have experience in both the clinical and regulatory aspects of moving a product through development in small and large projects. Much of my work has focused on the use of adjuvants, which can enhance the immune response, particularly when used in a prime-boost approach.
MR: I’m sure you could choose from any number of attractive T-cell immunotherapy companies to work with. What attracted you to TapImmune?
RK: It’s a combination of the people and the products. TapImmune is led by and employs a good group of hard-working people who are experienced in their various roles. The vaccines being developed have been shown to be safe and immunogenic and now need further work to demonstrate efficacy. We have an opportunity to use the latest scientific hypotheses to study novel combinations and are working with some of the nations’ best clinical investigators to generate robust approaches.
MR: In what way(s) is T-cell immunotherapy superior to other cancer therapies?
RK: Traditional chemotherapy is designed to kill cells directly and usually causes rapid shrinkage of the tumor. Unfortunately, that comes at a great cost in terms of the side effects on normal tissues and the cancer often becomes resistant and returns. Your immune system has been working to protect you from cancers since before you were born. Tapping into that protection by generating a targeted immune response where that system has broken down may be a better way to fight the growth of tumors and is usually much less toxic.
MR: TapImmune has multiple clinical trials underway primarily focused on aggressive breast and ovarian cancers. Would you provide an overview of these trials- where they are currently, what collaborative partnerships are involved, and the benefits of the FDA Fast Track designation where it has been granted?
RK: TapImmune has two main products in clinical trials. TPIV200, the folate receptor-alpha peptide vaccine, is in several Phase 2 trials looking at safety and immunogenicity in breast cancer and at efficacy in ovarian cancer. While the peptide vaccine itself is adjuvanted with GM-CSF, we are using the product alone, in combination with low-dose cyclophosphamide as an immunostimulant, or in combination with durvalumab, a checkpoint inhibitor of PD-L1, in collaboration with Memorial Sloan Kettering Cancer Center. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Fast Track designation has been granted for TPIV200 for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer, so we have more opportunity to work closely with FDA to resolve issues along the way.
The other vaccine, which has been called TPIV100, has 4 peptides directed against HER2/neu. We recently updated that product by adding a fifth peptide to enhance the immune response and now call the vaccine TPIV110. One of the clinical studies using TPIV100 will evaluate an early stage of breast cancer called DCIS before surgery. The other will study more advanced patients with triple-negative breast cancer (TNBC) starting later this year. Both studies are being done in collaboration with the Mayo Clinic and the Department of Defense.
MR: In addition to the T-cell vaccine development, TapImmune is working on PolyStart™, a DNA vector technology. Would you explain what “DNA vector technology” means and what the potential applications are for PolyStart™?
RK: DNA vectors have been used to generate immune responses against infectious diseases and cancers in humans for many years. Basically, we can use the gene to let the body make the protein that is required to generate an effective immune response. DNA vaccines engage different parts of the immune system that can complement the way tumors are being attacked. PolyStart is a technology that greatly augments the amount of protein that can be generated inside the cell, which should induce a more robust immune response. We can use this approach by itself or in combination with the peptide vaccines to boost the overall immune response and thereby enhance efficacy. Thus, PolyStart can be used to target any number of infectious diseases or can be studied along with our vaccines for breast and ovarian cancer.
MR: What clinical development milestones can investors in TapImmune look forward to over the next 6-12 months?
RK: We should see the data from the Phase 1 trial of the TPIV200 folate receptor-alpha vaccine published within the next few months and the ongoing Phase 1b/2 trial at MSKCC has a decision point for continuation that will be available late this summer. The Phase 2 trial in TNBC has an interim look at safety and immunogenicity by the end of the year and it should be fully enrolled by the end of the year. The preliminary efficacy trial in ovarian cancer is just starting to enroll – those results will take more time to mature as it is a larger trial, although an interim analysis is planned for late 2018. In addition, we expect to see the Mayo trials of the TPIV100 HER2/neu vaccine starting later this year. Finally, we will be amending that IND later this year for our own sponsored study in Her2neu breast cancer using TPIV110. This is an active period for TapImmune and our collaborators that will lead to multiple readouts over the next two years.
More About TapImmune:
U.S. Department of Defense Funds Phase II Trial of TapImmune Breast Cancer Vaccine source: Breast Cancer News
TapImmune Improves T-cell Vaccine Ahead of Phase II Trials source: BioPharma Reporter