TapImmune (TPIV) is advancing two Phase II studies that are funded by ~$17 million in non-dilutive grants from the U.S. Department of Defense.
In total, the company has 4 different Phase II studies underway and is planning to submit an Investigational New Drug (IND) Application with the FDA for another breast cancer vaccine this year.
Due to the unmet medical needs targeted by TapImmune’s T-cell vaccines as well as promising Phase I results, the FDA has granted Fast Track designation in two of the studies, providing an expedited review to facilitate development of the vaccines.
Additionally, TapImmune recently added Richard Kenney, MD, FACP, as Medical Director for the Company to lead the clinical development program. Dr. Kenney brings deep clinical development and FDA process experience to the Company as it continues to develop T-cell cancer vaccines that aggressively target breast and ovarian tumors.
Shares outstanding: 8.4 million
Closing Price 5/8/2017: $3.69
Market cap: $31 million
Total Cash (mrq) $8 million
Cash/Share (mrq) $0.93
Debt (mrq) 5k
Current Ratio (mrq) 4.6
TapImmune (TPIV) is developing immunotherapies for a variety of cancers that are designed to target both tumors and metastatic disease. The company’s next-generation technology is designed 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.
Full Funding for Phase II of TapImmune’s HER21-targeted T-cell vaccine
The U.S. Department of Defense (DoD) awarded Mayo Clinic researchers $3.7 million to conduct a Phase II trial of TapImmune’s HER21-targeted T-cell vaccine in women with the breast cancer known as ductal carcinoma in situ (DCIS). Her2neu is overexpressed in about 30% of all breast cancer patients, amounting to approximately 220,00 patients per year.
The 40 to 45 women who will be enrolled in the study will receive the TPIV 110 vaccine six weeks before surgery to remove the tumor.
This is TapImmune’s second T-cell vaccine candidate to be tested in a DoD-funded Phase II study at Mayo Clinic, and it marks TapImmune’s expansion into a second breast cancer indication. In addition to ongoing and planned Phase 2 studies of TapImmune’s lead TPIV 200 vaccine for treating triple-negative breast cancer, this new study of HER2neu vaccine in DCIS has the potential to validate the Company’s novel approach to establishing lasting immunity against breast cancer and precancerous lesions.
TapImmune’s new T-cell vaccine targeting HER2 consists of five carefully selected HER2 antigens that do the best job of activating HER2-directed T-cells. The mix is expected to cover a significantly larger patient population than the HER2-targeted therapy Herceptin (trastuzumab). TPIV 110 is expected to cover 90 percent of HER2-positive cancers, versus Herceptin’s 15-20 percent. TPIV 110 is also expected to remain effective for longer periods.
To date, the U.S. department of Defense has awarded approximately $17 million towards research using TapImmune’s targeted T-cell vaccines.
Additionally, investors should note that TapImmune has world-class sponsors and collaborators including AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic. The caliber of these sponsors and partners speaks volumes about the potential for breakthrough research in the cancer immunotherapy space by TapImmune.
Dr. Richard Kenney Taking Clinical Development to the Next Stage
The addition of Dr. Kenney to the team as Medical Director at TapImmune validates the Company’s technology and recent progress, and is a milestone for the Company. Dr. Kenney is superbly qualified to lead the clinical development programs TapImmune is advancing.
- M.D. from Harvard Medical School
- Residency at Duke University Medical Center
- Fellowship at the National Institute of Allergy and Infectious Diseases
- Served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, (Nasdaq: IMDZ), 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
- Served as Chief Medical Officer of Crucell Holland, BV, (a division of Johnson & Johnson), where he directed clinical development of a broad platform of vaccines
- Served as Senior Vice President, Clinical Development for Vical Incorporated, (Nasdaq: VICL), where he led the clinical development of DNA vaccines for cancer immunotherapy and infectious diseases
- Held key positions in vaccine development at GSK Biologicals most recently as Senior Director of Global Clinical R&D, Vaccines for Viral Diseases
Regarding his new position at TapImmune, Dr. Kenney stated:
“I am delighted to assist TapImmune during this exciting time of growth as the company advances two of its T-cell vaccine candidates though multiple Phase 1b/2 and Phase 2 clinical trials. Each of these novel vaccines are designed to address significant unmet needs for women with ovarian and breast cancer, where recurrence is high and prognosis can be very poor. Having led the development of multiple vaccine programs and immunotherapies for cancer and infectious disease, I am eager to utilize my experience to drive successful clinical programs for TapImmune in collaboration with the Company’s top-tier clinical partners.”
Attracting someone of Dr. Kenney’s caliber to TapImmune speaks volumes about the current and future potential of the Company’s T-cell immunotherapy programs.
Beyond Treatment, to Actual Breast Cancer Prevention
TapImmune believes that if the trials of HER21-targeted T-cell vaccine go well, the vaccine could replace a combination of chemotherapy and surgery as a breast cancer treatment, and could also be used as a preventive vaccine to keep healthy women from developing breast cancer.
Video: “Vaccine could prevent breast, ovarian, lung cancer”
Four Phase II Immuno-Oncology Trials Underway with Top Tier Partners
TapImmune has four clinical trials now in phase II for treatment of ovarian and triple-negative breast cancers.
Phase II Trial of TPIV 200 for Triple-Negative Breast Cancer with Fast Track designation from the FDA
About 15-20% of all breast cancers are found to be triple-negative (meaning the breast cancer cells tested negative for estrogen receptors, progesterone receptors, and HER2). This form of breast cancer does not respond to hormonal therapy (such as tamoxifen or aromatase inhibitors), or therapies that target HER2 receptors, such as Herceptin (chemical name: trastuzumab). Triple-negative breast cancer tends to be more aggressive with higher mortality rates than other breast cancers.
The open-label, 80 patient clinical trial by TapImmune is designed to evaluate dosing regimens, adjuvants, efficacy, and immune responses in women with triple-negative breast cancer. Key data from the trial is expected to be included in a future New Drug Application submission to the FDA for marketing clearance.
TapImmune announced a key clinical milestone in February, passing a planned safety review that was performed when enrollment had reached 25 percent benchmark (20/80 patients).
In the prior Phase I study of TPIV 200 at Mayo Clinic, 100% of patients demonstrated a T-Cell response lasting over 6 months and the drug was found to be safe and effective in treatment of both ovarian and breast cancers.
This study has Fast Track designation from the FDA which provides an expedited review to facilitate development of the drug. This designation is granted in studies that treat serious or life-threatening conditions and fill an unmet medical need.
Phase II Mayo Clinic Trial of TPIV 200 in Triple-Negative Breast Cancer Fully Funded by U.S. Department of Defense
This is a separate Phase II study of TPIV 200 for the treatment of triple-negative breast cancer, conducted by the Mayo Clinic and sponsored by the U.S. Department of Defense (DOD). The 280 patient study is being led by Dr. Keith Knutson of the Mayo Clinic in Jacksonville, Florida. Dr. Knutson is the inventor of the technology and an advisor to TapImmune.
$13.3 million worth of non-dilutive capital for trial.
While TapImmune is supplying doses of TPIV 200 for the trial, the remaining costs associated with conducting this study will be funded by a $13.3 million grant made by the DOD. This grant is a direct result of the very positive findings of the Phase I trial of TPIV 200 and validates TapImmune’s technology.
Phase II Trial at Memorial Sloan Kettering of TPIV 200 in Platinum-Resistant Ovarian Cancer in Collaboration with AstraZeneca on FDA Fast Track
Approximately 22,000 women were diagnosed with ovarian cancer in 2016 and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the five-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy.
There is currently no FDA approved cancer vaccine available for ovarian cancer.
This is a Phase II study of TPIV 200 in ovarian cancer patients who are not responsive to platinum, (a commonly used chemotherapy for ovarian cancer), sponsored by Memorial Sloan Kettering Cancer Center in collaboration with AstraZeneca. The open-label study is designed to evaluate a combination therapy which includes TapImmune’s TPIV 200 T-cell vaccine and AstraZeneca’s checkpoint inhibitor, durvalumab.
Because these patients are unresponsive to platinum-based therapy and have failed chemotherapy, there are unfortunately, no real options left at the present time. If the combination therapy proves effective, it would address a critical unmet need.
TapImmune received the FDA’s Fast Track designation to develop TPIV 200 as a maintenance therapy in platinum-resistant ovarian cancer.
Phase II Trial in Platinum-Sensitive Ovarian Cancer
TapImmune’s fourth Phase II trial utilizes TPIV 200 in ovarian cancer that is platinum-sensitive, and is being funded by the company. This study is an 80-patient double-blind placebo controlled study designed to examine the potential benefits of using the company’s lead product candidate TPIV 200 in combination with standard of care chemotherapy.
The study has Fast Track designation from the FDA and TPIV 200 has orphan drug status for ovarian cancer.
In the January press release announcing the launch of this Phase II trial, Dr. John Bonfiglio, President and COO of TapImmune explained:
“The opening of this study represents the fulfillment of a major 2016 milestone. We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients. A fourth study in triple-negative breast cancer sponsored by the Mayo clinic with a $13.3M grant from the Department of Defense is scheduled to begin shortly. We believe the depth of these clinical programs will give us an excellent understanding of how this exciting T-cell therapy can potentially be used in the treatment of both triple-negative breast and ovarian cancers.”
Preclinical Development of PolyStart™ Next Generation T-Cell Vaccine
PolyStart is a unique antigen expression system that ‘elevates’ the expression, and consequently the processing and presentation of desired antigenic peptide(s) for the stimulation of T-killer and/or T-helper cells to recognize and kill target cells. This novel vaccine technology platform creates a four-fold or greater increase in presentation of any antigen, giving it unlimited application in oncology and infectious diseases. This allows TapImmune to not only leverage the technology for its own vaccine candidates, but also generates additional value for the platform via licensing to third parties.
In February of this year, TapImmune expanded its patent on the PolyStart Platform for use in next-generation T-cell vaccines. Glynn Wilson, Chairman and CEO of TapImmune stated that:
“This patent significantly enhances our IP position for our PolyStart platform, further positioning TapImmune as a leader in the development of next-generation vaccines for cancer. The allowed claims cover enhanced expression of class I and class II HER2 antigens, enabling us to create future vaccines that should elicit robust and long-lasting T-cell immune responses against HER2/neu+ cancers with enhanced potency. While we focus on advancing our multiple Phase 2 clinical programs in ovarian and breast cancer, we expect to continue developing PolyStart to be used synergistically with our peptide-based vaccines as well as potentially monetized through licensing or partnership with other vaccine developers in oncology and infectious disease applications.”
PolyStart creates a 4 (FOUR) fold or more increase in antigen presentation. The increased cell surface presentation increases activated Helper and/or long-lived Killer T-cell populations that then effectively seek out and work to destroy a patient’s cancer cells.
PolyStart enhances immune responses in patients not only for cancer drugs but for infectious disease and other products. TapImmune believes PolyStart has unlimited application in oncology and infectious diseases not only in the Company’s own platforms, but that it can be applied to many others via licensing.
The Bottom Line
TapImmune has multiple phase II trials underway in the development of novel vaccines for the aggressive treatment of refractory breast and ovarian cancers. The Company’s technology is validated by research grants awarded by the U.S. Department of Defense totaling some $17 million, and by top research partnerships and collaborations with Mayo Clinic, AstraZeneca, and Memorial Sloan Kettering Cancer Center.
TapImmune has added a world-class Medical Director in Dr. Richard Kenney to lead clinical development programs. His extensive experience in both clinical trials and the commercialization of oncology drugs is a huge asset for the Company.
TapImmune’s current market capitalization of just $31 million is a gross understatement of the value of this innovative, exciting, and potentially game-changing company. I’ll be providing updates on TapImmune in the weeks ahead.
See also: TapImmune Fact Sheet