- TapImmune (TPIV) is proceeding on a total of four Phase II clinical trials in the development of a novel vaccine that aggressively attacks ovarian and breast cancers
- In the earlier 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
- TPIV has collaborative partnerships with AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic
- TPIV received a $13.3 million grant from the U.S. Department of Defense which is fully funding a Phase II study of TPIV 200 in 280 patients with triple negative breast cancer being conducted at Mayo Clinic
- TapImmune is well-funded and has no meaningful long term debt
- TPIV has several positive forward drivers in coming weeks and months
- With a Fast Track Designation and Orphan Drug Status under its wing, TapImmune is breaking down barriers at rapid speed and could very well have an up-and-coming commercial pipeline on its hands
- TapImmune’s current market cap of just $36 million is a bargain given the company’s cash balance + $13.3 million grant from the U.S. government, + four Phase II studies in progress
TapImmune, Inc. (web site) is a clinical-stage immune-oncology company specializing in the development of innovative technologies for the treatment of cancer and metastatic disease. The Company has made considerable clinical and financial progress over the last year, including the completion of positive Phase I clinical trials in breast and ovarian cancer at the Mayo Clinic, which showed that its TPV-100 and TPV-200 vaccines were safe and well tolerated, and demonstrated robust cellular immune responses in over 90% of evaluable patients. Since the results, TPIV has announced multiple Phase 2 clinical studies – and was also granted an Orphan Drug Designation and received fast track designation from the FDA for TPIV 200 in ovarian cancer.
Shares outstanding: 8.4 million
Closing Price 2/24/2017: $4.30
Market cap: $36 million
Total Cash (mrq) $9.6 million
Cash/Share (mrq) $1.14
Debt (mrq) 5k
Current Ratio (mrq) 4.40
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Four Phase II Immuno-Oncology Trials Underway with Top Tier Partners
Immuno-Oncology (or cancer immunotherapy) is a ground-breaking approach in the fight against aggressive cancer that uses the body’s own immune system to fight the disease. TapImmune has four clinical trials now in phase II for treatment of ovarian and triple-negative breast cancers.
Investors should note that TapImmune has world-class sponsors and collaborators in these trials, including AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, Mayo Clinic, and the U.S. Department of Defense. The caliber of these sponsors and partners speaks volumes about the potential for breakthrough research in the cancer immunotherapy space by TapImmune.
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 earlier this month in 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 TamImmune’s technology.
This Phase II launch is expected to begin shortly, and the announcement should be a positive driver for TPIV shares.
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.
On the Fast Track designation, Dr. Glynn Wilson, Chairman and CEO of TapImmune stated:
“We believe that the FDA’s decision to grant Fast Track designation to TPIV 200 for the treatment ovarian cancer significantly expedites our clinical development program. We believe TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis.”
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.”
See video from last week on TPIV:
“Vaccine could prevent breast, ovarian, lung cancer”
TPIV 100, TPIV 110 Also in Pipeline
The Phase 1 trial of TPIV 100 in 22 patients demonstrated the drug was safe and well-tolerated. The trial also showed that 19 out of 20 patients showed robust T-cell responses to two antigens while 15 out of 20 patients responded to all four antigens. The immune responses in these patients were durable for months after their final treatment.
The Phase 1b/2a program for TPIV 110 is designed to examine this novel T-cell vaccine both as a stand-alone therapy as well as a combination therapy with other standard of care therapies and newer experimental therapies. TapImmune plans to initiate TPIV 110 trials in breast cancer in 2017. The strategy is to obtain positive Phase 2 data and then look for a partnership or collaboration to fund the rest of the commercialization for TPIV 110.
Existing treatments such as Herceptin and Parjeta target the Her2/neu receptor and can work well in controlling the disease. However, the patient’s tumor must have the Her2/neu receptor (~30%) and in addition have the receptor in high enough density to make the antibody effective (~18% of the 30%). This leaves a void where patients who have the receptor but are not eligible for antibody treatment are relegated to chemotherapy, radiation and surgery.
TapImmune’s investigational product TPIV 110 also targets Her2/neu by stimulating the body’s own immune system to attack cancer cells with the Her2/neu target.
TapImmune plans to file an IND (Investigational new Drug) application with the FDA this year for TPIV 110.
Positive Upcoming Drivers
TapImmune has multiple positive drivers going forward, including:
- Participation in multiple oncology and biotech events in March and April
- Launch of the Phase II trial of TPIV 200 at Mayo Clinic, fully funded by a U.S. Government grant of $13.3 million
- Clinical data coming out of multiple Phase II trials of TPIV 200
- IND announcement on TPIV 110 expected during Q1 this year
- Initiation of the Phase 1b/2a studies using TPIV 110
Preclinical, A Next Generation T-Cell Vaccine: PolyStart
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 data below is from an earlier study showing the increased presentation and subsequent KILLING of the targeted cell population.
Dr. Glynn Wilson, Chairman & CEO of TapImmune explains:
“We are very excited about this technology, as we believe it marks a next generation of T-cell vaccines. PolyStart has unlimited application in oncology and infectious diseases not only within TapImmune’s own platforms but it can be applied to many others via licensing. As we move forward in Phase 2 trials for TPIV 200, which targets folate receptor alpha, and TPIV 100/110 our Her2/neu product, we fully expect to develop PolyStart as both a stand-alone therapy and as a ‘boost strategy’ to be used synergistically with our peptide-based vaccines for breast and ovarian cancer.”
Along with novel peptides and the PolyStart expression system, the TPIV vaccine platform can address multiple infectious diseases as well as pandemic and biodefense threats. TapImmune’s current Smallpox vaccine study at Mayo Clinic has already shown significant benefits over the current vaccine stockpile. It is naturally processed and peptide based, making it safer, longer lasting, cheaper and as effective (in animal studies) as the current product stockpile. The last DHHS contract for a smallpox vaccine stockpile was worth up to $2.8 billion.
TapImmune (TPIV) is at the forefront of the immuno-oncology space and has world-class collaborative partners in AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic. The fact that the U.S. government has fully funded the Phase II trial of TPIV 200 for the treatment of triple-negative breast cancer validates the strong data obtained from the preceding Phase I trial. Additionally, the grant provides $13.3 million of non-dilutive funding for TapImmune’s research.
Given that TapImmune has a healthy cash balance of $9.6 million (mrq) and is receiving some $13.3 million in non-dilutive grants from the U.S. government, the market cap of $36 million seems extremely low- especially given the company has four different Phase II trials on progress for what could be a game-changing vaccine in the fight against cancer.
Interview With TapImmune, Inc. (NASDAQ: TPIV) President And COO, Dr. John Bonfiglio (SmarterAnalyst- January, 2017)
TapImmune Developing Vaccines for Breast and Ovarian Cancer (Biosience Technology- December, 2016)
One Big Question: How close are we to a cancer vaccine? (NewAtlas- December, 2016)
Vaccine could prevent breast, ovarian, lung cancer (Fox News- February, 2017)