Home Page: https://markertherapeutics.com/
Investors Relations: investor.relations@markertherapeutics.com
Billionaire Baker Brothers Quietly Back Marker Therapeutics (NASDAQ: MRKR)
The Baker Brothers, many of which believe have the Midas Touch in the biotech world, invested $5.4 million
October 31, 2018
https://emerginggrowth.com/billionaire-baker-brothers-quietly-back-marker-therapeutics-nasdaq-mrkr/
MARKER Therapeutics OVERVIEW
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company with the potential to significantly disrupt the current cell therapy landscape. The Company is developing a portfolio of non-genetically modified, multi-antigen T cell therapies, which are able to recognize and kill heterogeneous tumors more effectively than conventional single-antigen CAR-T/TCR approaches.
A MAJOR LEAP FORWARD IN CELL THERAPY
Marker Therapeutics, Inc is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. Once infused into patients, this population of T cells attacks multiple tumor targets and acts to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells, when compared to current engineered CAR-T and TCR-based approaches, its products (i) are significantly less expensive and easier to manufacture, (ii) appear to be markedly less toxic, and (iii) are associated with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.
Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of cancer and metastatic disease, including our Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and our HER2/neu+ peptide antigen program (TPIV100/110) in Phase II clinical trials. In parallel, we are developing a proprietary DNA expression technology named PolyStart™ to improve the ability of the cellular immune system to recognize and destroy diseased cells.
Marker believes that its therapy presents a promising innovation in immuno-oncology. Marker’s therapy has been developed through its collaboration with the Cell and Gene Therapy Center at BCM, founded by Malcolm K. Brenner, M.D., Ph.D., a recognized pioneer in immuno-oncology. Marker’s founders include Drs. Malcolm Brenner M.D., PhD, Ann Leen, PhD., Juan Vera, M.D., Helen Heslop, M.D., DSc (Hon) and Cliona Rooney, PhD, who have significant experience in this field.
Company Management:
https://markertherapeutics.com/company-management/
Pipeline
A leader in the oncology field, specializing in next-generation T-cell vaccines and novel immunotherapy platforms
TapImmune, Inc. (NASDAQ: TPIV) is a leader in the field of oncology, offering pioneering T-cell vaccines and novel immunotherapy platforms. The company's proprietary technologies have the potential to bolster the potency of DNA-based immunotherapies against cancer and infectious disease. TapImmune is focused on maximizing its growth potential and value through leveraging the broad range of its technology as well as through collaborative partnerships and license agreements.
In cancer patients, it is metastatic disease rather than the primary tumor that is the chief cause of death. This spreading of cancer to untreatable parts of the body is targeted by TapImmune's immunotherapies. TapImmune has surpassed earlier cancer vaccine approaches by offering immunotherapies that treat both tumors and metastatic diseases. The company is further differentiated by its approach of enlisting a patient's own immune system to fight the disease.
Investment Highlights
- Lead vaccine candidate is in four Phase 2 clinical studies
Collaborations include the Mayo Clinic, AstraZeneca and the Memorial Sloan Kettering Cancer Center
2 clinical stage T-cell vaccine candidates advancing in multiple Phase 2 and Phase 1b/2a clinical trials
Fast Track and Orphan Disease designations granted by the U.S. FDA
Significant non-dilutive funding from U.S. Department of Defense
Off-the-shelf products involve simple, low-cost manufacturing
Technology
Peptide Antigen Vaccines
TapImmune's unique immunotherapy technology platform unites pioneering and proprietary peptide antigen sets that are designed to invoke killer T-cell (CD8) and helper T-cell (CD4) immune responses against well-characterized molecular targets that correlate with disease prognosis.
TapImmune's T-cell cancer vaccines are targeted at specific surface proteins found on most target tumor cells. These vaccines consist of naturally processed antigens derived from human immune responses that are recognized by more than 85 percent of the population and include a combination of antigens displayed by MHC class I and II molecules. TapImmune is thereby enabled to direct a distinctively strong and durable anti-tumor immune response across a broader patient population.
This comprehensive approach to cancer immunotherapy greatly distinguishes TapImmune in the field of oncology. Others in the field are developing immune-modulating technologies that elicit CD4 T-cell responses only, CD8 T-cell responses only, or none at all.
TapImmune's next-generation vaccine technology has been created to address and potentially complement the deficiencies of other immuno-oncology approaches, such as adoptive T-cell therapies, immune checkpoint blockades, and monoclonal antibody therapies like Herceptin. Herceptin is only effective in about 15-20 percent of patients, can only be effectively used for one year, and merely slows the growth of cancer without addressing either T-cell response necessary to actively target and eliminate cancer cells. Nevertheless, Herceptin's sales exceeded $6.4 billion in 2015, which demonstrates the huge potential for TapImmune's more effective vaccine technology.
Proprietary Antigen Expression System
PolyStart™ is TapImmune's groundbreaking novel peptide expression system. This enabling technology is designed to make DNA-based immunotherapies more effective.
In comparison with existing antigen expression technologies, PolyStart is able to significantly enhance the visibility of a target antigen, thereby increasing the immune system's recognition of target cells and enhancing the efficiency with which target cells can be identified and eliminated. PolyStart has the potential to bolster the potency of any existing DNA vaccine, including vaccines that are currently on the market and those that are in development.
Currently in pre-clinical development, PolyStart is a unique plasmid DNA construct that expresses four or more peptides for each molecule of mRNA instead of the narrow one DNA = one RNA = one protein. TapImmune invented and fully owns this proprietary technology, which has applications in immuno-oncology as well as other areas like infectious disease. PolyStart can be applied to TapImmune's current T-cell vaccine candidates and can also drive incremental value for the company through strategic out-licensing and/or collaboration with other companies.
Pipeline
TapImmune's pipeline currently includes the following products in the following stages of development:
Preclinical:
- PolyStart Her2/neu Class I Antigens – Her2/neu Breast Cancer
FRA Class I and Class II Antigens – Triple Negative Breast/Ovarian
Phase II:
- TPIV 200 – Platinum-Resistant Ovarian Cancer – Collaboration with AstraZeneca and Memorial Sloan Kettering Cancer Center
TPIV 200 – Triple Negative Breast Cancer
TPIV 200 – Triple Negative Breast Cancer – Collaboration with Mayo Clinic and U.S. Department of Defense
TPIV 200 – Platinum-Sensitive Ovarian Cancer
TPIV 110 – Her2/neu Breast Cancer
TPIV 200
Developed by Dr. Keith Knutson at the Mayo Clinic, TPIV 200 is a new vaccine approach that is designed to activate both CD4+ and CD8+ (helper and killer) T-cell compartments. Recent immunology developments suggest that activation of both CD4+ and CD8+ is necessary to elicit a strong immune response against foreign antigens. Peptides administered to patients are designed to be presented to the immune system to activate T-cell against the target.
TPIV 200 Platinum-Sensitive Ovarian Cancer
Currently, ovarian cancer does not have a favorable prognosis; average relapse time is approximately 18 months. The standard of care is treatment with carbo cis platinum. Survival odds are better for patients who respond to therapy than for those who fail therapy or have platinum-resistant cancer. Use of TPIV 200 that targets an over-expressed receptor-folate receptor alpha may have a beneficial effect on these patients by training the immune system to help eradicate cells with this receptor. TPIV 200 is a shelf-stable, lyophilized blend of five short peptides and is reconstituted at the site prior to injection. Patients are currently receiving one dose per month for six months, and alternative dosing strategies are being explored.
TPIV 200 Triple Negative Breast Cancer
Treatments for breast cancer have advanced greatly over the last three decades. The development of monoclonal antibodies has given patients a crucial new tool in the fight for survival. Triple negative breast cancer patients continue to be one of the most difficult groups to treat, as these patients do not respond to hormone therapies (progesterone and estrogen) nor do they respond to immunotherapies like monoclonal antibodies. The sole defenses for these patients are currently surgery, radiation and chemotherapy, and once these treatments have been exhausted, few options are left. Patients with triple negative breast cancer over-express the folate receptor alpha protein on their cancer cells. TPIV 200 targets an over-expressed receptor-folate receptor alpha and may have a beneficial effect on these patients by training the immune system to help eradicate cells with this receptor. Patients are currently receiving one dose per month for six months.
Trial Results
TPIV 200 was shown to be safe and well-tolerated during the Phase 1 trial, which involved 22 patients with triple negative breast and ovarian cancers. The trial also showed that 16 out of 16 patients showed robust immune responses against all five peptides in the product and that the immune response was durable for well over six months following the last treatment.
TPIV 110
TPIV 110, TapImmune's investigational product, targets Her2/neu by stimulating the body's own immune system to attack cancer cells with the Her2/neu target. This new vaccine approach has been developed by Dr. Keith Knutson at the Mayo Clinic and is a shelf-stable, lyophilized product that contains five small peptides designed to activate both CD4+ and CD8+ T-cell compartments.
TPIV 110 Breast Cancer
One of the most prevalent and malevolent cancers a patient can face is breast cancer. The good news is many therapies have been developed to treat this devastating disease, particularly monoclonal antibodies that target a receptor called Her2/neu. These antibodies, including Herceptin and Parjeta, target the Her2/neu receptor and can be remarkably effective in controlling the disease. The bad news is a patient's tumor must have the Her2/neu receptor (~30 percent) and in addition have the receptor in high enough density to make the antibody effective (~18 percent of the 30 percent). The result is that a void is left for patients who have the receptor but are not eligible for antibody treatment, and these patients are left with only chemotherapy, radiation and surgery as treatment options.
TPIV 110 also targets Her2/neu by stimulating the body's own immune system to attack cancer cells with the Her2/neu target. Similar to TPIV 200, TPIV 110 offers a mix of antigens that have been chosen for binding to both MHC Class I and Class II. This blend of epitopes is expected to cover a substantially larger Her2/neu patient population than Herceptin (up to 90 percent compared to Herceptin's 15-20 percent) and remain effective for significantly longer. Published data further shows that TPIV 110 is five times more effective than Neuvax in killing Her2/neu cancer cells.
Trial Results
The Phase 1 trial in 22 breast cancer patients showed TPIV 100, a predecessor to TPIV 110, was safe and well-tolerated (TPIV 110 contains an additional peptide and has not been in humans yet). The trial further showed that 19 out of 20 patients showed robust T-cell responses to two antigens and that 15 out of 20 patients responded to all four antigens. These patients' immune responses were durable for months after their final treatments.
Development Plan
The Phase 1b/2a program for TPIV 110 is designed to examine the novel T-cell vaccine as both a standalone therapy and a combination therapy with other standard-of-care therapies and newer experimental therapies. TapImmune plans to initiate trials in breast cancer in 2017. The company's overall strategy is to obtain positive Phase 2 data and then seek a partnership or collaboration to fund the remainder of the commercialization for TPIV 110.
Partnership Status for TPIV 200, TPIV 100 and TPIV 110
While TapImmune is collaborating with the Mayo Clinic, AstraZeneca and Memorial Sloan Kettering Cancer Center and is receiving sponsorship from the Mayo Clinic and funding from the Department of Defense, there is no business arrangement in place for the development of TPIV 200. TPIV 110 has no collaborations at this time. TapImmune holds the exclusive global rights to TPIV 200, TPIV 100 and TPIV 110.
Leadership
Peter L. Hoang
President & Chief Executive Officer
Peter L. Hoang brings over twenty years of investment banking, venture capital, immuno-oncology and public company executive management experience to Marker Therapeutics, Inc., serving most recently as President & CEO of TapImmune Inc. (Nasdaq: TPIV), one of the predecessor companies that merged to form Marker Therapeutics. He has also served as Senior Vice President of Business Development & Strategy at Bellicum Pharmaceuticals (Nasdaq: BLCM). Previously, as the Managing Director of Innovations at The University of Texas MD Anderson Cancer Center, he headed the new venture formation and development effort for the institution. There, he led the commercialization of MD Anderson’s Sleeping Beauty transposon-based CAR-T program, resulting in the largest public company-to-academic research institution upfront deal in history. Before joining MD Anderson, Mr. Hoang was a Managing Director and head of healthcare mergers & acquisitions advisory for CIT Group (NYSE: CIT). He also served as a senior investment banker in the M&A departments at Oppenheimer, J.P. Morgan, Merrill Lynch, and Deutsche Bank. He earned an M.B.A. with high honors distinction from the Anderson School of Management at UCLA and a B.A. from Yale University.
Michael J. Loiacono
Chief Financial Officer & Chief Accounting Officer
Michael J. Loiacono has more than 25 years of financial management experience. At his previous company, FCTI, Inc., Mr. Loiacono was responsible for the company’s strategic development to include new products and services, new market penetration and maximizing gross and net revenues. In 2013, FCTI, Inc. acquired Global Axcess Corp, a publicly-traded company, where he served as CFO since 2006. At Global Axcess, Mr. Loiacono oversaw the overall financial strategy of the company, including capital raises, mergers & acquisitions, corporate finance, treasury, financial planning and analysis, accounting, investor relations, external auditing and was responsible for Global Axcess’ corporate strategy function. In 2009, Mr. Loiacono was named a Jacksonville, Florida Ultimate CFO of the year. Prior to FCTI/Global Axcess, Michael held various positions of increasing responsibility in finance management through several private and publicly-traded organizations.
Richard Kenney, MD, FACP
Acting Chief Medical Officer
Richard Kenney currently serves as President of ClinReg Biologics, LLC. Prior to this role, Dr. Kenney served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, where he established and led the clinical development of the company’s cancer prime-boost immunotherapeutics 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. 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.
Ann Leen, PhD
Chief Scientific Officer
Ann N. Leen is a distinguished immunologist who has dedicated over 15 years to the characterization of immunogenic viral antigens and identification of novel T cell epitopes, ultimately translating these findings into innovative T cell-based therapies. She has established herself as a leader in the field of virus-specific T cell therapy by extending the pioneering efforts of Drs. Helen E. Heslop, Malcolm K. Brenner and Cliona M. Rooney towards utilizing the natural capacity of T cells to target a range of clinically problematic viruses. Her research efforts, in collaboration with Drs. Heslop and Rooney, were also the first to demonstrate the feasibility of using virus-specific T cells as a third party, off-the-shelf product to treat drug refractory cytomegalovirus and adenovirus infections. Dr. Leen was awarded the Outstanding New Investigator Award from the American Society of Gene and Cell Therapy in 2013 and Best Abstract for Outstanding Clinical Research at the 2011 American Society of Bone Marrow Transplantation Annual Meeting. Dr. Leen holds a Ph.D. in Immunology from the CRC Institute for Cancer Studies in Birmingham, UK and a BSc in biochemistry from the University of College Cork in Ireland.
Juan Vera, MD
Chief Development Officer
For the past 12 years, Juan F. Vera has worked extensively on developing novel T cell therapies and optimizing manufacturing processes for clinical applications at the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine. In collaboration with Wilson Wolf Manufacturing, he has been instrumental in the design and testing of the G-Rex® cell culture platform and pioneered its use for the large-scale production of T cells. Dr. Vera has extensive expertise in developing and streamlining therapeutic candidates from the research bench to the cGMP facility while ensuring robust production and scalability. Dr. Vera has previously collaborated with Celgene and Bluebird Bio in developing novel CAR T cell therapies. He has also been the recipient of different prestigious awards including the Idea Development Award from the Department of Defense and Mentored Research Scholar Award from the American Cancer Society. Dr. Vera attained his M.D. from the University El Bosque in Bogota, Colombia.
Ken Moseley
General Counsel
Ken Moseley, J.D. has more than 25 years of experience as Corporate Counsel for companies in the cell and gene therapy space, including Bellicum Pharmaceuticals, Osiris Therapeutics, SyStemix and Applied Immune Sciences. Most recently he was Senior Vice President and General Counsel at Bellicum, where he served from 2011-2018. From 2009-2011, he was General Counsel at REPAIR Technologies, Inc., a private biotechnology company. Previously, he served as General Counsel at Cognate BioServices from 2002-2009. Prior to Cognate, he was Vice President of Business Development & Patents at Osiris Therapeutics and he served as the Director of Intellectual Property at SyStemix, a Novartis company. He also served as Director of Intellectual Property for Applied Immune Sciences, a Rhone-Poulenc Rorer company. Mr. Moseley is a registered patent attorney and a member of the California and Texas Bars. Mr. Moseley received a JD and a BS in Biophysical Chemistry from the University of Houston and a BA from Rice University
Gerald Garrett
Vice President, Clinical Operations
Gerald Garrett brings over 29 years of clinical development experience in the Biopharmaceutical industry to the team. Prior to joining Marker Therapeutics, Inc., he owned and operated a small Contract Research Organization focused on providing clinical and project management leadership to multi-functional project teams in a variety of therapeutic areas with a focus on Phase 1-2 oncology clinical trials. Mr. Garrett spent his early as a study coordinator, a CRA for Fujisawa and Burroughs Wellcome and led the development of the Project Management team at Clinimetrics, Inc.
Tsvetelina P. Hoang, PhD
Vice President, Research & Development
Tsvetelina P. Hoang brings over 15 years of experience in cancer immunotherapy, including antibody-based and adoptive cell therapies. Most recently, she was the Director of Translational Research at Bellicum Pharmaceuticals where she oversaw the pre-clinical development of the company’s T cell receptor (TCR) and chimeric antigen receptor (CAR)-engineered T cell therapy programs and the translation of those programs into the clinic. Previously, she was a member of the faculty at The University of Texas MD Anderson Cancer Center, investigating the molecular mechanisms of immune checkpoint inhibitors’ function. Dr. Hoang worked closely with Dr. James Allison, the 2018 Nobel Laureate in medicine and a renowned pioneer in the field of tumor immunotherapy, as a member of his team at University of California-Berkeley, Memorial Sloan-Kettering Cancer Center and MD Anderson Cancer Center. She earned her Ph.D. from Johns Hopkins University and holds a combined B.S./M.S. degree with distinction, magna cum laude, from Yale University. She was a recipient of a Cancer Research Institute fellowship and is a member of the Phi Beta Kappa honor society.
Shelia Sterr
Director of Human Resources & Finance
Shelia Sterr spent more than six years at Bellicum Pharmaceuticals, where she was one of their first employees. Additionally, Ms. Sterr spent 15 years with Texas Digital Systems in office management, HR, payroll and finance roles. Previously Ms. Sterr held HR and administrative positions at the Houston-based law firm Bracewell & Patterson and oil and gas company Paradigm Geophysical.
TapImmune Inc.
http://www.tapimmune.com
Contact Information
About Us
TapImmune Inc. is an immunotherapy company specializing in the development of innovative vaccine technologies for the treatment of cancer and infectious disease.
The Company’s vaccine compositions, peptide or nucleic acid-based, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients’ killer T-cells, helper T-cells and to restore or further augment antigen presentation by the modulation of TAP (Transporter associated with Antigen Processing).
The Company believes that its vaccine compositions may be used as stand-alone medications or in combination with current treatment modalities.
TapImmune is conducting clinical trials and R&D programs, to explore the promising commercial potential of our comprehensive approach to immunotherapy that stimulates Helper T-cells; Killer T-cells and enhances antigen presentation.
This all-encompassing approach makes TapImmune a leading innovator and world class immunotherapy company.
Our Vision
TapImmune’s technology has broad applications in developing therapeutic and preventative vaccines.
Our strategy is to build a patented proprietary and unique product pipeline to capitalize on the breadth of the technology platforms we have developed or own and through collaborative partnerships and license agreements.
To achieve success, TapImmune’s strategy for growth is to:
- Conduct preclinical immunotherapeutic programs and move successes through to human trials
Develop a pipeline of Best in Class technology platforms that combine to make the most comprehensive T-Cell Immunotherapeutic vaccines in development.
Discover, acquire and develop technologies that modulate antigen presentation
Commercialize proprietary products through corporate alliances
Develop business partnerships that enhance the efficacy of other immunotherapeutic and vaccine product
We welcome inquiries concerning potential partnering opportunities (licensing or research/development collaborations) associated with the treatment of oncology and non-oncology disease indications including infectious disease.
Management and Directors
Glynn Wilson, Ph.D.
Executive Chairman
Glynn brings an extensive background of success in corporate management and product development with tenures in both major multinational pharmaceutical companies and start-up pharmaceutical/biotech organizations. Dr. Wilson’s former positions include Head of Drug Delivery at SmithKline Beecham Pharmaceuticals, Research Area Head in Advanced Drug Delivery at Ciba-Geigy Pharmaceuticals, and President and co-founder of Auriga Pharmaceuticals. As Executive Vice President of R&D at Tacora Corporation he was responsible for merging the Company with Access Pharmaceuticals. He is a recognized leader in the development of drug delivery systems. Glynn has a Ph.D. in Biochemistry and conducted medical research at The Rockefeller University, New York. He has been on the Board of TapImmune for 5 years.
John Bonfiglio, Ph.D MBA
President & COO
John is a highly successful Biotech CEO with broad experience in corporate strategy and financing, market interactions and business development. He was most recently President and CEO of Oragenics where he refocused the company and raised over $29 million dollars in the public markets while positioning the company for a successful re-listing on the NYSE: MKT stock exchange. He was formerly President and CEO of Argos Therapeutics where he raised over $35 million dollars for the Company and led the company in a successful Phase 2 study in renal cell carcinoma. As President and CEO of the Immune Response Corporation he was responsible for turning the Company around through improved therapeutic focus, capital raising (over $50 million) and improved investor relations resulting in a significant increase in stock price and shareholder value. John was also President and CEO of Peregrine Pharmaceuticals and Director of Business Development at Baxter Healthcare Corporation’s Immunotherapy Division. John has a Ph.D from the University of California, San Diego, and an MBA from Pepperdine University.
Michael J. Loiacono
CFO
Mr. Loiacono has more than 25 years of financial management experience. At his previous company, FCTI, Inc., Michael was responsible for the company’s strategic development to include new products and services, new market penetration and maximizing gross and net revenues. In 2013, FCTI, Inc. acquired Global Axcess Corp, a publicly-traded company, where Michael served as CFO since 2006. At Global Axcess, Michael oversaw the overall financial strategy of the company, including capital raises, mergers & acquisitions, corporate finance, treasury, financial planning and analysis, accounting, investor relations, external auditing and was responsible for Global Axcess’ corporate strategy function. In 2009, Michael was named a Jacksonville Florida Ultimate CFO of the year. Prior to FCTI/Global Axcess, Michael held various positions of increasing responsibility in finance management through several private and publicly-traded organizations.
Robert Z. Florkiewicz Sr.
Director of Molecular Biology & Virology
Dr Florkiewicz has experience in both academic and biotechnology environments. Most recently he conducted research on human embryonic stem-cell based therapies at the University of Washington. He was the Director of Cellular and Molecular Biology and co-founder of Ciblex Corporation, a spin-out from his laboratory at the Scripps Institute, San Diego. He was a patent agent at Seed Intellectual Law Group in Seattle and at ID Biomedical where he managed the Company’s intellectual property portfolio prior to and through its acquisition by GlaxoSmithKline. He has a Ph.D. in Molecular and Development Biology from the University of Arizona (focusing on the molecular biology of various RNA viruses) and was a postdoctoral fellow at the Salk Institute (focusing on the intracellular trafficking of proteins encoded by vesicular stomatitis virus). As a Research Scientist at Synergen, Inc. he helped establish the viral vector and animal cell expression group, and also discovered novel molecular mechanisms modulating FGF2 gene expression.
Tapimmune Pipeline
Clinical Trials
Phase I: Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.
Data published at ASCO 2015. 20 out of 21 clinical trial subjects proved the drug to be safe, easily tolerated, and, remarkably, 100% had a successful immune response.
Phase I: Vaccine Therapy and Cyclophosphamide in Treating Patients With Stage II-III Breast or Stage II-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This phase I clinical trial studies the side effects of vaccine therapy and cyclophosphamide in treating patients with stage II-III breast cancer or stage II-IV ovarian, primary peritoneal or fallopian tube cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy and cyclophosphamide may kill more tumor cells.
Phase II: TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer
This is a Phase 2 clinical trial, which tests two investigational drugs: TPIV200/huFR-1 (also called TPIV200), which is a vaccine consisting of proteins from the folate receptor alpha mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help un-block parts of the immune system. The aim of this study is to find out whether these drugs, when given together are safe, and whether they are effective in treating cancer.
Phase II: Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).
Tapimmune Patents US Patent No. 6,361,770
Method of Enhancing Expression of MHC Class I Molecules Bearing Endogenous Peptides
A method of enhancing expression of MHC Class I molecules bearing endogenous peptides on the surface of a target cell expressing low or nondetectable levels of MHC Class I molecules and expressing low or nondetectable levels of TAP-1 and TAP-2 transporter proteins comprising: introducing into the target cell a nucleic acid molecule comprising a sequence encoding TAP-1 or TAP-2 under control of a suitable promoter; and expressing TAP-1 or TAP-2 in the target cell under suitable conditions, thereby enhancing processing and presentation of MHC Class I molecules bearing endogenous peptides.
US Patent No. 5,792,604
Method of Identifying MHC Class I Restricted Antigens Endogenously Processed by a Secretory Pathway
A method of identifying antigens which are capable of being endogenously processed by a cellular secretory pathway comprising: introducing an antigen into a donor cell lacking in MHC class I molecules, incubating in an in vitro medium the donor cells, primed cytotoxic T lymphocytes having specificity for the antigen, and target cells which express MHC class I molecules and are labelled with a detectable intracellular marker, under suitable conditions such that the donor cells remain intact, and measuring the amount of detectable marker released into the incubation medium. A method of assaying a medium for the presence of a substance that affects processing of an endogenously processed antigen in a cellular secretory pathway, and; a method of characterizing a tumor or viral antigen capable of being endogenously processed by a cellular secretory pathway.
US Patent No. 7,378,087
Method of enhancing an immune response
&
US Patent No. 7,994,146
Method of enhancing an immune response
A method of enhancing an immune response to an antigen is provided. The method involves augmenting the level of a TAP molecule in a target cell bearing the antigen. Preferably, the TAP molecules enhanced by administering a nucleic acid sequence encoding a TAP-1 and/or TAP-2 molecule. The method is useful in treating infectious diseases and cancer.
US Patent No. 7,976,850
Pox viridae treatment
A vaccine composition for combating Pox viridae viral infections in living organisms such as mammals (including humans) comprises TAP-1 and/or TAP-2 to augment the antigen processing capability of infected cells and hence their immunogenicity. The composition may be used alone or, preferably, as an immunogenicity-enhancing adjuvant with a pox antigen-based vaccine, especially in the treatment or prophylaxis of viral infections such as smallpox.
Video Interview w/ Glynn Wilson on company updataes (Dated 9/16/2016): Click Here
Q & A w/ John Bonfiglio on uplisting, current & future trials (Dated 9/22/2016): Click Here
Innovative Immunotherapies in Oncology and Infectious Diseases
TapImmune Inc. ("TapImmune" "TPIV") is a biotechnology company specializing in the development of innovative therapeutics and vaccines in the areas of oncology and infectious disease. TPIV technologies are based on an understanding of the function of a protein known as TAP. Transporters Associated with Antigen Processing (TAP) are proteins responsible for supplying tumor-associated antigens (markers) and viral antigens to the surface of infected cells.
These markers are required for the effective recognition and destruction of cancer cells and virus infected cells by the immune system. A wide variety of metastatic cancers evade destruction by the immune system due to absent or insufficient amounts of TAP, making the tumors unrecognizable.
TPIV's lead product, the TAP vaccine performs a key step in moving characteristic markers called antigens to the surfaces of cells allowing the recognition and killing of cancer cells by the immune system. Without TAP, there are no cancer markers, so the immune system fails to spot the rogue cells and the cancerous cells can grow undetected.
Clinical studies to date have identified a large number of cancers deficient in TAP including but not limited to HPV related cancers such as melanoma, lung, prostate, breast and ovarian cancer. TapImmune believes these tumors would be responsive to the TAP therapeutic vaccine. In preclinical trials for melanoma and lung carcinoma, animal survival rates of 70% were achieved using TAP vaccine therapy and 100% survival when TAP was administered ex-vivo.
TPIV's vaccine has shown effective restoration of TAP and the TAP molecule also works as an adjuvant or to enhance targeted vaccines against infectious diseases. Including TAP in the much studied Smallpox Vaccine, its potency was increased by 100-1000 times. TPIV is currently developing models for the application of this technology for some of the most important societal pathogens.
This is a new paradigm in the treatment of infectious disease and could significantly advance the development of new vaccines as well as improve those that already exist.
Seattle-based biotechnology innovator TapImmune Inc. is on to something big, very big. The company has engineered a remarkable, yet elegantly simple, way for the body to recognize tumour and infectious disease cells and provoke an aggressive immune response whereby the body's own killer T-Cells attack and eradicate harmful foreign bodies. This with respect to any form of cancer or disease via a technology that's entirely non-discriminate in helping the body eradicate dangerous cells of many kinds.
Underscoring the vast potential of TapImmune's approach is its exclusive licensing option agreement with the Mayo Clinic for a breast cancer antigen technology complementary to the company's TAP (AdhTAP) protocol. In a novel approach, TapImmune and the Mayo Clinic will co-develop a specialized vaccine for patients with very aggressive HER2/neu breast cancer. What's unique is that TapImmune's technology actually re-activates the body's own immune system, triggering mission-critical self-curative mechanisms that would otherwise not function properly.
"We chose to work with the Mayo Clinic because they have great clinical expertise in breast cancer, and we're focusing specifically on HER2/neu breast cancer because we found complementary technology with Mayo that will work with TAP and address the problems found with earlier approaches," explains Dr. Glynn Wilson, chairman and CEO of TapImmune. "Importantly, we're able to work with a leading expert on breast cancer vaccines, Dr Keith Knutson of the Mayo Clinic, who will conduct the trials. Through these trials, we'll also address a huge clinical need for patients who express low to moderate levels of HER2/neu and are not candidates for treatment with Herceptin(R) (trastuzumab), an intravenously delivered monoclonal antibody."
How it Works
Simply put, TAP (transporters associated with antigen processing) plays a major role in the complex human immune system. When foreign bodies (viruses and disease) attack cells in the body, the normal response is for killer T-cells to find those invaders and destroy them. TAP is a transporter that helps trigger an immune response by providing a pathway for tumour antigens to be expressed on the surface of the cell. In most solid cancers TAP levels are greatly reduced, which prevents the antigen presentation required to stimulate T-cells into action.
In the treatment of cancer, TAP is analogous to turning on the light bulb on the surface of tumour cells, allowing immune cells to "see" them and inspire action accordingly. For infectious disease treatment, TAP turns the light bulb to a higher intensity to prompt more immune cells to act.
TAP potentially allows the immune system to see everything that's foreign on the surface, in contrast to other approaches that simply focus on a single tumour antigen to try and raise an immune response. Indeed, TapImmune's technology is entirely unique in that it isn't dependent on genetics such as other immunotherapies and doesn't directly target the tumour cells, but instead assists the body's own immune system to do what it was designed to do by turning the TAP back on and activating destroyer T-Cells into "kill" mode.
TAP and Breast Cancer
Wilson says with any vaccine, there are two requirements needed to create a good immune response: 1) stimulate the cytotoxic lymphocyte (Class 1 pathway) and 2) stimulate the pathway that stimulates the T helper cells (Class 2 pathway), which gives a long-lasting immune response. The failure to satisfy both of these requirements is one of the reasons other breast cancer vaccines haven't progressed.
For breast cancer, we are developing a unique multicomponent vaccine that stimulates the Class 2 pathway (CD4 - helper cells) for a prolonged immune response and the Class 1 pathway (CD8 - cytotoxic T cells) to activate killer T-cells that will infiltrate and destroy tumour cells. The HER2/neu vaccines that had been tested in the past either do not stimulate sufficient cytotoxic T-cell response on the Class 1 pathway or they do not give a long-lasting effect. I realized that we have the capability here with the Mayo technology plus TAP of creating good responses on both sides of the immune system required for a good vaccine. It is a very innovative, creative and exciting approach."
In the overall vision of the use of cancer vaccines, the ultimate goal is to have vaccines that can be used prophylactically at the earliest detection of pre-cancerous conditions such as DCIS, Corin continues. It is thought that the more advanced the cancer, the lower the TAP levels will be. TAP may be applicable to all stages of cancer if we consider experiments that treated smallpox, augmenting the normal levels of TAP and making a smallpox vaccine fully 100 to 1000-fold more potent.
The Science
The immune system distinguishes normal and cancerous (or virus-infected) cells by monitoring major histocompatibility complex (MHC) Class 1, a molecule on the cell's surface. Nearly all cell types display MHC Class 1 antigen on their surface, continually providing information to the immune system. The MHC molecule, which contains small protein fragments (peptides), cycles to the surface of the cell to present foreign antigens to the cellular immune system, thereby activating the cytotoxic T-cells to kill virus-infected or cancerous cells.
In many cancers, there is a disruption in the process and the MHC on the cell surface is missing the tumour antigen peptides that identify the cell as being cancerous. They are basically hidden from the immune system and grow into tumours that eventually kill the person. Because TAP is affected negatively in the disease process, TapImmune's vaccine technology turns TAP back on, supplying peptides to the MHC Class 1 molecule. TAP facilitates the binding of foreign peptides to the MHC Class 1 molecule. TAP facilitates the binding of foreign peptides to the MHC Class 1 complex, displaying them on the cell's surface. Cytotoxic T-cells recognize them as foreign and ultimately neutralize and destroy abnormal cells.
Clinical studies on melanoma when examining primary and metastatic (spreading) tumours show a clear and significant correlation between TAP expression and survival.
The History and Future of TAP Technology
TapImmune was formed in Vancouver, British Columbia, in the laboratories of immunologist Wilfred Jeffries, who with his colleagues produced exciting data showing that administration of TAP to replace deficient levels in tumours or augment natural levels in viral disease had significant therapeutic effects in animal models.
TapImmune principals acquired the technology and intellectual property outright from the university and set out to put together a board of directors and advisory board that understands the technology and its potential and to partner with credible collaborators like the Mayo Clinic and Aeras Global TB Vaccine Foundation, an organization largely funded by the Gates Foundation.
In discussions with Aeras Global TB Vaccine Foundation, we identified the potential of TAP for use in the joint development of their next-generation TB vaccine, said Denis Corin, TapImmune's president and CFO. But you could also look at influenza, SARS, HIV, H1N1 and many other societal pathogens. We're also working with Dr Poland and the Mayo Clinic on a new small pox vaccine. But, small pox is the tip of the iceberg. There are a number of nasty viruses that are potential bioterrorism threats and governments around the world could stockpile our TAP vaccine and call on it in the event of a bioterrorist threat.
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