Welcome!

News Feed Item

TapImmune Releases Positive Interim Data on Phase I Clinical Trial in HER2/neu+ Breast Cancer

TapImmune Inc. (OTCQB:TPIVD) is pleased to report that analysis of the interim data from the first set of patients in a Phase I clinical trial show that each of the patients have raised specific T-cell immune responses against a set of naturally processed HER2/neu Class II antigenic epitopes. The Phase I trial is being carried at the Mayo Clinic, Rochester, MN.

Importantly, this immune response data supports our contention that immune responses to our proprietary Class II antigens should be found in up to 84% of the patient population, making this potentially applicable to a much wider spectrum of patients when compared to other HER2/neu therapies; for example, Roche’s Herceptin®. Herceptin, a $6+B per year drug (2013) and the current standard of care for this patient population treats less than 20% of the HER2/neu+ breast cancer patient population, leaving a very large market opportunity for a TapImmune vaccine approach.

Glynn Wilson, TapImmune CEO said, “This is the second positive endpoint in the on-going study and when taken together, the promising data currently presented along with the earlier reported interim safety analysis are tremendously encouraging and provides a clear scientific rationale for progressing to a Phase II Clinical Study.” Moreover, Dr. Wilson stated that “The success in the current Clinical Trial supports the Company’s three pronged therapeutic approach augmenting the ability of Class I killer T-cells to kill by enhancing the biological activity of relevant Class II T-helper cells along with augmenting the fundamentals of antigen presentation, making this one of the most comprehensive therapeutic vaccines in clinical development. ”

Dr. Keith Knutson, Director Cancer Vaccines and Immune Therapies Program, Vaccine & Gene Therapy Institute of Florida, this trial’s Principal Investigator, further commented that “The finding of specific immune responses in all patients has confirmed expectations that our approach is well reasoned, capable of reaching a broad population of breast cancer patients and is amenable to other HER2/neu indications such as colorectal and ovarian cancers. We are extremely pleased with the results thus far and expect to advance these studies to a Phase II Clinical Study in the near future.”

Earlier the company had reported that the first endpoint to demonstrate safety on these patients was met.

In the current analysis of the first six patients, immune responses were stimulated against the HER2/neu antigens corresponding to T-cell epitopes mapping directly to both external and internal domains of the HER2/neu protein. Five patients showed immune responses against all four epitopes while one patient had immune responses to 3 epitopes. The use of these epitopes, discovered by Dr. Keith Knutson as naturally processed subdominant epitopes from breast cancer patient samples, illustrates an important focus of our vaccine development strategy, namely, to identify and amplify naturally occurring patient immune responses to cancer antigens.

Ultimately, TapImmune’s therapeutic approach is designed to stimulate a long-lived Killer T-cell (CD8+, Class 1 HLA) mediated immune response resulting from the concomitant stimulation of one or more Helper T-Cell (CD4+ Class 2 HLA) responses. In contrast, Herceptin®, a monoclonal antibody directed to an external domain only of the HER2/neu protein, is not designed or intended to stimulate a Killer T-cell response. Furthermore, we believe that the use of TapImmune’s candidate HER2/neu vaccine composition(s) could be expanded to include indications where there is a large market opportunity and unmet need, such as ovarian and colorectal cancers.

TapImmune is sponsoring this Phase I study and has an Exclusive Option to License the antigen technology at the end of Phase I. These studies are being conducted in breast cancer patients who have finished standard Herceptin®-based therapy and are at a high risk of disease recurrence.

About TapImmune Inc.

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. Please visit the Company’s website at www.tapimmune.com for details.

Forward-Looking Statement Disclaimer: This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
The financial services market is one of the most data-driven industries in the world, yet it’s bogged down by legacy CPU technologies that simply can’t keep up with the task of querying and visualizing billions of records. In his session at 20th Cloud Expo, Jared Parker, Director of Financial Services at Kinetica, will discuss how the advent of advanced in-database analytics on the GPU makes it possible to run sophisticated data science workloads on the same database that is housing the rich inf...
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
Things are changing so quickly in IoT that it would take a wizard to predict which ecosystem will gain the most traction. In order for IoT to reach its potential, smart devices must be able to work together. Today, there are a slew of interoperability standards being promoted by big names to make this happen: HomeKit, Brillo and Alljoyn. In his session at @ThingsExpo, Adam Justice, vice president and general manager of Grid Connect, will review what happens when smart devices don’t work togethe...
SYS-CON Events announced today that Ocean9will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldw...
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle.
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, will posit that disruption is inevitable for c...
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...