Combining immunomodulators with cancer vaccines

IRX Therapeutics announces cancer vaccine collaboration with Japan’s National Cancer Research Center

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NEW YORK—In late April, IRX Therapeutics, a developer of novel immunomodulators to treat cancer and viral diseases, announced that it has been selected to become a strategic partner with Japan's National Cancer Research Center (NCRC) to evaluate next-generation peptide-based cancer vaccines.  

Clinical research will be conducted in this phase in Japan. IRX Therapeutics will provide its proprietary IRX-2 immunomodulatory regimen, clinical trial design and technical support.  

This is the first collaboration of its kind between the NCRC and a U.S.-based biotechnology firm. The NCRC is analogous to the U.S. National Cancer Institute, says John W. Hadden II, president and CEO of IRX Therapeutics.

According to individuals familiar with the partnership, NCRC performed a rigorous, global search and evaluation of immunomodulators with high potential to enhance immune responses to a Wilms' tumor gene (WT1) peptide-based cancer vaccine. WT1 is expressed at high levels in hematologic malignancies and also in various types of solid tumors.  

IRX Therapeutics' IRX-2, a cell-derived biologic that has been shown experimentally to be a broad spectrum and potent activator of immune cells, was selected for use in clinical trials to be conducted by NCRC. IRX-2 has demonstrated that it has the potential to restore dendritic cell function and activate T cells upon vaccination, a combination of mechanisms showing unique promise. Phase I and Phase II clinical studies of IRX-2 in head and neck squamous cell carcinoma patients have been completed in the United States.

IRX-2 previously received fast-track designation by the U.S. Food and Drug Administration.

"The combination of restoring cells that improve immune function married to an activation on T cells is the key to IRX-2," says Hadden. "There are 20 academic research hospitals in the Tokyo area, and we expect that our partners will use them to quickly recruit volunteers for the study. Immunomodulators are really quite important in this stage of cancer research, and we are excited that our partners are thinking in this direction about how they would approach future vaccine development."

The NCRC will run proof-of-concept clinical trial programs on at least two cancer indications. The programs will include a Phase I proof-of-concept trial and Phase II confirmation trials. All programs will utilize state-of-the-art cancer vaccine trial designs and rigorous immune monitoring for biomarker data collection. The NCRC will recruit the study participants and conduct the trials, and IRX will provide technical support in trial development and support in immune monitoring. IRX representatives have been and will continue to travel between the two countries to support the work.

Representatives of the NCRC declined to comment for this story, saying the organization does not comment on collaborations such as this one until clinical trials are well underway, or have produced results.

Hadden says the research will target two types of solid tumors, but will not elaborate on the exact type of tumors. Company publications, though, indicate that IRX -2 has been used on head and neck tumors in previous trials.

"This collaboration is one of the most significant milestones achieved in the development of IRX-2, and we look forward to working with the NCRC on these important clinical programs," says Hadden. "There is increasing data demonstrating that therapeutic cancer vaccines can activate the immune system in cancer patients and mediate useful clinical activity. The NCRC conducted a very rigorous, global review to find a collaborator for these proof-of-concept programs. We're pleased that review resulted in this collaboration with us."

"Early trials have already demonstrated that specific immune responses can be optimized by rationally designed combination therapies, and more studies will help realize the full potential of these types of treatment for cancer patients," says Dr. Neil L. Berinstein, chief scientific officer of IRX Therapeutics. "Combining immunomodulators with cancer vaccines clearly has the potential to provide significant benefits to cancer patients, and these and other studies will help determine that potential."

Hadden says success with these trials could easily become broadly applicable.

"In concept," he says, " U.S. patients could become part of these trials of IRX-2. If this were to become a viable drug candidate going forward, it could be targeted at two or three very large markets quickly. We also see a great deal of potential for this approach to be broadly applicable to perhaps other cancers and diseases.

"We're at a really interesting point in the development of these potential drug candidates," Hadden concludes. "Immunomodulators are clearly a new therapeutic class with multiple mechanisms. The NCRC is making a major push to be an innovator in this space. We're impressed by the size and scope of their ambition and focus."

The NCRC was established in 1962 with the objective to form the ideal cancer center in Tokyo that would serve as the nucleus for national cancer measures, including the development of innovative therapeutics. It is operated by the Ministry of Health, Labour and Welfare and the central institute for comprehensive strategy for cancer control in Japan. Approximately 1,000 patients, including new and follow-up patients, visit the NCRC central hospital daily. The facility has 600 inpatient beds. It is one of the biggest clinical trial centers and concentrates its efforts on developing innovative therapies, including cancer vaccines.

IRX Therapeutics is a privately held biopharmaceutical company dedicated to the discovery and development of therapies for the treatment of cancer and viral diseases. The company's product platform under development seeks to restore an effective cellular immune response for the treatment of advanced cancers and viral diseases by correcting both dendritic cell and T cell defects. The company is now preparing to launch a pivotal global Phase III clinical trial for IRX-2, named the INSPIRE trial.

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