Our current developmental pipeline includes two candidate products: the first, ITK-1, is an HLA-A24-restricted cancer peptide vaccine and is currently at the clinical trial stage. The other, GRN-1201 is also a cancer peptide vaccine restricted to HLA-A2 targeting the global market, and its preparation for Phase I study in the US is under way. We have also undertaken the discovery of new drug candidates in collaboration with research institutes and pharmaceutical companies.

Development pipeline

A phase III clinical trial of ITK-1 is under way. We have filed Investigational New Drug (IND) application of GRN-1201 with the United States Food and Drug Administration (FDA) in October, 2015. Now a Phase I study in patients with malignant melanoma in the US has started, patients are being recruited.

ITK-1 for prostate cancer
  1. Out-licensed to FUJIFILM Corporation.
GRN-1201 for solid cancer tumors
  1. Under development in the US
Drug discovery research

We are currently undertaking research to discover novel cancer immunotherapeutic candidates. Our efforts include further therapeutic application of tumor-associated antigen peptides that succeeded from the Kurume University (therapeutic drug seeds other than those used for ITK-1 and GRN-1201) to different formats. Our primary goal is to develop new drugs and therapies using a combination of the patented tumor-associated antigens and other technologies to activate/control immune cells to help their activity against cancer. We will continue to develop new research seeds focusing on those relevant to cancer immunotherapy through in-house research as well as R&D collaboration with other institutes and licensing-in from outside parties.

ITK-1 for prostate cancer

  1. Personalized antigen peptide vaccination
  2. A phase III study is underway in Japanese patients with prostate cancer.
  3. Out-licensed to FUJIFILM Corporation.

Our lead candidate product, ITK-1, a cancer peptide vaccine, was out-licensed to FUJIFILM Corporation. A phase III double-blind placebo-controlled trial was initiated in Japan in June 2013.
This clinical study is being conducted in multiple centers across Japan in patients with advanced castration-resistant prostate cancer who failed the conventional cancer therapies such as surgery, radiotherapy, hormone therapy, and/or chemotherapy prior to entry the clinical trial.

ITK-1 is a personalized cancer peptide vaccine. Optimal antigen peptides will be selected for individual patients from a set of 12 tumor-associated antigen peptides based on the results of immunity test using peripheral blood samples obtained from the patients prior to vaccination. Selected peptides will be administered as a cancer vaccine. Therefore, prior to vaccination, patients are tested for pre-existing immune responses (i.e., immune memory; pre-exposure to the certain cancer derived antigens and experiences to attack on cancer cells using the peptides as markers) using our originally developed biomarker assay. Patients are vaccinated only with peptides with positive test results or immune memory. This procedure is based on the fundamental concept that boosting memory cells (induction of secondary immune responses) can induce stronger and more rapid immune responses, resulting in better clinical effects. One of the challenging aspects of developing cancer peptide vaccines is a time lag from the translation of immune and antitumor response into a survival effect. We are trying to overcome this problem by selecting vaccine peptides based on immune reactivity using the biomarker assay prior to the administration of peptides to induce secondary immune response in a more effective manner.

Our vaccine candidate products involve multiple peptide antigens. In order to evade attack from the host immune system, cancer cells can decrease or stop the production of the target molecule for the vaccine by altering their expression of the relevant gene. This phenomenon is called “escape phenomenon” or “tumor escape.” Single-peptide vaccines are more likely to lose their anti-tumor activity soon after they exert their effect because of gene mutations of the cancer cells. In contrast, multiple-peptide vaccines are more likely to prevent cancer cells from utilizing the escape phenomenon because cancer genes cannot develop mutations against multiple peptides as rapidly as they do against a single peptide.

GRN-1201 for solid cancers

  1. Cancer peptide vaccine for the global market
  2. Phase I trial ongoing in the US

Cancer peptide vaccine for the global market
Preparation to initiate phase I trial in the US
GRN-1201, a candidate product following ITK-1, is a cancer peptide vaccine comprising a set of peptides compatible to HLA phenotypes common in Caucasians. This vaccine is expected to be marketed globally, including in the US and the EU. We have filed Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) in October, 2015. Now a phase I clinical trial has started in patients with malignant melanoma in the US, as the first proposed indication for treatment with GRN-1201.