GreenPeptide Announces Filing of Investigational New Drug for a Phase 1 Clinical Trial of a Novel Cancer Peptide Vaccine GRN-1201

GreenPeptide Co., Ltd. (TSE Mothers Code:4594), a clinical-stage biopharmaceutical company focused on development of novel cancer immunotherapies, today announced the filing of Investigational New Drug (IND) to the United States Food and Drug Administration (FDA) to conduct a Phase 1 study of GRN-1201 for the treatment of melanoma.

The GRN-1201 cancer vaccine is a combination of four HLA-A*02 restricted peptides derived from four separate tumor associated antigens presented in cancer cells and required by cancer cells to grow and survive. Assuming future out-license to multi-national pharmaceutical companies, pre-clinical study was conducted in the US and clinical trial materials were manufactured in Europe, and a Phase 1 clinical trial will be conducted in the US after the clearance by the FDA.

The Phase 1 study will be conducted as GRN-1201 monotherapy in patients with melanoma as an initial indication, followed by clinical trials in combination with other cancer immunotherapies, especially with immune checkpoint inhibitors, and for additional indications in the future.

GreenPeptide has achieved the IND filing to the US FDA in 15 months since the start of candidate peptide selection, and intends to continue the clinical development with speed.

【EXPLANATION OF TERMS】
Food and Drug Administration (FDA): The FDA is an agency within the U.S. Department of Health and Human Services. FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. FDA is also responsible for regulatory approval of drugs to be sold in the U.S. market, and regulates its development process and approvals.

Investigational New Drug (IND) filing: The IND is the means through which the sponsor technically obtains the exemption from the FDA to run clinical studies in the U.S.A. IND is a document package in which information on safety and quality data of a candidate drug is provided, and it explains why the drug may be efficacious and safe to be tested in human. After submission of an IND, the FDA carries out an examination in order to ensure the safety and human rights of study participants, and FDA is required to complete this process within 30 days. If no notifications pointing out issues with the application are received from the FDA, the clinical studies can be initiated.

Human Leukocyte Antigen (HLA): HLA is a protein that plays important roles in immune function, and is expressed on the surfaces of most cells in the human body. It is also termed the "major histocompatibility complex", and is involved in removal of pathogens such as bacteria and viruses, elimination of cancer cells, and the rejection response associated with organ transplantation.
HLA is expressed even on the surfaces of cancer cells, and the mechanism of action of anti-cancer vaccines involves breakdown of cancer antigen proteins inside cancer cells, binding with the peptides formed, and transfer to the cell surfaces, so that the cells are recognized as cancer cells by cytotoxic T-lymphocytes, which attack cancer cells. HLA is a self/other recognition marker, enabling one's own body to be distinguished from other entities, and, as there is very great variety in the "other", it occurs in extremely diverse forms enabling them all to be distinguished from the "self". Peptides bind with specific forms of HLA, and do not bind with forms that do not match.

Malignant melanoma: This is a highly malignant type of cancer that develops on the skin. Melanocytes are the cells in skin that produce melanin, which is the pigment linked to dark skin coloration, and malignant melanoma is thought to be a tumor formed by these cells or by the cells in moles.

Contact: Teruhiko Sakai
　　　　CFO and Head of Business Administration
TEL: +81-3-5840-7697
E-mail: irpr@green-peptide.co.jp