Press Release
November 4, 2015

GreenPeptide Receives Clearance from FDA to Proceed with Phase 1Clinical Trial for Its Therapeutic Cancer Vaccine GRN‐1201
GreenPeptide Co., Ltd. (TSE Mothers Code: 4594), a clinical‐stage
biopharmaceutical company focused on development of novel cancer
immunotherapies, today announced that its Investigational New Drug (IND)
application for a Phase 1 clinical study with a therapeutic cancer vaccine GRN‐
1201 has been cleared by the United States Food and Drug Administration (FDA).
GRN‐1201 will be tested in patient with melanoma.
The GRN‐1201 cancer vaccine is a combination of four HLA‐A*02 restricted
peptides derived from four separate tumor associated antigens presented incancer cells and required by cancer cells to grow and survive.
Assuming future out‐license to multi‐national pharmaceutical companies, thePhase 1 study will be conducted as GRN‐1201 monotherapy in patients withmalignant melanoma as an initial indication, followed by clinical trials incombination with other cancer immunotherapies, especially with immune
checkpoint inhibitors, and for additional indications in the future.
Food and Drug Administration (FDA): The FDA is an agency within the U.S. Department of Health andHuman 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 medicaldevices. FDA is also responsible for regulatory approval of drugs to be sold in the U.S. market, and regulates
its development process and approvals.
Investigation 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 candidate drug is provided, and it explains why the drug may beefficacious and safe to be tested in human. After submission of an IND, the FDA carries out an examinationin order to ensure the safety and human rights of study participants, and FDA is required to complete thisprocess within 30 days.
Human Leukocyte Antigen (HLA): HLA is a protein that plays important roles in immune function, and isexpressed on the surfaces of most cells in the human body. It is also termed the “major histocompatibilitycomplex”.
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 form that donot match.

Malignant melanoma: Malignant melanoma is a potentially serious type of skin cancer. The 5‐year survival
rate is 16.1% particularly for advanced malignant melanoma that has spread to other parts of the body
(SEER 2004‐2010 and SEER Summary Stage 2000). In 2014, it’s estimated 76,100 new cases diagnosed ofand 9,710 deaths from melanoma in the U.S. Remarkable progress has been achieved in cancer
immunotherapy for melanoma after the approval of immune checkpoint inhibitor antibody ipilimumab in
2011, followed by those of pembrolizmab and nivolumab in 2014.

Type of Cancer

New Cases
2014, US

1. Prostate Cancer
2. Breast Cancer (for Woman)
3. Lung/bronchial Cancer
4. Colorectal Cancer
5. Melanoma Skin Cancer
6. Bladder Cancer
7. Non‐hodgkin Lymphoma
8. Cancers in the pelvis (the liver, the kidney)
9. Thyroid Cancer
10. Cervical Cancer
Source: National Cancer Institute 2014

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

233,000
232,670
224,210
136,830
76,10074,69070,80063,92062,98052,630Deaths 2014,US
29,48040,000159,260
50,3109,710
15,58018,99013,8601,890
8,590