Research and Development

a. Pipeline

ⅰ. Development Pipeline

4 Development Pipeline

Indication and Feature   

1) DFP-10917
Indication
Relapsed/refractory acute myeloid leukemia
Feature   
Nucleoside analog delivered as a low-dose continuous infusion
2) DFP-14323
Indication
Lung cancer
Feature   
Low dose of Ubenimex (bestatin) with enhanced antitumor effect and improved immune function
3) DFP-17729
Indication
Solid tumors
Feature   
Alkalizing agent that suppresses cancer cell growth
4) DFP-11207
Indication
Solid tumors
Feature   
Improved 5-FU with antitumor activity but without thrombocytopenia
5) DFP-14927
Indication
Solid tumors
Feature   
Once weekly polymeric delivery of DFP-10917
6) DFP-10825
Indication
Peritoneal metastasis
Feature   
Nucleic acid drug designed to be effective with peritoneal administration

ⅱ. Status of Development Pipeline

the detail about 4 Development Pipeline

b. Licensing

ⅰ. Revenue Model

the detail about 4 Development Pipeline

ⅰ. Development Pipeline and Patent Protection

Status of patent acquisition of 4 Development Pipeline

ⅱ. Partnerships

ProductPartnerCountryContract RightsContract DateContract TypeContract Term
DFP-10917 Nippon Shinyaku, Co., Ltd. JPN Manufacturing and marketing March 24, 2017 Exclusive Upon Japan patent expiry or 15 years from first sales, whichever is later.
DFP-17729 Nippon Chemiphar Co., Ltd. JJPN Manufacturing and marketing March 26, 2020 Exclusive Upon termination of sales by Nippon Chemiphar or sub-licensee.

c. Presentations and Publications

DFP-10917

  • Conference
    American Society of Hematology 58th Annual Meeting & Exposition San Diego, CA /December 2016
    Title
    Phase I/II Study of DFP-10917 in Relapsed/Refractory AML Demonstrates Efficacy and Safety Profile Suitable for Phase III Study
    Presenter
    H. Kantarjian, E. Jabbour, G. Garcia-Manero, T. Kadia, C. Dinardo, N. Daver, G. Borthakur, N. Jain, J. Waukau, M. Kwari, F. Ravandi, B.Anderson, K. Iizuka, C. Jin, C. Zhang, W. Plunkett
  • Journal
    International of Oncology January 16, 2018
    Title
    Analysis of the prolonged infusion of DFP-10917, a deoxycytidine analog, as a therapeutic strategy for the treatment of human tumor xenografts in vivo.
    Author
    Kenzo Iizuka, Chun Zhang, Kokoro Eshima, Cheng Jin, Kiyoshi Eshima, Masakazu Fukushima
  • Journal
    Cancer. May 15;125(10):1665-1673, 2019
    Title
    Phase 1/2 study of DFP-10917 administered by continuous intravenous infusion in patients with recurrent or refractory acute myeloid leukemia
    Author
    Hagop M Kantarjian, Elias J Jabbour, Guillermo Garcia-Manero, Tapan M Kadia, Courtney D DiNardo, Naval G Daver, Gautam Borthakur, Nitin Jain, Jane B Waukau, Monica I Kwari, Farhad Ravandi, Barry D Anderson, Kenzo Iizuka, Cheng Jin, Chun Zhang, William K Plunkett

DFP-11207

  • Journal
    Drug Design, Development and Therapy 2017:11 1693.1705
    Title
    Development of new promising antimetabolite, DFP-11207 with self-controlled toxicity in rodents
    Author
    Masakazu Fukushima, Kenzo Iizuka, Cheng Jin, Chun Zhang, Mei Hong, Kiyoshi Eshima
  • Journal
    Invest New Drugs. Dec;38(6):1763-1773, 2020
    Title
    Phase I study of DFP-11207, a novel oral fluoropyrimidine with reasonable AUC and low C max and improved tolerability, in patients with solid tumors
    Author
    Jaffer A Ajani, Milind Javle, Cathy Eng, David Fogelman, Jackie Smith, Barry Anderson, Chun Zhang, Kenzo Iizuka

DFP-10825

  • Journal
    Adv Drug Deliv Rev. 154-155:27-36, 2020
    Title
    An RNAi therapeutic, DFP-10825, for intraperitoneal and intrapleural malignant cancers
    Author
    Hidenori Ando, Tatsuhiro Ishida
  • Journal
    Cancer Med. Dec;8(17):7313-7321, 2019
    Title
    A novel intraperitoneal therapy for gastric cancer with DFP-10825, a unique RNAi therapeutic targeting thymidylate synthase, in a peritoneally disseminated xenograft model
    Author
    Hidenori Ando, Masakazu Fukushima, Kiyoshi Eshima, Taichi Hasui, Taro Shimizu, Yu Ishima, Cheng-Long Huang, Hiromi Wada, Tatsuhiro Ishida
  • Journal
    Drug Des Devel Ther. Mar 29;12:673-683, 2018
    Title
    Anticancer activity of the intraperitoneal-delivered DFP-10825, the cationic liposome-conjugated RNAi molecule targeting thymidylate synthase, on peritoneal disseminated ovarian cancer xenograft model
    Author
    Kenzo Iizuka, Cheng Jin, Kokoro Eshima, Mei Hua Hong, Kiyoshi Eshima, Masakazu Fukushima

DFP-17729

  • Journal
    ANTICANCER RESEARCH 40:873-880 (2020)
    Title
    Effects of Alkalization Therapy on Chemotherapy Outcomes in Metastatic or Recurrent Pancreatic Cancer
    Author
    REO HAMAGUCHI, RYOKO NARUI and HIROMI WADA
  • Journal
    Biol Pharm Bull. 44(2):266-270, 2021
    Title
    Neutralization of Acidic Tumor Microenvironment (TME) with Daily Oral Dosing of Sodium Potassium Citrate (K/Na Citrate) Increases Therapeutic Effect of Anti-cancer Agent in Pancreatic Cancer Xenograft Mice Model
    Author
    Hidenori Ando, Kiyoshi Eshima, Tatsuhiro Ishida