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KDDF-201406-09 Phase I study of a novel therapeutic antibody, DNP001 in acute leukemia(Oncology, Protein) [10.01.2014]

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Development and Market Objectives

Our goal is to complete phase I testing for DNP001, an antibody therapeutic targeting an acute leukemia-specific antigen called JL1 and to obtain IND approval for phase 2, followed by scale-up production. An additional global clinical phase 2 trial is expected to be undertaken in the future.

Unmet Medical Need & Target Patients

Target patients
JL1-positive acute leukemia patients and myelodysplastic syndrome (MDS) patients

Unmet Medical Needs
● Adult patients with ALL and AML have a long term disease-free survival rate of only 30-40%, and 20-30%, respectively, even with chemotherapy and bone-marrow transplantation. Of particular note, the 5-year survival rate for patients over 65 years of age in the AML patient group remains below 10%, and has not improved for decades (Lancet 2013;381:484-495).
● The primary reasons for the prevailing unsuccessful treatment of acute leukemia are due to recurrence of the disease, and the side effects of chemotherapy and bone-marrow transplantation, which contribute to a high mortality. Bone-marrow transplantation in particular is only attempted for leukemia patients that cannot be treated with chemotherapy. However, for high-risk AML and ALL, patients only survive long term and disease-free at rates of 20-30% and 30-40%, respectively, even after bone-marrow transplantation (Bone Marrow Transplant. 2005, 36_1021).
● To increase the long term survival rate and number of effective treatments for acute leukemia, we need to develop a curative alternative to bone-marrow transplantation and develop therapeutics that can reduce toxicity and retain remission. Novel therapies to overcome multidrug resistance without increasing toxicity are also needed, as well as techniques that can effectively destroy minimal residual disease with a high risk of recurrence and effective medicines for relapsed patients.

Status

Clinical phase 1 testing for DNP001, a new antibody treatment for acute leukemia, is currently in progress at Seoul Asan Hospital in KOREA and is expected to be completed by the end of 2015.

Intellectual Property

•28 patent registrations approved, 4 applications under examination
•Registered Countries: South Korea, United States of America, Japan, Australia, Mexico, Singapore, Canada, Europe, Germany, Indonesia, Philippines, India
•Countries where application has been lodged and is under examination: Brazil, Israel, Vietnam 
•Title of Patent: Acute leukemia and lymphoma-specific CD43 epitope and use thereof.
•Patent Registration Number/ Registration Date
 
•USA, 7,622,560 / 2005.12.20
•USA, 8,426,555 / 2009.10.09
•USA, 8,753,636 / 2013.03.15
•KOREA, 10-0738401 / 2005.08.24 

Competitive Advantages

Epitope-specific antibody that selectively binds to leukemia cells, while leaving other cells unaffected.
FIH (First-in-Human) trial antibody with a novel target for acute leukemia
An ADCC-reinforced antibody via defucosylation
There is a market with high unmet needs and potential for sustainable growth

Indication

Oncology (Acute leukemia)

Research Period

Sep. 01, 2014 - Jul. 29, 2016

Company

DINONA INC.

Developmental Stage

Phase 1

Additional Information

Contact Information

Contact
Address Company Name: DINONA INC.
WebSite Homepage: http://www.dinonainc.com Contact Person: Sangsoon Yun
E-mail: skkucom@hanmail.net Contact: 82-2-578-0810 (ext.102)

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