Recent News

Onconova is Developing Novel Small Molecule Products
for Cancer Therapy and Radiation Protection

Recent News
Anticipated Milestone

Targeted therapy trial for certain MDS patients initiated by the NHLBI.

Phase II and proof of concept in Q4-2008.

First Combination therapy trial of ON 01910.Na and chemotherapeutics initiated at the Albert Einstein College of Medicine.

Advance of lead compound to full development leading to an IND submission in 2008.

Clinical Advisory Board expanded; new members Drs. Gale Eckhardt, David Parkinson and Mark Ratain join Chairman Dr. Jerome Groopman and Drs. Ross Donehower, James Holland and Stephen Nimer.

ON 013105 for Mantle Cell Lymphoma - IND in Q4-2008.

Dr. Francois Wilhelm, M.D, Ph.D appointed Chief Medical Officer.

Human testing in 2008 leading to expedited approval of Ex-RAD™ is expected. This program is developed under Animal Rule.

Ben Franklin Technology Partners to fund a new development compound ON 013105 for targeted therapy of Mantle Cell Lymphoma.

 

Mission:
Onconova Therapeutics Inc. will create novel solutions for oncology that unequivocally benefit patients, empower healthcare professionals, and provide significant value and satisfaction to customers and shareholders.

Clinical Strategy:
Onconova's lead anticancer compound, ON 01910.Na, is currently in advanced Phase I clinical trials at major medical centers in the U.S. and overseas. These trials are open to all advanced cancer patients. Multiple Phase II studies are anticipated shortly. The primary indications for Phase II trials will include difficult-to-treat and drug-resistant tumors. Both single agent and combination therapy indications are supported by the pre-clinical profile of this molecule. Data suggests that ON 01910.Na enhances the activity of other chemotherapeutic agents and ameliorates the overall toxicity of combination therapy. Ex-RAD™, the radiation protection drug, is being developed under the FDA accelerated approval pathway where the drug can be approved after Phase I safety trials supported by animal efficacy studies.

Current Alliances:
Currently, none of Onconova's technologies or products is encumbered in commercial alliances. We have developed strategic alliances with academic institutions and government agencies to develop our programs in collaboration with scientists of world-renown.

Intellectual Property:
More than 100 U.S. and International patents covering Onconova's compounds have been issued. An additional >100 patent applications are currently in process. These patents cover proprietary small molecule NCEs directed to novel molecular targets including kinases.

Commercialization Strategy:
Onconova’s competence spans the early stages of drug discovery and development, from medicinal chemistry to early stage clinical development. Since none of our programs is encumbered at this stage, we are keeping options open to expanding our competency horizon to include later stage drug development and commercialization. However, it is highly likely that the initial product candidates will be partnered with pharmaceutical and biotechnology companies. We will endeavor to retain a participating role in further development as we build in-house expertise for advanced development and commercialization of future products. Earlier stage alliances will likely involve technologies such as immunoconjugate-enabling technology, non-oncology therapeutic areas, and ex-U.S. development of oncology products.

Products:

Name Indication Stage Milestone
ON 01910.Na Multiple Tumors Advanced Phase I Proof of Concept in Phase II
ON 01210.Na – Ex-RAD™ Radiation Protection IND Filed Phase I in Q3-2008
ON 013105 MCL Pre-IND IND Q4-2008
Immunoconjugates Enabling Technology R&D Licensing / JV
bcr-abl/Jak2 Inhibitor Gleevec™ Resistance Pre-IND IND-2009

Financing History:

Founding Round (Founders) 1999    
Preferred Series A-F 2000-2007    
Next Financing Planned 2009    

Executive Management:

Name Title
Preferred Series A-F President & CEO
Stanley C. Bell, Ph.D. SVP Pharmaceutical Discovery & Development
Manoj Maniar, Ph.D. VP Product Development
François E. Wilhelm, M.D., Ph.D. Chief Medical Officer & SVP
James Altland, CPA SVP Finance & Corporate Development

Board of Directors:

Name Affiliation
Michael Hoffman Riverstone, LLC
Ramesh Kumar CEO
Viren Mehta Mehta Partners
Marvin Miller Previously Baxter
Pankaj Patel Zydus Cadila
E. Premkumar Reddy Temple University; Scientific Founder
Rudolph Skalka Previously Amrep
K. Ravindra ICICI Ventures
Alan Williamson Previously Merck

Scientific Advisory Board:

Name Affiliation
Hilary Koprowski, M.D. Children’s Hospital of Philadelphia
Peter Nowell, M.D. University of Pennsylvania
Anna Marie Skalka, Ph.D. Fox Chase Cancer Center
George Vande Woude, Ph.D. Van Andel Institute
Peter Vogt, M.D., Ph.D. Scripps Institute

Clinical Advisory Board:

Name Affiliation
Jerome Groopman, M.D, Chairman Harvard Medical School
Ross Donehower, M.D. Johns Hopkins Medical Center
James Holland, M.D. Mt. Sinai Medical School
Steven NImer, M.D. Memorial Sloan Kettering
Mark Ratain, M.D, Ph.D. University of Chicago
David Parkinson, M.D., Ph.D. Nodality, Inc.
Gail Eckhardt, M.D. University of Colorado



Copyright 2006 • Onconova Therapeutics, Inc