Oncos Therapeutics Granted Orphan Drug Designation for CGTG-102 in Soft Tissue Sarcoma (STS) by FDA and EMA
HELSINKI, Finland, July 31, 2013 /PRNewswire/ –
Oncos Therapeutics Ltd, a private, clinical-stage biotechnology company focused on the
development and commercialization of targeted oncolytic immunotherapies for solid tumors,
announced today that the United States Food and Drug Administration (FDA) and European
Medicines Agency (EMA) have granted orphan drug designation for CGTG-102, a
granulocyte-macrophage colony stimulating factor-coding oncolytic adenovirus
(Ad5/3-D24-GMCSF) for the treatment of soft tissue sarcoma.
“We are pleased to receive orphan drug designations for CGTG-102 from the two leading
regulatory agencies in the world. These designations confirm the need for developing novel
therapies for rare cancers and are an important step in the development of CGTG-102″ ,said
Frans Wuite, M.D., President and Chief Executive Officer of Oncos.
Orphan Drug Designation applies to drugs that seek to treat rare diseases or
conditions for which there may be few adequate therapies. In USA, the designation will
provide Oncos with the opportunity of seven years of marketing exclusivity, grant funding
to defray costs of clinical trial expenses, tax credits for clinical research expenses and
potential waiver of the FDA’s application user fee. Similarly, incentives are provided for
Europe by EMA, which include fee reductions on future activities and the potential for 10
years market exclusivity.
About Soft Tissue Sarcoma
Soft tissue sarcoma is estimated to affect 3-4 in 10,000 people in the EU and US.
About 50% of soft tissue sarcomas are found in the early stage and advanced stage patients
have an average overall survival of 13 months with today’s standard of care. Several
efforts to develop additional chemotherapeutics for STS have failed, including two
products in Phase III development this year. Novel therapies with a different mechanism of
action are therefore needed.
Oncos’ lead product candidate, CGTG-102, is an oncolytic immunotherapy based on a
purposefully modified, GM-CSF encoding adenovirus that selectively replicates in tumor
cells and eventually kills them. Upon tumor cell death, newly synthesized viruses are
released and infect neighboring tumor cells. Simultaneously, tumor antigens are exposed
activating a tumor specific, systemic response by the patient’s immune system. This
response is further enhanced by the CGTG-102 induced production of GM-CSF in tumor cells.
A Phase I study with CGTG-102, will be completed this year and Phase II studies are
scheduled to start in 2014. Prior to the Phase I study, 115 patients with chemotherapy
refractory solid tumors had been treated with CGTG-102 in an individualized treatment
program regulated by the Finnish Medicines Agency as determined by the EU Regulation on
Advanced Therapy Medicinal Products, EC/1394/2007.
About Oncos Therapeutics
Oncos Therapeutics Ltd is a privately owned, clinical-stage biotechnology company
focused on the development and commercialization of targeted oncolytic immunotherapy
products for solid tumors. The company’s lead investor is HealthCap, one of the largest
specialized providers of venture capital within life sciences in Europe. Oncos is
headquartered in Helsinki, Finland and has an office in Switzerland. For more information
about Oncos, please visit http://www.oncos.com.
SOURCE Oncos Therapeutics Ltd