OREANDA-NEWS. Bioven, the late-stage biopharmaceutical company focused on cancer, is pleased to announce that it has secured an option to exclusive US marketing rights to EGF-PTI, a novel immunotherapy which the Company is currently progressing in an international, pivotal Phase III trial in non-small cell lung cancer (NSCLC).

Bioven earlier this year filed an updated Investigational New Drug application with the US Food & Drug Administration so that US study centres can be included in its current Phase III trial. 

The option to exclusive US rights was granted by Cuba's CIMAB SA, which has already granted exclusive rights to Bioven for territories in Europe, ASEAN and Australasia along with the first right of refusal in the Middle East.

Dr Agustin Lage, President of CIMAB SA, commented: "We have been working closely with Bioven since 2005 on the international roll-out of our exciting lung cancer treatment. We believe that this treatment, initially developed at the Centre of Molecular Immunology (CIM) and for which CIMAB SA is entitled to grant licences worldwide, is a major breakthrough for lung cancer sufferers and we are excited that Bioven is progressing it through an international Phase III trial. We were therefore pleased to grant Bioven a 12 month option period for exclusive US marketing rights."

Bioven has made an initial payment to CIMAB SA to secure the option, which will be exercised by the payment of a further instalment.

EGF-PTI was initially developed in Cuba as CIMAvax-EGF, and CIMAB and Bioven have further developed the product particularly in the identification of patient groups that are most likely to respond to treatment through targeting therapy with the use of a specific biomarker.

EGF-PTI is an immunotherapy that targets the epidermal growth factor/epidermal growth factor receptor (EGF/EGFR) pathway, which is implicated in tumour growth. EGF-PTI's mode of action is to induce the generation of anti-EGF antibodies, which bind with EGF circulating in the blood to prevent the EGF binding with the EGF receptor. In this way, EGF-PTI neutralises the EGF/EGFR pathway to uncontrolled cell division.

The Phase III trial is seeking to further establish the safety and efficacy of EGF-PTI in inoperable, late-stage NSCLC. A total of 418 patients will participate in the trial, the primary endpoint of which is overall survival. Dr Marianne Nicholson, consultant medical oncologist at Aberdeen Royal Infirmary, Scotland, is the trial's principal investigator.

A biomarker based on the concentration of EGF in the blood is being used to identify patients for recruitment into the trial, whose inclusion criteria also include an assessment of EGFR and other gene mutations. This biomarker was identified by a retrospective analysis of Cuban, Malaysian and European data.

About Bioven

Bioven is a late-stage biopharmaceutical company focused on the treatment of cancer. Its strategy is to in-license compounds and develop them through late-stage clinical trials prior to out-licensing to major healthcare or specialty pharma companies. 

Bioven's most advanced compound is EGF-PTI, a novel immunotherapy for non-small cell lung cancer (NSCLC), which is currently in an international Phase III trial. 

Bioven is a privately held company founded in 2002 in Malaysia and with offices in the UK and Kuala Lumpur.