Industry Trend Analysis - Combination Approach Increases Commercial Scope For Small Oncolytic Immunotherapy Developers - MAY 2016


BMI View : The first developed market approval of an oncolytic immunotherapy has validated the treatment modality. As with other emerging immuno-oncology areas, oncolytic immunotherapy's fortunes will be linked to checkpoint inhibitors initially. Oncolytic immunotherapy has demonstrated particular utility in boosting immu ne responses in combination. A s competition intensifies in the checkp oint inhibitor and wider immuno -oncology sphere, virotherapy specialists will be increasingly called upon to provide differentiation through effective combination approaches.

DNAtrix' lead product, DNX-2401, has been designated by the EC as an orphan medicinal product for the treatment of glioma. The company noted that it plans to continue its aggressive development programme in the EU for the candidate.

DNX-2401 is an oncolytic adenovirus engineered to be safe and effective for the treatment of gliomas and other cancers. DNX-2401 has been evaluated in over 100 subjects with high-grade gliomas in four clinical studies in the US and EU, with promising results. The company recently completed enrolment in a Phase Ib study conducted in Spain for recurrent glioblastoma and plans to initiate a study for newly-diagnosed disease in Europe later this year. The company has previously been granted orphan drug designation for DNX-2401 in the US for the treatment of glioma.

Burden Maintained By Lack Of Options
DALYs Lost To Brain Cancer In Europe (mn)
f/e = BMI forecast/estimate. Source: World Health Organization/BMI

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