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Inovio Product Pipeline: V934/V935: Breast/Lung/Prostate/Other Cancers

Product & Indication
Developed by Merck, V934 is delivered using electroporation; V935 is used alone or as a boost to a V934 + electroporation prime injection. The biologic is a proprietary, therapeutic DNA vaccine candidate designed to target cancers expressing the antigen hTERT, including non-small cell lung carcinoma; breast cancer; melanoma; upper GI tract (e.g. esophagus, stomach, gallbladder, pancreas); colon; renal cell; bladder; and prostate cancers. The vaccine is being delivered using Inovio's MedPulser® DNA Delivery System.

Market Potential
Breast, non-small cell lung and prostate cancers alone represent in aggregate an annual incidence of 610,000 in North America alone. An analysis of current treatments for such cancers suggests that an effective new DNA vaccine could command premium pricing, suggesting a potential market size in North America of greater than US$10 billion.

Technical
No further details disclosed regarding the vaccine.

Stage of Development
Phase: I, treating patients with selected solid tumors: non-small cell lung carcinoma; breast cancer; melanoma; upper GI tract carcinoma (e.g. esophagus, stomach, gallbladder, pancreas); colon carcinoma; renal cell carcinoma; bladder carcinoma; and prostate carcinoma.

Conducted by Merck.

Purpose: To determine safety, tolerability and immunogenicity.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Start Date: October 2008

Status: Enrolling

For more information: www.clinicaltrials.gov Identifier: NCT00753415

Commercialization
Vaccine: owned by Merck.

Delivery technology: owned by Inovio.

License agreement: Financial details undisclosed. Merck paid a $2M milestone payment in December 2007, triggered by the filing of an IND. The deal includes additional milestone payments, development fees, royalties, and a supply agreement based on progression of the program.

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