Potential market: all solide tumors

Common solid tumors are characterised by high percentages of CA IX expression: Lung (75%), Colorectal (67%), Breast (33%), Cervical/Uterine (97%), Oesophagus (100%), Stomach (100%) and Liver (64%).

DualTPharma has selected non-small cell lung cancer (NSCLC) as first focal indication with respect to the large unmet need, market size, industrial interest, and access to patient cohorts.

In 2010, there were 547,000 new cases of lung cancer in the seven major markets. Of these patients, 331,996 are non-small cell lung cancer (NSCLC) cases in stage III-IV. 57,400 patients account for stage III-IV small cell lung cancer (SCLC). Taking into account that lung cancer shows a 75% expression of CA IX, in total 292,047 patients are eligible for our unique  drug. Even a 1-5% market share would result in multi-million revenues and royalty payments.

Business strategy

DualTPharma aims to establish a stable and commercial-scale production process for its Dual CA IX inhibitors and initiate limited-size early-stage (up to and including Phase II) clinical trials in a range of oncologic indications. The first trajectory will be launched for NSCLC. For each indication, once early-stage clinical proof of concept has been obtained, DualTPharma will outlicense its IP for the specific indication to large pharmaceutical companies (some of them have already showed their interest in our approach). This will result in a lucrative stream of upfront, milestone and royalty payments.   

Investment and key milestones

Several key steps need to be taken in preparation of the first in-human trials:

  • Establishing in-vivo kinetics;
  • Defining and characterising oral formulation;
  • Establishing commercial-scale GMP production process;
  • Preparing IND application.

After these preparations, who will take between 1-2 years, the first planned trial will be launched including 12-24 patients, positive for expression of CA IX, which will run for one year.

DualTpharma provides a truly innovative opportunity with unique IP on the dual drug combination with CA IX inhibitors. An significant investment is needed to bring these drugs towards a first-in-human trial then a phase II trial.