Partnering and Licensing

Antisense Pharma researches and develops innovative targeted therapies for malignant progressive tumors. We have established numerous academic and clinical collaborations and seek to expand our business through further collaborations to support our research projects and licensing agreements. The company intends to develop and commercialize novel drugs either through license partnerships or in synergy with our own marketing and sales resources.

Out-licensing Business Opportunity

Trabedersen (AP 12009) – a TGF-beta2 (TGF-β2) antisense inhibitor for the treatment of solid tumors

 

Development Stage

Clinical Phase III (SAPPHIRE) for recurrent or refractory anaplastic astrocytoma (WHO grade III)
Clinical Phase I/II for advanced pancreatic carcinoma and malignant melanoma

Malignant brain tumors (high-grade glioma), advanced pancreatic carcinoma and malignant melanoma are among the most aggressive tumors known and have a dismal prognosis. Survival times of just a few months after diagnosis signify a high unmet medical need. The lack of a breakthrough in the treatment of these types of cancer is the reason why trabedersen was developed.

Trabedersen is a targeted selective inhibitor of TGF-beta2 (TGF-β2).  The drug specifically downregulates the synthesis of this multifunctional factor, which is selectively overexpressed in progressive, proliferating tumor cells. TGF-β2 exerts its pleiotropic activities on both cancer cells and the surrounding stroma. The overexpresseion of TGF-β2 correlates with local tumors progressing to aggressive late-stage metastasizing disease. By inhibiting TGF-β2, trabedersen deprives the tumor of this critical factor and intervenes in the vicious cycle of immune blockade and infiltrative spread to healthy tissue. The immunosuppressive effects and the induction of cell migration and metastazation into the extracellular matrix by TGF-β2 are essential tumor survival strategies.

molekuel

Inhibition of TGF-β2 by trabedersen leads to
-> reversal of the tumor-induced escape from immune surveillance
-> suppression of TGF-β2-induced migratory and angiogenic activity in tumors


Clinical Experience

A clinical Phase IIb Proof of Concept, active-controlled, dose-finding clinical study of trabedersen in adult patients with recurrent or refractory high-grade glioma (anaplastic astrocytoma, WHO grade III) and glioblastoma (WHO grade IV) has shown a positive risk-benefit profile for the investigational drug as well as establishing the optimal therapeutic dose. Remarkable survival rates, with a median overall survival benefit of 17.4 months and long-term tumor responses compared to standard chemotherapy treatment in the control group has been achieved with trabedersen as single agent.  An international, randomized clinical Phase III study (SAPPHIRE) of patients with recurrent or refractory anaplastic astrocytoma (WHO grade III) is ongoing and a clinical Phase III study of glioblastoma patients is in preparation.

Trabedersen is also being evaluated as monotherapy for advanced pancreatic carcinoma, malignant melanoma and colorectal carcinoma in an ongoing clinical Phase I/II study. Systemic infusion of different doses has been well tolerated and has shown first promising efficacy as 2nd to 4th-line therapy. The clinical Phase II confirmatory part of this study is underway.

Antisense Pharma offers co-development partnering opportunities and commercialization licenses for the USA, Japan and Europe. Further territories are optional.

License Contact

Antisense Pharma GmbH

Phone:leer++49-941-92013-0
Faxleer++49-941-92013-29


E-Mail: license@antisense-pharma.com