TRACON terminates Phase III trial for TRC105, Votrient combination in angiosarcoma; shares plunge

Shares in TRACON Pharmaceuticals dropped as much as 45 percent Friday after the company said it was ending the Phase III TAPPAS study evaluating TRC105 in combination with Novartis' Votrient (pazopanib) in patients with advanced or metastatic angiosarcoma. The company said the decision was based on the recommendation of an independent data monitoring committee following its review of interim data from more than 120 patients enrolled in the trial at the time of the analysis. 

The randomised TAPPAS trial was designed to compare TRC105 plus Votrient versus Votrient alone in as many as 340 patients with advanced or metastatic angiosarcoma. The primary endpoint was progression-free survival as assessed using RECIST 1.1, while secondary goals included objective response rate, overall survival, safety and tolerability. The drugmaker indicated that the TAPPAS data will be further analysed and submitted for presentation at a future research meeting. 

"We are disappointed that TRC105 in combination with Votrient did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic angiosarcoma," stated CEO Charles Theuer, adding that TRACON will terminate further enrollment in company-sponsored trials of the anti-endoglin antibody in oncology. However, he indicated that TRACON will continue to support partner Santen Pharmaceutical in their development of DE-122, the ophthalmic formulation of TRC105, in wet age-related macular degeneration, "where the anti-angiogenic and anti-fibrotic properties of endoglin inhibition may be more relevant than in oncology."

Meanwhile, Theuer said that TRACON will continue to develop other assets, including TRC253 in collaboration with Johnson & Johnson, and TJ004309 in partnership with I-Mab, as well as advance candidates within I-Mab's bispecific pipeline to the clinic in the US as early as the beginning of next year. The executive added that based on the anticipated savings due to ending TRACON-sponsored studies of TRC105, the company expects its current cash runway to extend into the third quarter of 2020. 

TRC105, an oncology formulation of carotuximab, previously received orphan drug designations for use in patients with soft tissue sarcoma in both the US and EU. 

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