Tracon Pharmaceuticals Says Prostate Cancer Drug Well Tolerated

By Chris Wack

Tracon Pharmaceuticals (TCON) on Tuesday said its TRC253 program for the treatment of metastatic castrate resistant prostate cancer, which was licensed from Janssen Pharmaceutica N.V. in 2016, was well tolerated.

The biopharmaceutical company said 21 patients with metastatic castrate resistant prostate cancer who had progressed on prior Xtandi enzalutamide or Erleada apalutamide treatment were enrolled into one of six cohorts of escalating doses of TRC253.

The company said data showed target PK exposures were achieved consistently with the 280 mg daily oral dose, which was selected as the recommended Phase 2 dose. TRC253 was well-tolerated and no drug-related serious adverse events were reported.

Enrollment is ongoing in a new cohort with a defined point mutation, as well as the two existing cohorts, the first including patients with a F877L AR mutation and the second consisting of patients with another basis for resistance to Xtandi or Erleada.

Following completion of the initial Phase 1/2 clinical trial, Janssen will have an exclusive option to reacquire full rights to TRC253 for an upfront payment of $45 million to Tracon, and obligations to pay regulatory and commercialization milestones totaling up to $137.5 million upon achievement of specified events and a low single-digit royalty.

If Janssen doesn't exercise its exclusive option to reacquire the program, Tracon would then retain worldwide development and commercialization rights to the program and would be obligated to pay Janssen a total of up to $45 million in development and regulatory milestones upon achievement of specified events, in addition to a low single-digit royalty.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 02, 2019 08:45 ET (12:45 GMT)

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