TRACON Pharmaceuticals (NASDAQ:TCON) terminated for futility its Phase 3 TAPPAS trial, evaluating TRC105 in combination with Votrient in patients with advanced or metastatic angiosarcoma, based on a recommendation of the Independent Data Monitoring Committee (IDMC).
The IDMC decision followed its review of interim unblinded safety and efficacy data from more than 120 patients enrolled in the trial at the time of the analysis.
Angiosarcoma is a cancer of the inner lining of blood vessels. The disease most commonly occurs in the skin, breast, liver, spleen, and deep tissue.
“We are disappointed that TRC105 in combination with Votrient did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic angiosarcoma,” Dr. Charles Theuer, president and CEO, said in a statement.
However, he said the company will continue to support its partner, Santen Pharmaceutical, in development of DE-122 in wet AMD, “where the anti-angiogenic and anti-fibrotic properties of endoglin inhibition may be more relevant than in oncology.”
TRACON also will continue to develop its other drug candidates, including TRC253 in partnership with Janssen, and TJ004309 (also known as TJ-D5) in partnership with I-Mab. TRACON also intends to advance candidates within I-Mab’s broad bispecific pipeline into the clinic in the U.S. as early as the beginning of next year, Dr. Theuer said.
As a result of the expected cost savings from terminating TRACON sponsored trials of TRC105, “we anticipate our current cash runway will now extend into the third quarter of 2020,” he added.
BTIG analyst Robert Hazlett downgraded TRACON to “neutral,” saying TRC105’s oncology indications represented a material portion of its net present value in his prior analysis of its operations. “With its removal and potential material catalysts from other partnerships in 2020, we are moving to the sidelines,” he added.
At midday on April 12, shares of TRACON were quoted at 63 cents, down 67 cents, or 51%.
