TRACON Pharmaceuticals Inc (NASDAQ:TCON) announced Friday that it retained the rights to prostate cancer drug candidate TRC253 following the completion of a Phase 2 trial and plans to find a partner to commercialize it in China.
The company bears sole responsibility for the development and commercialization of the drug after Janssen Pharmaceutica NV declined its option to reacquire the rights after the trial.
Under the terms of the deal, TRACON is obligated to make payments to Janssen upon certain development milestones and pay a royalty on net sales.
The trial evaluated TRC253 in prostate cancer patients with acquired resistance to the drugs Xtandi or Erleada.
“While TRC253 is as active as Xtandi in prostate cancer cell lines and in patient-derived xenograft models, we determined during clinical development that the F877L androgen receptor mutation TRC253 was designed to treat was far less common than predicted, and the product candidate was not highly active in prostate cancer patients with acquired resistance to Xtandi or Erleada,” TRACON CEO Charles Theuer said in a statement.
However, the company is optimistic that TRC253 could be effective as an earlier treatment option for patients, particularly in China, where androgen receptor inhibitors like Xtandi and Erleada are much less common.
“Given the preclinical data that suggest TRC253 may be as active as Xtandi in an earlier line setting, we believe TRC253 can be developed and commercialized successfully in China where many prostate cancer patients do not have widely available access to Xtandi or Erleada,” Theuer added.
“As we have established three corporate partnerships in China over the past three years, we have developed significant relationships with Chinese pharmaceutical and biotechnology companies that we intend to leverage to identify a potential partner for TRC253 in this large oncology indication.”
TRACON has begun an out-licensing process to identify a corporate partner to develop and commercialize the drug, and the company said it does not expect to devote further resources into developing the drug.
San Diego-based TRACON has positioned itself as a collaboration partner that leads the regulatory filings, clinical trials, as well as US commercialization of best-in-class drug candidates, as an alternative to expensive contract research organization (CRO) based development.
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