On December 21, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age‐related macular degeneration and fibrotic diseases, and Ambrx, Inc., reported that they have entered into a licensing agreement for the development and commercialization of TRACON’s proprietary endoglin antibody, TRC105 (carotuximab), in China (Press release, Tracon Pharmaceuticals, DEC 21, 2017, View Source;p=RssLanding&cat=news&id=2323733 [SID1234522743]).
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The transaction grants Ambrx the exclusive rights to develop and commercialize TRC105 in all indications (excluding ophthalmology, which are held by Santen Pharmaceutical Co., Ltd.) in China (including Hong Kong and Macau) and Taiwan. TRACON will receive an upfront payment of $3 million, and is eligible to receive development and regulatory milestones of up to $10.5 million, and commercial sales milestones of up to $130 million. TRACON is also eligible to receive tiered royalties from the high single digits to low teens on net sales of TRC105 in the Ambrx territories.
"We are excited to expand the development and commercialization opportunities for TRC105 into the Chinese market with a strong partner. The Ambrx management team has a strong track record of drug development in China and are backed by a top-tier syndicate of investors," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to Ambrx filing a Clinical Trial Application (CTA) for TRC105 in China, which we expect to occur in 2018, contributing to the ongoing enrollment of the Phase 3 TAPPAS trial in angiosarcoma, and leading the development of TRC105 in hepatocellular carcinoma (HCC) in China."
"Ambrx is delighted to partner with TRACON to develop this potential first-in-class medicine that we believe can benefit patients with significant unmet medical needs, including HCC, in China. With Ambrx’s proven expertise in pre-clinical, regulatory and clinical development, especially in the area of cancer therapeutics, we are uniquely positioned to bring this innovative molecule to China for patients with angiosarcoma and HCC," said Alex Qiao, Chief Executive Officer of Ambrx.
Ambrx intends to file an initial CTA with the Chinese Food and Drug Administration (CFDA) in 2018.
About TRC105 (carotuximab)
TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in the pivotal Phase 3 TAPPAS trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.