On May 5, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, reported that it has entered into an exclusive license agreement with LaNova Medicines Limited (LaNova) to develop and commercialize LM-302, a novel antibody drug conjugate (ADC) targeting Claudin18.2, in the U.S. and rest of the world, excluding Greater China and South Korea (Press release, Turning Point Therapeutics, MAY 5, 2022, View Source [SID1234614124]). Claudin18.2 is a protein expressed in many gastrointestinal cancers, including gastric, gastroesophageal junction and pancreatic cancer. LM-302, which going forward will be identified as TPX-4589, is currently in Phase 1 clinical trials in both the U.S. and China.

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Under the terms of the licensing agreement, LaNova will receive an upfront payment of $25 million and will be eligible to receive up to an additional $195 million in development and regulatory milestone payments; in addition, LaNova is eligible to receive commercial sales milestones, and tiered royalties ranging from mid-single digit to mid-teens percentages on net sales (subject to customary deductions). As part of the agreement, both parties agreed to potentially broaden the partnership by collaborating on up to three additional ADC programs.

TPX-4589 (LM-302) is a potentially first-in-class anti-Claudin18.2 ADC discovered by LaNova that suppresses cell proliferation of gastric and pancreatic cell lines with nanomolar potency in preclinical models. It also has demonstrated efficacy in gastric and pancreatic cancer xenograft models.

"We are excited to announce our first in-license as a company and strategically expand our clinical stage portfolio, specifically within GI tumors. Claudin18.2 is continuing to emerge as an important target," said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point. "We chose TPX-4589 based on it potentially being a first-in-class ADC to target Claudin18.2 and its preclinical data that show the potential to target tumors with low and high expression levels, which we believe could be an important differentiator versus other investigational therapies."

"LaNova Medicines is focused on discovery and development of innovative medicines in oncology. We are very pleased to partner with Turning Point for LM-302, an innovative drug molecule with the potential as a novel treatment for gastric and pancreatic cancers. This partnership is an example of our discovery and development capabilities and our ambition for global innovation and patients," said Dr. Crystal Qin, Chairman and CEO of LaNova.

It is estimated that the annual incidence of gastric and gastroesophageal junction cancers in the U.S. and EU5 is approximately 27,000 and 50,000, respectively1. The estimated annual incidence of pancreatic cancer in the U.S. and EU5 is approximately 60,000 and 70,000, respectively1. Approximately 65% of patients in pancreatic2, gastric and gastroesophageal junction3 cancers have tumors that express Claudin18.2.

Webcast/Conference Call Information
Turning Point will host a webcast and conference call on May 5, 2022 at 6 p.m. ET / 3 p.m. PT to discuss this announcement. Athena Countouriotis, M.D., President and Chief Executive Officer, will host the virtual event for investors and will be joined by Kumar Srinivasan, Chief Business Officer.

The event will be accessible through the "Investors" section of www.tptherapeutics.com or by dialing (844) 256-2297 (in the United States) or (236) 714-3006 (outside the U.S.) using conference ID 8780394. A replay will be available shortly after the live event through the "Investors" section of www.tptherapeutics.com.