On July 28, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, reported that it has entered into an exclusive license agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) to develop and commercialize EO-3021 (SYSA1801), a differentiated, clinical stage antibody drug conjugate (ADC) targeting Claudin18.2, in all global territories outside Greater China (mainland China, Hong Kong, Macau and Taiwan) (Press release, Elevation Oncology, JUL 28, 2022, View Source [SID1234617069]). SYSA1801 is currently being evaluated by CSPC in a Phase 1, dose-escalation clinical trial in China. Elevation Oncology expects to initiate a Phase 1 clinical trial evaluating EO-3021 in the U.S. in 2023.
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"This licensing transaction represents successful, continued execution of our business development strategy and expands our clinical-stage pipeline," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We look forward to unlocking the potential of EO-3021 alongside our partner CSPC as we continue to build an industry-leading precision oncology company. EO-3021 is an exciting, differentiated ADC that has significant potential for the treatment of patients with solid tumors that express Claudin18.2, including those with genomically defined cancers. This transaction is a significant milestone for Elevation Oncology which further diversifies our company, expands our commercial potential and allows us to leverage our existing expertise in genomically defined cancers."
Claudin18.2 is a protein expressed across several types of solid tumors including many gastrointestinal cancers such as gastric, gastroesophageal junction (GEJ), and pancreatic cancer. EO-3021 is an ADC containing monomethyl auristatin E (MMAE) payload, a potent anti-mitotic agent. MMAE has been clinically validated as an effective anti-tumor payload and is the cytotoxic component of four U.S. Food and Drug Administration-approved ADCs.
"Claudin18.2 is a clinically validated oncology target that has significant potential in multiple gastrointestinal cancers and several other solid tumors, and could be best addressed by utilizing a weaponized antibody like EO-3021," said David Dornan, PhD, Chief Scientific Officer of Elevation Oncology. "High Claudin18.2 expression is associated particularly with gastrointestinal cancers, but can also frequently be found in lung, breast and liver cancer, representing an attractive commercial market opportunity. The targeting of Claudin18.2 with EO-3021 could have a transformative role in addressing the unmet medical need in patients whose tumors express Claudin18.2."
Under the terms of the agreement, Elevation Oncology will develop and commercialize EO-3021 in all global territories outside of Greater China. In exchange, CSPC will receive a one-time, upfront payment of $27 million. CSPC will also be eligible to receive up to $148 million in potential development and regulatory milestone payments and up to $1.0 billion in potential commercial milestone payments plus royalties on net sales.
"This agreement with Elevation Oncology brings our innovative pipeline overseas with the potential to help patients battling cancer. We are delighted to partner with Elevation Oncology to realize the full global potential for SYSA1801 (EO-3021) in meeting the unmet medical needs in pancreatic and gastric cancer, as well as other types of cancers," said Zhang Cuilong, Chief Executive Officer of CSPC. "Recognizing the value that Elevation Oncology has created in building an industry-leading operational platform for enrolling clinical trials in genomically defined patient populations, this partnership gives us confidence in the potential worldwide development of this program targeting Claudin18.2."
Conference Call and Webcast Information
Elevation Oncology will host an investor conference call and webcast today, Thursday, July 28, 2022, at 5:00 p.m. ET to discuss the licensing transaction with CSPC. To access the live call, please dial 1-877-870-4263 (local) or 1-412-317-0790 (international) at least 10 minutes prior to the start time of the call and ask to be joined into the Elevation Oncology investor call. The live, listen-only webcast of the conference call can be accessed by visiting the "Events" page within the "Investors" section of Elevation Oncology’s website at www.elevationoncology.com. An archived replay of the webcast will be available on Elevation Oncology’s website approximately two hours after the event.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated, clinical stage antibody drug conjugate that targets Claudin18.2. Claudins are a family of proteins acting to maintain the tight junction that controls the interchange of molecules between cells and are mainly found in gastric, pancreatic, and lung tissues.1 Claudin18.2 is a specific subtype that is expressed in only cancer cells of the gastric epithelia.1 When the gastric epithelial cells become malignant, the tight junctions become disrupted, exposing the Claudin18.2 epitopes and allowing them to be targeted by anti-cancer agents.1 An Investigational New Drug application for EO-3021 has been cleared with the U.S. Food and Drug Administration.