HER3 overexpression in solid tumors is tied to poor prognosis, concretely in breast and non-small-cell lung cancers, where treatment resistance often occurs upon using targeted therapy, highlighting the need for novel targeted therapies against HER3. Since its expression is much higher in tumor than normal cells, HER3 is a robust candidate for antibody-drug conjugate (ADC) therapy.
Elevation Oncology Inc. has nixed its lead pipeline product, a claudin 18.2 antibody-drug conjugate (ADC) called EO-3021, on disappointing phase I data, sending shares tumbling by 42% and placing its preclinical HER3 ADC to the forefront of development.
Claudin 18.2 (CLDN18.2) is a member of the claudin family and is overexpressed in gastric, gastroesophageal junction and pancreatic cancer, among others. Researchers from Elevation Oncology Inc. recently presented preclinical efficacy data on the combination of EO-3021, an antibody-drug conjugate (ADC) targeting CLDN18.2, with VEGFR-2 or PD-1 inhibitors in models of gastric adenocarcinoma.
Elevation Oncology Inc. has nominated EO-1022 as its HER3 antibody-drug conjugate (ADC) development candidate for the treatment of solid tumors that express HER3.
Closely watched-for phase I data from Elevation Oncology Inc. in the Claudin 18.2 space sent shares of the Boston-based firm (NASDAQ:ELEV) down 63%, or $1.35, to close Aug. 6 at 78 cents. Elevation provided initial data from the dose-escalation portion of the ongoing experiment with antibody-drug conjugate (ADC) EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction (GEJ), pancreatic or esophageal cancers.
The U.S. FDA’s effort to push companies toward more and better randomized, controlled trials ahead of accelerated approvals – apparently driven by the lack of confirmatory studies done afterward – is “an important and meaningful move by the agency,” said Day One Pharmaceuticals Inc. CEO Jeremy Bender. “The industry’s history in that space has been a little mixed.” Bender’s remarks came Aug. 9 as part of a wide-ranging panel discussion hosted by analyst Robert Driscoll during the Wedbush Pacgrow Healthcare Conference.
Elevation Oncology Inc. has picked up the global rights to SYSA-1801, an anti-Claudin 18.2 antibody-drug conjugate (ADC) candidate, from CSPC Megalith Biopharmaceutical Co. Ltd. in a deal worth up to $1.195 billion. Under the terms, Elevation gets rights to develop and commercialize SYSA-1801 outside of mainland China, Hong Kong, Macau and Taiwan.
Wall Street must wait to learn more about factors that might distinguish the Claudin18.2-targeting asset at the center of Elevation Oncology Inc.’s $1.2 billion license deal with CSPC Megalith Biopharmaceutical Co. Ltd., a subsidiary of CSPC Pharmaceutical Group Ltd.
Elevation Oncology Inc. has picked up the global rights to SYSA-1801, an anti-Claudin 18.2 antibody-drug conjugate (ADC) candidate, from CSPC Megalith Biopharmaceutical Co. Ltd. in a deal worth up to $1.195 billion. Under the terms, Elevation gets rights to develop and commercialize SYSA-1801 outside of mainland China, Hong Kong, Macau and Taiwan.
When, late last year, Daiichi Sankyo Co. Ltd. won breakthrough status from the FDA for HER3-targeting lung cancer prospect patritumab deruxtecan, Wall Street began taking stock of other candidates in the space. “The winning strategy to therapeutically target HER3 remains to be seen,” noted a recent paper in Clinical Cancer Research, “but HER3 is a promising drug target, and the era of drugging the ‘undruggables’ has already started.”
