Therapies from Johnson & Johnson and Takeda Pharmaceutical have validated a particular rare genetic mutation as a viable drug target for treating lung cancer. Scorpion Therapeutics aims to best those products with drugs that hit that target but cause fewer toxic effects. The startup is nearing human testing. Now it has a global partner for clinical development.
France-based Pierre Fabre is paying Scorpion $65 million to begin an alliance on two Scorpion drug candidates. According to deal terms announced Tuesday, Scorpion will lead clinical development of one of them, STX-721. An investigational new drug application for this small molecule will be filed in the middle of this year in non-small cell lung cancer (NSCLC). Pierre Fabre will lead development of the second Scorpion drug candidate, a preclinical small molecule called STX-241.
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Both Scorpion molecules have been designed to address epidermal growth factor receptor (EGFR), a cell signaling protein that can drive cancer when mutated. In 2021, Johnson & Johnson’s Rybrevant became the first FDA-approved targeted therapy for this genetic signature, specifically, an exon 20 insertion mutation. The J&J drug is an antibody dosed as an infusion. Months after Rybrevant’s approval, Takeda won an FDA nod for Exkivity, an oral small molecule drug that also targets EGFR exon 20 insertion mutations.
One challenge of targeting EGFR with a drug is that the protein is also found on healthy tissue throughout the body, such as the skin and the gastrointestinal tract. A drug that targets that protein on cancer cells will also hit it on healthy cells, causing toxic effects. Rash, nausea, and diarrhea are among the adverse effects listed on the labels of both Rybrevant and Exkivity. According to Scorpion, these toxicities can lead to reductions or interruptions in dosing, which may reduce the overall efficacy of treatment. The biotech says its drugs have been designed to selectively hit the mutated form of EGFR while avoiding the protein on healthy tissue, an approach intended to minimize toxic effects.
STX-721, the more advanced of the two Scorpion small molecules, addresses exon 20 insertion mutations in EGFR. Meanwhile, STX-241 is designed to penetrate the central nervous system to address a particular EGFR mutation, C797S, which leads to drug resistance. Scorpion expects to file an investigational new drug application for this molecule in the first half of 2024.
According to the partnership agreement, Scorpion will retain commercialization rights for both molecules in the U.S., Canada, and Japan. Pierre Fabre will commercialize the drugs in all other regions, with a particular focus on Europe and China. Scorpion could earn up to an additional $553 million in milestone payments. The deal also calls for the French company to pay royalties from sales of the drugs—if they reach the market.
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“This partnership should help to expand the reach of our EGFR targeting programs, allowing us to help patients who urgently need these treatments, including in markets such as China, where nearly 50% of all cases of NSCLC are expected to be EGFR-mutant by 2030,” Scorpion CEO Axel Hoos said in a prepared statement.
Pierre Fabre is Scorpion’s second drug development partner. Early last year, AstraZeneca agreed to pay $75 million up front to begin a partnership with Scorpion focused on developing new drugs that target transcription factors as a way of treating cancer.
Public domain photo by Flickr user Joshua Tree National Park
