Mind cancers are notoriously tough to deal with, with surgical procedure and radiation persevering with to be the primary choices for these malignancies. A uncommon and aggressive kind of mind tumor pushed by a specific genetic signature might quickly have its first authorized drug remedy. Jazz Prescription drugs is now committing $935 million so as to add this prospect to its pipeline.
The drug, dordaviprone, was developed by Durham, North Carolina-based Chimerix. The most cancers is H3 K27M-mutant diffuse glioma, a high-grade glioma that impacts youngsters and younger adults. Whereas surgical procedure is a remedy possibility for mind cancers, IT’s often dangerous for H3 K27M gliomas as a result of these tumors have an effect on vital components of the mind and spinal wire. In the meantime, radiation introduces complication dangers and isn’t healing.
“It is a very excessive unmet want,” Jazz Chief Medical Officer Robert Iannone mentioned, talking throughout the firm’s presentation Wednesday at TD Cowen’s annual Health Care convention in Boston. “I’m a pediatric oncologist by coaching. There actually has been no progress on this space. I do know from treating these sufferers, IT’s been a really unhappy scenario to have solely radiation and surgical procedure because the efficient remedy.”
About 2,000 sufferers are affected by H3 K27M-mutant gliomas yearly within the U.S., in keeping with a Chimerix estimate. Dordaviprone is a part of a brand new class of most cancers medicine known as imipridones. These small molecules goal sure G protein-coupled receptors and enzyme targets, altering their exercise to result in most cancers cell loss of life. Dordaviprone, identified earlier in its improvement as ONC201, is designed to selectively goal mitochondrial protease ClpP and dopamine receptor D2.
Section 2 outcomes confirmed tumor regression in sufferers with glioblastoma who exhibited the H3 K27M mutation. Within the 50 sufferers included within the main efficacy evaluation, Chimerix reported a 28% goal response fee and a median period of response of 10.4 months. A Section 3 check enrolling sufferers newly identified with one of these mind most cancers might help first-line use of the drug; interim outcomes are anticipated within the third quarter of 2025. However based mostly on the Section 2 information, Chimerix is searching for accelerated approval of dordaviprone for recurrent H3 K27M-mutant diffuse glioma. Final month, the FDA accepted the brand new drug software under priority review, setting an Aug. 18 goal date for a regulatory choice.
Although most cancers is the therapeutic focus of Chimerix, IT’s a comparatively new space for the corporate, one of many older biotechs in North Carolina’s Analysis Triangle. Dordaviprone got here from Chimerix’s 2021 money and inventory acquisition of Oncoceutics, a clinical-stage developer of imipridones. Moreover the lead drug candidate, the deal additionally introduced ONC206, an imipridone that Chimerix has superior to Section 1 testing in central nervous system tumors. Per phrases of the Oncoceutics acquisition, that firm’s shareholders might obtain as much as $360 million in milestone funds plus royalties from gross sales.
Chimerix, based in 2000, started as an antiviral drug developer. For many of the biotech’s historical past, its focus was brincidofovir, a molecule initially developed for treating cytomegalovirus an infection. IT failed in that indication, however received FDA approval in 2021 as a remedy for smallpox and is now identified by the model title Tembexa. In 2022, Chimerix sold that drug’s rights to Emergent BioSolutions for $225 million up entrance and as much as $100 million in milestone funds. Chimerix utilized the money towards medical improvement of dordaviprone in mind most cancers.
Previously yr, Chimerix’s inventory worth has largely traded under the $1 mark. These shares bought a big carry in December after the biotech introduced IT would seek accelerated approval for dordaviprone. In response to acquisition phrases disclosed Wednesday, Dublin-based Jazz pays $8.55 in money for every Chimerix share, representing a 72% premium to the biotech’s closing inventory worth on Tuesday. There’s potential for extra monetary upside. As a result of Chimerix’s drug is below precedence evaluation, IT’s eligible for a uncommon pediatric illness precedence evaluation voucher if the drug is authorized. Such vouchers are usually bought to large pharma firms, they usually as soon as fetched costs within the vary of $100 million. Recent voucher sales have been within the neighborhood of $150 million.
The Jazz portfolio at the moment has 5 most cancers medicine. Chief Monetary Officer Philip Johnson described dordaviprone as a “nice match with our oncology enterprise,” including that the drug can leverage Jazz’s business capabilities and gives a patent life extending into 2037 and probably longer.
The Chimerix acquisition suits Jazz’s technique of buying belongings for uncommon alternatives in area of interest markets, Leerink Companions analyst Marc Goodman wrote in a observe to buyers. Past addressing a excessive unmet medical want, the deal leverages Jazz’s experience in uncommon ailments and oncology. Jazz prefers buying late-stage belongings which have a possible near-term business launch, Goodman mentioned. Leerink continues to be researching the H3 K27M market alternative, however he famous that given the scale of the affected person inhabitants for this ultra-rare kind of most cancers, IT is sensible for dordaviprone to fall throughout the $300,000 to $800,000 worth vary for orphan drug merchandise.
The acquisition has been authorized by the boards of each Jazz and Chimerix, however nonetheless should meet customary closing circumstances together with the tender of nearly all of the excellent shares of Chimerix. The businesses count on the deal to shut within the second quarter of this yr.
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