Medical Innovation Exchange

Jazz jumps into KRAS G12D space via $10M upfront deal with regular partner Redx

After a couple of recent trial misses for its sleep disorder and post-traumatic stress disorder (PTSD) candidates, Jazz Pharmaceuticals is looking to bolster its preclinical oncology pipeline. The company has returned to Redx Pharma’s well, this time paying $10 million upfront for a KRAS program that includes the much-hyped G12D space.

Initially Jazz and Redx will collaborate to advance candidates from the KRAS inhibitor program—which includes G12D selective and pan-KRAS molecules—through investigational new drug application-enabling studies, with Jazz taking the reins for all clinical trials and beyond.

In return, Redx is in line for up to $870 million in potential development, regulatory and commercial milestone payments—beginning with an FDA nod to begin human trials—as well as tiered, mid-single-digit percentage royalties on any resulting sales.

Jazz also referred to a “separate collaboration agreement signed in parallel,” where Jazz will pay Redx to undertake some research and preclinical development activities related to those IND-enabling studies.

“KRAS is a well-validated oncology target and there remains a high unmet need for innovation in this area based on challenges in developing molecules to target specific KRAS mutations,” Robert Iannone, M.D., executive vice president and global head of research and development at Jazz, said in the Feb. 7 release.

“Redx has discovered a number of preclinical KRAS candidates and we plan to leverage our collective oncology development expertise to identify and advance the most promising molecules toward the clinic,” Iannone added. “This transaction further expands our early-stage oncology pipeline, and we are excited to explore novel approaches to improving treatment options for cancer patients.”

Jazz will face some tough competition in the G12D space. The approved KRAS drugs—Amgen’s Lumakras and Mirati Therapeutics’ Krazati—target G12C-mutated cancer. Those mutations cover around 14% of all KRAS-driven cancers, while G12D mutations are more common.

It’s no surprise that various drug developers have already homed in on the G12D opportunity. Silenseed took a siRNA candidate into phase 2 in 2018, although ClinicalTrials.gov now lists its status as “unknown.” Mirati has an asset in phase 1/2, while AstellasJiangsu HengRui Medicine and Revolution Medicines are all testing G12D candidates in humans, too.

It’s far from the first time the two companies have inked a licensing deal. Back in 2019, Jazz handed over $3.5 million upfront to buy a preclinical pan-RAF inhibitor and returned the following year with $10 million for candidates against two targets on the Ras/Raf/MAP kinase pathway.

Jazz had a run of bad luck in the clinic toward the end of last year, pausing a phase 1 sleep disorder med due to adverse events in late November and then a month later dropping a PTSD therapy after it failed to beat placebo in a phase 2 study. In November, the company used its oncology pipeline as a more positive diversion from the bad news, announcing that the company planned to initiate a rolling submission of bispecific antibody zanidatamab before the end of the year.

In this morning’s release, Redx CEO Lisa Anson claimed the latest deal with Jazz was recognition “once again [of] our distinguished expertise in medicinal chemistry.”

Investors appeared to agree, sending the British biotech’s stock rocketing 50% to 31 pence in the opening hour of trading on the London stock exchange Wednesday.

https://www.fiercebiotech.com/biotech/jazz-jumps-kras-g12d-space-10m-upfront-deal-regular-partner-redx

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