Sanofi appears to be considering a buyout of cancer drugmaker Mirati Therapeutics, according to Bloomberg reporting on Thursday, citing sources familiar with the matter.

Deliberations surrounding the potential acquisition are ongoing and there is no certainty that Sanofi will push through with the deal, Bloomberg noted. Still, the possibility of the buyout has energized the market and Mirati was trading 45% higher Thursday afternoon in reaction to the rumors.

A Sanofi spokesperson declined to confirm or deny the acquisition in a statement to Reuters, saying that the company does not comment on market rumors. Mirati was likewise tight-lipped about the matter.

This is not new territory for Mirati. In October 2021, Merck had expressed interest in acquiring Mirati, according to people briefed on the matter. In November 2022, Mirati was attracting “fresh takeover interest” from large pharma companies, also reported by Bloomberg. At the time, the California-based biotech was still ushering its KRAS inhibitor adagrasib through the clinical space.

A month later, in December 2022, the molecule won the FDA’s accelerated approval for the treatment of locally advanced or metastatic non-small cell lung cancer with the G12C mutation in the KRAS gene. Adagrasib is currently being sold under the brand name Krazati and is Mirati’s only approved product.

Despite the regulatory win, however, Krazati still trails behind Amgen’s first-to-market G12C KRAS inhibitor Lumakras (sotorasib). In its second-quarter 2023 earnings report, Mirati reported net revenue of $13.4 million for Krazati. During the same period, Lumakras made $77 million.

Thursday’s buyout rumors also come as Mirati is facing clinical and business challenges. In May 2023, the company’s investigational kinase inhibitor sitravatinib failed the Phase III SAPPHIRE trial. When given as part of a combination regimen with Bristol Myers Squibb’s Opdivo (nivolumab), sitravatinib did not significantly improve overall survival in patients with non-squamous, non-small cell lung cancer.

The disappointing SAPPHIRE results convinced Mirati to terminate all development of sitravatinib outside the Asia-Pacific region.

In August 2023, CEO David Meek announced that he was relinquishing his leadership position at Mirati as well as his seat on the company’s board of directors. Meek has since stayed with the company as a consultant, but that is set to end on Oct. 15.

Despite these headwinds, Mirati isn’t the only player to face challenges in the space. On Thursday, Mirati’s chief KRAS competitor Amgen suffered a defeat at the hands of the FDA’s Oncologic Drugs Advisory Committee. The panel of external experts voted 10-2 that Amgen’s progression-free survival data for Lumakras could not be reliably interpreted due to concerns of study bias.

Amgen is seeking to convert Lumakras’ accelerated approval to traditional approval, and the adcomm convened to discuss the company’s Phase III confirmatory trial CodeBreaK 200. The FDA is set to release its decision on the matter by Dec. 14.

https://www.biospace.com/article/sanofi-mulls-mirati-therapeutics-buy-as-kras-battle-heats-up-bloomberg-/