Sevabertinib

iStock, SiyueSteuber For $1.3 billion in aggregate—including upfront and milestone payments—Bayer will get exclusive global access to Kumquat Biosciences’ small-molecule KRAS G12D blocker. Bayer is putting up to $1.3 billion on the line to partner with San Diego–based Kumquat Biosciences and advance its KRAS G12D inhibitor for a variety of oncology targets. The companies did not reveal a specific financial breakdown for the transaction, only noting that the $1.3 billion sum encompasses an upfront commitment plus clinical and commercial milestones down the line. Kumquat will also be eligible for tiered royalties on net sales of the cancer drug if it reaches the market, according to the announcement Tuesday. For its investment, Bayer will gain exclusive rights over Kumquat’s investigational KRAS G12D inhibitor, which last month won the FDA’s blessing to start clinical studies. Kumquat will be responsible for seeing the drug through Phase Ia development. Bayer will be in charge of completing the molecule’s clinical development from there and for running its regulatory and market activities. As per the terms of Tuesday’s pact, Kumquat will also have the option to negotiate with Bayer for a profit-loss sharing arrangement in the U.S. In a prepared statement, Juergen Eckhardt, head of Business Development and Licensing at Bayer’s Pharmaceuticals Division, said that the partnership with Kumquat will not only allow the pharma to “explore . . . a potential new treatment option” for patients with cancer but also give it a precision asset that complements its own oncology portfolio. Bayer’s oncology activities are anchored by the androgen receptor blocker Nubeqa, which was first approved in 2019 for non-metastatic castration-resistant prostate cancer. The drug picked up another indication in June this year for metastatic castration-sensitive prostate cancer with or without chemotherapy. Bayer is also working on sevabertinib, which is currently under the FDA’s priority review for HER2-mutant non-small cell lung cancer. With Kumquat, Bayer plays catch-up to Revolution Medicines, which is also targeting KRAS G12D with its drug candidate zoldonrasib. Phase I data released in April demonstrated “preliminary tumor activity,” the biotech noted at the time, with an objective response rate of 61% in 18 evaluable patients. Last week, Revolution revealed plans to take zoldonrasib into pivotal development next year. For Kumquat, Bayer is its third powerhouse partner. In July 2021, the biotech linked up with Eli Lilly’s Loxo Oncology in a partnership to develop small molecule cancer drugs. That deal entailed a $70 million upfront payment from Lilly and milestones of up to $2 billion. In April 2024, Kumquat received $130 million upfront from Takeda for one of its small molecule immuno-oncology inhibitors for an undisclosed oncology target. Takeda tacked on more than $1.2 billion in milestones.

Boehringer Ingelheim’s oral tyrosine kinase inhibitor, Hernexeos, has received accelerated approval from the FDA. Image credit: create jobs 51 via Shutterstock.com. Boehringer Ingelheim has received fast-track approval from the US Food and Drug Administration (FDA) for its targeted therapy, Hernexeos (zongertinib tablets) , to treat non-small cell lung cancer (NSCLC). This approval succeeds the positive results of the Phase Ib Beamion-LUNG 1 trial (NCT04886804), with the oral tyrosine kinase inhibitor (TKI) demonstrating an objective response rate (ORR) of 75% in patients with HER2-positive NSCLC who had received prior lines of platinum-based chemotherapy. Its FDA approval makes it the first oral treatment for HER2-positive NSCLC. Hernexeos also triggered a duration of response (DOR) of more than six months in 58% of the 71 patients previously treated with chemotherapy alone, while 27% of the 34 individuals with prior exposure to chemotherapy and a HER2 targeted therapy experienced a DOR of this length. Impacting 2%-4% of patients diagnosed with NSCLC, HER2 mutations are associated with poor prognosis and a higher risk of brain metastasis, while treatment options are highly limited in this population. Due to Hernexeos’ potential to fulfil unmet needs in this indication, the FDA granted Boehringer priority review and breakthrough therapy designation last year. The therapy’s full approval will likely rely on verification of clinical benefit in a confirmatory trial. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Dr John Heymach, co-ordinating investigator on the Beamion-LUNG 1 trial and chair of thoracic/head and neck medical oncology at the MD Anderson Cancer Centre, said: “The approval of zongertinib offers an effective and targeted treatment option for patients with HER2-mutant NSCLC in the US that not only elicits a durable response, but also has a manageable safety profile. “In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.” HER2-targeted therapy race heats up Though the current standard of care (SoC) for patients with HER2-mutated NSCLC still revolves around a platinum-based chemotherapy regimen, physicians are increasingly prescribing targeted therapies to improve outcomes. A notable example of this is AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC ) Enhertu (trastuzumab deruxtecan), which became the first HER2-targeting therapy to receive approval for NSCLC in 2022. Following its accelerated FDA approval, the drug has already reached blockbuster status – raking in $4.1bn in 2024 for the company, according to Pharmaceutical Technology ’s parent company, GlobalData. GlobalData predicts that the drug is on track to pull in $14.6bn by 2031, highlighting the lucrative nature of the targeted oncology market. However, Hernexeos has demonstrated a higher ORR of 75% compared with Enhertu’s 56% in the DESTINY-Lung02 trial. The TKI has also proved efficacious in patients who had previously received treatment with an ADC, suggesting that the TKI could absorb some of Enhertu’s market share. Looking ahead, the drug may also face competition from other targeted therapies currently in Phase III clinical trials, with GlobalData giving Bayer’s TKI sevabertinib a likelihood of approval (LoA) score of 81% in this indication. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now