Boehringer Ingelheim has revamped its portfolio and pipeline by inking a immunology-focused licensing deal with Sitryx Therapeutics worth more than $500m, while seperately securing an expanded US approval for its cancer therapy, Hernexeos (zongertinib).
At the heart of Boehringer’s deal with Sitryx is the latter’s early-stage immunometabolic programme – which includes several oral small molecule inhibitor candidates targeting an undisclosed novel mechanism. Boehringer has touted these candidates as “potentially disease-modifying” options across certain inflammatory and autoimmune conditions.
In exchange for the exclusive global license to Sitryx’s preclinical programme, Boehringer will hand over an undisclosed figure in upfront and near-term payments. The British biotech could also receive development, regulatory and commercialisation milestone payments worth more than $500m through this deal, as well as tiered royalties in future sales if any drug from the partnership were to reach the market.
“Autoimmune and inflammatory diseases remain areas where innovation is urgently needed,” said Carine Boustany, head of immunology and respiratory diseases research at Boehringer Ingelheim. “Sitryx’s small molecule inhibitor programme brings forward a promising new mechanism that aligns with our focus on advancing first-in-class approaches,” Boustany added.
According to GlobalData’s Pharmaceutical Intelligence Center, Boehringer Ingelheim signed the largest number of licensing deals in over a decade of its history in 2025, with a large proportion (>50%) of these agreements being oncology and immunology-focused.
Hernexeos progresses to frontline NSCLC
Elsewhere in its business, Boehringer has posted a win for its oncology portfolio through the US accelerated approval of its tyrosine kinase inhibitor (TKI), Hernexeos (zongertinib) in frontline, HER2-mutant non-small cell lung cancer (NSCLC). This makes Hernexeos the second therapy to get the US Food and Drug Administration (FDA) greenlight through the Commissioner's National Priority Voucher (CNPV) pilot programme, which has prompted discourse amongst experts on how voucher awards are prioritised. Boehringer previously got the FDA go-ahead for Hernexeos in chemotherapy-refractory NSCLC back in August 2025.
Hernexeos’ frontline approval was based on the results of the Phase Ib Beamion LUNG-1 trial (NCT04886804), which saw the drug trigger an objective response rate (ORR) of 76% in patients with treatment-naïve disease. To secure full approval, Boehringer is enrolling patients onto the confirmatory Beamion LUNG-2 study (NCT06151574), which the company estimates will reach primary completion in November 2026, as per ClinicalTrials.gov.
Hernexeos’ label expansion sees it become the only targeted therapy approved for use in treatment-naïve patients with HER2-mutant NSCLC. However, Bayer is also looking to push its recently approved TKI, Hynruo (sevabertinib), into the first-line setting through the Phase III, open-label SOHO-02 study (NCT06452277).
The current standard of care in HER2-mutant NSCLC is chemotherapy with or without immunotherapy. According to board chair and head of human pharma at Boehringer Ingelheim, Shashank Deshpande, Hernexeos’ approval will “mark a shift towards personalised care” in patients with this type of lung cancer. A 2024 paper published in Clinical Lung Cancer estimates that 1% to 7% of patients with NSCLC have HER2-mutated disease.
In conversation with Clinical Trials Arena, sister company of Pharmaceutical Technology, practicing oncologist and NSCLC expert, Balazs Halmos, noted that it will be hard as a physician to prioritise either Bayer’s TKI, sevabertinib, or Hernexeos based on efficacy and safety.
