ODM-216 / Orion Corp - LARVOL DELTA

A novel anti-PVRIGxPD-L1 bispecific antibody demonstrated improved anti-tumour efficacy in pre-clinical murine tumour models (ESMO 2026) - "To further support the efficacy observed in mouse tumour models, mechanism-of-action studies revealed a significant upregulation of immune activation–related gene signatures in tumours. In vitro and in vivo preclinical data demonstrates an acceptable nonclinical safety profile for anti-PVRIGxPD-L1 bispecific antibody, with no dose-limiting toxicities.Conclusions Collectively, these findings support simultaneous blocking of PVRIG and PD-L1 as a promising therapeutic approach that may be both safe and effective treatment option for patients who do not respond to current standard-of-care therapies."

Bispecific • IO biomarker • Preclinical • Oncology • Solid Tumor • NECTIN2

Two-part, first-in-human trial evaluating a PVRIGxPD-L1 bispecific antibody in participants with selected advanced solid tumours (ESMO 2026) - "Eligibility for the Part 2 expansion cohorts requires participants to have the specific cancer type designated for that cohort, along with measurable disease per RECIST v1.1 and documented disease progression. Prospective biomarker testing, including PVRL2 expression status, may be utilized for participant selection for specific cohorts during this part."

Bispecific • First-in-human • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor • NECTIN2

Orion Corporation…announced that the first patient has been dosed in the BICIDES Phase 1/2 clinical trial evaluating the safety, pharmacokinetics and preliminary anti-tumor activity of ODM-216, an investigational bispecific antibody simultaneously targeting PVRIG and PD-L1 in patients with advanced solid tumors (GlobeNewswire) - "ODM-216 is Orion Pharma’s first biologic candidate and first immuno-oncology treatment to enter clinical testing in humans."

First-in-human • Trial status • Solid Tumor

BICIDES: Trial to Study the Safety, Pharmacokinetics and Preliminary Antitumour Activity of ODM-216 in Patients With Cancer (clinicaltrials.gov) - P1/2 | N=195 | Recruiting | Sponsor: Orion Corporation, Orion Pharma

First-in-human • New P1/2 trial • Oncology • Solid Tumor