Biomedicine Daily · Sunday, 20 September 2026
CBA FRONTIER INSIGHTS
Ivonescimab Beats Pembrolizumab on Overall Survival in PD-L1-Positive NSCLC
Akesu Bio's PD-1/VEGF bispecific antibody ivonescimab has beaten pembrolizumab on overall survival as first-line monotherapy in PD-L1-positive non-small cell lung cancer, data presented by Professor Zhou Caicun at the WCLC presidential symposium show. In the HARMONi-2 trial, median overall survival reached 30.8 months versus 22.6 months with pembrolizumab, with HR=0.73 and P=0.009. Ivonescimab is now the first drug to outperform pembrolizumab in a randomized controlled trial on two endpoints. Also today: the FDA approved Bayer's Kerendia for chronic kidney disease associated with type 1 diabetes, the first new therapy for this population in over 30 years, and Abogen reported in Cell that its mRNA-encoded CD19×CD3 T cell engager fully depleted B cells in three refractory autoimmune patients.
Clinical readouts and safety
Ivonescimab Beats Pembrolizumab on Overall Survival in HARMONi-2 Trial
Ivonescimab, Akesu Bio's PD-1/VEGF bispecific antibody, beat pembrolizumab as first-line monotherapy in PD-L1-positive non-small cell lung cancer in the HARMONi-2 trial. Median overall survival was 30.8 months versus 22.6 months with pembrolizumab, HR=0.73, P=0.009, presented by Professor Zhou Caicun at the WCLC presidential symposium. It is the first drug to beat pembrolizumab in a randomized controlled trial on two endpoints.
Regulatory and policy
FDA Approves Bayer's Kerendia for Type 1 Diabetes-Related Chronic Kidney Disease, First New Therapy in Over 30 Years
The US FDA has approved Bayer's Kerendia (finerenone) for chronic kidney disease associated with type 1 diabetes, making it the first entirely new therapy for this population in more than 30 years. The approval is finerenone's third in the US, following July 2021 approval for reducing cardiorenal risk in adults with CKD related to type 2 diabetes and July 2025 approval for symptomatic chronic heart failure with LVEF of at least 40%. Finerenone is now the only mineralocorticoid receptor antagonist approved for CKD related to both type 1 and type 2 diabetes.
Research papers
A retinoic acid autoregulatory loop governing prefrontal-motor arealization.
A conserved retinoic acid autoregulatory loop, RA → MEIS2 → ALDH1A3 → RA, reinforces a PFC-enriched RA gradient and organizes the motor cortex–prefrontal cortex axis. MEIS2, a transcription factor linked to intellectual disability and autism spectrum disorder, acts as a key hub of an RA-associated gene regulatory network defined in the developing human PFC. Conditional deletion of Meis2 in postmitotic cortical excitatory neurons in mice partially respecified prospective prefrontal association territories towards motor-like molecular and connectivity features, and reduced ALDH1A3-expressing neurons and RA signalling in the developing medial PFC.
Abogen's mRNA-Encoded CD19×CD3 T Cell Engager Fully Depletes B Cells in 3 Refractory Autoimmune Patients
Abogen published in Cell an mRNA approach encoding a CD19×CD3 T cell engager in vivo, and in 3 patients with refractory autoimmune disease it achieved complete B cell depletion. This moves mRNA-encoded T cell engagers from oncology toward autoimmune disease.
Methods and resources
Translational efficiency guides microbial community remodeling
A commentary in Gut Microbes highlights the MIND framework (Microbial Interaction and Niche Determination), introduced by Moyne et al. in Cell. MIND uses translational efficiency to map resource competition and niche partitioning among microbes, moving beyond the correlative limits of metagenomics. It provides a mechanistic blueprint for causal, rational engineering of microbial communities.