Onco-Summaries: Daily Oncology Updates at a Glance

08/09/2025

Beyond Air's BA-101 received the Orphan Drug Designation for GBM (Ref)

The US FDA granted the Orphan Drug Designation to Beyond Air's BA-101 for the treatment of Glioblastoma (GBM).

• Amir Avniel, CEO, NeuroNOS: “We are pleased to receive orphan drug designation from the FDA for the treatment of glioblastoma. This is our second orphan drug designation and further highlights our mission to bring targeted therapies to individuals and families affected by rare neurological conditions, while also marking our entrance into oncology".

  
  

  • Glioblastoma is one of the most common and deadliest brain cancers in adults, however, patients have seen little improvement in treatment options over the past several decades. Emerging industry research shows that NO is an important modulator of biological therapy response in Glioblastoma. We believe this data and the urgent unmet medical need have highlighted the opportunity for our groundbreaking science to develop small molecule therapies that balance nitric oxide levels in the brain. We believe an NO inhibition strategy has the potential to transform outcomes for patients.”

BioNTech & BMS' pumitamig + chemo showed promising outcomes in ES-SCLC (Ref)

BioNTech SE and Bristol Myers Squibb presented interim data from a global randomized Phase 2 NCT06449209 trial of pumitamig (BNT327/BMS986545; PD-L1 x VEGF-A BsAb) + chemotherapy in patients with extensive-stage SCLC.

• In 38 efficacy-evaluable patients, the confirmed ORR was 76.3% and the DCR was 100%

  
  

• mPFS was 6.8 months, with mOS not being mature at the time of the analysis

  
  

• The combo showed a manageable safety profile