Onco-Summaries: Daily Oncology Updates at a Glance

21/01/2026

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• BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1

  
  

• Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies

  
  

• Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis

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BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 (Ref)

The US FDA granted the fast track designation to BioNTech's BNT113 (HPV16 E6/7 mRNA vaccine) + pembrolizumab for the treatment of pts with HPV16+ R/M SCCHN with PD-L1 CPS ≥1. 

• The designation has been granted based on results from the Ph2 safety run-in part of the Ph2/3 AHEAD-MERIT trial of BNT113 + pembro in HPV16+ R/M SCCHN with PD-L1 CPS ≥1

  
  

  • At mFU of 12.0 mos, following results were reported in 15 pts

    
    

    • ORR: 40.0% (CR: 26.7%)

    
    

    • mPFS: 6.0 mos

    
    

    • mOS: 22.6 mos

    
    

    • ​Gr≥3 TRAEs: 13.3% (no Gr5 TRAEs)

Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies (Ref)

The US FDA granted the Breakthrough Therapy Designation to Wugen's Soficabtagene Geleucel (sofi-cel; anti-CD7 CAR-T cell therapy) for the treatment of T cell malignancies.

• A pivotal Phase 2 T-RRex study of sofi-cel for relapsed or refractory T-Cell ALL/LBL in pediatric and adult patients is ongoing

• The designation was granted based on data from the global Phase 1/2 clinical trial evaluating sofi-cel in patients with R/R T-ALL/LBL.

Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis (Ref)

The US FDA granted the orphan drug designation to Opna Bio's zavabresib (OPN-2853; BET small molecule inhibitor) for the treatment of myelofibrosis.

• Reinaldo Diaz, CEO, Opna Bio: “Receiving Orphan Drug Designation for zavabresib in myelofibrosis is a significant regulatory milestone for Opna Bio and highlights the urgent need for new and effective treatment options for patients with this disease. Our investigator-sponsored clinical trial with zavabresib and ruxolitinib has shown impressive results to date, including durable spleen reduction in patients with advanced myelofibrosis. We believe that selective BET inhibition alongside JAK inhibition offers a promising new therapeutic approach for patients with myelofibrosis. We are further encouraged by recent positive meetings with the FDA to continue to test zavabresib in additional clinical studies.”

• In the Phase 1 PROMise study, zavabresib is being evaluated as an add-on to ruxolitinib in patients with myelofibrosis who are no longer responding to ruxolitinib