Onco-Summaries: Daily Oncology Updates at a Glance

14/04/2026

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• FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma

• FDA sBLA Submission & NCCN Guideline Inclusion for BIZENGRI in NRG1 Fusion–Positive Cholangiocarcinoma

  
  

• Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement to advance OBX-115 TIL Therapy

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FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma (Ref)

Renaissance Pharma's Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody, has received Fast Track status from the U.S. FDA for treating high-risk neuroblastoma (HRNB), a rare pediatric cancer

• Clinical trial progress: The FDA has cleared the IND application, enabling the start of the SHINE Phase II/III clinical trial in relapse or refractory children with HRNB in the US

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FDA sBLA Submission & NCCN Guideline Inclusion for BIZENGRI in NRG1 Fusion–Positive Cholangiocarcinoma (Ref)

Partner Therapeutics (PTx) submitted a supplemental Biologics License Application (sBLA) to the FDA for BIZENGRI® (zenocutuzumab-zbco), seeking approval for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion

• The sBLA is supported by data from the eNRGy study evaluating zenocutuzumab-zbco in patients with NRG1 fusion-positive cancers, including cholangiocarcinoma

  
  

  • Overall response rate (ORR): 36.8% (95% CI: 16.3–61.6%).

  
  

  • Median duration of response (DOR): 12.9 months.

  
  

  • Treatment was generally well tolerated; no discontinuations due to adverse events

NCCN added zenocutuzumab‑zbco to the Oncology Clinical Practice Guidelines for:

• Category 2A recommendation for subsequent-line therapy for biliary tract cancers

• Category 2B recommendation for front-line treatment in NRG1 fusion–positive cholangiocarcinoma

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Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement to advance OBX-115 TIL Therapy (Ref)

• Obsidian Therapeutics and Galera Therapeutics have entered into a definitive merger agreement in an all-stock transaction

• The combined company will operate as Obsidian Therapeutics, Inc., applying to list on Nasdaq under the ticker OBX

• A $350 million oversubscribed private placement will close immediately before the merger, funding operations into 2H 2028

Pipeline & Lead Asset:

• Lead candidate: OBX-115, an engineered autologous TIL cell therapy

  
  

  • Phase 2 trial: advanced melanoma

    
    

  • Phase 1 trial: non-small cell lung cancer (NSCLC)

    
    

Key milestones:

• NSCLC Phase 1 data expected 1H 2027

  
  

• Melanoma registration-enabling data expected year-end 2027

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