Onco-Summaries: Daily Oncology Updates at a Glance

02/02/2026

---

• OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma

  
  

• Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA

  
  

• TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma

---

OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma (Ref)

OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.

• The non-clinical and the CMC modules of the BLA have been submitted to the FDA

  
  

• OS has requested for a Rolling Review

  
  

• The company expects to submit the clinical BLA module by the end of Mar 2026, keeping it on schedule to be eligible to receive approval by Sep 30, 2026

Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA (Ref)

The US FDA accepted Exelixis' NDA for zanzalintinib (multi-TKI) + Roche's atezolizumab (anti-PD-L1) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-EGFR therapy

• The FDA assigned a standard review with a PDUFA target action date of Dec 03, 2026

  
  

• The NDA is based on the results of the Phase 3 STELLAR-303 pivotal trial

TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma (Ref)

The US FDA granted the orphan drug designation to TuHURA Biosciences' IFx-2.0 (innate immune agonist) for the treatment of stage IIB to stage IV cutaneous melanoma.

• The ODD was based on data from the Company's previously completed Phase 1 study of IFx-2.0 in patients refractory to checkpoint inhibitor therapy (anti-PD1)

  
  

• Dr. James Bianco, President and Chief Executive Officer, TuHURA Biosciences: "Our current focus with IFx-2.0 is targeting completion of enrollment in our Phase 3 study of IFx-2.0 in combination with Keytruda® for the first-line treatment of advanced or metastatic Merkel Cell Carcinoma. We believe receiving ODD in advanced cutaneous melanoma demonstrates not only the significant need for new treatments in skin cancer but also highlights IFx-2.0 as a potential new therapeutic approach in this patient population."