Onco-Summaries: Daily Oncology Updates at a Glance

20/08/2025

Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer (Ref)

The US FDA granted the Orphan Drug Designation to Invion's INV043 (photodynamic therapy) for the treatment of anal cancer.

• Invion is working with Peter Mac to conduct an trial of INV043 in combination with ICIs in anogenital cancer including anal, vulvar and penile cancers

  
  

• Prof Thian Chew, Executive Chairman and CEO, Invion: “This regulatory milestone enhances our ability to bring INV043 forward more quickly and cost-efficiently, with meaningful benefits for patients suffering from this challenging disease. Over the next five years, the pharmaceutical industry is facing its biggest patent cliff since 2010 as several blockbuster drugs, including ICIs, are expected to lose their patent protection. The Orphan Drug Designation may increase our appeal to strategic partners because of the potentially accelerated pathway to leverage intellectual property that combines their ICIs with our complementary technology.”

Novocure filed the PMA application for Tumor Treating Fields Therapy in Locally Advanced Pancreatic Cancer (Ref)

Novocure submitted a premarket approval application to the US FDA for TTFields therapy for the treatment of locally advanced pancreatic cancer.

• This submission was based on results from the Phase 3 PANOVA-3 trial in which TTFields + gemcitabine + nab-paclitaxel as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma met its primary endpoint of OS vs chemo alone

  
  

• Novocure anticipates an approval decision in H2'26

Mural Oncology to be acquired by XRA 5 Corp., a wholly owned subsidiary of XOMA Royalty (Ref)

Mural Oncology and XOMA Royalty Corporation have entered into a definitive agreement under which XRA 5 Corp., a newly formed company wholly owned by XOMA Royalty will acquire Mural.

• Each Mural shareholder would receive a base cash price of $2.035 per share, and may receive an additional cash amount per share of up to $0.205  

  
  

• Caroline Loew, CEO, Mural: "The Transaction Agreement with XOMA Royalty announced today is the result of a thorough and wide-ranging strategic review process, conducted with the support of our legal and financial advisors. We believe that this transaction, which is supported by our Board, achieves the goal of this strategic review process, which was to maximize shareholder value."