Olaptesed Pegol Wins FDA Fast Track Designation in Brain Cancer

3D illustration of tumor in brain: © peterschreiber.media - stock.adobe.com

• Olaptesed pegol (NOX-A12) is a CXCL12 inhibitor being developed as a combination therapy with bevacizumab (Avastin) plus radiotherapy for the treatment of brain cancer.
• In March 2024, the FDA cleared the investigational new drug application of olaptesed pegol.
• With this fast track designation, TME Pharma, manufacturer of olaptesed pegol, is eligible for more frequent interactions with the FDA as well as accelerated approval and priority review.

The FDA has granted a fast track designation to olaptesed pegol plus bevacizumab and radiotherapy for the treatment of patients with newly diagnosed glioblastoma that is resistant to chemotherapy and where measurable tumor remains after surgery.¹

A fast track designation from the FDA is indicated for agents that treat serious conditions and address unmet needs and expedites the development and review of these agents. TME Pharma, the manufacturer of olaptesed pegol, is now eligible for more frequent meetings with the FDA, and olaptesed pegol may be eligible for priority review and accelerated approval, if additional criteria are met.

In March 2024, the FDA cleared the investigational new drug application for a phase 2 study of olaptesed pegol in this intent-to-treat population.²

In the phase 1/2 GLORIA study (NCT04121455), olaptesed pegol plus bevacizumab and radiotherapy delivered a median overall survival of 19.9 months, and the 19-month survival rate was 10 times higher in the olaptesed pegol cohort vs a matched reference cohort received the standard of care (50% vs 5%, respectively).³

"At the start of this year, we announced the next phase of our development of [olaptesed pegol] by targeting [investigational new drug] approval and an expedited regulatory pathway in the US, and we are very proud to have successfully achieved these milestones within the timeframe we set out," said Aram Mangasarian, chief executive officer of TME Pharma, in a press release.1 "We now have a clear clinical development roadmap with which to take [olaptesed pegol] forward in the treatment of glioblastoma and to support engagement with potential partners. We expect our new phase 2 study will build on the unprecedented results of our GLORIA trial, which strengthens the potential of [olaptesed pegol] to become the treatment option of choice for newly diagnosed chemotherapy-resistant glioblastoma.”

The GLORIA trial is ongoing across 6 sites in Germany and has a planned completion date of December 2024.

Investigators also plan to evaluate olaptesed pegol for the treatment of pancreatic cancer in the phase 2 OPTIMUS study (NCT04901741), which has a planned start date of June 2024.

REFERENCES:

1. TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer. News release. TME Pharma. April 2, 2024. Accessed April 3, 2024. https://tinyurl.com/muvexvm4

2. TME Pharma announces FDA clearance of investigational new drug (IND) application for NOX-A12 phase 2 trial in brain cancer. News release. TME Pharma N.V. March 5, 2024. Accessed April 3, 2024. https://tinyurl.com/5t3zvayv

3. TME Pharma announces further improvement in median overall survival at 19 months follow-up in GLORIA brain cancer trial. News release. TME Pharma. December 20, 2023. Accessed April 3, 2024. http://tinyurl.com/yc27wz5m