The clinical ambitions of these two ASX biotechs just got a boost from the FDA

Immutep (ASX:IMM) and Opthea (ASX:OPT) both received the blessing of the FDA for their clinical trial ambitions this morning, with Immutep winning approval to start a clinical trial and Opthea winning Fast Track Designation.

Opthea gets Fast Track Designation

Opthea is a biotech targeting eye diseases (most particularly macular degeneration).

It’s OPT-302 drug works by targeting Vascular endothelial growth factor (VEGF) which can cause blindness through excess fluid leaking into the retina.

Unlike many other treatments, OPT-302 targets multiple VEGFs rather than just one (VEGF-A).

After passing Phase II clinical trials in 2019 and 2020, it is eyeing off a larger Phase III clinical trial for Wet Age-Related Macular Degeneration (Wet-AMD), as well as DME.

Today Opthea announced the FDA granted it Fast Track Designation.

The company says this gives it benefits to expedite the program. Further down the track, it also offers a potentially faster pathway to formal approval and commercialisation, including more frequent meetings and communications with the FDA.

Opthea’s boss Megan Baldwin said she welcomed getting Fast Track Designation and the support it provided not just to her company, but wet-AMD providers who needed better treatments.

“The recognition from the FDA to grant OPT-302 Fast Track designation reflects the seriousness of wet AMD as a debilitating eye disease and the importance of advancing new therapies such as OPT-302 to address the significant unmet medical need for wet AMD patients, many of whom experience an incomplete response to VEGF-A inhibitors despite regular, ongoing therapy,” she said.

“By targeting a novel mechanism of action, OPT-302 has the potential to be a truly differentiated treatment option that when used in combination offers patients improved vision outcomes over standard of care anti-VEGF-A monotherapy.”

Opthea (ASX:OPT) share price chart

Immutep obtains approval

Immutep was granted approval to start a Phase IIb trial with its eftilagimod alpha (“efti) drug against Head and Neck Squamous Cell Carcinoma (HNSCC).

This drug works as PD-1 pathway inhibitor – blocking a method cancer cells use to hide from the body’s immune system.

Immutep says it will now begin patient recruitment for the study in America.

The trial is planned to take place across 35 clinical sites in the US, Australia and Europe pending regulatory approval in the latter two jurisdictions.

The study will be run in conjunction with Merck & Co/MSD’s immunotherapy IV injection Keytruda.

Earlier clinical trial results in smaller groups of patients have shown encouraging results for the combination of efti and Keytruda and the company said today it looked forward to building on them.