Medigene axes staff and refocuses its TCR pipeline

Medigene has said it will cut 40% of its workforce and delay the start of clinical trials of its lead asset as it re-jigs its pipeline of T-cell receptor (TCR) therapies for cancer.

For the time being, the German immuno-oncology specialist has shelved the development of lead candidate MDG1015 – a first-in-class, TCR-based T-cell therapy (TCR-T) targeting NY-ESO-1/LAGE-1a-positive tumours – and all the rest of its autologous cell therapy programmes, including a trio targeting KRAS (MDG2021, MDG2011, and MDG2012).

Those may be resurrected if the biotech can find partners or additional financing to take them forward but, for now, it intends to direct its energies on off-the-shelf (allogeneic) TCR therapies that don't rely on harvesting cells from patients and lengthy manufacturing and treatment processes.

It will also continue to work on a TCR-guided T-cell engager (TCR-TCE) programme – codenamed MDG3010 and targeting hard-to-treat solid tumours – which was partnered with China's WuXi Biologics in the summer, and said it expects to announce additional alliances for its TCR-TCE pipeline.

In a statement, Medigene's chief executive, Selwyn Ho, said the "difficult decision" to reduce the company's headcount and reduce its cash burn "enables us to keep our strategic options open."

FDA approval to start the first clinical trial of MDG1015 came in September and Medigene had been intending to start dosing patients within the next few months, with results expected before the end of 2025. The biotech said it remains confident in the potential of MDG1015.

"Medigene has continuously prioritised projects and optimised the allocation of our resources to the R&D work and programmes that we believe create the most value for patients and shareholders," said Ho.

"As we implement these changes, we are grateful to all our employees for their dedication, passion, and commitment in advancing TCR-guided therapies to patients and we will support all our employees through this difficult process," he added.

Medigene ended the third quarter with cash reserves of €9.7 million ($10.2 million) – down from €16.7 million at the end of last year – which it said would allow it to keep operating through July 2025.

The cost savings from the restructuring will offset lower income expected in 2025, and the company is now looking into "appropriate financing and strategic options" to finance the business into 2026 and beyond.