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Orphan drug status for Synovo's immune modulator SYD003

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to Synovo's investigational compound SYD003, a first in class tumour-targeted immune modulator.

Michael Burnet, CEO of Synovo GmbH © Synovo GmbH

SYD003 will be evaluated for safety and efficacy in patients with pancreatic cancer as well as other cancers. Pancreatic cancer is one of the most lethal cancer types. Each year in the U.S. and Europe, roughly 100,000 people are diagnosed with pancreatic cancer, which has a five year survival rate of less than three percent with the majority of patients succumbing within 6 to 12 months after diagnosis.

"The orphan drug designation is an important regulatory achievement towards our goal of developing tumour-targeted immune modulators for pancreatic cancer" said Dr Michael Burnet, Managing Director of Synovo. "We are pleased, to continue developing SYD003, a first in class compound with a unique mode of action in cancer." He added.

Immune modulation as a therapy for cancer

“SYD003 is a novel compound that causes the inhibited immune cells around a tumour to become active. Under the influence of SYD003, these cells can directly attack the tumour, or activate other immune cells, so-called T-cells, that were suppressed by the tumour during its growth” said Synovo Pharmacist Enriqueta Vallejo. “It is a compound of great potential because it can be combined with many therapies and it appears to be better tolerated than many conventional cancer treatments”, She added.

The candidate is the product of a multi-year international program sponsored in part by European Research funding. European Research Fellow Dr Linda Sandin, a Swedish scientist now based in Tübingen, Germany, explained “Most tumours are killed by the immune system soon after they arise as a small cluster of cells. Indeed, the immune system is normally very efficient at detecting and killing small tumours. However, most tumours that become malignant evolve to secrete signals that cause the immune response to be suppressed and immune cells that detect the growing tumour are rendered inactive as soon as they contact the tumour. Many aggressive tumours are very effective at not only making immune cells inactive, but causing them to cooperate with the tumour helping it to grow even faster. These cells that are seduced by the tumour not only orchestrate a local immune suppression, but they also make it possible for tumour cells to migrate and they encourage blood vessels to grow into the tumour. This leads to metastatic disease and poor prognosis.

Better than standard chemo therapies

SYD003 interrupts the signalling by tumours to these cells and causes them to be aggressive toward the tumour. This immune attack on the tumour is itself helpful, but it also supports and enhances other types of therapy like chemo and antibody-therapy, to make them more effective.”

The pre-clinical studies evaluating SYD003 in pancreatic cancer models over a number of years demonstrated remarkable activity for a non-cytotoxic compound. Such compounds are more easily tolerated than conventional chemotherapy. Indeed, in earlier safety studies in human subjects, the active ingredient of SYD003 was well tolerated at doses much higher than those planned for pancreatic cancer trials.

Synovo is now working with its partners and collaborators to move SYD003 into clinical trials.

Synovo GmbH
Paul Ehrlich Str. 15
D - 72076 Tübingen
Phone: +49 7071 6397812
Fax: +49 7071 964326
E-mail: contact(at)synovo.com

Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/orphan-drug-status-for-synovo-s-immune-modulator-syd003