Glenmark spin-out Ichnos Sciences wants its pipeline of biologic and small molecule drug candidates to be generating clinical data within two years.

New Jersey Ichnos announced its plan this week to coincide with the official launch of the company.

It said it will progress its most advanced assets – the cancer drugs GBR 1302 and GBR 1342, the autoimmune disease MAb GBR 830, and the non-opioid pain meds GRC 27864 and GRC 17536 – through trials by 2021.

Glenmark’s facility in La-Chaux-de-Fonds, Switzerland. Image: Google

Biologics

The immune-oncology candidates – GBR 1302 and GBR 1342 – are bi-specific antibodies, which are capable of binding several targets. The former drug is in Phase I trials for the treatment of HER2 positive breast cancer.

GBR 1342 binds both the CD3 receptor on T cells and a molecule called CD38 on target cells. Binding activates T cells and directs them toward CD38+ tumour cells that are found in a range of blood cancers.

GBR 1342 is being studied for multiple myeloma. In September, the US Food and Drug Administration (FDA) granted the candidate orphan drug designation.

Both drug candidates were developed using a proprietary CHO cell line-based antibody production platform – known as Beat – which Ichnos describes as a key asset.

Although Ichnos is headquarted in the US, its biologics operations are based in Switzerland. They include a research and development site in Lausanne and a GMP manufacturing and process development facility in La-Chaux-de-Fonds.

Separation

Ichnos’s foundations were established in February when parent firm Glenmark Holding SA said it would spin off the organisation as a stand-alone biotech.

At the time Glenmark Pharmaceuticals MD Glenn Saldanha said the portfolio of drug candidates justified the move.

“With the pipeline at an advanced stage, we believe it’s the right time for the innovation business to be an independent entity and charter its own journey towards becoming a leading biotech organization globally.

He added, “This change will provide enhanced focus to the business, a better operating ecosystem and additional opportunities to unlock value for the parent company in future.”

This separation process is still ongoing according to Ichnos, which said it “is in the process of obtaining all the necessary statutory, legal, corporate and regulatory approvals for completion of the spin-off, which is expected to occur in the first quarter of calendar year 2020.”