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Merck takes novel immuno-oncology drug into clinical trials

Potential to offer alternative to anti-PD-1/anti-PDL1 immunotherapies 
Merck KGaA

Merck KGaA has started trials of a novel immuno-oncology drug that tackles two pathways in one molecule and could represent an advance on current cancer immunotherapies.

The bifunctional immunotherapy - called M7824 - was one of the highlights of an R&D update held yesterday at which the company highlighted its pipeline of new drug candidates in its three target areas of oncology, immuno-oncology and immunology.

The drug is double-headed fusion protein that is thought to work by restoring and enhancing anti-tumour immune responses and - in preclinical animal models - has demonstrated a 100% complete response rate.

Merck is not ready to divulge the molecular targets for M7824 just yet, but says it has started phase I trials and is due to start additional trials in solid tumours in the middle of next year. The drug "has the potential to offer an alternative therapy to anti-PD-1/anti-PD-L1 and other immunotherapies," according to Luciano Rossetti, global head of R&D at the company's Merck Serono division.

In the oncology pipeline, Merck highlighted tepotinib, an inhibitor of c-Met that is moving forward in multiple phase II trials including patients with non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC), with data due in 2017.

Merck also discussed a Bruton's tyrosine kinase (BTK) inhibitor that is in early trials but promises to be a best-in-class therapy with fewer side effects than its rivals, such as Johnson & Johnson's already-marketed Imbruvica (ibrutinib) for chronic lymphocytic leukaemia (CLL).

In the field of DNA damage repair, Rossetti pointed to the company's orally-active DNA-PK inhibitor M3814, which delays the repair of DNA double strand breaks in tumour cells and could accentuate the activity of a number of DNA-damaging therapies, including drugs and radiation. This candidate has completed a phase Ia dose-ranging trial with a phase Ib study due to start shortly.

Avelumab 'could launch in 2017'

Andrew Schiermeier, head of global oncology at Merck Serono, gave an update on the alliance with Pfizer on immuno-oncology which focuses at the moment around avelumab, a PD-L1 inhibitor under investigation for more than 15 tumour types.

If successful, the companies expect the first potential commercial launch for avelumab in 2017, and are working toward at least one additional potential launch per year through 2022, with a particular focus on Merkel cell carcinoma as well as NSCLC, ovarian, gastric and bladder cancer as well as mesothelioma.

"We have a focused and differentiated pipeline in immuno-oncology, oncology and immunology that has the potential to make a substantial difference in the lives of patients," said Rossetti. 

Article by
Phil Taylor

2nd October 2015

From: Research



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