Cancer Research UK and the Institute of Cancer Research, London (ICR), said they will partner with Merck KGaA on three research projects focused on cancer drug discovery, expanding on several earlier collaborations focused on discovering single treatments and validating targets for new therapies.

Under the latest collaboration and licensing deal—whose value was not disclosed—Merck KGaA would join Cancer Research UK and ICR on projects ranging from target hit discovery to nomination of candidates for preclinical development.

The partners would work to develop biomarkers for target engagement and patient selection, as well as advance the discovery and development of potential treatments, Cancer Research UK’s Commercial Partnerships Team and ICR said.

Merck has gained worldwide rights to advance into the clinic molecules discovered through the collaboration. In return, the biopharma has agreed to pay Cancer Research UK and ICR undisclosed payments tied to achieving research and development, regulatory, and sales milestones—as well as royalties on net sales of future products discovered or developed under the latest agreement.

Any payments made by Merck KGaA to Cancer Research UK and ICR will fund future research, the organizations said.

“We hope that through the diverse projects in this collaboration, we can identify molecules that are effective against a number of different tumor types. Together we can create innovative new treatments for the benefit of patients,” Raj Chopra, Ph.D., director of the Cancer Research UK Cancer Therapeutics Unit at ICR, said in a statement.

The new collaboration builds on previous partnerships stretching back to 2009, when Merck, Cancer Research UK, ICR, and Cardiff University agreed to identify and develop small-molecule inhibitors of the WNT signaling pathway as anticancer drugs. That alliance was extended four years later.

In 2010, Cancer Research UK and its commercial arm Cancer Research Technology (CRT) took over preclinical and early clinical development of DI-B4, an anti-CD19 monoclonal antibody targeting low-grade B-cell lymphoma as well as chronic lymphocytic leukemia and Waldenström macroglobulinemia. DI-B4 has been under study in a Phase I trial (NCT01805375 and CRUKD/12/003) launched in 2013, but not recruiting patients according to Cancer Research UK and 

Modulating “Key Culprits”

In June 2017, Merck KGaA’s corporate venture arm Merck Ventures created immuno-oncology spinout iOnctura, combining three potential treatments from CRT with two treatment candidates contributed by the company. “Our goal is to modulate key culprits of immunosuppression in the tumor microenvironment to maximize the therapeutic potential of checkpoint inhibitors for patients,” Catherine Pickering, Ph.D., CEO and co-founder of iOnctura, stated at the time.

At the same time, CRT and Merck KGaA agreed to discover new cancer drugs targeting the Hippo pathway, following what CRT said was a successful one-year target validation and drug discovery feasibility partnership between its Discovery Laboratories and the biopharmacompany. Under that partnership, Merck KGaA agreed to pay CRT undisclosed royalties and milestone payments.

Merck KGaA has stepped up its focus in recent years on developing new medicines in oncology and immuno-oncology, as well as immunology. As of November 1, the company’s pipeline showed no fewer than 13 cancer candidates in various clinical phases of development.

During the first three quarters of 2017, Merck KGaA’s second-best selling drug was the Merck/Eli Lilly-partnered cancer treatment Erbitux® (cetuximab), with Merck accounting for €638 million ($778.5 million) of the drug’s total $1.256 billion in sales.

Another anchor of the company’s cancer portfolio is the Merck/Pfizer-partnered marketed checkpoint inhibitor Bavencio® (avelumab), an anti-programmed death ligand-1 (PD-L1) antibody that won FDA approval in March 2017 for its first indication, treating metastatic Merkel cell carcinoma (mMCC) in adults and children aged 12 years and over.

Two months later, Bavencio won its second FDA authorization as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Merck KGaA—which operates as EMD Serono in the U.S. and Canada—has nine Phase III studies exploring avelumab’s potential role against various cancers. Merck KGaA and Pfizer are developing Bavencio through an up-to-$2.85 billion strategic alliance launched in November 2014.

Bavencio is one of two recent approvals won by Merck KGaA; in August, the company won European Commission approval of Mavenclad® (cladribine) for highly active relapsing multiple sclerosis (RMS).

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