MerckMerck KGaA, a leading science and technology company that operates its biopharmaceutical business in the US and Canada as EMD Serono, has entered into a licensing agreement with Vertex Pharmaceuticals, for the worldwide development and commercialisation of four promising R&D programmes that represent novel approaches to the treatment of cancer.

“With this strategic deal, we significantly strengthen our oncology pipeline in two attractive areas where we have leading competence, DNA damage and repair and immune-oncology — areas that also have promising therapeutic synergy,” says Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany.

“This deal underscores our commitment to accelerating innovation for cancer patients, and we are excited for the opportunity to build on Vertex’s rigorous science and advance these leading programmes.”

As part of the agreement, Merck, will license two clinical-stage programmes targeting DNA damage and repair, along with two additional novel preclinical programmes.

Vertex will receive an upfront payment of $230 million, in addition to royalties on future net sales. Merck will assume full responsibility for the development and commercialisation of all the programmes.

“The Vertex R&D team has produced a portfolio of first-in-class compounds with the potential to enhance the therapy of multiple cancers,” said Jeffrey Leiden, Chairman, President and CEO of Vertex. “We are pleased to partner with Merck, a leader in oncology with exciting complementary assets that will help fully realise the value of these unique compounds and accelerate the programmes’ potential benefits for patients.”

The two clinical-stage programs represent first-in-class approaches to inhibit the DNA repair pathways that are fundamental to the survival and proliferation of certain cancers:

  • An ataxia telangiectasia and Rad3 related (ATR) programme comprising two compounds, VX-970 and VX-803. VX-970 is being investigated broadly through 10 ongoing Phase I and Phase II trials across a variety of tumours and patient subtypes expected to be responsive to ATR inhibition based on biomarker data. Preliminary VX-970 clinical data were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2016 American Association for Cancer Research (AACR) Annual Meeting. VX-803 is an orally dosed ATR inhibitor currently in Phase I trials evaluating escalating doses of VX-803 alone and in combination with chemotherapy.
  • A DNA-dependent protein kinase (DNA-PK) inhibitor programme including the clinical candidate VX-984. A Phase I trial is now evaluating escalating doses of VX-984 alone and in combination with pegylated liposomal doxorubicin in subjects with advanced solid tumours. Merck KGaA, Darmstadt, Germany will combine these assets with its existing DNA-PK assets into a single development programme.

The preclinical programmes include one immuno-oncology programme against an attractive target with first-in-class potential, and a programme against a completely novel target. For both of these programs, Vertex research has demonstrated efficacy in relevant preclinical models, including demonstration of combination potential with immune checkpoint inhibition for the immuno-oncology programme.

Merck will continue to characterise the Vertex compounds in these programmes with the goal of taking them forward into the clinic.

The strength of Merck KGaA, Darmstadt, Germany’s oncology R&D programme, including a leading presence in immunotherapy and DNA damage and repair, demonstrates how the company is reimagining the way cancer can be treated.