Business Wire

Merck Aims to Double R&D Productivity in Oncology, Neurology and Immunology to Deliver More Medicines to Patients Faster

Share

Merck, a leading science and technology company, today shared updates on the company’s healthcare research and development strategy, aimed at doubling R&D productivity. To achieve the goal of introducing one new product or major indication every 1.5 years on average, the company will focus its expertise and capabilities and leverage synergies within the existing pipeline to deliver transformative medicines in Oncology, Neurology and Immunology, augmented by an increased focus on external innovation. The company expects to maintain the output of its internal discovery engine, while more than 50% of future launches will result from external co-development partnerships and strategic in-licensing of assets for further in-house development. The strategy was shared today at the company’s R&D Update Call.

“We are driven by our ambition to accelerate the discovery, development and delivery of innovative medicines to patients with cancer and neuroinflammatory and immune-mediated diseases,” said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck. “With a mindset of design simplicity and resource discipline paired with agility of execution, we will speed the generation of high-quality data that will support our efforts to bring forth more medicines for more patients, faster.”

To increase R&D productivity, the company will build on its established expertise in the underlying biology of its focused therapeutic areas of oncology, neurology and immunology and will leverage technological capabilities, particularly its industry-leading antibody-drug conjugate (ADC) technology.

Oncology: Synergistic Approaches to Striking Cancer at Its Core

The company’s oncology research and development strategy centers on cancer DNA while building on existing leadership in key cancer types, including head and neck, urothelial and colorectal cancers. The oncology pipeline is focused on synergistic approaches targeting key pathways involved in cancer cell survival, deploying mechanisms to hit cancer at its core:

  • Delivering tumor DNA-damaging payloads right to the cancer with cutting-edge ADC technology
  • Preventing cancer cells from repairing DNA damage, through inhibition of the DNA damage response (DDR)
  • Restoring sensitivity to apoptosis, the cells’ natural death mechanism, which cancer can inhibit

The lead asset in the oncology pipeline is xevinapant, an investigational first-in-class potent oral small molecule IAP (Inhibitor of Apoptosis Protein) inhibitor being evaluated in the curative setting of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN)—an area that has not seen significant advances in treatment in the past 20 years. Xevinapant, which was in-licensed from Debiopharm in March 2021, builds on the company’s long heritage and extensive expertise in SCCHN. Based on the promising efficacy and safety profile seen in the Phase II trial and the urgent need for new treatments, the company is evaluating xevinapant in two ongoing randomized, double-blind, placebo-controlled Phase III clinical trials with the goal of transforming the standard of care: the TrilynX study (NCT04459715) in patients with unresected LA SCCHN, and the XRay Vision study (NCT05386550) in patients with resected LA SCCHN who are at high risk of relapse and are ineligible for cisplatin. Additional external studies and real-world evidence are expected to elucidate the potential for xevinapant across additional patient segments.

The company’s broad portfolio of selective and potent DDR inhibitors includes several agents under development that directly inhibit DDR pathways required for cancer cell survival. By attacking the inherent genetic instability of cancer cells, these agents have the potential to exploit this weakness and tip the therapeutic balance in difficult-to-treat cancers. The oral ATR (ataxia telangiectasia and Rad3-related) inhibitor M1774, which has been designed as a potentially best-in-class molecule, is the leading DDR asset in the pipeline. Recently presented dose-escalation results showed that M1774 at its recommended dose expansion level showed pharmacologically robust exposure and a favorable safety profile. M1774 has broad potential in combination with other DDR inhibitors and other medicines, and as monotherapy in the right genomic context. The DDR portfolio also includes inhibitors of ATM (ataxia-telangiectasia mutated) and DNA-PK (DNA-dependent protein kinase) and has recently been complemented by a collaboration with Nerviano Medical Sciences with the option for a license agreement on the next-generation selective PARP1 (poly (ADP-ribose) polymerase) inhibitor NMS-293.

Earlier this year, M9140, the first ADC developed using the company’s own technology, advanced into human trials. The ongoing Phase Ia study is assessing M9140 in patients with colorectal cancer. M9140 is an anti-CEACAM5 ADC with a topoisomerase 1 inhibitor (exatecan) payload that has been rationally designed for stability in circulation and superior cancer cell killing activity with a broad therapeutic window. M9140 has synergistic potential with DDR inhibition as well.

Neurology and Immunology: Expansion Building on Strength in Neurology and Immune Biology

In neurology and immunology, Merck aims to expand its multiple sclerosis (MS) portfolio with evobrutinib, an investigational, oral, CNS-penetrating, highly selective inhibitor of Bruton’s tyrosine kinase (BTK) with the potential to become a best-in-class treatment option for relapsing multiple sclerosis (RMS). In a Phase II study and follow-up, evobrutinib is the first BTK inhibitor (BTKi) to demonstrate sustained clinical efficacy for people with RMS through three and a half years and impact early biomarkers of ongoing central inflammation that correlate with disease progression, including slowly expanding lesions volume and levels of blood neurofilament light chain protein.

In pre-clinical studies, evobrutinib modulated both B cells and macrophages (in the periphery)/microglia (in the brain). This approach has the potential to positively impact both progression caused by relapses and silent progression occurring independent of relapse. During Phase II, the BTKi dose-finding study demonstrated that BID dosing achieved maximal efficacy with >95% BTK occupancy maintained in 98% of patients before the next dose. The Phase III readout for evobrutinib is expected in Q4 2023.

Merck also seeks to expand in neurology by evaluating the potential of oral cladribine in neurological diseases where inflammation is a primary driver, such as generalized myasthenia gravis.

The company is looking to diversify the pipeline with immunology and accelerate R&D by focusing on targets with proven biology via novel modalities. Key to these efforts is the ongoing Phase II WILLOW study of the TLR7/8 inhibitor enpatoran in cutaneous and systemic lupus erythematosus. Building on expertise in neurology, the company is initiating a proof-of-concept study in neuromuscular conditions dermatomyositis and polymyositis with enpatoran in 2023. These conditions have a high unmet medical need characterized by progressive muscle weakness and show lupus-like patterns of immune activation and TLR7/8 expression.

“Patients rely on us. By building on our existing strengths and maximizing synergies within our in-house discovered pipeline and with external assets, we will secure sustainable R&D productivity that leads to innovative medicines for patients in need,” Bar-Zohar added.

To access the presentation and a recording, please visit the company’s website at https://www.merckgroup.com/en/investors/events-and-presentations.html

All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck

Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 60,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Relations
gangolf.schrimpf@merckgroup.com
Phone: +49 151 1454-9591

Investor Relations
investor.relations@merckgroup.com
Phone: +49 6151 72-3321

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

BLUETTI Opens First Flagship Store in Munich, Germany for Hands-on Experience3.12.2022 12:40:00 EET | Press release

To enhance the user experience, BLUETTI, a top-three solar generator brand, has opened its first physical storefront in Munich, Germany, on November 4. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221202005505/en/ (Photo: Business Wire) This so-called WOC X BLUETTI store is set up as a physical hub of what the brand represents online. It showcases BLUETTI's entire product range, from the latest releases to iconic models, along with other accessories. Customers can get a real feel for products before making any purchases. However, it does not currently offer repair services. BLUETTI's new inventions, the AC500&B300S and EP600&B500, are already displayed there. Both are modular in design and substantially updated in capacity and capability. With a 5.000W output and 16 outlets, the AC500 can be used as a solid backup power source on the go or in the house. Sporting a max capacity of 80kWh, the EP600 can be integrated into exi

Esri Named a Leader in 2022 Climate Risk Analytics Report by Independent Research Firm2.12.2022 18:42:00 EET | Press release

Organizations are using modern geographic information system (GIS) technology to better understand the risks presented by climate change and take action. With GIS-driven mapping, analytics, and visualization, leaders can weigh the costs and benefits of plans, mitigate climate-related damage to assets, and make sustainable decisions despite an unpredictable planet. Esri—the global leader in GIS used by many Fortune 500 companies and governments worldwide to improve these sustainability practices—has been recognized by independent research firm Forrester in its report, The Forrester New Wave™: Climate Risk Analytics, Q4 2022. In the report, authored by principal analyst Renee Murphy, Esri received a differentiated rating, the highest score possible, in nine out of ten criteria, including “Advanced Data Processing,” “Visualization,” and “Threat Modeling.” The Forrester report says Esri “offers leading data visualization and advanced processing capabilities,” and that “Esri’s platform acts

Huawei Publishes First White Paper on Approaches to Fairness, Equity & Opportunity2.12.2022 06:07:00 EET | Press release

Huawei called on the ICT industry players to create a level playing field for all people, not just their own employees in its first White Paper on Approaches to Fairness, Equity & Opportunity at their Women in Tech event held at the Peter Drucker Forum. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221201006045/en/ (Graphic: Business Wire) This White Paper is part of Huawei's ongoing campaign aimed at increasing digital skills education and access for women across the world. Huawei, like many other companies within the ICT industry, has advocated on fairness, opportunity, and equity within their own operations. Notably, the company has taken measurable steps to increase diversity in their workforce and increase internal representation of marginalized groups. It is widely understood that significant, tangible results from such programs are often slow to materialize. And thus Huawei has focused many of its efforts beyond the

H&M and Webhelp Finalize Acquisition of H&M’s Nuremberg Customer Service Center1.12.2022 18:29:00 EET | Press release

The responsible authorities have officially approved the transfer of fashion brand H&M’s Nuremberg customer service center to Webhelp, a leading global customer experience BPO player. The companies, having already signed an agreement in this regard on 19 October 2022, will see Webhelp operate the service center from 1 December onwards under its own name. With this acquisition, Webhelp doubles the number of its employees in Nuremburg and is now one of the largest employers in the industry in northern Bavaria. Today, Webhelp employs more than 110,000 employees in over 60 countries. Webhelp's German headquarters in Nuremberg already provides an attractive working environment with state-of-the-art technical equipment for over 500 employees. Furthermore, Webhelp is committed to investing in the development and wellbeing of its customer advisors, known as 'game-changers,' around the world. Webhelp will welcome the 500 employees of the H&M Service center from today, 1 December, to the Webhelp

Morgan Stanley Sustainable Signals: New Survey Shows Opportunities Exist for Asset Managers to Better Meet Asset Owner Sustainable Investing Needs1.12.2022 18:00:00 EET | Press release

Asset managers have the opportunity to meet asset owners’ growing demands for sustainable investment practices, products and reporting, according to new research by the Morgan Stanley Institute for Sustainable Investing. The latest in the Firm’s Sustainable Signals series, this institutional investor survey polled 110 asset owners in North America, Europe and Asia, as well as 201 asset managers across the same regions to understand what asset owners want and what asset managers are offering—and where the gaps lie in delivering environmental, social and governance (ESG) solutions. “The results of our latest Sustainable Signals survey show that sustainable investing remains an important focus area for institutional investors globally, with the vast majority reporting an increased interest over the past two years,” said Jessica Alsford, Chief Sustainability Officer and CEO of the Institute for Sustainable Investing at Morgan Stanley. “At the same time, our findings show a significant oppo

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom