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

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Philip Morris International Announces New Regional Structure and Senior Management Changes to Accelerate Growth Toward a Smoke-Free Future25.11.2022 19:05:00 CET | Press release

Philip Morris International Inc. (PMI) (NYSE: PM) today announced a new regional structure and related senior management changes to enable continued growth as a multicategory leader internationally and advance its rapid transition toward a smoke-free future. “We are changing the company’s regional structure to further support the growth of our smoke-free business, reinforce consumer centricity, and increase the speed of innovation and deployment—all in alignment with our ambition of becoming a majority smoke-free business by net revenues by 2025,” said Jacek Olczak, PMI’s Chief Executive Officer. “The new structure will also create new opportunities to further grow our senior talent, deepening the bench of leaders who will spearhead PMI’s progress toward a smoke-free future for the years to come. I am confident of the exceptional caliber and determination of our people and wish them the best in their new roles.” By the end of January 2023, PMI will rearrange its operations in four regi

China’s Vanke Foundation presents fruitful green development achievements at COP2725.11.2022 15:44:00 CET | Press release

China’s Vanke Foundation invited dozens of Chinese charitable organizations, institutes and industry associations to present the fruitful achievements of China's green development at the recently concluded 2022 United Nations Climate Change Conference (COP27) in Sharm El-Sheikh. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221125005204/en/ Wang Shi(L4), Chairman of Vanke Foundation, and other Chinese delegates called for joint action on climate change at COP27 in Sharm El-Sheikh, Egypt on Nov. 11, 2022. (Photo: Business Wire) According to Wang Shi, Founder of Vanke Group, Chairman of Vanke Foundation, and Founder of C Team, only a few nongovernmental Chinese individuals, including himself, representing about 100 Chinese companies attended COP15 in Copenhagen back in 2009, while this year, together with numbers of partners from different sectors, approximately one million Chinese enterprises and institutions have been invol

Fruits Eco-Blockchain Project Completes its Security Audit of their Native Blockchain Conducted by Quantstamp25.11.2022 15:00:00 CET | Press release

Fruits Eco-Blockchain Project is pleased to announce their completion of a security audit of the Fruits Blockchain's contract system conducted by Quantstamp, a leader in web3 security. The focus of the audit was to verify that the smart contract system is secure, resilient and working according to its specifications. The audit activities can be grouped in the following three categories: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221120005089/en/ Fruits Eco-Blockchain Project completes its security audit of their native blockchain conducted by Quantstamp (Graphic: Business Wire) Security: Identifying security related issues within each contract and within the system of contracts. Sound Architecture: Evaluation of the architecture of this system through the lens of established smart contract best practices and general software best practices. Code Correctness and Quality: A full review of the contract source code. The prim

Abu Dhabi Hosts Annual Investment Meeting May 202325.11.2022 14:49:00 CET | Press release

Abu Dhabi will host the 12th edition of the Annual Investment Meeting from 8 to 10 May 2023, which will take place under the theme of “The Investment Paradigm Shift: Future Investment Opportunities to Foster Sustainable Economic Growth, Diversity, and Prosperity”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221125005180/en/ Abu Dhabi Hosts Annual Investment Meeting May 2023 (Photo: AETOSWire) At a press conference held today in Abu Dhabi, the announcement of the launch of AIM Global 2023 which is supported by the Ministry of Industry & Advanced Technologies, with the Abu Dhabi Department of Economic Development (ADDED) as a lead partner was made in the presence of H.E. Dr. Thani bin Ahmed Al Zeyoudi, Minister of State for Foreign Trade, Vice Chairman of the UAE Industry Development Council and H.E. Mohamed Ali Al Shorafa, Chairman of ADDED. AIM Global 2023 pillars will discuss the global capital market transformation, way

Alberto Bona’s Exploit on the Class40 IBSA : Eighth at the Route Du Rhum25.11.2022 13:13:00 CET | Press release

Thursday, November, 24, at 3:34:50 pm local time (8:34:50 Paris-Rome time) in Pointe-à-Pitre, Alberto Bona on the Class40 IBSA crossed the finish line of the twelfth edition of the Route du Rhum in eighth place. His race time is 15 days, 6 hours, 19 minutes and 50 seconds. The skipper of the Class40 IBSA sailed the 3,542 miles between Saint-Malo and Pointe-à-Pitre at a speed of 9.67 knots on the great-circle course, actually covering 4005.51 miles at an average speed of 10.93 knots. He arrived in Pointe-à-Pitre 1 day, 3 hours, 11 minutes and 10 seconds after the Class40 winner, Yoann Richomme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221125005116/en/ Alberto Bona on the Class40 IBSA crosses the finish line of the twelfth edition of the Route du Rhum (©IBSA | Beppe Raso) “A very nice but extremely hard regatta, especially in the upwind week”, stated Alberto upon arrival. “I am extremely happy: IBSA and I made it togethe