Alnylam Pharmaceuticals, Inc.

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Under the deal, Novo Nordisk will reimburse research and development costs. Credit: Victor Golmer via Getty Images. Novo Nordisk has signed a deal with AI-driven protein design company Gensaic to develop tissue-targeted therapies for cardiometabolic diseases. The collaboration is valued up to $354m, but financial specifics remain undisclosed. The companies aim to advance precision drug delivery by leveraging Gensaic’s AI-guided ligand discovery platform. Novo and Gensaic did not say which specific cardiometabolic conditions they are targeting. Tissue targeting is a key focus in drug development, as it allows therapies to be delivered directly to specific organs or cell types rather than affecting the entire body. This precision can enhance drug effectiveness while minimising side effects. However, targeting tissues beyond the liver remains a challenge, limiting the reach of many existing therapies, Gensaic said in the 3 March announcement. Gensaic’s platform, dubbed FORGE, is designed to address this issue by identifying protein ligands that enable selective delivery of therapeutic molecules, potentially unlocking new treatment options for cardiometabolic diseases. “Tissue targeting has so much potential – both in terms of the modalities that can be leveraged, but also for the diseases that can be addressed,” said Uli Stilz, head of Novo’s bio innovation hub. The FORGE platform combines AI-driven protein design with laboratory-based protein evolution to discover new ligands – molecules that bind to specific targets in the body. By mapping and optimising protein interactions, the platform aims to identify ligands that can transport drugs into specific tissues. This approach could enable the targeted delivery of a range of therapeutic molecules, including small interfering RNA (siRNA), which is used to regulate gene expression in diseases. Several biotech companies are exploring tissue-targeting approaches to improve drug delivery. Alnylam Pharmaceuticals has developed GalNAc conjugates such as Amvuttra (vutrisiran), which enable targeted delivery of RNA-based drugs specifically to liver cells. Similarly, Arrowhead Pharmaceuticals has advanced its targeted RNAi molecule (TRiM) platform to enhance the delivery of RNAi therapies to tissues beyond the liver, including the lungs and muscles. Novo Nordisk is an established leader in the cardiometabolic space and has secured several deals in the past few years to maintain its dominant position in this market. In September 2024, the company signed a $600m deal with NanoVation to develop genetic medicines for rare and cardiometabolic diseases. As part of the agreement, Novo secured a licence to use NanoVation’s long-circulating lipid nanoparticle (lcLNP) technology for RNA delivery targeting cells outside the liver.

Making sure a drug works in all populations requires testing it in all populations, including in groups that have been historically excluded from clinical trials.\n Even as President Donald Trump wages a very public fight against diversity, equity and inclusion (DEI) initiatives in the government and beyond, several large drugmakers say running diverse clinical trials is not optional or extraneous but a core part of the work they do. Despite public silence from many pharmas—and some seeming acquiescence—in the face of Trump’s high-profile fight against DEI, four large drugmakers told Fierce Biotech they remain committed to ensuring diverse representation of patients in their clinical trials.Spokespeople for Eli Lilly, Bristol Myers Squibb, Sanofi and Roche’s Genentech confirmed in emails to Fierce Biotech that their work on advancing clinical trial diversity remains ongoing. The commitments come after a flurry of Trump actions to end DEI practices across the government, including at the Department of Health and Human Services. Beyond his actions specifically relating to the government, Trump this week pressured tech giant Apple to \"get rid of DEI rules,\" signaling that his ideological campaign extends to the private sector.In statements to Fierce, Lilly, Sanofi and Genentech explicitly said they will follow all applicable laws and regulations issued by the government.“Lilly’s commitment to developing safe and effective medicines for all patient populations is unwavering,” a spokesperson told Fierce Biotech on Feb 14. “We know that to meet our purpose of making life better for people around the world, we must design our trials so that we can test safety and efficacy for diverse patient populations.”French pharma giant Sanofi expressed a similar sentiment. “As a global company held to the highest standards of scientific integrity, Sanofi believes appropriate representation in clinical studies is crucial for ensuring that the efficacy and safety profile of all medical treatments developed are understood for all people,” a Sanofi spokesperson said on Feb. 24. Making sure a drug works in all populations requires testing it in all populations, including in groups that have been historically excluded from clinical trials. To bring in these excluded groups, many pharmas and clinical research organizations have developed strategies to reach marginalized populations. Global CRO IQVIA, for example, detailed in its 2024 sustainability report its efforts to expand diversity in trials it runs.Eli Lilly’s efforts “include reducing barriers to access in trial design and delivery and understanding the communities we seek to support,” the company\'s spokesperson added.One technique Lilly employs is community-based clinical trials, where remote visits and new technology—such as wearable devices and artificial intelligence— are used to bring trials directly to patients rather than them having to travel to a physical site.Sanofi, too, is making inroads to underrepresented communities. In October 2024, the firm committed $18 million to three historically Black medical schools to help the schools recruit clinical research staff, develop customized training programs and establish clinical trial infrastructure.Sanofi’s clinical study enrollment programs aim \"to ensure we generate critical scientific data on the broadest population of potential patient groups,” the spokesperson explained. “We will continue to pursue this approach going forward.”Public displays of affection Rather than keeping quiet and working behind the scenes, some pharma leaders have boldly embraced the new president.Pfizer CEO Albert Bourla, Ph.D., for one, has courted controversy by cozying up to Trump, drawing boos at a White House event, dining at Mar-a-Lago and touting his “very long-lasting relationship” with the president. Bourla is the new chair of industry lobbying group PhRMA, which has its own set of policy priorities (PDF) for the U.S. government to pursue. Pfizer did not respond to Fierce Biotech’s request for comment for this story. The company’s web page detailing its vision to be a “best-in-class organization that embeds DEI in our workplace and into our purpose of delivering breakthroughs that change patients’ lives” is still active. The potential impact of a close relationship between Bourla and Trump on Pfizer’s own clinical trial diversity programs remains to be seen.Other possible responses to Trump’s second term have been less obvious. In early February, Genentech wiped old diversity and inclusion reports from its website, saying the page was undergoing construction and that the 2025 version of the report would be posted there once it was ready.Reached for comment at the time, a spokesperson added that the company is “taking time to understand any potential implications of executive orders and other actions by the new administration.”For the time being, this vigilance hasn’t affected Genentech’s flagship clinical trial diversity program, the Site Alliance, the spokesperson told Fierce on Feb. 14. This program has been shown to increase enrollment of Black and Hispanic/Latinx patients at clinical study sites.“The Site Alliance work is ongoing,” the spokesperson said, and Genentech is still committed to advancing inclusive research. Around the same time as Genentech’s website revamp, BMS made a subtle editing decision in its latest annual report. In its 2024 report, the drugmaker opted not to include a section that previously spelled out the company\'s goals of diversifying clinical trials and supporting \"inclusion, diversity and health equity,\" Bloomberg reported.Reached for comment, a BMS spokesperson said on Feb. 14 that the firm routinely updates its annual filings, and that “inclusion and belonging are core to how we do our business.”When it comes to trial diversity, the New Jersey pharma echoed other companies in reaffirming its own commitment. “As patients around the world are counting on us to deliver innovative medicines, we remain committed to ensuring representative populations are included in clinical trials,” the spokesperson said.With other drugmakers such as Johnson & Johnson, Biogen and Alnylam also scrubbing DEI phrases from their filings, per Bloomberg, and continued actions from the Trump administration aimed at ensuring health agencies follow its executive orders, it remains to be seen how the demographics of clinical trial participants may shift over the next four years.In response to Fierce\'s questions about J&J\'s changes to its filing and the company\'s stance on ensuring diverse enrollment in clinical trials, a spokesperson said on Feb. 26 that \"Johnson & Johnson has always been and will continue to be compliant with all applicable legal requirements and remains dedicated to the values in Our Credo.”The company\'s credo stresses the importance of an inclusive work environment, but does not mention diversity in clinical trials.Biogen, Alnylam and Merck & Co. did not respond to requests for comment. Amgen declined to comment for this story.