When Mike Nally stepped down as executive vice president and CMO of Merck’s Human Health division, he aimed to have a greater impact on humanity wherever he went than he felt he could at the big pharma. 

That was a pretty high bar to set, given that Nally oversaw Merck’s vaccine group, which was in charge of developing an HPV vaccine that could potentially eliminate cervical cancer worldwide, as well as working on products like Keytruda, which are revolutionizing cancer care across 30 different tumor types. 

It does not get much bigger than that.

However, Nally may be flirting with the expectations he set for himself at Generate:Biomedicines, as the company is now beginning to see the translational impact of the company’s generative AI platform which aims to expand the druggability of the protein universe. 

Because of their ability to target cryptic epitopes most effectively, Nally, the chief executive, and his team at Generate:Biomedicines have been able to focus their efforts on what they consider to be unique value opportunities in infectious and inflammatory diseases. The natural progression from there, for Nally, is to take on the infectious diseases that affect the most people or have the greatest disease burden. 

They started with the flu and COVID-19, two of the greatest killers of all infectious diseases worldwide. In the summer of 2023, their pan-COVID-19 antibody, GB-0669, entered the clinic. But where Nally thinks that GB-0669 will make a splash is not necessarily in the prophylactic treatment of COVID-19. Rather, he thinks the real benefit lies when a cancer patient is headed for chemotherapy and, thus, a major dip in immune system function. That’s when GB-0669 would be administered. 

“You’d have six months of coverage or something along those lines, as you are more vulnerable,” Nally told GEN Edge shortly before the company’s presentation at the 42nd Annual J.P. Morgan Healthcare Conference. “You could dose this biannually for the elderly population. You could do it for transplant patients.”

For inflammatory disease, Nally has pointed Generate:Biomedicines toward asthma. The first patient was dosed with Generate:Biomedicines’ anti-TSLP antibody GB-0895 for asthma in December 2023.

Nally said they have scaled up several development-stage assets with “best-in-class” profiles to add to their work on infectious and inflammatory diseases. These include an anti-hemagglutinin (HA) monoclonal antibody that targets the flu and a highly potent anti-IL-13 monoclonal antibody for some type-2 inflammation-mediated diseases, such as atopic dermatitis. 

But Nally cannot depend on the bandwidth and financing, of which they have plenty, having raised the highest series C in biotech in 2023. To make the impact he envisions, Nally and Generate:Biomedicines need partnerships. 

That’s why the announcement that Amgen has exercised its rights under an existing collaboration agreement with Generate:Biomedicines to opt in for a sixth program is noteworthy. This represents the first expansion of the original agreement. Amgen will make an undisclosed upfront payment and will pay up to $370 million in future milestones and royalties up to double digits for this new program. 

The original collaboration agreement signed two years ago was initially a five-target collaboration, with Amgen paying Generate:Biomedicines $50 million upfront and providing some equity financing into the series C financing. The agreement also outlined the opportunity for Generate:Biomedicines to earn up to $370 million in milestones on each of the five targets.

There was also the provision for Amgen to exercise the right to opt into more targets for additional economic consideration, and this is the first of those additional opt-ins. 

“The way the deal works is that anything that we are working on ourselves or a series of reserve targets are off limits to Amgen, or, at a minimum, we can say, ‘Do we want to do that outside of that universe?’” said Nally. “[Amgen] can nominate any target across any disease area for us to work on, and that structure has worked well. They give us some of the challenges they’ve had a hard time solving in their labs. Amgen brings a wealth of expertise in… engineering, manufacturing, clinical development, and commercialization, and we bring our unique approach to applying machine learning to protein design.” 

So, is Nally living up to his expectations?

It’s too early to tell how big a splash generative AI can make in drug development—the field is in its nascent stages. 

Amgen’s move coincides with David Reese, MD, the key architect of Amgen’s artificial intelligence and advanced technology initiatives with a focus on R&D, taking on the CTO role. The move opened up the head of R&D position, which Jay Bradner, MD, will fill as he looks to pursue the next chapter of scientific contribution after leaving Novartis in 2022, much like Nally is doing.

It’s possible that the therapeutics born out of work at Generate:Biomedicines will create an asteroid-driven tsunami that will shake the entire world. It’s also possible that the splash will cause no more than a ripple from a raindrop. With somewhere over $400 million in runway cash and Amgen’s decision to opt-in to the collaboration with Generate:Biomedicines (for perhaps not the last time), it’s possible that in a few years, we’ll experience the kinds of waves that the surfers in The Endless Summer dreamed of. 

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