If The CDMO Shoe Fits, Wear It Now
By Louis Garguilo, Chief Editor, Outsourced Pharma
Acumen Pharmaceuticals, a clinical-stage biopharmaceutical company developing a novel therapeutic targeting toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), began life as an outgrowth of academic laboratories, went through a partnership with Merck, reacquired all rights to its asset, and then went public in 2021.
That asset is sabirnetug (ACU193), now in a phase two trial called ALTITUDE-AD, for individuals with early Alzheimer’s disease.
The company has 50 employees, distributed between office locations in Indianapolis and Boston, and relies on outsourcing for the further development and manufacture of sabirnetug.
“I worked for a small biotech previously [he spent nearly a dozen years at Sage Therapeutics, and nearly as long before that at AstraZeneca], and I think it's about the right size for our stage of development, and the right mix of professionals,” he explains.
Some of those professionals provide scientific content, performing "a lot of work on the antibody," and the relatively novel approach to the treatment of Alzheimer's disease.
“There's a great deal of science that goes into all of this,” says Doherty.
For certain.
But what caught my attention regarding Acumen, besides this hope for a drug to combat AD, was the announcement it had already selected and contracted with its CDMO to manufacture sabirnetug for clinical development, and if it is commercially approved.
Nuts And Bolts
In November of 2022, Acumen entered an agreement with Lonza that granted it a worldwide non-exclusive license to use Lonza’s glutamine synthetase gene expression system to manufacture and commercialize ACU193/sabirnetug.
Although that predates his joining Acumen (in February of this year), Doherty says there had been an earlier round of work performed with a different set of providers, “but as we announced, we are working with Lonza moving forward.”
The contract’s point of departure is the phase two study mentioned above. To manage the contract, Acumen’s internal manufacturing group works directly with the CDMO, and it has a clinical team devoted to the outsourcing of the trial management.
“When you look at the rest of the organization, finance and G&A and the other functions you have for a company, virtual or not, you get to 50 must-have employees relatively quickly,” he says.
“And now we have a good external group with us. We will be able to leverage their commercialization and regulatory expertise.”
However, the nuts-and-bolts of the contract is based first on the CDMO’s experience in antibody manufacturing, and its global network.
“With the aspirations we have for sabirnetug as a potential best-in-class treatment for Alzheimer's disease, both those elements will be important,” says Doherty. “Obviously,” he adds, “we've got a long way to go.”
With that path still well ahead, how did they enter this future-oriented contract? What specifically was the process to select a manufacturer?
“First," Doherty replies, "It was a rigorous process of evaluating all capabilities."
And then some.
Putting It Together
Rigorous, he says, “but in the end, it is really looking for the best fit. Which group matches what Acumen is trying to do?”
Doherty says selection requires a substantial process of going through capabilities, just as substantial is determining “the fit.”
“For any small company, the right capabilities is important for relationship success. We see our partners as part of our team; the process we go through bares that view out.”
“What's most important is finding the individuals who are aligned with the way you think about doing things, so you can work together effectively.”
But is this current relationship really a “fit”?
He’s suggesting that his relatively small biotech, with a single asset in the pipeline, in a disease field that has thwarted everyone else for decades upon decades, fits hand-in-glove with one of the largest CDMOs in the world.
As we’ve documented often in these pages, that size differential often doesn’t work out well.
Doherty is well aware of this dynamic. “Unfortunately, that challenge is often a part of our outsourcing industry,” he admits.
Nonetheless, he perseveres.
"For us, It is absolutely a fit. I can say there's been a lot of detailed back and forth between the companies and the individual groups on each side. You can gain an understanding, and yes, there needs to be a level of trust that is acquired.”
Some of that was gained in earlier work together.
Another factor of fit, says Doherty, is location.
“They're right up the road in Portsmouth, New Hampshire, from our Boston site,” he says. “We're confident we've got good communication between teams. We will be able to leverage their specialized and broad experience. That's the benefit of a substantially larger organization.”
“So that’s how we see it," he says. But does Acumen see far enough to contract now for potential commercial supply later?
Final Competition
“Developing a monoclonal antibody is a complex effort,” Doherty says, “but of course there are many monoclonal antibodies being developed, and there are a number of CDMOs who have the capabilities, and some certainly have the capacity we need.”
“I'm sure those other CDMOs and their teams are quite good at what they do.”
“It really is a process where you're trying to find the right CDMO from a technical perspective, but philosophically, there is something that develops as you are evaluating opportunities.
“You get the feeling the two sides will form a solid and long-term partnership, should that opportunity arise.”
And that opportunity, he says, may arise via a supply contract consummated now. We'll go into those specifics next.