When Should You Select Your Supply Partner?
By Louis Garguilo, Chief Editor, Outsourced Pharma
Acumen Pharmaceuticals is a biotech developing a novel therapeutic targeting toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). (see part one here)
The company pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is advancing its investigational candidate, sabirnetug (ACU193), a humanized monoclonal antibody, in a three-arm phase two study, ALTITUDE-AD, targeting 540 participants.
Acumen has announced it entered a contract with Lonza, for both clinical supply requirements and its commercial supply should the program obtain regulatory approval.
James Doherty, President and Chief Development Officer, is gracious in providing readers with a window into that contracting strategy.
Day To Day, And Tomorrow
As the program advances, Doherty suspects his internal team will grow proportionally.
“However,” he says, “we will keep our efforts focused, and only expand over time.”
It’s that “over time” component of the contract that’s of interest. Reading through the press release announcing the Acumen-Lonza clinical and (potential) commercial agreement, I wonder, how the two sides inserted that future contingency into a series of set and defined milestones, stop-and-go options, and pricing considerations.
Does Doherty define the contract as a binding clinical-supply contract set under a master service agreement including the contingency for commercial supply?
While he would not go into specifics, he summarizes it this way:
“In effect, this is as an agreement combining the accomplishing of short-term goals [a reliable supply of clinical material], and the mutual thinking around long-term expansion [commercialization].”
“Given the diligence effort to choose a long-term partner as sabirnetug advances into Phase 3 and BLA submission, we hope our CDMO will be the partner to support us with scale up and commercial preparations.
That factors now into our long-term planning, given the input Lonza has and continues to provide related to our commercial approach.”
Alternatively, he says, “You could take the approach, ‘We want a partner who can do what we need to do right this second – transfer in our program and supply our clinical trial material. That’s what matters. We'll figure out the future in the future, should there be a commercial need.’”
“That is," he says, "a fair approach."
"I agree it's an efficient way to concentrate on generating the material you need for the next phase of your work," and keeping a lean organization.
“But we're planning for success now. We have an asset we think can make a difference in Alzheimer's disease, a disorder affecting millions of people.
"You don't want delay and introduce unnecessary white space into the process at any stage, so you prepare now to build on any potential success.”
Sounds prudent. If you can in fact work it out with your CDMO, why not add commercial-manufacturing clauses of some kind to your clinical supply agreement?
Well, I can think of some reasons not to.
- Doherty already mentioned any potential lack of current focus.
- Relationships can go south; priorities, management, workers can change (on both sides) over time.
- It might be a better strategy to have a competition among CDMOs for your commercial contract at a later date.
- Your company or program may get swept up by a Big Pharma suitor (be that your current strategy or not).
Doherty of course understands all this, and Acumen has weighed the risk-reward return.
“I agree, you have to keep your eye focused on what's in front of you," he says. "You don't want to get distracted and not get the work done that you need to get done now."
“But in our case, with forward planning and preparing for success, the ideal way forward for us was to identify a partner who can grow and scale up with us as the program matures.”
“In the background, we worked with Lonza to determine what our path to Phase 3 and commercial looks like, even without knowing all the details of future activities.
“This is not a transactional partnership.”
Ramping Up
Currently, Lonza is gearing up to manufacture sabirnetug needed for patients in Acumen’s phase two study.
But even this activity, Doherty wants to make it understood, is not as cut-and-dry as it sounds.
The monoclonal antibody (sabirnetug) is a complex material, and needs to meet the highest GMP and quality standards for clinical-trial use.
“All these responsibilities around quality and other aspects are in our contract. It is a major effort. Our goal is to get the study rolling as quickly as we can. Our CDMO is absolutely critical for that,” he says
I ask whether there are elements of further process development work to be done at the CDMO, and if there might be the need for a concentrated scale-up initiative.
He replies there will likely be some further process optimization to support increased scale, and to consider "process economics given the potential scale of demand."
This is part of the ongoing discussions between the two companies as they lay out sabirnetug’s path to BLA.
Doherty says Acumen has material from phase one, and thus there is a set process that was transferred to Lonza.
"However," he adds, "I think there's always a certain process of understanding what's been done previously, and to continue to make suggestions for improvements."
“This is not necessarily a huge component, but in a collaboration of this kind, if there are thoughts around how we can improve the process, we’ll be all ears.”
For now, though, the primary responsibility of the CDMO is to quickly produce material for Acumen’s phase-two study.
And thus our bottom line.
If you are convinced a CDMO is the best fit for your clinical supply; has what is needed scale-wise for potential commercial needs; and you can reach mutual agreement via contractual commitments; then an "early" selection of your long-term CDMO can be the preferred outsourcing path.