Asher Biotherapeutics embarked on a search for a contract development and manufacturing organization (CDMO) that could handle phase II and III production and commercial supply of its novel cis-targeted immunotherapies. Its two lead candidates were in the investigational new drug (IND)-enabling stage and phase I, respectively. Having been with another provider for early development, there was now the need to transfer to an outsourcing partner capable of late-phase work. A looming question was whether the relationship would be transparent and if there would be robust communication between a large CDMO and a small biotech.

Narrowing the Field of Specialists

Many CDMOs follow a platform approach, particularly in the case of monoclonal antibodies (mAbs), because it works well. The big CDMOs in particular are exponents of this, and in the past some have had the reputation of being rigid on their process, not always wanting to work with small biotechs, and not being as communicative and collaborative as these customers would like.

Asher Biotherapeutics is developing a pipeline of cis-targeted immunotherapies, which are fusion proteins. This approach to immunotherapies is pioneering, engaging two receptors on the same immune cell — one immunomodulatory and the other a specific target. The lead candidate that was transferred first is a CD8-targeted IL-2 immunotherapy, which enables selective activation of CD8⁺ effector T cells, while limiting activity on immunosuppressive regulatory T cells and NK cells.

Because we are developing novel fusion proteins, we needed to work with a CDMO for phase II and beyond that had strong scientific expertise. We also need a partner that could scale with us. I had worked with Lonza when I was at a different company, and I had reservations about the channels of communication and how much listening and adaptability we would see from Lonza. 

Selection Process Reinforced our Thinking

We put together a very robust process to evaluate a shortlist of CDMOs, identifying parameters that were important to us, as well as our programs. It covered the technical needs of the pipeline, as well as values, partnering approach, transparency and communication. We mapped it out on a 3x3 grid, and Lonza led the others in the benchmarking against our criteria.

I still had a lingering concern about how much a large CDMO would want to work with a small biotech like us, but this changed when communication began with our original Account Manager. She conveyed how committed Lonza is to working with biotechs like Asher. I was skeptical at first, but verified Lonza’s new approach with people I had previously worked with. When we visited Lonza’s Slough, UK, facility for a kick-off meeting, they had a roomful of experts — the site head, department leaders and the whole project team — ready to discuss every aspect of our programs.

Transparency Follows

When we signed with Lonza and transferred the first program, we began working with our program manager, but we were also granted access to the whole project team for stronger collaboration. The process is very transparent, which is key for us as we like to work closely with a partner. We have an 8-hour time difference between the Slough facility and our location in California. But we actually use this to our advantage too, communicating back and forth so our respective teams can accomplish things while the other is either asleep or outside business hours.

We transferred a cell line and a cell culture system from our previous CDMO when we first started. This presented some technical hurdles but Lonza was very flexible as we worked through them. We’ve had meetings on a weekly basis, adapting to the data we’re getting, making decisions, and proceeding to the next step. It has not always been easy, but with Lonza’s communication it has been as successful as it could be.

Open and Extensive Communication

Lonza’s approach to supporting us has been consistent throughout our relationship. They assigned a team with representation across all of the different functions. So we have our program manager, but also access to a broad team of experts when needed. Lonza has been responsive and transparent. We are visiting both the Slough, UK, and Visp, Switzerland, sites in early 2023 to continue our close collaboration.

Our lead program has been with Lonza for almost a year now. When it made sense, we transferred in our second program, and we will eventually bring more projects from our pipeline to Lonza. For Asher Biotherapeutics, they are the best fit. We look forward to moving through the clinic, delivering on our CMC and clinical data goals, and hopefully on to commercialization.