Cis-Targeted Immunotherapies Need Large CDMO Expertise But Also Flexibility

Asher Biotherapeutics is developing a pipeline of cis-targeted immunotherapies that selectively activate only the immune cell types that drive the desired therapeutic response. The company was seeking a contract development and manufacturing organization (CDMO) that could handle phase II through to commercial production of its lead candidates, as well taking early-stage projects in its pipeline all the way through their life cycle. The technical capability and capacity of a large CDMO like Lonza was attractive, but Asher wanted to be sure that a large provider would be committed to its pipeline and offer flexibility in terms of technical approach and program structuring.

New Approach to Immunotherapies

Asher is pioneering a new approach with cis-targeted immunotherapies, which are fusion proteins that engage two receptors on the same immune cell — an immunomodulatory receptor and a specific target. Our lead compound is a CD8-targeted IL-2 immunotherapy, allowing selective activation of CD8+ effector T cells while limiting activity on immunosuppressive regulatory T cells and NK cells. This is expected to result in improved on-target pharmacology, antitumor immunity, and enhanced tolerability.

A successful transfer requires careful attention to many moving parts, but I knew Lonza would make it work.

Asher’s development candidates are unique in terms of their structure, which led us to look for a CDMO with the experience and technical expertise to handle fusion proteins. Our cis-targeting platform is also modular and we have generated a robust pipeline in a short period of time, so our choice of CDMO also needed to be able to keep pace with our rapid progress.

Technical Expertise for Fusion Proteins and Scale-Up

Initial manufacturing of our two lead candidates was performed by a CDMO that supports only early-stage programs. As these programs advanced, we needed to transfer them to a CDMO capable of taking the products through later phases and into commercial production.

We were not only looking for a CDMO with the technical capabilities to take on these programs from phase II, we were simultaneously looking for a long-term strategic partner for our overall pipeline — including programs in earlier stages.

We established a very thorough assessment process and sent an RFP to several CDMOs. Lonza led our scoring system against criteria we established for both the transferred projects and prospective new programs. Some of our team had had positive experiences with Lonza at other biotechs and noted its strong technical capability. Lonza’s expertise inspired confidence, which was important for our programs. 

Our first two programs would be tech transfers. With Lonza’s platform being developed primarily with a focus on monoclonal antibodies (mAbs), we needed to be sure they could handle our fusion proteins. We also needed to be sure they were interested in working with a biotech like Asher.

Flexibility Combined with Scientific Strength

The Account Manager at Lonza conveyed their enthusiasm for our business. I had previously had a good experience working with Lonza, but I wasn’t entirely sure they would be a good fit for Asher Biotherapeutics. The Account Manager and other people I had previously worked with at Lonza convinced me that Lonza had adopted a new approach to biotechs in recent years and that this could be a successful partnership.

When we attended a project kick-off meeting at Lonza’s Slough, UK, facility, the room was full of people. We were gratified to have the site head, department leaders, and the large project team all present.

We are a small company, and demands on our time meant we had to delay the start of the tech transfer into the Slough facility. Lonza was accommodating and reworked the schedule twice. This was refreshing, as we have experienced CDMOs who are unable to shift the schedule.

It Boils Down to Trust

Our initial project has been with Lonza for about eight months at this point. A successful tech transfer requires careful attention to many moving parts, but I knew Lonza would make it work. It boils down to trust in their expertise. If we had chosen another CDMO, I don’t know that it would have been successful.

We are happy to be here and our hope is to get good data in the clinic, for the programs to move forward, and that this excellent relationship will continue to grow. That is certainly the intention, as Asher has plans to bring more programs to Lonza.

Julie Trulson, Ph.D.

Dr. Julie Trulson is Vice President & Head of CMC at Asher Biotherapeutics. She has 25 years of experience in biopharmaceutical sciences, and has led teams in CMC and Process Development at innovators and CDMOs. Prior to joining Asher Biotherapeutics, she was CMC Team Leader at Allogene Therapeutics, working on CAR-T programs. Before that, she headed CMC at OncoMed Pharmaceuticals. Julie also has experience earlier in her career at Boehringer Ingelheim and Amgen. She received her BS in Biochemistry from Washington State University and her Ph.D. in Chemistry from the University of California at Santa Cruz.