Amgen Bets $45m Plus Up To $1.7bn On Xencor's Bi-Specifics
This article was originally published in Scrip
Amgen's Blincyto (blinatumumab) was the first US FDA-approved bi-specific antibody and now the biotechnology giant may spend nearly $1.75bn on bi-specifics developed with Xencor Inc.'s XmAb platform for monoclonal antibodies that bind to two separate targets.
Thousand Oaks, California-based Amgen will pay Xencor $45m up front and up to $1.7bn in clinical, regulatory and sales milestone fees plus royalties across six novel bi-specific antibodies in the fields of cancer immunotherapy and inflammation. Monrovia, California-based Xencor will prepare its "plug-and-play" platform for Amgen's use and the bigger company will take over preclinical and clinical development of bi-specific antibodies and commercialization worldwide.
"Our workload is quite modest, but the reason for that is that [the collaboration] is built on our proprietary technology," Xencor president and CEO Bassil Dahiyat told Scrip. "We don't need to do much, because all of the value creation has been built. It really doesn't take us a long time to build a specific molecule."
Xencor has inked several deals with major pharmaceutical and big biotech companies that wanted to tap into the firm's XmAb monoclonal antibody discovery technology. The new Amgen transaction is Xencor's second for its bi-specific XmAb platform following a discovery deal signed in December with Novo Nordisk that's worth up to $175m in upfront and milestone fees.
Amgen will combine its target discovery and protein therapeutics expertise with Xencor's molecular engineering capabilities to advance five T-cell engagers and bi-specific antibodies. The sixth program under the partners' agreement pertains to Xencor's existing preclinical bi-specific T-cell engager (BiTE) targeting CD38 and CD3 for the treatment of multiple myeloma.
There are no general limitations in its agreement with Amgen regarding what Xencor can pursue for its own internal pipeline. Some of the programs under the partners' collaboration are combinations of targets that can be used in cancer, particularly looking at T-cells, while other undisclosed targets are applicable in inflammatory diseases.
"Within the specific targets they're going after or that they want us to build bi-specific antibodies for, that's actually a small number of targets," Dahiyat said. "This doesn't impact any current internal programs. We never want to broadly restrict Xencor's ability to build our own pipeline."
Xencor will earn mid to high single-digit royalties on therapies against Amgen's five targets as well as high single and low double-digit royalties on sales of Xencor's molecule.
"We are especially excited about the T cell-engaging bi-specific antibody directed against CD38, which complements Amgen's BiTE platform, while growing our hematology and oncology portfolio that includes two bi-specific T cell engager antibodies, Blincyto (blinatumomab) and AMG 330, as well as Kyprolis (carfilzomib) for relapsed multiple myeloma," Amgen executive vice president of research and development Sean Harper said in a joint statement from the company and Xencor.
Partnership Progress
The bi-specific antibody agreement between Xencor and Amgen is not the first deal between the two companies. Xencor renegotiated the terms of a 2011 collaboration with Amgen in October to regain the rights to its lead therapeutic candidate XmAb5871, for which the company successfully completed a Phase Ib/IIa clinical trial in rheumatoid arthritis.
Xencor will pursue development of XmAb5871 in rare autoimmune diseases, but Amgen retained a right to license the antibody for late-stage development and commercialization.
Xencor's other monoclonal antibody discovery and development partners include CSL Limited, MorphoSys and Johnson & Johnson's Janssen Biotech subsidiary (via Centocor).
Dahiyat described the upfront cash from the bi-specifics deal with Amgen as meaningful for Xencor, because it gives the company more resources to pursue development of current clinical programs or to move preclinical assets into the clinic or both.
Before Amgen's investment, Xencor already had plans to begin clinical trials in 2016 for XmAb14045 in acute myeloid leukemia and XmAb13676 in B-cell malignancies.
"We don't feel like there's any need [to do other bi-specific collaborations], but if there's an opportunity to expand the scope of what our technology can do, we'll consider other deals," Dahiyat said.
Of course, Amgen also is a prolific dealmaker in pursuit of new therapeutic candidates for its research and development pipeline. The bi-specific agreement with Xencor will expand the company's BiTE portfolio led by Blincyto, which was approved and launched in the US in December.
Amgen also is focus on immuno-oncology opportunities, such as its collaboration to test the company's oncolytic vaccine talimogene laherparepvec (T-VEC) with Merck & Co.'s Keytruda (pembrolizumab), an agreement with Kite Pharma to co-develop chimeric antigen receptor T-cell (CAR-T) therapies, and another collaboration testing T-VEC with Roche's atezolizumab.