CSL Behring, based in King of Prussia, Pennsylvania, is acquiring Vancouver, British Columbia-based Vitaeris. The two companies inked a strategic partnership in 2017 to accelerate the development of Vitaeris’s clazakizumab. At that time, CLS Behring also had an option to acquire Vitaeris, the therapeutic, and the rest of Vitaeris’s assets.
No financial details were disclosed. In the 2017 deal, Vitaeris retained control of projects through the end of Phase III development. There was an upfront cash payment of $15 million, with research-and-development milestone payments over that period, which included future sales-related payments, as well as a royalty to Alder BioPharmaceuticals, who originated clazakizumab.
Clazakizumab is an anti-interleukin-6 (IL-6) monoclonal antibody for the treatment of chronic active antibody-mediated rejection (AMR), which is the top cause of long-term rejection in kidney transplant patients. There are currently no treatments approved for transplant recipients who develop antibody-mediated rejection.
Clazakizumab will join CLS842 and CSL964 as part of CSL Behring’s late-stage program related to transplants.
“Clazakizumab has been a promising monoclonal antibody in the Transplant therapeutic area since we started working with Vitaeris several years ago,” said Bill Mezzanotte, executive vice president, Head of R&D, CSL Behring. “Acquiring Vitaeris and their associate expertise helps us to continue to grow our strategic scientific platform of recombinant proteins and antibodies. We look forward to continuing to advance this treatment candidate as a potential option for people experiencing rejection—an area where current treatment options for transplant recipients are limited, at best.”
Also today, CSL Behring announced results from a Phase II clinical trial of garadacimab (formerly CSL312), an investigational novel Factor XIIa-inhibitory monoclonal antibody to prevent hereditary angioedema (HAE). The company presented results at the European Academy of Allergy and Immunology (EAACI) Digital Congress 2020.
The trial met the primary endpoint, showing a decreased number of attacks compared to placebo in patients with HAE. HAE is a rare, genetic and potentially life-threatening disease. HAE is one of two types of bradykinin-mediated angioedema, with the other being nonhereditary or acquired angioedema. HAE is the result of deficient or dysfunctional C1-INH, a blood protein that helps control inflammation.
Last month, the U.S. Food and Drug Administration (FDA) granted garadacimab orphan drug designation for bradykinin-mediated angioedema.
“The attacks that HAE patients experience can be very frightening, and clinicians want to do anything in their power to reduce the frequency of these attacks, lessen the need for rescue medicine and simplify treatment,” said Timothy Craig, lead study investigator with Allergy, Asthma and Immunology, Department of Medicine and Pediatrics, Penn State Hershey, Hershey, Pennsylvania. “The findings of this study are very encouraging and we look forward to further research assessing the safety and efficacy of garadacimab.”
CSL Behring has been quite busy recently. On June 2 the company announced a strategic alliance with Seattle Children’s Research Institute to develop stem cell gene therapies for primary immunodeficiency diseases. The initial focus will be on Wiskott-Aldrich Syndrome and X-linked Agammaglobulinemia.
The company is also working on several fronts to develop treatments and preventions for COVID-19. The company is part of the CoVIg-19 Plasma Alliance, which is working to develop an unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin therapy. The Alliance is also working with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to test the hyperimmune therapy in adult patients with COVID-19. CSL Behring Australia is developing an anti-SARS-COV-2 plasma product for the Australian market. CSL Behring is also partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) and The University of Queensland (UQ) to speed the development, manufacture and distribution of a COVID-19 vaccine, as well as other initiatives in this space.
And on May 27, 2020, CSL Limited entered into a strategic partnership with Thermo Fisher Scientific to “meet the growing demand for biologic therapies while also accelerating CSL’s broader manufacturing objectives.” Thermo Fisher will leverage its pharma services network to support CSL’s product portfolio, and via a long-term lease deal, will operate a new state-of-the-art biologics manufacturing facility in Lengnau, Switzerland, which is being built now and is expected to be completed in mid-2021.
Of the acquisition by CSL Behring, Kevin Chow, president and chief executive officer of Vitaeris, stated, “We’re pleased to become part of CSL Behring, a well-established, global industry leader, and know that the future of clazakizumab is in excellent hands. Together, we have already achieved much progress through our partnership over the past few years and are now in an even stronger position to realize our collective goal of addressing one of the greatest unmet needs in the organ transplant community.”