CSL: Driven by Its Promise to Deliver for COVID-19 Patients

Vicky Pirzas, CSL Behring’s Vice President of Recombinant Product Development (left) and Deirdre BeVard, CSL Behring’s Senior Vice President for Research and Development Strategic Operations (right).

Industry-leading biotech CSL is leveraging its integrated global portfolio to bring urgently needed therapeutic COVID-19 treatments to patients around the world. 

“You may have heard either our CEO Paul Perreault or our Executive Vice President, Head of R&D and Chief Medical Officer Bill Mezzanotte say the following: ‘If someone wanted to create a company with the capabilities and the culture to fight COVID-19, it would look an awful lot like CSL,’” said Deirdre BeVard, CSL Behring’s Senior Vice President for Research and Development Strategic Operations.

With a mandate to serve patients and an emphasis on public health, CSL Behring is a co-founder of the CoVIg-19 Plasma Alliance, which aims to develop an anti-coronavirus hyperimmune globulin (H-Ig) made from a convalescent plasma for the treatment of hospitalized adults at risk for serious complications of COVID-19.

“It [the H-Ig] recognizes a diverse array of multiple epitopes of the SARS virus. It says, ‘yes, I’m recognizing you,’ and prevents it from binding to the ACE receptors on the human cells. Therefore, because it already has that recognition, it limits the progression of the disease during those early stages of COVID-19,” said Vicky Pirzas, CSL Behring’s Vice President of Recombinant Product Development. 

BeVard made a point to emphasize “how appreciative and humbled we are by the people who are willing to donate their plasma.” 

The investigational therapy is currently undergoing a global multi-center Phase III Anti-Coronavirus Immunoglobulin (ITAC) trial comprised of 500 adult patients at up to 58 sites across the U.S., Mexico and 16 other countries on five continents. If proven effective, the H-Ig could become one of the initial treatment options for patients when they are hospitalized with COVID-19. BeVard told BioSpace that the Alliance anticipates the completion of the trial during the first quarter of 2021.

BeVard added that once the trial, which is being sponsored by the National Institutes of Health (NIH), is completed, and assuming the results are positive, the Alliance will submit for regulatory authorizations.

CSL, along with Takeda and two other companies, is providing all of the investigational H-Ig materials for the trial – a trial that, incidentally, fits right into CSL’s company ethos and global business model.

 CSL has R&D centers located in nine countries and employs more than 27,000 scientific and professional employees worldwide. Parent company CSL Limited is headquartered in Melbourne, Australia, a geographical arrangement that explains the company’s defining global culture.

“We have a set of values that guide the way we work, and we’ve seen that come to light in every aspect of this,” BeVard said. “Collaboration is a core value at CSL, and we really leverage both internal and external collaborations to address patients’ needs. Globally, it also means the work can get done kind of around the clock, and capacity-wise, in multiple locations. That gives us a lot more flexibility.”

The CoVIg-19 Plasma Alliance “is really an unprecedented industry partnership,” Pirzas said. 

It is one of many such partnerships undertaken in a crisis year that has only served to make the planet even smaller. Life sciences companies across the world have rolled up their sleeves and asked, where can I help? For CSL, the more appropriate question may have been, where can’t we?

CSL is progressing new disease areas across six different therapeutic areas: immunology, hematology, cardiovascular and metabolic, respiratory, transplant, and influenza vaccines. 

The company is developing these novel therapies through four different scientific platforms: plasma fractionation, recombinant technology, cell and gene therapy and cell and egg-based vaccines. 

“We were well-positioned through our two business of CSL Behring and Seqirus because of our acumen in vaccines, in monoclonal antibodies, in recombinant technology, our manufacturing capabilities and our external collaborations and partnerships,” BeVard said. “That, in combination with what was already our focus therapeutically on immunology and respiratory, really enabled us to be able to respond very quickly to the needs for potential solutions in the world’s fight against COVID-19.”

As they made the decision to devote significant resources to the global battle against COVID-19, CSL, which has a primary focus on helping patients lead full lives, also needed to ensure they were not shortchanging others who rely on its vast portfolio of therapies.  

“We looked at opportunities right across the spectrum of infection and disease and took on projects that made sense both scientifically and with our capabilities. So we didn’t look to extend beyond those,” BeVard said. “We leveraged what our experience and expertise has been, because that best positions us to deliver on the promise to patients and to the protection of public health, and allowed us to look for solutions that could stop the virus, as well as treat the damage it inflicts on patients who contract it.”

In terms of plasma donation itself, CSL Behring explained that the pandemic has served an educational purpose. 

“The role of plasma collection in the U.S. is also gaining greater awareness as a result of the pandemic and potential benefits of plasma therapies. As each week passes, our plasma collections have been growing. We are also continuing to expand our plasma collection center network,” CSL Plasma said in a statement.

Notably, CSL has leveraged its substantial capabilities in both recombinant technology, and its respiratory focus, to repurpose Garadacimab, an investigative FactorXIIa-inhibitory monoclonal antibody, for the treatment of patients suffering from severe respiratory distress –  a leading cause of death in those with COVID-19 related pneumonia.

“You can see the flexibility of CSL’s employees around the world to really target projects and products across these categories to make sure we utilize this portfolio in the recombinant and the plasma space,” Pirzas said. 

In April, CSL Behring announced a partnership with SAB Biotherapeutics, combining its protein science capabilities with SAB’s DiversitAb™  immunotherapy platform, which is capable of rapidly developing and producing natural, highly-targeted, high-potency, fully human polyclonal antibodies.

Both BeVard and Pirzas repeatedly highlighted that the company’s culture of resilience and dedication to patients are what have allowed it to truly maximize its vast portfolio of capabilities for the COVID-19 effort. 

“There was such a readiness for the organization to help, and what we have found is an incredible resilience under what are some really unique and challenging circumstances,” BeVard said. “The team, overall, is very relentless to succeed, really resourceful in getting it done.”

“I think you see that in our people, they have that focus, they have the drive. They want to deliver for the patients,” Pirzas added.

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