Agenus Trials Continue to Accrue Despite COVID-19

Our Key Clinical Trials are Advancing Despite COVID-19

Even with the challenges the world is facing, wherein major clinical trial centers and hospitals have been converted to COVID-19 treatment centers, we are continuing to enroll patients in our clinical trials. In fact, in some of our trials such as with AGEN1181 (our next generation, multipurpose CTLA4), we actually have a queue of patients who are being evaluated for enrollment. Our investigators, who are affiliated with major cancer immunotherapy centers with deep clinical trial expertise, expect to continue accruing patients.

Importantly, we have fully accrued patients into our balstilimab (anti-PD-1) trials, as monotherapy or in combination with zalifrelimab (anti-CTLA-4) in second line cervical cancer, and remain on track for our planned BLA filings in the coming months.

The Agenus team is managing patient safety and logistics to ensure that they receive their potentially life saving treatments and are able to continue follow-ups. We make sure that patients are provided secure transportation to visit sites safely and that site staff are also protected from potential exposure.

We have supplied sites with protective gear to overcome any gaps in the system and to ensure everyone’s safety and well being. We have also instituted remote monitoring and telemonitoring where possible, to continuously maintain oversight of our clinical trials. During the early phase of the pandemic spread, in anticipation of potential supply chain disruptions, we collaborated with our colleagues from Global Supply Chain, and strategically supplied our regional depots with enough study drug to ensure uninterrupted treatment to our patients.

COVID-19 has Paved The Way for Innovative Clinical Trial Practices

In addition to repurposing some of our research capabilities to advancing potential COVID-19 treatments, the pandemic has also driven high efficiencies in the way we conduct clinical trials. We are designing more patient and site centric studies without compromising the scientific merit of clinical trials. COVID-19 has paved the way for the increased adoption of practices such as telemedicine for patient monitoring, or home visits for collecting blood samples / taking vital signs. Since the visit/data collection is done remotely, we are helping the system by not exposing the patients and sites to potential infection.

While these may seem like simple practices in theory, they are new in the world of clinical trial operations and may continue to exist post COVID-19. It is something that many innovators in the clinical development community have tried for so long, but there were no guidelines from regulatory agencies to define good clinical practice (GCP) compliant telemedicine. Hence, they were rarely practiced. In March 2020, the FDA issued guidelines for the conduct of clinical trials during COVID-19, accommodating these practices. At Agenus, we swifly implemented these practices to facilitate the continuation of our clinical trials. We will continue to bring innovative therapies and best trial practices
aimed to maximize patient comfort and increase efficiencies at treatment centers.

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