How can COVID-19 pave the way for global access pathways for monoclonal antibodies?

On January 19, IAVI co-convened a webinar with Wellcome and Unitaid on how COVID-19 may pave the way for global access to monoclonal antibodies (mAbs). Introductions by Jeremy Farrar and Mark Feinberg juxtaposed the wide-reaching application of mAbs for various diseases against the inequitable access plaguing the global mAb pipeline, particularly in low- and middle-income countries (LMICs). An overview of the IAVI-Wellcome call to action, provided by Feinberg, outlined key guiding principles to facilitate equitable access, including optimized product profiles, alternative business models, and investment in market preparedness.

“As the COVID-19 pandemic has shown, no country is immune to the threat posed by EIDs [emerging infectious diseases],” Mark said, following comments on the need for robust epidemic preparedness. “If mAbs prove to be effective for COVID-19, ensuring prompt, equitable, and affordable global access to these products, as well as others, will be imperative.”

The first half of the webinar, moderated by Shelly Malhotra, focused on the COVID-19 therapeutic pipeline. Representatives of the Access to COVID Tools-Accelerator’s (ACT-A) Therapeutic Pillar provided a high-level overview of the more than 610 assets developed to treat COVID, which focus primarily on host-directed treatments for severe disease. ACT-A, in providing oversight to the pipeline, seeks to mitigate anticipated gaps in uptake, with an emphasis on developing fit-for-purpose products and identifying elements to support and overcome market challenges in LMICs. Equitable allocation and deployment of mAbs underpins these efforts.

Lindsay Keir introduced the second half of the webinar, featuring a panel discussion moderated by Michel Kazatchkine. Speakers delved further into the novel public-private partnerships that have arisen from the global COVID-19 therapeutic response, sharing consensus that a coordinated global partnership, especially with LMICs, will be needed to enable effective epidemiological surveillance, a robust manufacturing pipeline, and ultimately global access.

“The business model of public-private partnerships is key,” noted Jessica Martinez in discussing the role of funders as the risk backstop, adding that “it’s important to create time for optimization and not build these platforms in a crisis, and it’s important to challenge the assumptions that these markets [in LMICs] do not exist.”

Scientific innovations remain a key driver of equitable global access, not least characterized by optimized product profiles. GSK’s VIR-7831 and Celltrion’s CT-P59 mAb candidates, developed to reduced rates of clinical progression to severe disease, are two such products demonstrating favorable profiles following high levels of optimization, including for increased potency. Celltrion’s CT-P59 is currently under review by the U.S., EU, and Canadian regulatory authorities. Lessons learned from existing models and mechanisms, such as those developed in the COVID-19 vaccine pipeline, will facilitate this process. A clear, unified, and coordinated procurement and regulatory pathway will be critical to this end.

Kazatchkine opened the panel discussion, stating, “We have a remarkable opportunity now, a momentum, to really address these challenges in the short term and also prepare for future investments, platforms, and preparedness.” Of note, panelists commented that prevention of severe disease should be a priority endpoint for clinical research, reflecting the need to alleviate pressure from health systems. With vaccine coverage in LMICs expected to be below 20% in 2021 and the prospect of COVID-19 becoming endemic, demand for mAbs in these regions will likely persist.

In closing, Phillipe Duneton reaffirmed that we must remain responsive to the evolving pandemic and ensure holistic allocation of mAbs, urging for a well-informed, collaborative, and inclusive long-term strategy to make equitable global access to COVID-19 mAbs a reality.

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A recording of this webinar is available via Wellcome.

Another webinar in this series, co-sponsored by IAVI, the Department of Biotechnology of India, and Wellcome, entitled “Innovative bio-therapeutics for COVID-19: can monoclonal antibodies for SARS-CoV-2 be made accessible in LMICs?”, is scheduled for February 24 from 8:00 a.m. – 10:15 a.m. (EST).