From “The Way Forward" Conference: Esther Krofah, Executive Director, FasterCures

Therapeutic Landscape and Progress

• Faster Cures is currently tracking over 200 treatment candidates for SARS-CoV-2, a significant increase from the few dozen identified in early March.
• Approximately 65% of tracked treatments are currently in Phase 2 or Phase 3, with remaining programs in various scanning stages.
• The primary therapeutic modalities under development include antibody treatments, antivirals, cell-based therapies, and compounds targeting ARDS or cytokine storms.
• Early data indicates that Remdesivir provides moderate improvement for hospitalized patients, leading to its inclusion as part of the standard of care.
• Researchers are repurposing oncology therapies for COVID-19, specifically investigating prostate cancer treatments like Dapagliflozin to inhibit the TMPRSS2 protein.
• Clinical consensus anticipates that effective treatment will likely be a combination of therapies (e.g., antivirals paired with anti-inflammatories) rather than a single solution.
• Platform trials such as the UK's "Recovery" and the WHO's "Solidarity" are currently testing various combination therapy protocols.

Specific Treatment Categories

• Antivirals: The NIH launched the ACT2 study on May 8 to evaluate the combination of Remdesivir with anti-inflammatory compounds, aiming to assess mortality impact which the initial ACT study could not determine.
• Gilead Data: Gilead reported on June 1 that a five-day course of Remdesivir performed better than placebo, though long-term mortality data remains pending from platform trials.
• Convalescent Plasma: The Mayo Clinic, leading an FDA expanded access program, has treated over 21,000 patients with convalescent plasma, observing safety in an observational study of 5,000 subjects.
• Plasma Supply Constraints: While observational data suggests potential for faster recovery, experts note that supply is limited by the availability of willing donors, likely preventing universal availability.
• Regeneron: Early studies on Regeneron's engineered antibody therapies are considered promising, alongside efforts to utilize antibodies from recovered patients.
• Cell-Based Therapies: Stem cell transplantation is being investigated for severely ill patients but remains in early clinical research stages.

Clinical Development Timeline and Expectations

• Enrollment for many major Phase 2 and Phase 3 therapeutic trials is expected to close by early summer 2020.
• Substantial clinical data for therapeutics is projected to read out from late summer through early fall 2020.
• FDA Emergency Use Authorizations (EUA) for promising therapeutics are anticipated to be granted as data emerges in the fall or potentially carry into early 2021.
• The timeline for effective treatments is expected to align roughly with the timeline for vaccine availability.

Vaccine Development Status

• Faster Cures is tracking 163 vaccine candidates globally, with 10 currently in clinical testing.
• Leading programs include Moderna's mRNA vaccine and the University of Oxford/AstraZeneca vaccine, both of which are now entering Phase 2 trials.
• AstraZeneca has partnered with the University of Oxford to scale manufacturing for the Oxford vaccine candidate.
• Moderna leveraged prior MERS research and NIH collaboration to move from viral sequencing to clinical trials in just 48 days.
• Moderna and Oxford have expressed targets for limited-scale vaccine availability by late 2020 for frontline workers and at-risk populations.
• Broader vaccine availability is projected by early 2021 if clinical development proceeds without major setbacks.

Risk Factors and Strategic Considerations

• Conventional vaccine development typically requires up to 10 years and over $1 billion; the current 12-to-18-month timeline is considered highly aggressive.
• Concurrent manufacturing scaling (starting before final trial completion) is a deviation from standard protocol to achieve the accelerated timeline.
• Experts warn that public expectations must be managed regarding rollout prioritization, specifically identifying that initial access will be limited to healthcare workers and the immunocompromised.
• Success of the timeline depends on the smooth reporting of clinical data and the ability to maintain supply chains for both production and distribution.