Cyfendus (anthrax vaccine adsorbed, adjuvanted): how was the first human dose set?

Atlas/Oligonucleotides/Cyfendus/First dose

Cyfendus: how was the first human dose set?

anthrax vaccine adsorbed, adjuvanted · TLR9 (CpG 7909 adjuvant)

First-in-human starting dose

Not stated in public reviews

Why it's blank

The public FDA and EMA reviews of Cyfendus don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

How it's usually set for oligonucleotides outside oncology

Find the highest dose with no adverse effects (NOAEL) in each animal species, convert it to a human equivalent dose, usually by body surface area, pick the most appropriate species, then divide by a safety factor (default 10) to get the maximum recommended starting dose.

“In general, one should consider using a safety factor of at least 10. The MRSD should be obtained by dividing the HED by the safety factor.”

✓ VerifiedFDA 2005: Estimating the Maximum Safe Starting Dose in Initial Clinical…, p. 7Source ↗

This product's starting point

NOAEL / key findings: Injection-site necrosis and granulomatous inflammation judged adverse but expected to resolve (FDA summary basis for approval, p. 16)

Full method, every step sourced →

NOAEL / key findings

Injection-site necrosis and granulomatous inflammation judged adverse but expected to resolve

“The necrosis and granulomatous inflammation at the injection sites were considered adverse reactions and were expected to resolve over time.”

✓ VerifiedFDA summary basis for approval, p. 16Source ↗

Summary across all 28 oligonucleotides →

Cyfendus: how was the first human dose set?

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