From Founding to Clinical Trial in 28 Weeks

After reviewing every Phase 1 clinical trial in the last 35 years, we found that our time from startup formation to first patient dosing (196 days) was faster than any other startup on record has ever taken a new drug into the clinic.

Alvea’s plasmid DNA Omicron variant-optimized COVID-19 booster vaccine was first conceived on December 16th of 2021, as the Omicron wave of COVID-19 was surging. Alvea was officially formed on January 7th, 2022, to respond to the new variant. By June 30th, 2022, Alveavax-v1.2 was being dosed in humans, just 196 days after work on it had begun, making Alvea the fastest biotech company to move a new drug from idea into a Phase 1 clinical trial.

Speed is Key for Biosecurity

Setting this record isn’t just evidence that Alvea can move quickly to make life-saving drugs. Setting records for how rapidly new vaccines can be safely developed is also a core part of our strategy and plan to halt the spread of new infectious diseases. In fact, we designed Alveavax-v1.2 for quick validation by building on others’ prior work on DNA vaccines.

When a new pathogen begins to threaten humanity, we need teams prepared to move quickly to test new vaccines and drugs that might stop its spread. Doing this requires pre-built infrastructure for safely moving ideas rapidly from the lab bench to first-in-human trials. CEPI, the Coalition for Epidemic Preparedness Innovations, has said that “delivering a vaccine in 100 days would give the world a fighting chance to extinguish the existential threat of a future pandemic virus.” We see this first milestone as a first exercise aimed at helping humanity build the muscle to protect the world in 100 days.

Methodology

Most drugs that are evaluated in a Phase 1 clinical trial by very new companies are drugs that have either:

1. Been recently acquired in an IP transaction from one company by another, meaning the drugs weren’t new.
2. Initiated by a company spinning out of an academic lab that has been working on the drug for many years.
3. A part of a trial that was initiated immediately after a smaller biotech company spun off of a larger company.

To determine that our 196 day time was record-setting, we relied on datasets available at clinicaltrials.gov, a government repository of clinical trial registrations, and Crunchbase, a user-edited database of information on startup formation and funding. Using clinicaltrials.gov, we created a dataset of all Phase 1 clinical trials sponsored by a corporation in the last 35 years, and found matching dates of company formation for each of these trial sponsors in Crunchbase, a database of startup information. We then evaluated the set of companies that appeared to have gone from formation to Phase 1 in less time than us. In some cases, this meant manually searching public filings to understand when a biotech company was actually formed (Crunchbase records can be imprecise). 

For every company with a nominally faster time from founding to Phase 1 trial initiation, we found public information that the corporation in question was a spin-off, had team members who had been developing its drug for years or decades prior, or was formed in a transaction that also purchased a ready-for-trial drug asset (meaning that someone had purchased the right to test a drug already under development by someone else, and formed the company as a vehicle for the drug asset they had purchased).

Please contact us (info@alveavax.com) if you find or represent a startup that you believe has gotten a drug into clinic on an even shorter timeline than Alvea: We love connecting with and learning from anyone who has figured out how to make important trials execute rapidly.