AC Immune (ACIU) is up 60% in pre-market after the company announced it was advancing their anti-tau vaccine in Alzheimer’s Disease (AD) to higher dosing cohorts. Although the release was vague, we think the progress announced is positive and could be the trigger that gets markets to realize ACIU’s potential.
ACI-35.030 Targets AD Causing Tau Protein
ACI-35.030 is a vaccine candidate for early stage AD patients that is partnered with JNJ’s bio-arm, Janssen. This vaccine candidate aims to generate an antibody response against phospho-Tau (“pTau”) proteins in the brain. pTau is seen early during AD, years before accumulation of “actual” Tau deposits that cause neuro-inflammation, cell death and cognitive decline associated with AD.
ACIU and Janssen are betting that anti-pTau antibodies generated by ACI-35.030 have the potential to reduce the spread Tau protein throughout the brain.
In the Phase 1 trial (see design here), the companies are testing ACI-35.030 in 3 dosing cohorts. Low/medium/high. In the “low” cohort, ACIU said in today’s press release that data showed encouraging interim safety, tolerability, and immunogenicity results. Although the press release itself did not include any data, and was rather vague, we think it is a positive for AC Immune.
Vaccine Safe & Efficacious Enough to Move To “Medium” Dose
ACI-35.030 is the second-generation vaccine between ACIU & Janssen. The first-generation vaccine was shown to be safe, but it lacked the desired immune response. This 2nd gen ACI-35.030 candidate demonstrated immunogenicity results at the “low” dose. That means that the vaccine provoked an immune response in the form of antibodies that could potentially stop the spread of pTau.
Theoretically, if "low" dose provoked a promising result, medium and high doses should generate an even greater response. This early Phase 1b / 2a data, albeit vague, builds on the pre-clinical data that generated a highly specific antibody response against p-Tau.
4 More Catalysts Lined Up for 2020
In addition to today’s release, ACIU has multiple catalysts lined up for remainder of 2020.
- Semorinemab, an anti-Tau antibody partnered with Genentech, will report Phase 2 in prodromal/mild Alzheimer’s Disease. This will be the first Phase 2 readout of an anti-Tau antibody in AD.
- ACI-24, anti-Amyloid beta vaccine, reporting Phase 1b in AD-Down syndrome.
- ACI-3024, a small molecule Tau inhibitor partnered with Eli Lilly, will report Phase 1 results. Data will be disclosed at discretion of Eli Lilly.
- ACI-24 will report interim 12-month Phase 2 data in AD
Even with today’s price action, AC Immune has a $800M market cap and about $300M in cash. A $500M EV for the potential leader in tau for AD is not a stretched valuation. With the 2020 readouts mentioned above, we think the company can justify a $1B+ valuation (read more here). Given the multiple shots on target, we like the company’s chances.
PropThink contributors are LONG ACIU
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