I coated AC Immune (NASDAQ:ACIU) almost two years in the past, and the inventory is down 70% from that point. AC Immune is a developer of medicines for Alzheimer’s illness, and it used to concentrate on the previous abeta/tau speculation. In my earlier article, I mentioned its then lately failed trial for semorinemab in AD, and I famous that they’d no trials working at the moment. I additionally mentioned their diagnostic pipeline and mentioned that this might be a strong income generator outdoors of their drug pipeline.
ACIU is a dementia-focused program and virtually each considered one of its molecules goal some kind or different of dementia. There are 3 applications concentrating on tau, and yet another tau program that’s for prognosis. Two extra applications goal abeta, and a variety of others produce other novel targets. Of those dozen or extra applications, 4 are in section 2 or above.
So why is such an organization down 70% in two years?
The primary cause is, in fact, the trial failure, nevertheless this occurred 3-4 months earlier than I wrote that article, and the inventory had dropped 50%. By the point I coated the inventory, although, it was already again up, having recovered virtually that whole 50%. Thus it has fallen once more considerably from that time.
In case you have a look at ACIU’s two 12 months value chart, there’s a regular decline within the inventory. There aren’t any sudden declines as such, besides perhaps one or two such spots, particularly round June final 12 months when crenezumab failed.
Crenezumab’s failure was an enormous setback for the complete Alzheimer’s illness house. The molecule was developed at ACIU, then partnered with Genentech. It’s an abeta concentrating on molecule, and has gone by way of rigorous trials underneath Roche. In June final 12 months, the 2 firms introduced that Crenezumab didn’t sluggish or forestall cognitive decline in Colombian sufferers with the Presenilin 1 E280A genetic mutation which causes early-onset Alzheimer’s illness. There have been two main endpoints within the examine – the speed of change in cognitive skills and episodic reminiscence operate – and Crenezumab failed to satisfy both of them.
Crenezumab has been a continuing disappointment for AC Immune. In 2019, accomplice Roche determined to discontinue crenezumab’s two pivotal trials, Cread 1 and a pair of, when an interim evaluation confirmed that the trials are unlikely to satisfy their main endpoint, change in CDR-SB rating. Within the newest failure, as effectively, the information was resoundingly towards crenezumab, nevertheless, as common, the businesses, particularly AC Immune, tried its greatest to spin it positively. One remark that truly made me smile was this from AC Immune CEO Andrea Pfeifer:
I believe the image we’re giving is clearly exhibiting that the molecule appears to do one thing.
The molecule really failed to cut back abeta plaques on this inhabitants so firms with rival medicine working in the identical house took that as a optimistic signal for his or her property. That is in all probability the most effective factor that may be mentioned in regards to the trial – that it nonetheless didn’t disprove the amyloid speculation.
The supply cited above discusses a variety of possible positives from the trial, however till we all know Roche’s plans for the molecule, let’s not go into that. What’s necessary for the present protection is that we appear to have recognized the reason for ACIU’s fixed decline – two of its lead AD molecules have now led to failures.
AC Immune has moved in the direction of the tau tangle speculation, in addition to in the direction of AD vaccines, now. Lately, ACI-24.060 noticed an anti-Abeta antibody response as early as week 6 in a small trial, setting the sector for additional analysis. These had been interim outcomes from the ABATE trial, which noticed this drug exercise in addition to a secure and usually well-tolerated drug. Nonetheless, as has usually been the case with AC Immune knowledge launch, it ” …was skinny on particulars, past the headline that the shot elicited a response.” PET imaging knowledge from this trial to see if the molecule really reduces abeta plaques will probably be obtainable solely in 2024.
A second AC Immune vaccine known as ACI-35.030 is partnered with Johnson & Johnson, and has produced “optimistic” interim section 1b/2a knowledge. This molecule can also be in additional improvement. This can be a tau-targeted vaccine whose “interim knowledge confirmed that the high-dose of ACI-35.030 led to a powerful induction of antibodies selective for pTau and its aggregated kind, enriched paired helical filaments (ePHF).”
Swiss firm ACIU has a market cap of $177mn within the US and a money reserve of CHF 122.6 million (1 CHF = $1.08). R&D bills had been CHF 60.3 million whereas G&A bills had been CHF 15.8 million for the complete 12 months in 2022. At that fee, the corporate has a money runway of almost two years. They anticipate milestone funds this 12 months after beginning trials for the JNJ partnered candidate.
Alzheimer’s is a troublesome discipline and sadly for ACIU, it has confirmed that again and again. The corporate is admittedly a number one researcher within the discipline, as proven by its offers with massive pharma together with Roche, Lilly and JNJ. Nonetheless, none of its property have thus far turned out effectively. Every thing could change in the event that they present only one optimistic trial knowledge. Nonetheless, the inventory may be very dangerous proper now, and I would not wish to put money into ACIU given my danger urge for food is fairly low.
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