Affimed NV (NASDAQ:AFMD) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) were big movers heading into the close of last wee week in biotech. Both have put out fresh news rooted in their respective lead development programs and both have picked up some strength on the back of the development.
Here’s a look at what happened and what it means for each going into this week.
This one is rooted in some data from two early-stage trials that the company set up to investigate the safety and efficacy of a drug called AFM13 as used in combination with Keytruda (pembrolizumab). Keytruda is a blockbuster oncology asset developed and now marketed by Merck & Co., Inc. (NYSE:MRK) that’s used as a standard of care first line for a range of cancer types.
With the trials that have just read out data, Affimed was trying to show that the addition of its own asset, AFM13, could improve on the current outcome expectations as compared to Keytruda on its own in patients with Hodgkin lymphoma (HL). This is a tough to treat cancer and it’s one that doesn’t have a wide range of treatment options available to patients, especially those who have already undergone first or second line chemotherapy.
So what did the data show?
As per the latest results, an 89% objective response rate (ORR) (n=8/9) was noted, which included four complete metabolic responses and four partial responses. To put this another way, eight out of the nine patients that received the combination drug showed some response, with 50% of these eight patients reporting a much-improved result over the other 50%.
That was the combination therapy. The drug was also tested in three patients suffering from CD30-positive cutaneous lymphoma, this time as a monotherapy.
And again, it performed pretty well. In this sample, an ORR of 66% (n=2/3) was noted with one complete metabolic response and one partial response.
What does this mean?
It’s a pretty strong result and that’s why the company is trading higher on the news – at close of trading on Thursday, Affimed went for a 40% premium to its pre-announcement capitalization.
The data has to be taken with a pinch of salt, however, given the small sample size and the fact that Keytruda in and of itself can often bring about a high percentage ORR rate, meaning there’s no guarantee in the combination study that the Affimed asset had much if any impact.
Still, it’s good news and the company could continue to gain strength heading into mid-stage trials during the second half of this year.
This one also relates to a development stage drug but, in the case of Alnylam, it’s an asset that’s much farther along its development pathway.
This time, the drug is patisiran and it’s an under investigation as a potential therapy for patients with hereditary ATTR (hATTR) amyloidosis.
The latest news is that the FDA has accepted a New Drug Application (NDA) for the asset, which Alnylam initially submitted during the latter half of last year, and that in line with the acceptance, the agency has set a PDUFA date of August 11, 2018.
Amyloidosis is a rare disease caused by the build-up of amyloid plaque within the tissues of the body, the same plaque that builds up in the brain in Alzheimer’s Disease. There’s essentially no treatment on the market right now for this. The only options are to treat symptoms as opposed to addressing the underlying condition), even though the condition is serious and often fatal.
So, there’s a market already in place for patisiran to fill and Alnylam is hoping that the FDA will give the drug a green light for commercialization by the August PDUFA date.
The program produced some pretty strong data so, assuming there are no concerns rooted in manufacturing or something similar (read: the parts of the NDA we know nothing about), there’s a pretty decent chance of the drug picking up approval this year.
Enjoyed this article? Read this next: Cascadian Therapeutics Scores Big On Seattle Genetics Acquisition