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Welcome to another edition of “3 Things In Biotech,” a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Amgen gets its thumbs up for blinatumomab
Company: Amgen (AMGN)
Disease: Acute lymphoblastic leukemia
News: The ODAC meeting to discuss the use of blinatumomab in patients with ALL and residual disease after treatment ended in AMGN’s favor, with 12 of the members voting yea to 4 nays. This signals a likely approval for blinatumomab, making it the first immunotherapy to be allowed for use in patients with this residual disease but no overt relapse.
Looking forward: The main disagreement from the panel came with respect to what cutoff of detectable disease should be considered “residual.” This is a broader point of contention in the field, as there is favorable consensus that minimal residual disease is important, but how should it be defined, and what should we do about it? With this, in the US, we are getting some answers here, and this will be a continuing active area of investigation moving forward.
In the meantime, this is important for AMGN’s bottom line, as approval here will extend the eligible patient population for blinatumomab therapy further.
BioTime moves its eye study into earlier AMD
Company: BioTime (BTX)
Disease: Dry age-related macular degeneration (AMD)
News: BTX announced that its data safety monitoring board has allowed the fourth cohort of the phase 1/2a trial involving OpRegen in dry AMD to move forward. This cohort of patients is intended to include those with better vision, and it will evaluate functional endpoints, such as visual acuity measured by BCVA. The company guided that it expects preliminary data from this cohort to be presented in the fourth quarter of 2018.
Looking forward: BTX has always been good about keeping tabs on its regenerative medicine trials, offering small updates to the progress where others are generally mum. This one would seem to be a fairly momentous update, since the entire premise of its cell therapy, replacing the retinal pigmented epithelium, is designed to slow or stop the progression of dry AMD, for which there is currently no approved therapy. BCVA is a tricky measure of efficacy, though, as patients with AMD follow a highly variable disease course, making it difficult to draw clear conclusions.
For now, I would not buy based on this news alone, but there is still quite a bit to consider with respect to BTX.
Caladrius gives a tantalizing update in type 1 diabetes
Company: Caladrius Biosciences (CLBS)
Disease: Type 1 diabetes
News: CLBS announced that an interim analysis has been triggered for the phase 2 T-Rex Study involving its autologous T cell therapy in recent-onset type 1 diabetes. The assessment continued to demonstrate that CLBS03 is well tolerated, and predefined futility criteria were not met. Thus, the study was recommended to be continued. 12-month follow-up data are anticipated in early 2019.
Looking forward: This is an interesting development to follow, ever since my article on CLBS that covered the preclinical findings of CLBS03 was published a little over two years ago. So I’m definitely rooting for the company, and I’m glad to see that there are small advances being made. Will it make it to approval? That’s anyone’s guess. But for now they continue to fight and scrape, and this is admirable. I would watch out for these data to come, as the first big readout of data is going to be crucial.
It’s still too early in my opinion to buy in based on this technology alone, but I would keep an eye on CLBS.
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