Anyone who follows oncology knows the field has attracted so much attention and research money that it sparks a continual eruption of biopharma news as companies joust over blockbuster markets. That’s kept me busy this year with a string of global confabs — as ASCO becomes just one big event in a frenzied competition.
So now I’ll be attending ASH in Atlanta in early December for the first time. What’s on my radar? I turned to Leerink today for some suggestions, and boiled them down here.
Approvals for Novartis $NVS and Gilead/Kite $GILD for their first CAR-T applications are a historic first step, but this technology is just now beginning to write its first commercial chapter. Juno $JUNO is now back after getting derailed with the disaster that JCAR015 became. And in figuring out what went wrong there, they are promising to come up with the next big thing in CAR-T: JCAR017. The therapy has produced some jaw-dropping efficacy results and a much improved safety profile, and now we all want to see every update to determine if Juno can leapfrog the leaders.
Novartis, the big pharma company that figured out how to work like a biotech on this one, will be offering some important details on Kymriah for DLBCL, where it’s looking to go head-to-head with Gilead’s Yescarta. So the update on that front from the Gilead/Kite team will earn a close inspection.
Then there’s Pfizer $PFE, another of the Big Pharma players that has made oncology a top priority. The giant bagged rights to Cellectis’ $CLLS UCART19 in ALL, and a presentation in Atlanta will be closely followed. Cellectis’ recent clinical hold for its own off-the-shelf approach to CAR-T — another potential leapfrog therapy — will keep the Paris-based biotech in the industry’s eye.
Bluebird bio $BLUE is seemingly always at ASH and always has something interesting to say. In this case it’s the “LentiGlobin gene therapy program in transfusion-dependent beta-thalassemia and severe sickle cell disease, as well as updated results of the bb2121 anti- BCMA CAR-T Phase I study in patients with relapsed/refractory multiple myeloma,” to quote Leerink.
Bluebird, by the way, just announced that it has dosed the first patient in its Northstar-3 (HGB-212) trial, a Phase III study of LentiGlobin.
Celgene $CELG has had its ups and downs this year, with some stunning and uncharacteristic setbacks that have triggered a small rout on their stock, dinging a large swath of big biotechs in the process. A good showing in Atlanta would go a long way to earning back some of the respect it’s long enjoyed. Leerink’s assessment of what to watch for on their closely watched appearance at ASH:
(O)ral presentations from the bb2121 Phase I study in multiple myeloma, and from the phase I TRANSCEND study of JCAR017 in NHL. CELG prepares to initiate a pivotal Phase III trial with bb2121 in myeloma in the coming months. CELG also will report several sets of Phase I data from next-gen CelMod CC-122 in NHL indications.
I’m also plucking Alexion $ALXN out of the mix. Their next-gen PNH drug is about the only important program they have in the pipeline, for now, and the early-stage snapshot on ALXN1210 will get some attention as well.
This next part is web only. I’m rounding out my list now with suggestions coming in over e-mail along with some suggestions via analysts remarks.
Spark $ONCE has one of those landmark drugs we all like to watch in Luxturna, and analysts at Jefferies say they’ll be on hand to make sure that the biotech demonstrates consistently positive data on the leading drug in the gene therapy field. “At ASH, we expect SPK-8011 to show general consistency of 11-14% and 20-25%, with the third cohort ideally showing 50-100% higher levels than the prior cohort,” says an upbeat Michael Yee.
I also plan to talk to Axel Hoos at GSK about their early-stage BCMA-targeting therapy, an antibody drug conjugate dubbed GSK2857916. Just a few days ago GSK flagged the FDA’s breakthrough drug designation, which will likely keep it on fast-track development. And the pharma giant is likely to use this program to highlight a return to late-stage development in oncology.
Also adding Regeneron, which has Phase I trials of their anti-PD-1 cemiplimab and CD20xCD3 bispecific REGN1979 in b-cell lymphomas, specifically B-cell non-Hodgkin lymphoma.
There’s also Gamida Cell, which will have the full Phase II data available on NiCord, now in late-stage development.
That’s it for now. These are only the highlights I’m zeroing in on. But if you have suggestions for anything important I missed, let me know. You can email me at email@example.com.
Image: The Georgia World Congress Center in Atlanta Shutterstock
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