January is inevitably a month where several worlds collide for us.
There might be initial data from SITC and solid data from ASH that bears the advantage of showcasing in the context of corporate presentations at JPM or company announcements of competitor trial progress.
That’s very much the case today.
Earlier this month, Incyte announced the phase 3 trial miss for their JAK1 inhibitor in acute graft versus host disease (GVHD), perhaps coming as a surprise to a few observers familiar with the positive ruxolitinib result, but not so much to clinicians.
In the latter case, one transplanter in the itacitinib study told me at ASCO that he hadn’t noticed any difference between the steroid only and steroid plus itacitinib arms in his SCT patients. Although admittedly that was a small sample of the whole, it did make me wonder if the trend was repeated then it wouldn’t augur well for the overall readout expected year end. Come January, his observation turned out to be rather prescient.
Incyte are presenting on the JPM20 slate in San Francisco today and we’ll be keen to learn if they have anything to add beyond the terse Jan 2nd announcement on the itacitinib miss.
More importantly though, there are still plenty of other agents in development are being investigated for the treatment of acute GVHD, one of which from Alpine Immune Sciences in Seattle we are particularly enthused about following discussions at the recent ASH meeting last month.
In our latest expert interview, we learn more about that development and explore the context for the evolution of a novel molecule likely not on many people’s radar. If the results turn out to be encouraging that situation could well change in the future.
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Bellicum have just announced that the FDA placed a clinical hold on BPX–501 clinical trials in the United States following three cases of encephalopathy “deemed as possibly related to” treatment with their new product in development, BPX–501.
The FDA clinical hold does not affect the ongoing BP–004 registration trial in Europe.
Here we take a look at some of the issues underlying the unfortunate news.
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With various acquisititions occurring in the wake of #JPM18 plus CAR T cell therapy being back in the news this morning following the proposed Juno acquisition by Celgene following on from the recent Kite/Gilead deal, not to mention some recent publications on the role of checkpoints in enhancing the technology, I wanted to explore a related area:
It’s time to talk about ICOS…
Before you think I’ve gone completely over to the dark side talking about blockchains, rest assured that we do not refer here to Initial Coin Offerings i.e. an unregulated means by which funds are raised for a new cryptocurrency venture, but rather to an inducible co-stimulator of T cells that is structurally and functionally related to CD28.
In short, it’s an immune stimulatory rather than inhibitory checkpoint target that is gaining attention of late and is something we are likely to hear a lot more about over the near term.
Related to this is highlighting up and coming biotechs in the IO space who are exploring novel targets beyond the obvious anti-PD(L)1 focus since we need to see what might happen with IO-IO combinations as a way to improve responses and outcomes such that more people with cancer can receive benefit from immunotherapy.
Here, we offer a look at a biotech active in this space to learn what their approach is and where their pipeline is going in the near to medium term future.
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One of the most common questions we have received from subscribers in the last 6 months relates to Bellicum Pharmaceuticals (NASDAQ: BLCM) and the opportunity for their adjunct T Cell therapy in development for allogeneic hematopoietic stem cell transplantation (HSCT), BPX–501. This product is given after the transplant and uses genetically modified donor T cells incorporating a CaspaCIDe safety switch.
We first wrote an in-depth piece about Bellicum and BPX-501 back in January 2015 with an interview with their CEO and CMO for those interested in more background (Link).
At the recent 2016 BMT Tandem meeting in Hawaii, we had the opportunity to hear the latest data on trends in haplo-identical (Haplo) bone marrow transplants. This posts reviews some of the data presented and considers the implication of this on the market opportunity for Bellicum.
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National Harbor, MD – the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) kicked off today with a series of workshops, and mini-symposia before the main meeting starts on Friday.
It is currently glorious weather for Maryland in November, almost too nice to be indoors, which probably means it’s going to be a cold winter for those who live up North!
Of note this afternoon/evening at SITC 2015 was an International Symposium on Cancer Immunotherapy entitled “Today’s Innovators, Tomorrow’s Leaders.”
Organized in collaboration with the World Immunotherapy Council (WIC), the symposium showcased up and coming researchers, each of whom had an expenses paid trip to SITC to present their work before an audience that included many of the “great and good” in cancer immunotherapy. It was useful learn from the questions being asked from the floor too, further adding to the value of the session.
@BernardAFox introduces the International Cancer Symposium and acknowledges the vision behind it.
Dr Bernard A Fox (@BernardAFox), a past President of SITC, in his introduction acknowledged the vision behind it, and in particular, the contribution of Dr Nora Disis (@DrNDisis). Those of you who listen to Novel Targets Podcast heard her in the most recent show.
Today’s daily highlights post offers a few of my “take homes” from this afternoon. It doesn’t discuss unpublished data but some of the presenters went into more detail about posters they are presenting later this week which was interesting.
The symposium was highly enjoyable and well worth attending. Hopefully, it will be repeated at next year’s SITC annual meeting.
Tomorrow here in National Harbor, I’m looking forward to the workshop on new perspective for target antigens in the changing immunotherapy landscape. That will be the subject of tomorrow’s daily digest. Stay tuned!
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San Francisco – “Manic Monday” is what I call Monday at the annual meeting of the American Society of Hematology. It’s when the majority of oral presentations take place in multiple parallel sessions that require you to run between meeting rooms if you want to follow a particular drug across different blood cancers.
It’s even more challenging this year by the fact the conference is in three buildings at the Moscone Center in San Francisco. While Moscone North and South are interconnected thanks to an underground atrium, to get to sessions in Moscone West from North/South you have to go out of the building, cross one or two main roads, then go up elevators to the second or third floors. Not ideal! I think ASH is now too big for the venue.
Looking back on yesterday, it was a privilege to be in the audience when Dr Kanti Rai received a well-deserved lifetime achievement award for his work in chronic lymphocytic leukemia (CLL). A visibily moved Dr Rai was given a standing ovation by the thousands present in the plenary hall.
Expect the #ASH14 Twitter stream today to be like opening the tap to run a bath. I congratulate all the hematology experts who have shared data and commentary from sessions via social media. #ASH14 stands out in terms of expert engagement and a high signal to noise ratio.
If there was an award for best conference coverage of #ASH14 on Twitter I would nominate @drmiguelperales.
Not only does Dr Perales from Sloan-Kettering share tweets from the sessions that he is in that are accurate and informative, but he frequently offers links to relevant papers for those that want to learn more. In addition to showcasing his expertise, this is a really good way to use social media to educate and inform. I look forward to his commentary, particularly if I am in another session at ASH. A must follow on Twitter!
To the extent possible we’ll be providing updates to today’s live blog throughout the date, subscribers can login to read more or you can purchase access by clicking on the blue icon at the end.
National Harbor, MD – The 2014 Society for Immunotherapy of Cancer (SITC) annual meeting officially kicked off today, with a record-breaking 1,500 attendees. The organization has grown by 33% over the past year highlighting the explosive progress in the field, and the growing importance of SITC!
There was a lot of thought provoking science on display as researchers and translational scientists came from all around the world to share results and talk about the future.
What struck me at the meeting today was the collegiality and friendliness of all who are here. It’s exciting times in immunotherapy and immuno-oncology and everyone at the meeting is bound by a common goal of making a difference to the lives of cancer patients.
The President of SITC, Francesco Marincola (Sidra) quoted Winston Churchill in his introductory address:
“Now this is not the end.
It is not even the beginning of the end.
But, perhaps it is the end of the beginning.”
Dr Marincola’s choice of quote seemed to strike the right balance of where we are at today: there’s still a long way to go to optimize cancer immunotherapy treatments, but equally there’s been tremendous progress to reach the point we are at where there are durable long-term responses in many patients who would otherwise not be alive today.
What was the highlight of Day 1 of SITC 2014?
For me, this morning, it was the presentation by Marcel van den Brink (MSKCC) on the influence of the microbiome on graft-versus-host disease (GvHD) for which there’s been no effective new treatment for over 25 years:
In the afternoon, it was the presentation by Roy Herbst (Yale) on the top ten lessons learned about immunotherapy for NSCLC.
It’s unfair to single out two presenters when there were multiple presentations and posters of note, but they stood out for me. If you’d like to read our more detailed notes from the road after Day 1 of SITC 2014, do log-in if you are already a subscriber.