This is an important and necessary follow-up to the ongoing Juno JCAR015 story in July after three patients had died due to complications associated with cerebral oedema. At that time, the company attributed the deaths to the inclusion of fludarabine in the lymphodepletion given prior to CAR T cell therapy infusion, leading to severe neurotoxicity, and clinical hold was lifted by FDA after the protocol was subsequently amended.
This morning came the dramatic announcement that following the protocol amendment, Juno has voluntarily placed the ROCKET trial on clinical hold again following another two deaths from cerebral oedema.
What gives and what are the consequences here?
We take a joint look at some of the issues that arise from this situation in terms of the CAR T cell therapy market and also pen thoughts from the analyst call this morning.
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The abstracts (apart from the late-breakers) for the 2016 annual meeting of the American Society of Hematology (Twitter #ASH16) went live at 9am ET today. Link to 2016 ASH Abstracts.
ASH16 takes place in San Diego from December 3-6.
In this initial post, I’m sharing my first impressions of what may be some hotly contested trials at ASH16 in San Diego, as well as a few intriguing abstracts with combination data that caught my attention.
With over 3,000 oral and poster presentations, all typically of a high quality, this by post by definition, is a highly subjective one.
After we’ve had more time to process the data, further ASH16 Previews will roll out over the next few weeks highlighting more key abstracts to watch out for by tumour type or treatment modality.
In-depth commentary and analysis will follow after we’ve heard or seen the data presented at the meeting.
I’ll be flying to ASH from the EORTC-NCI-AACR Molecular Targets meeting. Do say “hello” if you have plans to be in Munich or San Diego.
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The race to the be first to market in the United States with a CD19 directed CAR-T cell therapy is a bit like the America’s Cup Challenge Race Series – one boat/company is ahead and then another is ahead, it’s an ever changing and fluid situation…
In this post, we’re looking at questions from subscribers – so what’s in the July BSB mailbag?
* CAR T Cell Therapy: Is the recent FDA hold – that came and went in record time, a setback to Juno? Who will win the CAR-T race to market in the United States? What is the market opportunity in Europe?
* Jounce/Celgene Deal: Celgene have a reputation for doing deals with innovative biotech companies, but then what? Is the Jounce deal a good one, or is it a value destroyer?
There are a few other questions in the mail bag, but the above gives you a flavour of some of the commentary in this post.
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Late this afternoon, Juno Therapeutics ($JUNO) announced (link to press release) that the FDA had put a clinical hold on enrollment into a phase 2 trial of their JCAR015 construct in relapsed refractory acute lymphoblastic leukaemia (ALL) in adults in the ROCKET Trial: NCT02535364.
The decision by the FDA was as a result of three recent patient deaths reported to be due to neurotoxicity. In after-hours trading the stock dropped 30% from a market close of $40.82, reaching an after hours low at time of writing of $26.66 at 4.43pm ET.
In this post we look at what happened, the possible reasons behind it, and what it may mean for other CAR T companies. A leading CAR-T cell expert also provided BSB with some commentary after the news broke.
Good News: Post now updated following FDA lifting hold on ROCKET trial.
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This morning, like many folks, I woke up to the latest immuno-oncology news on the bispecific front that Xencor, a Los Angeles based biotech, announced their latest collaboration, this time with Novartis.
Over the last few years, we have seen a surfeit of bispecifics emerge that are focused on stimulating the immune system, particularly with regard to T cells and natural killer (NK) cells, as well as antigen targets on the surface of tumours. The first one approved was Amgen’s blinatumomab (Blincyto), a CD19 targeted bispecific for the treatment of acute lymphoblastic leukemia (ALL), which we have written extensively about.
The Xencor/Novartis deal has a number of interesting implications that are well worth exploring in more depth that go far beyond the information provided in the press release.
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Spring has arrived in many parts of the world, and with it I am always reminded of William Wordsworth’s classic poem, “I Wandered Lonely as a Cloud:”
I wandered lonely as a cloud
That floats on high o’er vales and hills,
When all at once I saw a crowd,
A host, of golden daffodils;
Beside the lake, beneath the trees,
Fluttering and dancing in the breeze.
So what does the future hold for cancer immunotherapy?
Inspired by Wordsworth, I’ve sat on my cloud and have looked at some of the recent review papers and thought pieces published by experts in the field. Do they offer a Jerry Maguire – like mission statement: “The Things We Think and Do Not Say: The Future of Our Business” or will we have to wait till AACR 2016 in New Orleans to learn more?
This is the latest in our pre-AACR 2016 annual meeting series. Subscribers can login to read more or you can purchase access below.
The 2016 annual meeting of the American Association for Cancer Research (AACR) takes place next month in New Orleans. (Twitter #AACR16).
While many people have focused on the presentation of clinical data at ASCO, we have long argued that emerging scientific data at AACR actually give early hint of what’s to come down the pipeline.
Anticipating these trends and spotting promising new compounds or combinations is probably more art than science, but nonetheless is a very useful and important exercise.
AACR is the most important meeting of the year for cancer new product development!
Tomorrow, we will be reviewing the actual abstracts, posters, late breakers and what they entail, including important new data such as BMS’s CheckMate–141 exploring nivolumab in Head & Neck cancer as well as the combination of nivolumab plus ipilimumab in CheckMate–069 for advanced melanoma.
In the meantime, what are the main hot topics emerging from this year’s meeting in targeted therapies and immunotherapies? What do the key scientific sessions tell us about new directions that lie ahead?
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Honolulu: At the BMT Tandem meeting that ended yesterday in Hawaii, one of the hot topics was CAR T Cell Therapy. This should, perhaps, come as no surprise to readers given that bone marrow transplanters are not only the investigators doing the clinical trials, but will be the initial target market for this product.
One of the pioneers in the development of adoptive cellular therapy is Michael Jensen (pictured) who is Director, Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute (SCRI) and the Sinegal Endowed Professor of Pediatrics at the University of Washington School of Medicine. Dr Jensen is also a scientific co-founder of Juno Therapeutics, Inc.
He’s been doing research in the field for over 20 years, and told me that not so long ago there would only be a handful of people in the room for a CAR T cell presentation!
In a plenary scientific session at the Tandem meeting, he presented to over 3,000 attendees on “CD19-Specific CAR T Cells as a Post-ALLO HSCT Relapse Salvage Therapy.”
After his presentation, he kindly spoke with BSB. This post describes some of the key take-homes from his talk.
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Cell therapy is one of the hottest topics in cancer immunotherapy; however, it remains a field still in it’s infancy as companies and researchers work on strategies and concepts to increase efficacy and overcome resistance. The strategic landscape is still being defined. In cell therapy the ultimate winner may not be the company that is first to market.
Drs Seth Ettenberg and Michael Vasconcelles, Unum at #ASH15
In this post, we’re continuing this week’s theme of posts around novel cell therapies. Unum Therapeutics is a company that is no doubt already on your radar if you are into CAR-T cells.
Back at ASH 2015, I had the pleasure of interviewing Dr Seth Ettenberg (CSO) on the left and Dr Michael Vasconcelles (CMO) on the right.
We talked about what differentiates their approach from others in the CAR T cell space.
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Aloha! It will soon be time to pack your Hawaiian shirts for the forthcoming BMT Tandem Meeting in Hawaii (Twitter #BMTTandem16 – what a long hashtag!!)
Commonly known as “Tandem,” it’s the combined annual meetings of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT).
Hawaii is great location for a meeting in February, and one that I’m sure will generate a lot of envy for those who can’t attend and are stuck in the winter cold and chill. Who said we don’t go the “extra mile” for BSB subs?
One of the presentations I’m looking forward to hearing at Tandem is by Ann Leen, PhD, who is an Associate Professor at Baylor College of Medicine.
Dr Leen will be talking about “Immunotherapy for Lymphoma using T cells Targeting Multiple Tumor-Associated Antigens.”
At last December’s ASH annual meeting, Dr Leen presented preliminary data with this novel approach in patients with Hodgkin’s Lymphoma (HL) and non-Hodgkin’s lymphoma (NHL). After her ASH presentation, she kindly spoke to BSB.
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