We’re overdue a roundup and discussion on various key topics of interest to BSB readers, so here goes…
Today’s topics include an in-depth look at the impact of some negative events:
- Kite and the cerebral oedema death with axi-cel
- Genentech’s atezolizumab OS miss in urothelial cancer
Subscribers can login to read our latest expert interview or you can gain assess to the insights via the blue box below….
Some cancer conferences attract more questions and queries than others.
Old Town San Diego
Interestingly, ASH is always a popular meeting for attendees and readers alike, so it is good to see another batch of critical questions come in so soon after the last one. It’s a while since we did two BSB reader Q&A mailbags from a single meeting!
Not surprisingly, there were also a bunch of questions on CAR T cell therapies, which continue to dominate readers minds, as well as related issues. Here, we answer the most pressing questions that have come in over the last week.
Subscribers can log-in below or you can sign up via the blue button
San Diego – Monday at the 2016 Annual Meeting of the American Society of Hematology (#ASH16) is typically a day of multiple oral sessions in parallel.
This year it was a major challenge doing a mad dash between sessions as the meeting is now so big that in San Diego it’s being held, not only at the vast convention center, but is also using the meeting rooms of three nearby three hotels – it’s literally a mile walk to go from one end of the convention to the other, so you have to factor that time into your crazed schedule with multiple clashes.
On the positive side, there’s even courtesy pedicabs – cycle rickshaws (great idea & fun) – I caught one at 7am the other day to save my toes from at least one #blisterwalk…
Following on from our ASH Highlights 2016 Part 1, this post answers critical BSB Reader questions that have come in thick and fast and require more than 140 characters on Twitter to answer.
Predictably, the majority of the first tranche of questions have been CAR T cell therapy related, so if you have a keen interest in this area, this is the post for you. We tackle 5 critical questions and offer some insights.
Subscribers can login to read more or you can purchase access below via the blue box.
San Diego – after “Flying Friday” where I flew from Munich to San Diego, Biotech Strategy Blog coverage of the 2016 annual meeting of the American Society of Hematology (ASH) is now done for another year.
With over 27,000 attendees – it’s the largest ASH annual meeting I’ve seen in 20 years of coming here! ASH is definitely the pre-eminent global meeting for hematology and blood cancers.
As you might expect, the thought leaders at this event are super-busy, but we’ve already managed to catch up with a few, and we’ll be rolling out interviews in the “post-game show.”
Subscribers have been asking what’s really hot at ASH this weekend, so reflecting my interests and the sessions I went to, here are my seven highlights/learnings of ASH 2016 (so far). There’s a lot more data to come!
Subscribers can login to read more or you can purchase access below…
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.
Subscribers can log-in below or you can learn more about our insights by clicking on the blue box…
It was only five years ago that the number of abstracts on CAR T cell therapies at the American Society of Hematology (ASH) ran to a dozen or less. Fast forward to 2016 and we now have tens of them, almost too many to count, let along review quickly and easily.
A scene from ASH 2015…
To give you an idea of the staggering speed of progress, in 2010 it took me less than half an hour to search and read all the CAR T cell abstracts, now it takes nearly a whole day to peruse and review them carefully.
We can’t resist a challenge…
As usual, we will write in more depth from the meeting as the data emerges in real time since many of the abstracts are often placeholders with updated information provided at the conference itself.
For now, here we provide an in-depth preview of the CAR T cell landscape in terms of the players, the products, new scientific research, biomarkers, emerging trends and more in a handy What to Watch For (W2W4) guide on key areas to expect at ASH to enable better enjoyment and awareness as the data rolls out next month.
Subscribers can log-in or you can sign up via the blue box below to learn more insights and which highlights matter…
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.
Subscribers can login to read more or you can purchase access in the blue box below.
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.
To learn more, subscribers can log-in or you can sign up in the blue box below.
Yesterday, Juno Therapeutics and Celgene announced a ten year collaboration that is expected to close in July-August. In short, Celgene has exclusive right to entire the Juno portfolio in oncology and auto-immune cell therapy products in development outside North America and co-promote certain programs globally (not specified). Juno, meanwhile, gains the option to co-develop and co-promote select Celgene programs (also not specified).
You can see the terms of the deal here.
And listen to the webcast from the call after hours.
This news comes hot on the foot of an earlier announcement that the FDA accepted the Juno IND for JCAR017, a CD19 CAR T cell therapy being developed in relapsed/refractory NHL scheduled to initiate in 2015, with the possibility of a registration trial commencing in 2016.
What was fascinating, however, was the BioTwitter reactions last night – predictably, people either loved or hated the news – it clearly came as a surprise to many.
This morning my inbox is full of questions on this dramatic topic from subscribers, so here are some topline thoughts on this issue to answer the questions coming in.
Subscribers can log-in or you can sign up in the box below.
“Nothing lasts forever, because nothing ever has.”
James Shelley, The Caesura Letters
This year’s annual AACR meeting was so good, we could probably write another 50 posts and still not be done! With ASCO fast approaching, however, it’s almost time to draw it to a close and the final post conference note will be published on Monday.
Today is the penultimate report and focuses on the key highlights that caught my attention in immuno-oncology, which covers the gamut from checkpoint inhibitors, co-stimulants, innate immunotherapy and CAR T cell therapy to bispecific antibody TCRs.
To learn more about our insights on the highlights and lowlights, you can sign in or sign up below.