Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘JCAR015’

Dr Stephan Grupp at SITC17

National Harbor, MD – SITC 2017 wouldn’t be the same without an in-interview with Dr Stephan Grupp (CHOP) on the issues surrounding the Juno ROCKET trial and CAR T cell therapy safety.

This data has been eagerly awaited and anticipated by the field since the news of a cluster of lethal cerebral oedemas hit Juno in the summer 2016, seemingly out of the blue.

Yesterday, we reviewed the salient points from Dr Mark Gilbert (CMO) presentation highlighting their findings from the in-depth analyses performed to date.

In the second part we turn to a CAR T cell therapist with experience in treating children and young adults for his perspectives and candid reactions to the information presented.

We also talk about where the field is headed and some of the new developments we can look forward to hearing more about in the near to medium term future.

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With the annual meeting of Society for Immunotherapy of Cancer (SITC) fast approaching this week, it’s time for a look at some of the final highlights to watch out for.

National Harbor from Gaylord HotelIn this latest conference preview, we have chosen a dozen key topics of interest that readers may find worth checking out plus an honourable mention for early compounds in development that we may well hear more about going forward.

Some of the early warning signs were offered up in the earlier Previews and with the abstracts now available, things are getting very interesting indeed…

How are things panning out so far with the abstract drop and are the new products in development living up to the hype and expectations?

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Hans Bishop, Juno

After a rocky 2016 for Juno with JCAR015 and the trial that imploded unexpectedly and badly, the CEO Hans Bishop quietly announced that announced that ROCKET has been abandoned:

“2016 was a year of progress and learning for Juno and the cancer immunotherapy field. We continue to experience encouraging signs of clinical benefit in our trial addressing NHL, but we also recognize the unfortunate and unexpected toxicity we saw in our trial addressing ALL with JCAR015. We have decided not to move forward with the ROCKET trial or JCAR015 at this time.”

A strange year of hubris attracting nemesis might be another way of describing the events for some observers.

We covered the Juno roller coaster and events in July and December 2016 for those who want to catch up on the full history of this unfortunate and ongoing debacle:

Where does the latest Juno news leave things and what can we expect going forward?

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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.

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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…

Pedicab at ASH16 in San Diego

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.

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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.

Downtown San Diego during ASH 2016 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!

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Juno Therapeutics LogoThis 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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