Biotech Strategy Blog

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

Posts tagged ‘Novartis’

Coney Island Roller Coaster

In the roller coaster of life that is oncology R&D, molecules come and molecules go… a rare few reach blockbuster heights while many others are quietly packed off to dog drug heaven, never to be seen or heard of again.

This is also very true of targets as well…

What about the in-between space?

Unfortunately, that’s where most molecules and cancer targets end up – into a deep black nothingness where we seek the high affinity targets with low grade side effects – and fall short in some way. It’s a frustrating place to be, to be sure.

One of these conundrums is compounds against CD123 (IL3Rα), which have been in the spotlight on and off this year and are turning out to be a rather mixed bag.

After our recent update on Cellectis and their CD123 direct CAR T cell therapy (UCART123), I wasn’t expecting to write any more on this until ASH in mid December. How wrong that prediction turned out to be!

Today we have quite a few things to discuss on this topic, so if interested in CD123 in hematologic malignancies and going beyond that to find better targets in AML then this is the poster for you…

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Yesterday Novartis announced the initial data from the JULIET trial in relapsed/refractory aggressive lymphomas such as diffuse large cell lymphomas (DLBCL) that were presented at the upcoming International Conference on Malignant Lymphoma (iCML) meeting in Lugano.

Here at BSB, we’ve been following CAR T cell therapy developments in earnest since 2012 when Penn and Novartis first announced their collaboration to develop what is now known as CTL019.

Five years on, we now have two such cell therapy products already filed with the Health Authorities and the JULIET trial will likely be the third indication submitted by the end of the year. This niche is now well established for regular readers and not something that has been a flash in the pan over a year or so.

There are a few interesting points of note on the CAR T cell front that are also worth exploring in conjunction with this news.

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Chicago RiverAlthough ASH and ASGCT are important meetings for CAR T cell therapies, there are still some intriguing data to be had at ASCO next month, including both oral and poster abstracts.

In our latest ASCO 2017 Preview, we take a look at what to expect from in the CAR T cell space.

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San Francisco: A look at what’s new in gastric cancer (GC) from the 2017 ASCO GI meeting.

Day 1 of #GI17 is filling up…

There were several phase 3 trials presented in GC and gastro-esophageal junction (GEJ) carcinoma in both targeted therapies and immunotherapies this past weekend.

  • When we look carefully at the latest data, what do we find?
  • Where are the opportunities and challenges in this niche?

Another critical question that many observers will be interested in is…

Will BMS’s checkpoint inhibitor, nivolumab (Opdivo), overcome recent setbacks in lung cancer and make a mark in stomach cancer to challenge approved targeted therapies such as ramucirumab (Cyramza)?

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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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Post 2016 US Election, we move on and get back to business with an in-depth review of some new science and clinical data.

ash-2015Yes, it’s time for another Bushidō – “Way of the Warrior” – guide to the key ASH abstracts!

Here we focus on acute myeloid leukemia (AML), a difficult and challenging disease to treat with a high unmet medical need for new effective therapies.

In this Preview we look at key companies in the AML space, as well as a look at what’s happening in classic targets and also some new ones that are receiving notable attention, both preclinically and also in the clinic.

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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.

ash-annual-meeting

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.

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