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

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Yesterday sudden and unexpected news from Seattle Genetics caused quite a stir…

“Seattle Genetics Announces Clinical Hold on Several Phase 1 Trials of Vadastuximab Talirine (SGN-CD33A).”

Part of the Seattle Genetics exhibit booth at #ASH16, taken with permission

In short, over 300 patients have been treated with the ADC and six experienced hepatotoxicity, including several cases of veno-occlusive disease, with four fatalities.

We’ve written about AML several times recently and also received a number of reader questions on this latest development, so it’s time to explore the issue in more depth and look at the implications. We also include some expert commentary from a leukemia specialist for their take on the issue.

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The 2016 annual meeting of the American Society of Hematology with over 27, 000 attendees, a record high, was the venue for the announcement of a major new initiative by the Leukemia Lymphoma Society (LLS), called Beat AML.

It is lead by three well respected researchers in the Hematology/Oncology field:

  • Dr John Byrd (Ohio State)
  • Dr Brian Druker (OHSU)
  • Dr Ross Levine (MSK)

Beat AML is a special project at LLS, who have developed a broad collaboration with academic researchers, pharmaceutical companies, a genomic provider, and a clinical research organization:

 

Source: LLS

Initially, there will be five trial sites, which will each offer all arms of the trial. The centers are:

  • Memorial Sloan Kettering Cancer Center in New York
  • The Ohio State University Comprehensive Cancer Center in Ohio
  • OHSU Knight Cancer Institute in Oregon
  • Dana-Farber Cancer Institute and
  • Massachusetts General Hospital Cancer Center, both in Massachusetts.

Further sites and (hopefully) also other drugs from pharma companies will be added in due course, so if you’re interested in joining this project, do contact them after checking out more details here!

For our industry readers, this would be a great opportunity to get involved in an exciting and landmark study for AML, whether you are a researcher or a company with a promising drug in early development. These types of trials can help speed up drug development if a therapy graduates in a particular subset.

Here, we offer an in-depth analysis of the scientific and clinical rationale behind this important landmark study and the targets/drugs selected to date.

BSB also spoke with Dr Brian Druker, Director of the Oregon Health and Science University (OHSU) Knight Cancer Institute in Portland, Oregon, who offers additional insights on the special project.

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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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After regularly reporting here at BSB on several readouts in terms of antibodies and CARs since ASH last year, it’s reasonable to conclude now that there has been growing interest in BCMA–APRIL as a target in multiple myeloma (MM). The CAR T cell therapies have generally focused on BCMA or BCMA-TACI as a target, while antibody approaches such as Aduro’s, BION–1301, target APRIL.

T cells attacking a cancer cell

T cells attacking a cancer cell

These new therapies have all been either preclinical in nature or preliminary phase 1 studies in a very limited number of patients, meaning that the best we can characterise them is that old reliable chestnut, ‘promising but early’… to do otherwise would be rather extravagant and hopeful at best.

Given the data from several CAR T cell therapy studies were being presented at two meetings on two separate continents only a few days apart, it makes sense to review them as a whole.

It’s therefore time for a detailed update, including a review of the differences in the key studies, a look at where we are now, as well as tips on what to look for going forward.

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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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Munich – the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics conference is one of my favourite meetings on the cancer circuit. It’s small enough that you can catch people in the corridor and have a quick chat, while at the same time large enough that it attracts quality data. It’s also the place where you find people who think outside the box.

I want to hear from thought leaders who have the potential to be disrupters.

feuerwurstTalking of another kind of disruption, sadly the travel chaos caused by the Lufthansa pilot’s strike(s) meant some people didn’t make it to the meeting or arrived late. Despite the best efforts of Lufthansa, there was still a good turnout of posters today and several caught my attention!

Those who follow our cancer conference coverage know that the poster hall is often where the gems and insights are to be found, particularly when it comes to early drug development.

If you couldn’t make it to Munich, this post has commentary on four gems from the Wednesday poster session at EORTC-NCI-AACR that caught my attention. I’ve chosen to focus on novel targets and novel combination approaches…

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The first day of the 2016 EORTC-NCI-EORTC Molecular Targets meeting brought us chilly weather and a frozen lake outside the conference centre in Munich.  Brrrr!

gluhwein-munchenIt also heralded a great lineup of cancer researchers largely characterised by unconventional thinking. This, of course, is a good thing because it is only by dismissing dogma that a field can move forward unconstrained.

There were several talks that I will come back to in a separate post, but here I wanted to focus on one particularly good talk on breast cancer, something we haven’t covered in a while.

A decade or two ago, breast cancer made a lot of progress – we saw the emergence of gene expression profiling, the identification of different histology types, treatments for hormonal sensitivity or HER2-positivity and then… nothing.  Meanwhile, the issue of drug resistance plagued researchers – why don’t all women respond and why do they become resistant?

In the meantime, we’ve seen a wealth of progress in melanoma, lung, kidney and bladder cancers, enormous strides in hematologic malignancies and many other areas.  Breast cancer, the early star, seems to have faded and we haven’t had much to be cheerful about aside from a few isolated cases.

The good news is that things are a-changin’ though and research is looking more promising as we learn from lessons in basic and translational research and how they can be applied to new therapeutics and drug resistance.

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Having heard about a one day symposium on immunotherapy organised by Charles River, I headed over to Munich and the EORTC-NCI-AACR conference a day early… Providentially it seems, as the Lufthansa strike will likely affect a few travellers en route to the Triple and ASH/WCLC/SABCS conferences.

cr-ena2016The focus of this excellent one day event was on ‘Mapping the future of cancer drug discovery.’

So what stood out as interesting and intriguing?

Quite a few things, as it turned out, including a novel target in cancer research that I haven’t come across before.

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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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