Biotech Strategy Blog

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

Posts tagged ‘vadastuximab talirine’

Stacking up the various modalities – what do we find?

It’s time to talk about an particular target in AML because there are now a variety of different modalities involved since we last covered it, which makes it rather more intriguing than most. There’s antibodies, ADCs, CAR-T cell therapies, stem cells, and various bispecifics to name a few such examples.

To be clear, we’re not talking about CD123 here either, but rather an entirely different protein that is receiving increasing attention from multiple companies.

How does the evidence stack up?  Will one particular approach stand out from all the others?

Next, perhaps what makes this post even more interesting is we have an engaging interview with one of the company CEO’s in this niche to share, so we can see how they view things from the lens of looking at things in a different way from many of the other competitors.

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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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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.

View of San Diego from ASH 2011In 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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