Biotech Strategy Blog

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

We tend to think of the Fall cancer conference season as full of hope for new molecules showcasing encouraging yet early new data.  Rarely does negative data or unexpected trial glitches immediately jump to mind, although it unfortunately happens with startling regularity!

We’ve received a few enquiries and questions about an update on the Macrogenics platform recently.

The company have what they call a Dual-Affinity Re-Targeting (DART) program that includes bispecifics, mostly with CD3 as a standard co-stimulatory domain, although some are dual inhibitory checkpoints instead.

After writing about rather modest clinical efficacy with enoblituzumab monotherapy (anti-B7-H3 antibody) at the SITC 2015 meeting, I suspect that few of the attendees were envisioning an unexpected side swipe after this year’s event with one of their bispecific molecules, but so it came to pass.

As always, there’s a lot more to the central issue of ‘raised liver enzymes’ than meets the eye, so by popular reader request we walked through the issues and evidence to take a look at what’s behind this phenomenon…

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Standing from the crowd in refractory CLL?

Last year the two FDA approvals of tisagenlecleucel (Novartis) and axicabtagene ciloleucel (Kite/Gilead) CAR T cell therapy for hematologic malignancies such as pediatric acute lymphoblastic leukemia (pALL) and non-Hodgkins lymphoma (NHL) have captured a lot of attention.

It’s worth remembering, however, that back in 2010 the first patient who had a dramatic response to CD19 targeted CAR T cell therapy was actually a gentleman with advanced chronic lymphocytic leukemia (CLL), the case study of which was subsequently published by Porter et al., (2011) in the New England Journal of Medicine.

We’ve been following CAR T cell therapy and its potential in CLL for some time now, with all the successes, trials and tribulations along the way.

Dr David Porter (Penn) told BSB earlier this month:

“The very first patients we treated are now eight years out from their infusion, a little over eight years, and still in remission, still doing extremely well with no evidence of disease or progression, never had any other therapy. So, I think it’s become very clear that for some patients this is effective in the far advanced setting.”

It’s now two years since we last spoke and it was a great pleasure to reconnect with Dr Porter. As he told BSB at ASH in San Diego:

“One way you make it better is to understand why it’s working and why it’s not.”

What have we since learnt about the potential for adoptive cellular therapy in CLL and what new insights did we gain from new data presented at ASH18? The answers may well surprise you.

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San Antonio – As the Fall conference season is rapidly drawing to a close, it’s time to highlight some key findings on breast cancer from the San Antonio Breast Cancer Symposium (SABCS).

In this in-depth post where we explore the breast cancer landscape in terms of updates on key trials that stood out as well as highlights from several thought leader interviews on translational and clinical aspects of the disease.

We also explore some important biological and biomarker aspects to think about in future IO trials.

Are you ready? Let’s roll!

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What latest ASH18 data jumps to our attention?

San Diego – It’s time to put another dozen studies in the spotlight and review what we can learn from the existing data with a view on where we’re headed in the future.

Today’s list covers a whole gamut of targeted therapies, bispecific antibodies, CAR-T cell therapies and other immunotherapies, what’s more we have a range of targets in the list too, and not the obvious ones either.

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For today’s post, we’ve curated our individual highlights from the tsunami of data that flew thick and fast yesterday between science sessions, oral presentations and poster hall gems.

There were some pleasant surprises in the mix, to be sure, plus the weather brightened up immeasurably!

Yesterday’s lunch time ASH Dash was quieter than usual

Having whittled the number of trial highlights for review and critique down to thirteen key insights and learnings, what made our joint list?

To find out more, check out the post below!

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What a wet wet wet start to the annual meeting of the American Society of Hematology (ASH) meeting being held in San Diego – quite a change from the snow in Atlanta at last year’s event!

Either way, does it precipitate a windfall of excellent data?

A lull between the rain – a soggy day in San Diego

Here are some of our early highlights, which include updates on neoantigen vaccines, novel approaches with CAR T cell therapies, NK cell therapies, targeted therapies and more…

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This week I’ve been attending the excellent AACR Special Conference on Tumour Immunology and Immunotherapy here in Miami Beach. I must say that it’s really rather nice to have a local event literally less than 20 blocks away for once – it sure beats all the stress and hassle of long distance travel!

Were any of the early IO developments flying high in Miami Beach this week?

The meeting is designed to “integrate multidisciplinary facets of basic cancer immunology and immunotherapy to broaden the understanding of ways to harness the immune system to treat cancer.”

In this latest conference report, we cover some key highlights and insights learned, as well as review some early clinical data that was presented on several fronts including new companies and novel approaches to CAR-T cell therapy, as well as an important update on STING agonism.

We also identify some emerging trends that may teach us more about the future landscape developments in immuno-oncology.

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We have covered BCMA-APRIL approaches in multiple myeloma for a couple of years now and it’s time for a much needed update and look at where this niche is.

The BCMA market is heating up

Beyond Bluebird’s bb2121 BCMA CAR T cell therapy, there are now a raft of different products across multiple companies including CARs, bispecific antibodies, and even ADCs.

What was a new target three years ago now is rapidly becoming a very crowded space indeed and the pressure will be on companies to differentiate their product in some way, otherwise they risk being a me-too or just another bowl of red chills…

As a new target is validated, it doesn’t take long for another ten companies to immediately try to capitalise on it in the ever increasing race to market with new product development.

Here, we take stock of where things are at.

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ASH is heading to San Diego!

Every year we eagerly await the American Society of Hematology (ASH) late breaking abstract reveal.  They can be sublime or disappointing, depending on the data available.

This year the conference is back in sunny San Diego.

We’ve already created some order from the chaos of the initial data dump and highlighted some key abstracts to watch out for in our first Preview post in the ASH18 series.

This time we look at what’s in store and – more importantly – what can we learn about the chosen LBA selections? What sort of caveats do we need to be mindful of?

It turns out that that’s quite a bit to think about…

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SITC Phase 1 Review Part 1 – It’s time for a two-part mini-series on recent phase 1 clinical trials and how to interpret the findings.

Are we at a crosswords with IO combos?

As a former new products development professional, this is something that I’m particularly enthusiastic about.

While it is fascinating to see other people’s reactions to early oncology trials, these should often be taken with a very large pinch of salt, in my view.

In Part 1, it’s time to take a step back and understand not only what companies are doing, but also how they set the trials up and what they are looking for. We highlight some examples of data readouts to illustrate the points.

In Part 2 on Monday we take a rock around the clock at some of the other recent phase 1 readouts and explain what we can learn from what was presented. The devil is often in the small details that many observers miss at first glance.

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