Biotech Strategy Blog

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

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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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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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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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AstraZeneca miss on OS in the phase 3 MYSTIC trial – what next?

Getting there… in 1L NSCLC

At one point we were posting almost quarterly updates on the runners and riders in the 1L NSCLC niche and what a roller coaster it has turned out to be!

There have been some successes, failures, and even mixed results so far, suggesting that there’s no room for complacency here.

Previously, AstraZeneca were the first to readout out on PFS in the MYSTIC trial and missed, meaning they had to go to the back of the queue and patiently await the OS data. Since then, we’ve seen several phase 3 trials from Merck, Genentech/Roche and BMS all readout without any real rhyme, reason or consistency between them.

Now AstraZeneca are back in the spotlight with a not altogether unexpected miss on median OS.

It’s easy for people to kick a dog when it’s down rather than take a moment to reflect on the deeper meaning – what does the result mean both for the company and other key players in this highly competitive landscape? What can we learn from this experience and other recent results?

To answer that, we put some insights and analysis together in our latest update on the space…

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Dr Adi Diab (MD Anderson) at SITC18

Washington DC – At the Society for Immunotherapy of Cancer (SITC) meeting on Friday evening, Dr Adi Diab (right) presented an update on the NKTR–214 plus nivolumab data from the phase 1b/2 dose escalation and RP2D expansion trial (PIVOT–02) in patients with 1L metastatic melanoma in the cytokine session chaired by Dr James Gulley (NCI) and Dr Darrell Irving (MIT).

Nektar also held an investor meeting over the weekend to discuss the data as well as where they are headed with their early pipeline compounds.

As we seek to find new and effective partners to add to immune checkpoint blockade, there are going to be some hits and misses in the mix.  This year alone April turned out to be a pivotal month in the calendar, as chemotherapy plus pembrolizumab was a big hit in 1L NSCLC from the KEYNOTE-189 trial at AACR, while Incyte’s IDO inhibitor, epacadostat, bombed as 1L treatment of unresectable or metastatic melanoma in the phase 3 ECHO-301 study.

Cytokines have definitely garnered a lot of interest of late, with some very creative molecules now emerging to address the systemic toxicities associated with traditional approaches. We’ve been covering the Nektar pegylation story for several years now with numerous updates, so how are the data looking this time around?

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