Biotech Strategy Blog

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

Posts tagged ‘Amgen’

AACR22 Preview 1 – Key topics to watch out for

Opening the door on our AACR22 coverage

Yes, it’s that time of the year already…

In our first Preview from the AACR annual meeting coming up next month, we’re going to highlight a couple of key topics of interest to many of our readers and also offer some context for where the selected fields are currently at and just as importantly, where they are likely headed.

The abstracts haven’t dropped yet – the regular abstract titles, authors, and text will be released tomorrow (March 8th) at 4:30 pm ET – although based on our knowledge of the field, recently published data, or presentations already rolling out we can put a good picture together of what’s what and where things are at…

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Sotorasib impresses unexpectedly in pancreatic cancer

It’s time to go through the keyhole and take a look at progress with the KRASG12C inhibitors beyond lung cancer.

Years ago, there really wasn’t much hope in pancreatic cancer – it was an area big Pharma avoided because just about nothing worked well.  But those were the days of chemotherapy and promiscuous dirty kinases akin to a blunderbuss approach.

As we learn more about the biology of the disease and develop more selective inhibitors against oncogenes known to be active, have things improved at all?

In our latest cancer conference Preview, we pivot from a cell therapy meeting to the ASCO plenary series and take a look at how Amgen’s sotorasib is doing outside of lung cancer, an area where Mirati’s adagrasib was thought by some to have an advantage.

It’s always tricky to make judgment calls on the basis of a few patients in a catch all phase 1 trial – sometimes it’s better to wait until there’s a larger sample in a given cohort before rushing to declare winners and losers.

Often though, the data is something of a kaleidoscope – it depends on which angle or lens you view the data from.

In this post we include some expert reaction and commentary too…

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New trials and tribulations in drugging KRAS mutations

Is the ride going to be a thrilling long or disappointingly short one?

The KRAS niche continues to rattle on at an incredible pace with new findings, new trials, or even a new molecular entity (NME) coming along seemingly every month.

In this latest update on the landscape, we discuss some important new findings, as well as a novel agent to thing about in this space, which is quite different from what we have seen before.

To be clear – this doesn’t mean a novel approach doesn’t have any legs, nor that the latest science behind where we should be going with combinations is doomed.  Indeed, sometimes finding a balance is a bit akin to a highwire act.

The important thing is to focus on the learnings and determine where the field might be headed…

BSB subscribers can read up on our ongoing commentary and analysis from the cancer conference season – you can either log-in or click to access our latest analysis.

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No, no absolutely not!

When it comes to targeted therapies, far too many external observers do not ‘see’ beyond the pretty scenery.

There’s an old obvious yet wise fable down here in Florida, which is often applicable to early stage oncology drug development – if it looks, snaps, or waddles like an alligator, do not feed it for you will surely get bitten (badly).

In this post we take a careful look at the updated adagrasib data in colorectal cancer presented at ESMO21.

There’s a lot of nuance, subtlety and questions this trial so far has not answered, and that will need to be considered if you don’t want to run the risk of being bitten by the lurking alligators.

BSB subscribers can read more about the challenges in interpreting the adagrasib CRC data presented at this year’s ESMO congress – you can log-in or click to access our latest analysis.

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A novel target to explore in prostate cancer

Source: AlphaFold

Our latest post discusses key topics around the novel target shown on the right – brownie points to anyone who can guess which one it is!

Aside from having a lot of fun exploring protein targets with DeepMind’s AlphaFold tool, they also help illustrate something important, which is the degree of confidence around the various aspects from dark blue for high confidence and yellow for very low confidence predictions.

Tau, if you haven’t yet seen it, is truly a hot mess compared to today’s choice!

While there is always the concern about whether a particular protein is a marker or a valid oncogene target, we have to start somewhere and see where the clinical trials take us because some modalities might turn out to be much better ways of approaching the problem of ‘druggability’ than others.

I went into this foray with an open mind and some degree of hope because let’s face it, we need more new agents against novel targets than we do of yet more me-toos against old targets…

BSB subscribers can read more on our latest update regarding a novel early stage pipeline target – you can log-in or click to access our latest content.

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New developments on the T cell engager front

It’s time to switch horses and take another look at the evolving bispecific antibody niche with a look at a particularly promising T cell engager in early clinical development, which might offer a few surprises.

We have seen these agents evolve in both hematologic malignancies as well as solid tumours, with a common challenge being CRS events.

What if this side effect could be made more manageable, enabling the agent to do its job on a dual front, namely reinvigorating T cells and reducing some of the hostile immunosuppression dampening down the immune responses?

How about as a potential partner for CAR-T cells to help improve expansion kinetics or in combination with checkpoint blockade so they could work more effectively?

It turns out all this can be done, perhaps in an unconventional and creative fashion…

BSB subscribers can learn more about our latest look at the T cell engager niche – you can log-in or click to access our ongoing oncology coverage.

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AACR21 Preview 8 – The growing bispecific niche

The first virtual 2021 AACR annual meeting starts tomorrow in earnest and we’ll be posting throughout the conference with various highlights and analysis.

There’s an explosion of new targets, novel combinatorial partners, expanding strategies and even an increasing number of companies entering the bispecific niche beyond the regular players we have covered in the past.

In our final Preview post we’re highlighting some of the AACR21 presentations which caught our attention, the science behind them, and some of questions we hope to see answered.

Stay tuned for our conference coverage and post meeting interviews!

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A critical look at the Amgen sotorasib data in KRAS G12C mutated lung cancers

It feels weird to be covering the WCLC from Singapore remotely after remembering the rain in Spain at WCLC19!

If we look at the more mature phase 2 data now available for Amgen’s sotorasib (AMG 510) in KRAS G12C driven lung cancers, we learn there are quite a few nuances and subtleties at play. These aren’t always obvious in top line press releases or even in presentations until we consider the broader niche in which they are competing.

Amgen submitted the sotorasib applications to both the US and EMA health authorities in December.  With breakthrough designation status and clinical evidence of activity in an area of high unmet medical need, it’s hard to believe the approval won’t be forthcoming sooner rather than later, at least in the US.

Mirati is expected to showcase their phase 2 data later this year, so I would highly encourage people to hold off with cross-trial comparisons until we see how their more robust data look at the RP2D.

In the meantime, we can take a careful look at the latest Amgen data.  We do those not only from a BSB review but also through the lens of a company perspective and consider some of the key strategic issues we need to start thinking about…

To learn more about the WCLC20 data and get a heads up on our latest oncology insights, subscribers can log-in or you can click to gain access to BSB Premium Content.

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ASCO20 Preview on the importance of modality in oncology R&D

Continuing our ASCO20 coverage with another Preview in the pre-meeting series, we turn our attention to a particular modality of keen interest to many of our readers.

In this latest article, we highlight ten areas within the niche and include an array of companies, both big and small, across Pharma and Biotechs.

Some of them have some nice data to share, others will be footnotes to the meeting, but who fits into what category and what can we learn from the abstracts upfront?

To find out more, we looked very carefully at the hints and nuance which inevitably grace the writer’s pen – it’s time to hone in on where are the flourishes and the crossings out this year?

To learn more from our oncology analysis and get a heads up on insights and commentary emerging from the ASCO meeting, subscribers can log-in or you can click to gain access to BSB Premium Content.

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A look at Mirati in the context of the broader KRAS niche

As we continue to follow the emerging KRAS niche longitudinally, we can easily imagine the kind of roller coaster ride that ensues with new product development in oncology R&D.

Early last year we posted an interview with Mirati’s CEO, Dr Chuck Baum, discussing their selective KRASG12C inhibitor.  A year on much has happened in the intervening time – additional competitors and potential collaborators have entered the clinic, a few mechanisms of resistance identified, and numerous combination partners have been suggested.  The company have also aired their own phase 1 data and new trials are expected to open during 2020.

This time around we talk to both Dr Baum and the company’s CSO, Dr James Christensen, about their experiences in the front line in terms of translating the preclinical data into clinical trials, their thoughts on important scientific data as well as the competition, and what to watch out for going forward.

This field is going to not only go fast judging by the emerging research published to date, but it’s also going to get way more complicated than many observers realise.

To learn more from our oncology coverage and get a heads up on our latest analysis, commentary, and expert interviews from a company active in the KRAS space, subscribers can log-in or you can click to gain access to BSB Premium Content.

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