Biotech Strategy Blog

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

About MaverickNY

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Posts by MaverickNY

After a couple of years in the doldrums with a bunch of negative phase 3 readouts, I thought this was a good opportunity to sit back and reflect on the next tranche of targets and see what we can learn about them.

The answers were quite surprising when you look at the group as a whole because not everything is about the PD(L)1 – CTLA4 axis, thank goodness.

In the latest preview we explore five different categories and highlight mostly early and novel developments coming along from early stage biotech companies, which may be of interest to our eager readers..

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In their first of our annual SITC Preview series for 2022 we are going to be focusing on addressing a critical issue, which has long stumped many a researcher.

Fall in Boston

I’m not a bit fan of combining two agents just because that’s what any given company has in their pipeline and trying to justify some vague rationale of what might work. This is akin to throwing spaghetti or mud at the wall and hoping something will stick – it’s a rather basic, if not crude, way to proceed with clinical development and relies more on hope than reason for success.

What if we looked at the data available from patients tumours and learned from the information instead?

This sounds obvious, yet few actually attempt a deep dive on this critical endeavour.

The good news is some companies making progress and are seeking to address the underlying biology of what lies beneath – as these examples we have selected highlight nicely…

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Immune cells and tumour cells can act like a changing kaleidoscope depending on the situation

While we have seen many studies on the mechanisms of primary and acquired resistance to small molecule inhibitors leading to rational combination therapies, our understanding of what’s going on under the hood in response to protein degradation or immunotherapies is much less certain.

In our latest post, we explore how these worlds are now starting to collide and how tumour behavior at the time of resistance can better inform translational studies as well as future clinical combinations.

While there have been numerous studies emerging on the dual IO-IO front, let’s not forget there are still many opportunities to explore synergies with small molecule agents to address mechanisms of resistance…

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Time for a new dawn

In order to identify opportunities for cancer new product development, you have to be able to identify early emerging trends.

Coupled with this is uncovering the science capable of challenging current thinking or conventional wisdom, while providing a useful solution to what has been an intractable problem or better still, offers a technology solution, which previously did not exist.

With these issues in mind, in this post we’re taking a look at some recent developments in the fast moving field of targeted protein degradation (TPD), highlighting early data we think are not only noteworthy, but also offer potential for clinical impact down the road.

If you’re interested in protein degraders and molecular glues, you can find all our relevant content in this niche grouped here.

Want to know where the field may potentially be going? Then this post, and the next one are for you.

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Fishing for oncology new product gems

One of my favourite exercises at conferences is exploring new or emerging targets in the the poster halls, either in the context of preclinical or early phase 1 data.

Undoubtedly it often ends up as a bit of a fishing expedition – you have all the anticipation and excitement upfront and just as in real life, sometimes you go home empty when nothing bites as happened to a couple of guys I was watching fishing in the bayou last weekend!

Much to their frustration, the mullet gleefully jumped around them without going near.

Assessing early stage oncology pipeline development is a bit like this too.  After following this particular niche for a while, it was time to take stock with a new clinical readout available.

Did the data live up to expectations or not?

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Vive La France! 

Despite the raft of negative trials presented in Paris this year, it wasn’t all bad news, although for a while it certainly seemed this way with quite a few phase 3 trials missing their primary endpoints.

It’s time for our ESMO review where we highlight no less than 10 trials offering positive vibes and encouraging signals, particularly in early stage development.

So what were the standouts and why do they matter?

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Et tu, Brutus?

Perhaps the most controversial readout from ESMO22 this week was the phase 3 readout on Amgen’s pivotal trial for their KRAS G12C inhibitor in second line non-small cell lung cancer (NSCLC).

Instead of being an obvious shoo-in, quite a few surprising issues came to the fore – almost in a perfect storm fashion – acting to hobble the results in an unexpected fashion.

Here we review the issues and challenges facing sotorasib and also explore the potential impact on the field at large…

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Which direction should we go in early stage RCC?

The battle for early stage RCC at the European Society of Medical Oncology (ESMO) is turning out to be quite a humdinger this year with quite a few unexpected surprises in store given the variety of trials with different agents and combinations generating a disparate variety of readouts.

Why is this and what can we do/learn from the findings?

In this post, we offer an in-depth discussion and commentary from various GU and IO experts…

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A familiar Paris Metro sign

To get around Paris efficiently, we might start off at one particular Metro station and need to change lines or direction several times in order to arrive at our destination on the other side of the city.

Similarly, I’ve often wondered if repeating endocrine or hormonal therapies in breast or prostate cancers is a big like staying on the same line and never getting to where we really need to go.

Just as CDK4/6 inhibitors revolutionised the treatment of HR+/HER2- advanced breast cancer by allowing physicians to target a different pathway or axis, should we be rethinking new approaches to an old problem?

In our latest story from the ESMO22 conference, we explore some of the emerging evidence…

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Time for some commentary and review of ESMO highlights and lowlights from Paris

One of the fascinating aspects of the PARP inhibitor niche is how often the results across several different company trials have gone the same way more often than not.

This has been a rather unusual streak, let’s face it.

At some point I was half expecting the wheels to fall off the wagon and the trend to be bucked, to much consternation from outside observers.

It’s already starting to happen, although perhaps not in the way we might have anticipated.

After all, you can’t enroll patients willy nilly and expect to see a positive result every time because patient selection can and does matter over the long run.

Here, we discuss some of the emerging controversies coming out from ESMO…

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