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

COAST to coast – contemplating key Stage III trials in NSCLC

With regards to today’s focus on a phase 2 randomised controlled trial (RCT), it is an intriguing development to be thinking about because usually it is phase 3 trials which tend to be rather controversial and generate a lot of reader questions.  This especially true when it’s a negative study and people want to know why, or what on earth happened?!

Between the lonely sea and sky…

It’s rare for a positive phase 2 trial to lead to more questions than any other studies being presented at a given cancer conference.

I must admit this was probably my favourite data of the ESMO meeting because it offers plenty of possibilities and also broader encouragement for the field when you consider how many studies have tried to manipulate the tumour microenvironment and not succeeded.

Between the current readout and the forthcoming pivotal phase 3 trial, however, lie a number of key questions which need to be addressed, as well as plenty of subtleties and nuance to think about carefully.

So what’s in store on the lung cancer front?

BSB subscribers can read up on our latest commentary and analysis from the ESMO conference, including expert opinions and reactions – you can log-in or click to access our latest analysis.

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Spotting the path forward

Early developmental therapeutics is often akin to finding Nemo or spotting the hidden nuggets in the wild

In our latest look at novel agents in Developmental Therapeutics, we discuss some of the inherent challenges many companies face when conducting phase 1 research through the lens of Syros’s progress with their early stage agent targeting both transcription and cell cycle arrest.

Finding a balance between efficacy and tolerability is often much trickier than many outside observers realise, but it can be done.

Of course, this is before we even consider which tumour types might be optimal to pursue in further trials…

BSB subscribers can read more on our latest update and commentary from the ESMO conference – you can 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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And the data at ESMO21 is…

Dawn of new era?

Not what many might have expected before the meeting.

Many presenters will likely make claims for a particular regimen or treatment changing the standard of care, but few will really make us stop and go… WOW!

One trial has had this effect at ESMO this year thus far.

So what’s the skinny?

BSB subscribers can read more on our latest update and commentary from the ESMO conference – you can log-in or click to access our latest analysis.

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Storm Clouds or Sunny Skies? What’s on the horizon for Early Stage IO Development Data at ESMO21

As we continue our review and discussion of early new product developments at ESMO this year, it’s time to turn our attention to some IO based agents, either along or in combination with other approaches.

Is the situation a bright and breezy one or full of gloomy clouds with little or no silver lining to speak of?

Yesterday’s review of early targeted agents was a surprisingly popular one, so let’s see how the immunotherapy based approaches do…

BSB subscribers can read more on our latest update and commentary from the ESMO conference – you can log-in or click to access our latest analysis.

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ESMO21 Highlights from Day 1

Pathways to success – or not?

When it comes to oncology new product development there are always multiple factors to consider, from novel targets, new combinations, different tumour types or settings, biomarkers, to patient subsets and much more.

At ESMO this year the poster session provides a particularly rich resource of early stage trials involving fresh ideas or novel approaches to explore on both the translational and clinical fronts.

In our latest conference coverage we highlight a few noteworthy ones and also point out some of the important subtleties and nuances to be aware of, since they may have a key impact on future trial success.

What’s not to like?

BSB subscribers can read more on our latest update and commentary from the ESMO conference – you can log-in or click to access our latest review.

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Standing out from the crowd in lung cancer

What’s standing out from the crowd in lung cancer?

It seems hard to imagine only a few years ago lung cancer was still in the doldrums with various chemotherapy doublet and triplet regimens showing little or no benefit for people with small cell (SCLC) or non-small cell (NSCLC) lung cancer.

Fast forward and my, how things have changed today with a raft of targeted and immunotherapies making a real difference to many people’s lives!

In our latest discussion highligting important trial readouts and published data, we also offer some potential new developments which might be useful down the road…

BSB subscribers can read more on our latest update and commentary regarding lung cancer – you can log-in or click to access our latest analysis.

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Novel strategies for addressing an intractable cancer target

Source: AlphaFold

In today’s post we’re going to discuss some new findings and explore important research published on different aspects of the same central target.

What can we learn, what are the implications, and what new developments are emerging in this niche?

You can clearly see from the Alphafold database representation of the protein structure (right), while the blue central section can be predicted with a high degree of confidence there is quite a bit on the spindly periphery with much less confidence.  Does this impact our ability to drug the target?

Perhaps, but there is also much around the cell interactions and processes involved we don’t know either.

The good news is there are some intriguing new developments worthy of review and discussion…

BSB subscribers can read more on our latest commentary and progress on an intractable drug target – you can log-in or click to access the sparkly content.

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Coming back full circle

Where are we headed in the DDR niche?

The dog days of summer always seem to portend a mix of sunny days and stormy skies ahead…

In this latest report we cover important issues around homologous repair deficiency (HRD), new replication stress targets, as well as how both analysis and assays are being developed to meet the evolving needs of the field.

There is much nuance going on behind the scenes, which will be important to keep up to date with, including some tumour types not previously associated with DNA damage repair, something we highlight in this post.

These findings might have implications for future regimens and may explain some of the undetected mechanisms of resistance we are seeing in existing trials being presented at ESMO or the forthcoming Molecular Targets (TRIPLE) meeting.

There are also diagnostic developments to think about, not just therapeutic ones…

BSB subscribers can read more on our latest update regarding HRD and DDR inhibitors, plus our latest expert interview from ASCO – you can log-in or click to access the new content.

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WCLC21 Preview of key data to watch out for

Time for some new directions in lung cancer?

It seems only a few months ago we covered WCLC20 and here we are again with another lung cancer conference.  This is because the pandemic certainly made an impact last year in more ways than one since the meeting was split into two, with the second half of the sessions being showcased in January.

This time around we highlight quite a few presentations on the IO and KRAS related pathway fronts, as well as some updates on various targeted therapies – with a few unexpected surprises in store.

There are also some important genomic and biomarker presentations to watch out for…

BSB subscribers can read more on our latest cancer conference preview  – you can log-in or click to access our latest expert interview.

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