Biotech Strategy Blog

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

Posts tagged ‘PI3K’

Dark side of the moon

Image credit: kevron2002

Every time a new class of agents emerges in oncology, I’m reminded of a partial solar eclipse where there’s just enough sunshine to offer some promise or hope, which needs to be balanced with the much larger area of darkness visible to the naked eye.

This darkness can take many forms from tolerability and a narrow therapeutic window to lack of clinical activity.

In the beginning it’s always hard to see the wood from the trees and often there is more conflicting information available than congruence, at least until things shake out more clearly.

There’s also the tricky matter of cross pathway interactions and how they can influence the broader picture in hidden and obvious ways.

As we head into AACR in a few weeks time, this is a good opportunity to take stock on the various landscape changes and put the situation into perspective.

In this review we look at ten key areas and break down what’s known, what’s not known, and how some of the future directions may take shape…

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Expect the unexpected

While there has been much speculation and rah-rah over the supposed demise of oral therapies thanks to the introduction of the Inflation Reduction Act (IRA) of 2022 including the Part D Redesign, I’m increasingly finding important developments on the targeted therapies front to watch out for.

In the third part of our ongoing mini-series on the PI3K and PIK3CA landscape we’re going to switch to a different example in this niche.

There are some key clinical data due out later this year, which ought to bear watching out for.

The question though, is why – and what ought we to be thinking about in a broader context?

Our latest article reviews the science, the players, the drugs, and explains how we got here…

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Piking the winners and shipping the new combos

Picking the winners in the race

In the second part of this mini-series on an important oncogenic target, we’re going to explore some topics around the theme of coalescence.

This means we can look at how do cancers hijack multiple pathways or co-opt critical cell growth related genes to help drive their own growth, proliferation, and survival.

If we understand the processes involved then we can start thinking about what we can do to interrupt or shut them down then develop relevant therapeutic strategies to tackle them.

Additionally, several targets have now been made druggable where they were considered intractable when this pathway axis was at its peak.  This may offer some fresh opportunities for progress in ways which were not feasible before.

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The perils of misreading oncogenic signalling

The moon   Credit: NASA

There was a frustrating point during the development of today’s target focus when one harried researcher turned to me and drolly noted,

“It’s like trying to go to the moon with just a plastic rocket on hand!”

You could see where he was coming from… we had a oncogene, some nice preclinical data, numerous approaches to tackling the target in the clinic and yet none – not one of them – were panning out as expected.

Failure after failure hit the niche, not all for the same reasons…

Too toxic, not enough activity, narrow therapeutic window – it was all there and not all of the issues were predicted in preclinical experiments either.  Some observers even began to question whether the target was in fact, a valid oncogene.

Then came some success and the floodgates opened.

These days we know a lot more about what works, what doesn’t and where things are headed.  We might not be going to the moon yet, but things are headed in the right direction.

In the first of a four-part series we take a look at the troubled waters and learn how the situation was rescued by a few smart scientists and companies invested in finding the right cell/right compartment to aim at…

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A rock around the breast cancer clock

Sadly not the #blisterwalk this year

Not in Chicago – Breast cancer has been a hot topic again on several fronts after a bit of a lull on the R&D front.

Writing about such trials across ESMO Breast, ASCO and the second AACR meeting is all very well, but what about some KOL commentary and reactions to some of the data we get to see?

If this has been a burning question for you, this is a handy article to catch up on. Of course, to be clear – not all the trials will be positive or biomarker analysis helpful, so here we tackle the issue and look at what’s what though the lens of a specialist…

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ASH18 Highlights from Day 3

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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Gems from the AACR Poster Hall – Part 2

If you had told me several weeks ago that we would write over 28 posts on #AACR16 and become very interested in mouse models, then most likely I would have laughed out loud and told you not to be so ridiculous!  Here we are with the 29th one and, another, on the bromododomain landscape yet to go.  Such was the vast richness of data and concepts being discussed or presented in New Orleans for those who chose to look.

Today, I want to start the segue from AACR to ASCO coverage.

Nawlins MGRAS FIOne way to do that is through the second part of the Gems from the Post Hall series. This latest one looks at a range of intriguing new targeted therapies and novel targets that are emerging, including a pharma company with a particularly interesting early pipeline.

Several pharma companies presented interesting data on their very early compounds currently in development, plus I noticed a trend for a new class of targeted therapies to emerge, MNK inhibitors, which we will also discuss.

Companies mentioned: Bayer, Orion Pharma, Lilly, Novartis, Pfizer, Agios.

Targets mentioned: PI3K, CDK, Akt, TWEAK, FGFR, BUB1, IDH1, SMYD2, MNK

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Gems from the EBCC10 Poster Hall

EBCC10

EBCC-10 Cancer Conference

Amsterdam: The 2016 European Breast Cancer Conference organised by the European CanCer Organization (ECCO) is underway (Twitter: #EBCC10 – it’s the 10th official one they have organised).

We thought it would be a good opportunity to take a break from our coverage of #BMTTandem16 to look at some of the posters that are of interest at the meeting.

As regular readers know, we spend a lot of time reading posters – it’s where we pick up new trends and early data. Most go unnoticed or unpublicised in press releases.

For this post, I’ve highlighted four posters that I’m quite interested in and that merit further discussion.

They range from basic and translational research to clinical new product development. By chance, they are evenly split between immunotherapy (PD-L1 and TILs) and acquired drug resistance to different targeted therapies.

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AUA 2014 – New targets in prostate cancer

Over the last few years we have seen new therapies emerge for the treatment of advanced prostate cancer from immunotherapy to chemotherapy and second generation hormone therapies. Each of these has increased survival and outcomes. Along the way though, a host of other agents have fallen by the wayside with a raft of negative phase III trials that did not live up to their phase II promise. These include atrensentan, dasatinib, ipilimumab, lenalidomide and more recently, custirsen.

Much of the focus has, however, been on the hormonal drugs, abiraterone (Zytiga) and enzalutamide (Xtandi) in both the pre and post chemotherapy settings. One thing has become clear though – over time the responses attentuate as resistance sets in. This is very common with oral therapies.

Some big questions to consider here are:

  • What causes it?
  • How can we overcome adaptive resistance?
  • Would combination approaches produce synergistic results?
  • Or should we consider new targets with a different mechanism of action (MOA)?

The answers to these questions are now being eagerly explored through basic, translational and clinical research. I was very impressed with the quality of research and breadth of fresh ideas and approaches emerging from the SBUR, SUO and UOR sessions at AUA this year, including new combination trials already in the planning phase.

In the past, Bertrand Tombal (Belgium) talked about the Grand Cru year for clinical research in CRPC. In the future we may well look back at 2014 as a similar Grand Cru year for basic research for prostate cancer, if the findings translate to clinic. The bench-to-bedside process is very much alive and well in urologic research.

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6 important things I learned from AACR 2014 on immuno-oncology

 

“Nothing lasts forever, because nothing ever has.”

James Shelley, The Caesura Letters

This year’s annual AACR meeting was so good, we could probably write another 50 posts and still not be done! With ASCO fast approaching, however, it’s almost time to draw it to a close and the final post conference note will be published on Monday.

Today is the penultimate report and focuses on the key highlights that caught my attention in immuno-oncology, which covers the gamut from checkpoint inhibitors, co-stimulants, innate immunotherapy and CAR T cell therapy to bispecific antibody TCRs.

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