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

A case to answer

Every now and again something intriguing comes along, which generates a flurry of interest from our readers in terms of early stage pipeline developments.

This example is no exception to the rule, judging from the enthusiastic questions we’ve received over the last couple of months.

Wit a raft of new clinical data available there’s a clear opportunity to explore exactly what’s what and is there something special coming along or is there a real risk/worry this might turn out rather like the IDO pathway with mixed red and green signals floating around?

The only problem here is after carefully reviewing all the evidence I found myself firmly in the sceptics/bear camp, at least for now.

It’s time to walk you all through what we found and what it all means…

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Une Baguette Magique

Quote of the Day from Tower Hill Tube station a couple of years ago is rather apt when comparing different cancer therapies

Every novel cancer immunotherapy has its day in the limelight, although it obviously goes without saying we shouldn’t compare them unless in a head-to-head trial.

What if the comparisons are made using the wrong parameters, however?

Well, this just compounds the problem further and does neither product nor company or researchers any justice.

This time around we continue the latest chapter in an story we have been following for several years now before it was really in many people’s conscience.

Sometimes it helps to go back to the beginning to see how far things have come, other times it is more useful to look in a broader context of the space it is competing in.

In this latest installment we attempt a look at both plus offer some commentary on how it could be viewed…

 

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Emerging developments and trends in advanced lung cancer

Gems from the poster halls are always a popular series at cancer conferences where we highlight emerging early stage agents of interest.

Not every oncology development has gone to the dogs – there are some gems out there too

This time around we look at some data from a China biotech, another peek at TIGIT, resistance to a targeted therapy, a novel antibody target and a real world study, which both inspired and caught my attention.

As always with oncology R&D it isn’s always plain sailing – there are sometimes some surprising results (good and bad), spanners in the works and also some really useful trial designs to consider.

What can we learn from the latest round of presentations?

Let’s roll!

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A look at the exon 20 landscape in lung cancer

A couple of decades ago it was fun to follow and write about the first generation of EGFR inhibitors and the EGFR mutation versus wild-type race in non-small cell lung cancer (NSCLC).

Singapore skyline – a reminder of where WCLC was broadcast from last week

A number of resistance mechanisms have since evolved and these also vary according to what is given in each line.  One increasing area of interest has been exon 20 insertions, which can be seen with both EGFR and HER2+ lung cancer.

I’m willing to bet no one back then would have imagine we would be talking about a highly competitive sub-niche of exon 20 insertion small molecule inhibitors and bispecifics twenty years on.

We wrote about this niche a few times last year and with increasing competition the landscape is heating up so it’s time for a strategic look at the various developments…

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What happens when genomics, KRAS, and IO converge in lung cancer?

It’s February 2nd, which means Groundhog Day in America. I was idly wondering how accurate the rodent Punxsutawney Phil was, after all, he’s got a 50:50 shot of being right or wrong.  Who knew someone had analysed the predictions already and what’s more – published them?!

Meanwhile we don’t need no predictions for today’s post, where we look at the evidence gleaned from several clinical studies in lung cancer and come to some important strategic conclusions about the findings.

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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…

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How will AI impact oncology R&D?

There is no doubt in my mind artificial intelligence (AI) has the power to improve cancer diagnosis because if the system is trained sufficiently then an algorithm should potentially be able to spot subtle patterns, which can be missed by the human eye. Even well trained pathologists are not infallible, after all, as we have seen in other areas of cancer research diagnostics relating to immunotherapy.

There are a number of benefits to using computers and machine learning, such as reduced error rates in diagnosis thereby limiting misdiagnosis, as well as increased precision in determining low versus high risk lesions, leading to appropriate clinical intervention rather than under or over treatment. There are other potential advantages too, including speeding up processing of thousands of scans in a screening and prevention study.

A couple of years ago I was fascinated by a Google study published in Nature Outlook, which explored the value of 3D deep learning in low dose computed tomography of the chest for the purposes of lung cancer screening. They proposed a deep learning algorithm using a patient’s current and prior computed tomography volumes to predict the risk of lung cancer. This was something they were able to accomplish with surprisingly high accuracy, even to the extent they could beat out half a dozen radiologists with absolute reductions in the rate of both false positives and negatives.

The ultimate value of this kind of analytical approach?

“While the vast majority of patients remain unscreened, we show the potential for deep learning models to increase the accuracy, consistency and adoption of lung cancer screening worldwide.”

This month brings a confluence of an specialist AACR meeting plus WCLC, which means there are some fresh ideas to learn from and also some emerging clinical data to consider…

To learn more from our oncology analysis and get a heads up on the latest insights and analysis pertaining to oncology R&D, subscribers can log-in or you can click to gain access to BSB Premium Content.

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Old Dog New Tricks

As often happens in cancer research, a new class of compounds emerges every so often, fades out with various tricky clinical challenges then roars back again anew with target variations on a similar theme, as new data become available.

Most cancer signalling pathways veer towards the complex rather than simple, so can we learn from the past and try again by aiming at different compartments and cells?

Some recent translational data relating to IO and cancer immunotherapy can offer us fresh hope for potential novel combinations, especially with immunotherapies rather than chemotherapies.

The molecule designs have also moved on too thus offering additional opportunities and possibilities, which may not have the same difficulties with the therapeutic window limitations seen a decade ago.

There’s always something new to be hopeful about, so let’s take a look at what new ideas are emerging from the doldrums…

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Lessons learned from phase 1 oncology trials

One of the big challenges with cancer research is sorting out the wheat from the chaff in terms of viable targets.

If you think about it, just as we have drivers and passengers in traditional targeted therapy approaches to consider, there are also valid targets versus markers in immuno-oncology too.

We have written quite a bit about novel targeted therapy approaches of late and now it’s time to switch to IO again.

Sometimes aiming at a particular target might lead to a series of rather disappointing results in certain tumour types, yet suddenly looks much more intriguing and useful in a quite different setting.

We’ve talked about finding the sweet spot in aiming at the right cell, right compartment quite a bit on BSB, and this latest example certainly fits into this category…

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Parallel lines: opportunities and challenges in GI cancers

This weekend saw a variety of updated data presentations roll out from ASCO GI – think of the wide range of tumour types encompassing gastric, colorectal, liver, biliary, and pancreatic cancers.

What stood out from the crowd and why?

What are the threads and connections which might hold things together?

And why does KRAS keep cropping up in unusual and unexpected places?

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