Biotech Strategy Blog

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

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TRIPLE highlights and lowlights in Developmental Therapeutics

We have two stories to share today from the EORTC-NCI-AACR Molecular Targets conference, which are posted separately owing to different embargo times.

The second posting later focuses exclusively on KRAS and Mirati’s turn in the spotlight.

Due to the embargo, it will not be available until 1545 hrs CET (1045 hrs ET) and will include some thought leader perspectives on the data.  I’ll add the link here in due course.

Developmental Therapeutics is often a cases of sunny days or stormy waters ahead…

Meanwhile, in the first post (below) we take a keen look at some of the new developmental therapeutics approaches coming through company pipelines.

Which ones shine might brightly and which ones lose their lustre?

As is often the case with early stage trials, translating rational science in preclinical setting doesn’t always translate well into the clinic when humans receive a therapy or particular combination of agents.

To this end, you might be surprised at how much PK/PD issues, half life, dosing/scheduling and other many other factors can severely impact the therapeutic window.

In this post, we look carefully at several targets we have been following preclinically for a while and finally initial clinical is either available or they are heading into the clinic – what can we learn from the presentations?

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

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On finding new targets and boosting existing therapies

Science drives oncology new product development and the AACR special conferences are always a good place to look for insights into where the field is both emerging and also going in the future.

At the recent AACR Tumor Immunology and Immunotherapy conference, several presentations stood out for us as being noteworthy for either building on an existing story or the new perspectives they offered, some of which involved new targets we’d not heard before.

In this post, we take a take at some of the data presented, how it builds upon what we already know, and possible directions it may take us in.  After all, the best way to predict the future is to invent it.

It’s time to shine some light on novel targets, biomarkers, and emerging combination approaches…

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Potential new targets and biomarkers for immunotherapy

While it is universally true much more attention is focused on success in clinical trials in the sense of patients who respond well to a particular therapy, this doesn’t mean we can’t learn from people who tumours either don’t respond to treatment up front or relapse early.

In our latest review, we look at three different examples of what we can learn from biomarkers of T cell exhaustion with both CAR-T cell therapies (with two different targets) as well as immune checkpoint blockade.

In short, there’s more to think about beyond antigen loss and target downregulation.

Why does this matter?

Well if we can identify markers of early relapse then we can either intervene earlier and switch to another therapy or we can add something else in to try and rescue the patient’s immune response.

Here we discuss some of the scientific findings from different research labs and explore how the information uncovered may be key to either future novel developments or clinical strategies with current immunotherapy approaches…

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New developments in the KRAS landscape

A look through the window at the evolving KRAS landscape

It’s time for an important update on the KRAS landscape and emerging opportunities in this niche.

I’ve mentioned this a few times, but the real kicker is going to come from rational combinations in different settings.  Those companies who figure these out will emerge a stronger player than their competitors who focus on monotherapy.

With this idea in mind it behooves us to be alert and aware of what’s going on in the broader landscape beyond selective KRAS inhibitors against certain mutants.

Here we discuss the latest findings from two such targets, each quite different and yet both could have important roles to play going forward…

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New ways of thinking about the immune landscape

Earlier this year we highlighted how machine learning, artificial intelligence and big data might have an earlier than expected impact on clinical decision making. Quite a few sceptics scoffed at this idea.

Since then we have seen some nifty examples emerge at various conferences relating to clinical analyses such as this one at ASCO, although there have been quite a few others.

AACR Tumour Heterogeneity 2020

This latest post isn’t about deep learning per se though, but rather how can we look at the tumour microenvironment differently in ways which might help us make better or earlier clinical decisions?

There are a quite a few high profile examples where the emerging research is starting to look helpful so it’s time to link all the loose ends and take a thoughtful look at what we can learn from a particular example involving a high profile study.

The results, some of which intuitively make sense and others are surprising, may give us some useful clues of where to start looking next in terms future therapeutic interventions…

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A contrarian view of key cancer trial results

One thing I really miss from attending live conferences – aside from catching up with people in person – is “the living like a local” experience. Last time I was in Madrid, for example, there was this fishmonger (pescaderia) just a block down from the rented apartment. They were only open in the mornings, so you could dash down the hill, quickly nab some fresh produce, refrigerate it and have something nice to look forward to for dinner with a glass of wine at the end of a tiring day while writing up the highlights…

The image also offers another analogy – do some data presented at a meeting end up, well, a bit fishy on closer examination or reflection despite much of the hype enthused or extolled by others?

At the ESMO20 virtual Congress, we covered a tremendous amount of details from the data during both the daily highlights as well as the previews exploring what to watch out in the run-up to the event.  You can find all those reviews here.

There are always some surprises in store, however, both good and bad.  There’s also layers of obfuscation going on to consider in the form of cheerleading from companies, investigators, or stock holders, which may add positive spin on what is essentially so-so data, cases where great data goes largely ignored for whatever reason, or important lessons to be learned from failure.

In this wrap-up post, we take a sharp look at the ESMO20 winners, losers, and risers from a contrarian’s perspective…

To learn more from our oncology analysis and get a heads up on the latest insights and commentary pertaining to ESMO20 virtual congress, subscribers can log-in or you can click to gain access to BSB Premium Content.

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On black holes and rising supernova stars in oncology

Hubble Space Telescope, Spitzer Space Telescope

Hubble Space Telescope, Spitzer Space Telescope – Image credit: NASA/ESA/P. Jeffries

With the latest Nobel Prize in Physics being awarded to three scientists (Roger Penrose, Reinhard Genzel, and Andrea Ghez) for their work on black holes in the galaxy, it occurred to me there are some handy analogies for cancer research and development too.

As NASA aptly put it:

“Every second a star somewhere out in the universe explodes as a supernova. But some extremely massive stars go out with a whimper instead of a bang. When they do, they can collapse under the crushing tug of gravity and vanish out of sight, only to leave behind a black hole.”

Almost every Pharma company with an oncology pipeline is faced with the same fundamental challenge at some point in its life cycle – which ones are the rising stars that could explode as a blockbuster versus which compounds are doomed to vanish and be sucked back into the black hole (aka the screening library)?

Can we always tell from the basis of what are usually relatively simple allcomer trials in phase 1 with dose escalation in advanced solid tumours?

It’s fairly straightforward to tell when something is too toxic for patients to tolerate, as the number of grade 3+ serious events will quickly indicate, but activity isn’t so easy to determine.  This begs an important question to be answered – what are researchers and new product professionals actually looking for and how do they interpret the data?  Are they looking from a similar lens or are there differences in perception, much as a kaleidoscope changes even with the same elements included.

Here we take an in-depth look at a couple of early compounds against targets, which have garnered some attention this year and explore reactions from both sponsor and KOL angles.  As anyone involved in clinical trials knows, not everyone sings from the same hymn sheet every time!

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A phoenix rises from the ashes

A phoenix rises from the ashesResilience in purpose and openess in strategic direction are key dual features in the DNA of strong biotechs which succeed in the long run and live to survive the roller coaster ride that is oncology R&D.

Setbacks are to be expected, but what matters more is not that they happen, but the mettle and toughness to deal with them over time.

There is no doubt Clovis Oncology encountered a major setback with the abandonment of rociletinib in lung cancer, while the rise of PARP inhibitors meant they were well placed with the rucaparib development.

Beyond these events, what next?

It’s time to take a bigger picture look at what’s happening with the pipeline and where they might be heading since there could be some surprises in store…

To learn more from our oncology analysis and get a heads up on the latest insights and commentary pertaining to ESMO20 virtual congress, subscribers can log-in or you can click to gain access to BSB Premium Content.

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Important learnings from ESMO20

A typical scene from ESMO 2019

Not in Madrid – Is it really only a year ago many of us were frantically dashing around at ESMO last year navigating crowded corridors, long queues for coffee, hunting down the last empty seat in jam packed halls, not to mention feeling the anticipation build for key data being presented in the Presidential sessions?

There are undoubtedly many advantages to virtual digital meetings, aside from the broader access for more people it provides and being able to see the slides unimpeded, yet it must be confessed the things I miss the most are the social interactions and catching up with people and their lives, however brief a moment it may be amongst the hurly burly of 20,000 other souls.

The cultural things we take for granted are often the very essence of what we miss most when they’re no longer obtainable.

Who truly would have guessed our world could be completely upended by the unexpected events of a global pandemic since then? In some ways, it has changed our perception of both time and space.

We have also seen some surprising changes in the fortunes of various clinical trials; some completely rational and predictable, others quite the opposite, as we learned yesterday in a very topsy turvy kind of way.

It’s time to discuss and review the highlights – and lowlights – from ESMO20 Sunday in part 2 of our daily coverage…

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Highlights of Super Saturday at ESMO20

Not in Madrid: Unlike the Tour de France, which finishes with the peloton procession in Paris today, we’re not yet at the ESMO20 finish line and there’s plenty of the data at Congress yet to come.

Macarons anyone?

As you can see, we’re hoping ESMO21 will actually take place in Paris next year, but it’s definitely too early to make travel plans the way COVID-19 infection rates are increasing in Europe.

If we think of cancer drugs as like macarons that come in many versions – which ones do you like at #ESMO20 so far? There are are also subtle gradations in colour and flavour, reflective of a few trial differences to consider.

In this latest post we’re continuing our coverage of highlights from Saturday at ESMO20 with the second part of our commentary and analysis around some of the oral presentations involving numerous solid tumours, excluding breast cancer (see separate highlights of the day post), which caught our attention.

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