Biotech Strategy Blog

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

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Insights on targeting the oncogene SHP2

Fall in Boston during the AACR-NCI-EORTC Triple meeting

After recent updates on targeting KRASG12C and HRAS, let’s not forget that there are plenty of other elements of the RAS pathway that can be considered, not least is upstream receptor kinases such as EGFR and sideways to SHP2.

What happens when those worlds collide?

Quite a bit it would seem.

If we want to seriously impact patient outcomes for the better then we need to explore rational combination approaches.

Here’s one way to do it…

Please note that this is an early target with not very many competitors, so there’s plenty that can happen here on multiple fronts!

To learn more from our oncology coverage on the RAS pathway and get a heads up on insights from our latest company interview, subscribers can log-in or you can click to gain access to BSB Premium Content.

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New path to market opportunity for Kura in SCCHN

Fall in Boston in time for TRIPLE19

Boston – It looks like being RAS week at the AACR-NCI-EORTC Triple meeting aka Targets19. Yesterday we explored the first-in-man data for the Mirati small molecule inhibitor, MRTX849, in KRASG12C mutant cancers that included lung and colon carcinomas.

In terms of aberrant activity in cancer, RAS comes in three different flavours, if you will – KRAS, NRAS, and HRAS.

After plenty of coverage of KRAS (and more yet to come!), it’s now time to turn our attention to a rather different oncogene driver and put HRAS to be in the spotlight.  Here, we offer an updated look at the progress of Kura Oncology’s tipifarnib in squamous cell carcinomas of the head and neck (SCCHN) and assess the potential opportunity for approval in this setting.

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What do we learn from a first look at Mirati’s KRAS G12C inhibitor MRTX849?

Boston – One of the most enjoyable things about writing about science and early clinical oncology data is the relationships we build with thought leaders, such that they can be open and honest about their reactions, without them being judged, misinterpreted, or misquoted. We’re on a journey with them, whatever the ups and downs might bring, in a bid to capture the realities of the oncology R&D rollercoaster.

Don’t be fooled by the gloomy Boston weather as a metaphor for data presented at Targets19!

Each story becomes a snapshot in time, a short of ‘Kodak moment’, if you will.

Imagine then, capturing a discussion with a global lung thought leader discussing the initial data from the first-in-man trial with a KRASG12C inhibitor from Mirati (MRTX849) and his experiences in treating people with advanced lung cancer who have the dreaded KRAS mutation, which until recently there were no effective options for.

Thus, we captured the exuberance of seeing objective responses in patients for the first time, “It’s fantastic!” and at the same time qualifying that with a balanced and candidly objective perspective, “it’s still early days.”

Both are true, and not mutually exclusive.

In between these two extremes there is much to think about including understanding the inevitable resistance mechanisms that evolve (primary and secondary), figuring out how to optimize the combination trials as well as reactions to other, seemingly competitive, developments. Our expert in the hot seat today had some rather thought provoking ideas on these important topics to discuss that we wanted to share and stimulate some debate on.

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Further issues surrounding RAS inhibition in oncology

As we head into the AACR-NCI-EORTC Triple meeting in Boston this weekend, excitement is growing around a suite of RAS inhibitors in lung, colon and other cancers.

Charles River, Boston in October

Over the last couple of weeks we’ve received a bunch of questions from readers on several topics relating to this niche that I thought would be useful to spend some time on to set the scene ahead of the data dump expected on Monday and Tuesday.

Some people do like to try and simplify things thinking that it’s just a matter of adding in a checkpoint blocker or something else and boom! off we go… Except that we know from past experience with similar agents against different related targets that this won’t necessarily be the case and we look at some of the reasons why.

Yes I know folks are likely expecting too much in terms of efficacy, but we can put some framework and structure around the issues on which to build on, which are actually more than many may realise plus it could also be tumour and even patient dependent.

So here we go with a joint KRAS mailbag, together with a short expert interview with a view to highlighting some crucial roadblocks that are likely heading our way…

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A novel approach to targeting BRAF and KRAS mutant cancers

With all the furore surrounding the new developments with KRAS G12C inhibitors in lung and colon cancer, it is easy to forget that there are plenty of other promising related ideas in the pipeline too. After all, there’s more than one KRAS mutation that can act as an oncogenic driver in patients that can portend poorer prognosis.

Aside from the obvious small molecules, there are other modalities to consider.

Here’s one such novel design that caught our attention — it has the potential to be elevated into an elegant platform approach with different molecules targeting a variety of critical mutations in tumour cells including KRAS G12D, which is prevalent in colon and pancreatic cancers.

I’ve had my eye on this work for a couple of years and now it’s a good time to showcase it in the spotlight given the sheer energy and attention focused on this niche…

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Insights from KEYNOTE-522 in early stage TNBC

Cui bono?

Imagine arriving at ESMO19 at the crack of dawn for a press briefing and you’re not presenting until after 4.30pm!

To whom is it a benefit is a fundamental principle in modern day medicine given the often vast array of options that oncologists may have at their disposal.

Conversely, we also need to know nec refert – for whom it doesn’t matter or doesn’t benefit – since we don’t want to over-treat people either.

Between those two extremes might be a couple of sweetspots i.e. one subset who may need a boost from chemotherapy and another in whom chemo plus IO therapy might be a better option.

For sure, we are not advocating that all people with early stage triple negative breast cancer (TNBC) should receive the same thing and certainly not everyone will need checkpoint therapy, no matter what the intent-to-treat (ITT) curves or response rates might try to imply.

There’s a lot of factors to think about and consider so here we look at the KEYNOTE–522 data in neoadjuvant and adjuvant TNBC and unearthed with some solid evidence that might help us understand and think about what needs to be done.

Following on from our in-depth ESMO19 Preview on TNBC and what to watch out for, we also now have a thought leader interview to share plus several other commentators chipping in…

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ESMO19 Day 4 Highlights including the PROfound trial in advanced prostate cancer

Gah, if only we hadn’t enrolled allcomers in our study, the differences would have been so much bigger!

Barcelona – This is the day when many people get absolutely walloped by exhaustion at ESMO even after three double espressos – if you’re still going strong then I commend your stamina and fortitude!

This is a big day for several companies with important phase 3 trial readouts due to be presented at the conference today.

One in particular is the phase 3 PROfound trial exploring the role of the PARP inhibitor, olaparib, in HRD+ advanced prostate cancer.

Beyond the top line findings (the PFS endpoint was met) there are a LOT of subtleties and nuances to consider so we have an analysis to share of some of the pitfalls and potential issues that may be missed in the hurly burly and noise.

Are you ready?

There’s a lot to think about today, not just in PROfound, but also quite a few other studies have been put under the microscope too.

Here we go unto the breach, my friends…

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ESMO19 Day 3 Highlights and Commentary

Morning, morning, where’s the strong hot java today?

Barcelona – Here we are on the third day of ESMO 2019 and this is where many presenters and attendees (especially international ones) start to hit the wall with a combination of tiredness, sore feet, late nights, lack of coffee, and jet lag all combine to create a perfect storm of exhaustion.

No matter – the conference schedule marches on!

After the craziness of posting not one, but three, extensive long form posts with commentary and analysis yesterday, I’m delighted to only have to worry about managing the daily highlights today. We’ve also been busy conducting interviews, running round the poster halls and listening to some elegant science talks as well.

If you’ve missed the rest of our ESMO19 coverage, it’s building up nicely so far on this magazine page – do check it out and take your pick of topics to browse.

There are some key phase 3 readouts expected in breast cancer alone, plus a raft of Developmental Therapeutic updates to ponder as well.

As usual, we start off with some known highlights and then move on to updating on oncologic developments that catch our attention through the day.

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ESMO19 Highlights from Day 2

The calm before the morning storm surge at ESMO19!

Barcelona – I can’t recall the last time we published three long form posts from a conference before high noon (US time) on the same morning, but that certainly illustrates how busy this year’s ESMO is and there’s a lot more to come yet.

The initial starting coverage for today includes hot topics in ovarian, lung, and colorectal cancers and more will be added in due course.

If you are looking for osimetinib in FLAURA and AMG 510 in KRASm colorectal cancers, click on the BSB log in the top left corner to check out the front page slider for more information on those write-ups and commentary!

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Insights on osimertinib in 1L NSCLC from the lens of the FLAURA trial

Barcelona – It seems only in only four years we have gone from discussing the phase 1 osimertinib data in EGFRm lung cancer with one Boston expert to reviewing the survival data from the phase 3 study with another expert from the same city… how time flies!

Today was a crazy day with multiple different embargoes lifting at different times so to make things simpler we carved out three different tracks to make it easier for readers to focus and follow the stories they are most interested in.

The KRASG12C clinical trial readouts continue apace with a look at the new non-lung cancer data. That post already went live at 1.30am ET if you’re looking for that evolving story.  The main highlights post with a daily running live blog and multiple updates throughout the day can be found here.

Meanwhile this particular post will contain everything related to osimertinib and the FLAURA trial, as well as where we are on uncovering resistance mechanisms. To get started we have a new press release to look at as well as some independent expert commentary to put the data in context.

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