Biotech Strategy Blog

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

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Not in San Diego – What we wanted to explore in this post was some nice examples of either creative thinking outside the box or where researchers have challenged existing dogma and revealed some intriguing or unexpected findings. These are all examples from talks or posters showcased yesterday during the second AACR virtual meeting…

We take a look at several quite different approaches, which may either turn out to be useful new agents in clinical development, new targets, or even some unexpected tweaks in clinical trial design based on emerging evidence on the biology side that may lead to a new understanding in an area where previous attempts failed to yield a positive result…

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

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Not in San Diego – In normal times of past years, the AACR annual meeting generally takes place once a year in April before we haed onto oter events such as ASGCT, ASCO, and EHA. In these abnormal times in the middle of the COVID–19 pandemic, however, the virtual event was split into two, with the first online event in April covering mainly early clinical data, and now we get to learn from the meaty scientific presentations, which are being highlighted this week.

A network of mutations, tumour suppresses, metabolic and immune processes, as well as other hidden factors can unexpectedly impact therapy outcomes in NSCLC

We have a lot of translational researchers reading BSB, so I wanted to kick off the first of the AACR Virtual Meeting series with a scientific focus, which is likely of interest to many for a number of obvious reasons.

The good news is this a topic we have covered before and so there’s already a body of work to build on for reference since this latest round of information not only adds to what we know, but also highlights some additional unknown unknowns yet to be elucidated.

The dichotomy is an essential part of the very essence and fun of science – the more we think we know, the less we really know in practice, especially as the various layers of the onion get gradually peeled off over time.

This latest review mixes up translational research with clinical research…

To learn more from our in-depth oncology analysis and get a heads up on insights and commentary emerging from the second AACR virtual meeting, subscribers can log-in or you can click to gain access to BSB Premium Content.

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Stormy waters – Oncology R&D is a fine line between success and over the edge sometimes!

BSB Reader Mailbag – With the FDA approval of lurbinectedin on Monday and two very different recent announcements regarding adjuvant therapy readouts for CDK4/6 inhibitors, we received a bunch of BSB reader questions on both topics.

It’s been a while since we dived into the mailbag in a busy conference season, so this is a great time to reflect on some broader thoughts in oncology R&D for context.

Here, we look at two key aspects…

  • Am I enthused about the lurbinectedin data or not?
  • What half dozen factors could we be thinking about when considering CDK4/6 inhibitors in adjuvant HR+/HER2- breast cancer in order to decide if one is better than the other or does luck play a part?

To learn more from our oncology analysis and get a heads up on insights and commentary emerging from recent company announcements, subscribers can log-in or you can click to gain access to BSB Premium Content.

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Virtual meetings mean we miss the fun of German pop-up sausage stands and focus solely on the new emerging clinical data!

EHA25 Virtual, Not-In-Frankfurt – There’s a lot of commercial interest in CD20 x CD3 bispecifics, and in this post we’re taking a look at some of the latest clinical data presented at recent ASCO and EHA virtual meetings. Companies mentioned include Regeneron, Roche/Genentech, Genmab/Abbvie, Xencor, and IGM Biosciences.

Any analysis of a rapidly evolving and fast-moving landscape only represents a snapshot in time at the point it was taken, and this post is not intended to be a comprehensive landscape report, you’d pay a lot more than a yearly sub to BSB for that, but we’ve been following the field, and there are some trends emerging.

What makes it interesting is there is some nuance required in the interpretation of data, and with that in mind we spoke to an investigator at the forefront of clinical research who has done trials with several of the CD20 x CD3 bispecifics in development; the insights were quite illuminating.

This post offers an update on the CD20 bispecific landscape, analysis of some of the recent data at EHA and ASCO, as well as expert opinion, what more could you ask for?

To read our latest expert interview, and gain insights from our oncology analysis and commentary around data emerging from the ASCO and EHA virtual meetings, subscribers can log-in or you can click to gain access to BSB Premium Content.

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Looping across different types of analyses can yield intriguing and unexpected results

Not in Chicago It still feels surreal not to have been to windy city and back for the annual meeting at ASCO this year, such was the ongoing effect of the pandemic in the oncology world.

That said, the virtual meeting has produced some gems this year, including some very important findings many may have missed.

In our latest post meeting report we focus on both biomarkers and clinical findings.

We look at how there are various elements may interplay in unexpected ways, whether signatures from one trial are helpful in another, are there likely to be changes in treatment patterns as a result of data presented and where some emerging early signals might be useful.

One other aspect which crossed my mind was how a deep scientific approach used in one particular cancer might have potential applications in other tumour types with few somatic mutations present such as TNBC, prostate cancer or soft tissue sarcomas.

The results might produce quite different results, yet the process itself might be rather useful to consider…

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

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Do any of the early trials in advanced cancers aspire to be great?

Not in Chicago – Of relevance to the ongoing ASCO20 coverage, in the Preview series this year, two of the companies we highlighted going into the meeting (Innovent and Alphamab) both announced deals this week with Roche and Sanofi, respectively – talk about highlighting hot topics ahead of time 😉

After last week’s look at winners and losers in hematologic malignancies, this time around we now turn our attention to explore what’s happening on the new product development front regarding solid tumours.  In this review, we critique some of the trials presented and put them in broader context.

As always, there are both some important learnings we can glean as well as some, well, head/desk moments to contemplate…

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

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Not in Chicago: It’s that time of the year when my inbox rapidly fills up with folks wanting to know which were selections our winners and losers from the annual ASCO meeting.

Happy or surreal days?

There are several different ways we can organise this analysis such as Top 10 selections, by company, by trials, by product, by tumour type, by disease setting etc. The first is undoubtedly easier and shorter to write, but in general it’s really hard to pick five winners and five losers to debate and some years are more mixed in any case.

At BSB we almost rarely think about oncology R&D in terms of companies, stocks, or even individual studies per se, so this leaves organising products by tumour type and subsets.

In part 1 today we are going to focus on hematology and key developments in this area. What was under-rated, over-rated and what bombed?

There are several developments which made our short list and here we cover the highs and lows as well as a pithy ratings scale at the end. Be warned, there are likely a few surprises in store…

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

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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…

To learn more from our oncology analysis and get a heads up on insights and commentary emerging from the ESMO Breast, ASCO and second AACR meeting, subscribers can log-in or you can click to gain access to BSB Premium Content.

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Not in Chicago: We continue our ASCO coverage with a look at the evolving TIGIT landscape and the initial tiragolumab data in lung cancer.

With all the breathless hype of late one wonders if some observers believe (accompanied by loud trumpeting of horns) this is the next big checkpoint target after CTLA-4 and PD(L)1, but is it?  The field has barely got started with a raft of new trials opening to evaluate several molecules in different combinations across solid tumours, and yet we have something of a fanfare already.

Will TIGIT roar and fire up the immune system in some people with cancer or will it fizzle out?

To those of us familiar with new product development and early stage development the ‘hot’ status is likely leaving us somewhat bemused at the noise around the emerging targets, after all it’s going to be a long while before we see those all important phase 3 readouts with appropriate head-to-head comparisons.

In this latest article, we take a look at the Genentech antibody, tiragolumab, and also discuss the development with a company executive to gain their perspectives, insights and rationale on what was behind the recent trial expansions beyond the phase 1 study in advanced solid cancers.

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

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Time for some reflections from ASCO

Many eyes at ASCO this weekend will be eagerly turned towards the plenary session on Sunday and the stunning osimertinib data in the ADAURA (adjuvant osimertinib therapy for EGFR positive disease) where 69% were stage II/IIIA and for those patients, DFS HR was 0.17 with a 2 year DFS rate of 90% (only 44% with placebo).

There is no doubt this is the data of the meeting for me – when was the last time we saw a hazard ratio of 0.17?! More on this development after the data has been presented.

Beyond the plenary there are plenty of interesting studies to discuss and ponder at various stages of development. Over the next couple of days a number of other stories and interviews will be also posted.

Here, we provide an update on one of the early drug development stories we’ve been following longitudinally over the last five years from preclinical through to the clinic and offer some reflections on progress to date.

A KOL interview and commentary are included as well…

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

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