Biotech Strategy Blog

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

In our latest expert interview, we depart from the usual focus on one of two particular or narrow topics and indulge in a more wide ranging discussion to explore a variety of issues facing the IO field and look at them from the perspective of a researcher who is experienced in working with antibodies in various forms.

We cover a lot of ground from CAR-T cells to bispecifics to NK cells – while many people in industry may see these approaches as separate modalities in different niches, in the future we may well see a greater convergent and opportunities for regimens and combinations rather than a more nihilistic either/or approach.

I have long been fascinated with design of molecules and how different tweaks or enhancements can change the way something works – for better or worse. Just as we have learned much from immune agonists and their biphasic curves that result from constant stimulation (and ways to fix that too), so too will we see CARs, T cell engagers, and NK cell therapies adapt and improve in terms of how they are constructed.

Who better to talk about these changes and the learnings to be had lately than someone who has built and tested many antibodies for a living and is now running his own company?

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With the continued noise in cancer immunotherapies all too often focused on the now well established checkpoint blockade and CAR-T cell therapies, with bispecifics often seen as the next up and coming area, it is all too easy to forget or perhaps not be aware of plenty of other promising approaches in biotech pipelines.

Who would have guessed a decade ago that any of those three approaches would have ended up as becoming mainstream in the oncology space?

Time for a different perspective on the immunotherapy front?

At ASCO in 2010 I distinctly recall writing enthusiastically about early phase 1 data on ipilimumab, plus BMS–936558 (nivolumab), MK–3475 (pembrolizumab), and MPDL3208A (atezolizumab), while many others were more into eulogising vaccines such Dendreon’s sipuleucel-T (Provenge) and Celldex’s CDX–110, and mainstream outlets explored late stage clinical updates on BRAF inhibition (PLX4032, vemurafenib), targeting ALK (crizotinib), or even Sunesis’s voreloxin (remember that?) – fun times! Many people thought it was crazy to get excited about initial phase 1 data on the immunotherapy antibodies back then and few would have imagined them subsequently garnering a billion dollars a month in revenues back then either.

It’s now time for the horses to change as we continue our look at emerging biotechs with quite different scientific approaches to immunotherapy, which we think are well worth looking at. These are young companies going places with early clinical pipelines and a fresh approach to R&D.

After all, the checkpoint inhibitors mentioned earlier started at the beginning too – look how they turned out, not too shabbily either.

In this latest example, we take a look at a promising biotech’s immunotherapy pipeline through the lens of a CSO’s perspective and chat about the basic immunological underpinings that are driving their scientific innovation… it is well thought out, in my view.

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Are GI cancers still marooned on an island or are they catching up with other solid tumours in terms of progress?

San Francisco – In the past, whenever I posted updates on any of the GI cancers they attracted noticeably less attention than other solid tumours and rightly so, especially given the lack of new agents and compelling data. If the highlight of a meeting is debating the merits of left versus right side tumour responses or bolus versus infusional administration then the plot has kind of been lost in the morass of abstracts available.

This year, however, things are looking up with a tidy group of studies that have what I call ‘interestingness’ – in other words, results that will tempt us to look deeper rather than merely skim in the hope of something new and shiny.

This weekend in San Francisco saw some highlights (and also lowlights) in the form of new clinical data emerging from the 2020 ASCO GI conference. That means we’re due a review so let’s rock ’n roll though the important studies to see what stands out from the crowd…

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Stacking up the various modalities – what do we find?

It’s time to talk about an particular target in AML because there are now a variety of different modalities involved since we last covered it, which makes it rather more intriguing than most. There’s antibodies, ADCs, CAR-T cell therapies, stem cells, and various bispecifics to name a few such examples.

To be clear, we’re not talking about CD123 here either, but rather an entirely different protein that is receiving increasing attention from multiple companies.

How does the evidence stack up?  Will one particular approach stand out from all the others?

Next, perhaps what makes this post even more interesting is we have an engaging interview with one of the company CEO’s in this niche to share, so we can see how they view things from the lens of looking at things in a different way from many of the other competitors.

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The calm before the storm as the KRAS competition heats up and also gets more complex in the process

I was very tempted to tease everyone and say something along the lines of… ‘while you were all partying, there was some new KRAS clinical data being presented somewhere in the world’ but that would be rather naughty, I suspect.

Instead, I’ll simply point out that it’s time to take a look at the latest phase 1 data in the KRAS niche.

What more clinical data already?!

Yes there is and what’s more it doesn’t belong to the either of the leading two in the early race to market, aka Amgen and Mirati.  There’s a whole bigger world out there for those interested in following the broader slate runners and riders.  It pays to pay attention because this is not a race about single agent therapies, rather it’s about who figures out the optimal combinations and is able to finesse that better than their competitors.  Like real horse races, an unexpected runner can surprise a few folks by making a strong push on the rails or a bounding leap round the outside like Lester Piggott was famous for doing.

This highly specialised field is moving much faster than the BRAFV600E arena was a decade ago and there’s also more players involved too, plus multiple different approaches and targets to consider, which I expect we will be covering quite a few times during 2020.

Are you ready?

Get set, GO!

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A wet gloomy day in San Francisco was brightened up by some small biotech talks

San Francisco – The other day I mentioned that we could expect some cross pollination across several recent conferences and this latest post on Kura Oncology is one such example of that genre.

We’ve been following their story longitudinally for a while now and with a lot suddenly going on, 2020 could well turn out to be an crucial year for the company.

There is no doubt they have been pursuing a very focused precision medicine approach with tipifarnib and executing nicely on that strategy so far, but as more indications and additional pipeline agents move into the clinic do the same principles still apply?

To find out, we interviewed a couple of their senior executives and discussed both current progress as well as where they are headed…

To learn more from our oncology coverage and get a heads up on our latest commentary from the JPM and ASH annual meetings, subscribers can log-in or you can click to gain access to BSB Premium Content.

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Downtown San Francisco

San Francisco — Amongst all the chaos and frenetic activity that abounds big Pharma at JPM each year, I always look forward to hearing what the smaller biotechs are up to on days 3 and 4, as well as seeing how far some of them have progressed since our previous update on their pipeline agents.

In this latest update, there are definitely some companies we have been following longitudinally who are either poised for future success and growth… or due for a correction if the promising science doesn’t pan out as expected in the clinic.

Indeed one of those companies has already hit success and disappointment in the last two months alone, such is the roller coaster that is oncology R&D.

Please note that this is a rolling blog, which means that numerous updates are added throughout the day as new information becomes available.

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San Francisco – the 2020 JP Morgan Healthcare conference is now in full swing, and we’re continuing our coverage with another rolling blog that provides review and analysis of company presentations, deals, and plans for the coming year.

Some of the companies featured in yesterday’s commentary were: BMS, Incyte, Novartis, Deciphera, Allogene, Nektar, Seattle Genetics, Mirati, and Clovis.

While our focus on BSB is mainly writing about the science driving innovation and new product development, especially in oncology and immunology, it’s good to hear what companies are looking to accomplish in the coming year and then put that in context.

Cancer drug development, whether it be with targeted therapies or immuno-oncology remains a fast moving and continually evolving field, and one you have to keep your finger on the pulse of if you don’t want to be left behind.

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January is inevitably a month where several worlds collide for us.

There might be initial data from SITC and solid data from ASH that bears the advantage of showcasing in the context of corporate presentations at JPM or company announcements of competitor trial progress.

That’s very much the case today.

Earlier this month, Incyte announced the phase 3 trial miss for their JAK1 inhibitor in acute graft versus host disease (GVHD), perhaps coming as a surprise to a few observers familiar with the positive ruxolitinib result, but not so much to clinicians.

In the latter case, one transplanter in the itacitinib study told me at ASCO that he hadn’t noticed any difference between the steroid only and steroid plus itacitinib arms in his SCT patients. Although admittedly that was a small sample of the whole, it did make me wonder if the trend was repeated then it wouldn’t augur well for the overall readout expected year end. Come January, his observation turned out to be rather prescient.

Incyte are presenting on the JPM20 slate in San Francisco today and we’ll be keen to learn if they have anything to add beyond the terse Jan 2nd announcement on the itacitinib miss.

More importantly though, there are still plenty of other agents in development are being investigated for the treatment of acute GVHD, one of which from Alpine Immune Sciences in Seattle we are particularly enthused about following discussions at the recent ASH meeting last month.

In our latest expert interview, we learn more about that development and explore the context for the evolution of a novel molecule likely not on many people’s radar. If the results turn out to be encouraging that situation could well change in the future.

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San Francisco – This week is mostly about business news as pharma and biotech companies congregate around the JP Morgan Healthcare conference.

It’s JPM time!

As of today (January 13th) I think a lot of investor and journalistic observers have probably been rather disappointed with no news of any major M&A activity, as this seen as setting the tone for the year ahead. I don’t personally see things that way because there’s always plenty of interesting small deals, new early funding, new science and even newco’s forming.

Indeed, Allogene already announced a new clinical collaboration with SpringWorks Therapeutics to evaluate their investigational anti-BCMA allogeneic CAR-T cell wherapy with their gamma secretase inhibitor in multiple myeloma.  They clearly see this as one way to address the shedding problems that have led to relapse with BCMA therapies.

As in previous years, we have a rolling live blog each day at JPM to highlight some of the scientific and company findings that emerge during the meeting…

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