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

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10 things innovators should know about novel cancer targets at AACR19

Pierre de Coubertin Statue, Atlanta

On BSB we write about the science driving innovation in the biotechnology and pharmaceutical industry, and how that translates into new product development.

One of our favorite meetings of the cancer conference calendar is the annual meeting of the American Association for Cancer Research (AACR). The 2019 annual meeting starts in Atlanta later this week and is the cancer research mecca that we and others will be heading to later this week.

Ahead of the meeting we’re continuing our #AACR19 previews with a look at some of the innovative, novel cancer agents we expect to hear more about in Atlanta.

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Sailing into the IO headwind

Imagine being becalmed on boat in the doldrums patiently waiting for the wind to pick up…

Just as experienced sailers learn to make best use of the available knowledge on sea breezes, tides, tidal winds, catspaws, headsails, heels, genoa etc, so immunologists are experimenting with various modalities.

This enables them to develop a more extensive knowledge base before they can use all the available tools more effectively at their disposal in order to chart a course in each tumour type and setting.

That’s a tremendous amount of information and skills that needs to be gathered before we can even consider racing against competition. So it is with cancer immunotherapy, with all its different approaches that are available to combine or sequence in a multitude of tumour types. We are still largely in the unknown unknown stage of figuring things out.

That said, each cancer conference brings new nuggets and gems that on their own do not appear to offer much, but added together in the broader picture can contribute more than many observers realise.

That was certainly the case with our latest update on IO therapies, as you will see…

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Sorting signals from the noise

The annual ASCO-SITC meeting (#ImmunoOnc19) was held in San Francisco this year and has come a long way from the inaugural event we attended in Orlando.

Finding the signals amongst the noise

In the original 2017 event, I vividly recall as stirring presentation from Dr Limo Chen on targeting CD38 in solid tumours, last year we wrote an update on GU cancers including the STING pathway.

What’s in store from San Francisco and how do we go about finding key signals from the noise?

Over the next two posts I’m going to focus on new findings in various approaches that either look interesting and worth watching, or where there are lessons that can be learned for future developments.

This time around, some of the highlights surprised even me…

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Gamma delta T cell cancer immunotherapy in China

Chinese Pagoda in Hoxton

Yesterday on BSB we looked at the emerging landscape in western countries for cancer immunotherapies that target gamma delta T cells. Today we’re turning our attention to China.

There’s a lot of interest in cell therapies in China. Anyone who has seen one of Dr Carl June’s recent presentations will no doubt recall the slide he shows of how many CAR T trials are underway there.

What’s happening with gamma delta T cells in China, and in particular CAR γδ T cell therapies? Do the Chinese have a competitive advantage in this emerging field and what can we learn from some of the results that have been reported?

This is the fourth post in our mini-series on the potential of gamma delta T cells for cancer immunotherapy.

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Window through the world of early STING agonist development

Continuing our STING mini series, the third part looks at a company with a next generation agonist that is heading into the clinic soon.

What sort of challenges have the overcome, what can we expect to learn more about? Are they thinking narrowly or broadly?

One of the most exciting times for me in new product development is not when they move from phase 2 to approval, launch, and subsequent commercialisation, but that window between preclinical studies and first-in-man trials. The IND-enabling phase is an intense period with much to get done that can make or break subsequent advanced solid tumour dose finding trials.

Get your various key predictions wrong and you could be looking at a spate of unwanted severe side effects that will rapidly grind your trial to a halt. Sometimes they are a predicted risk at a much higher dose, for example, other times the PK/PD predictions don’t turn out as expected at all (oops). Then there’s scheduling and timing issues to think about on top of dosing and therapeutic window for combination trials.

Despite a lot of research, it’s still a very imperfect science. As one of my mentors used to say, “Better to be lucky than pedantically dotting all the i’s and t’s!”

So imagine a young up and coming IO biotech in that window between preclinical and clinical development – what are they going to do and where do they see themselves fitting in the broader landscape?

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Can next generation STING agonism make a difference?

Yesterday, we started the first of a multi-part mini series on STING agonism with a quick look at the broad landscape and some of the competitors in this space, which has definitely grown over the last four years since we first wrote about the STING/cGAS pathway.

In the latest part of the STING series, we talk to a small, privately held biotech who are developing a slightly different approach to the first generation agonists currently in early phase clinical trials.

One goal that many are looking at with STING agonism is to try and take less inflamed tumours and turn them into inflamed ones (or cold to hot in layman’s parlance).

We also need strategies for adding those middling tumours that are neither purely inflamed nor non-inflamed i.e. immune excluded and may have other factors influencing their tumour microenvironment, which is something else we also discuss in the interview.

No one would ever describe the trials and tribulations of oncology R&D as a cakewalk, there are certainly plenty of challenges to address on the discovery, preclinical, and even clinical front before we even get to consider the financial need to raise money, pharma collaborations and (hopefully), eventual commercialisation post approval. It can be a wild roller coaster ride at the best of times.

We have an agnostic approach to cancer drug development and cover small and large companies in equal measure.

So what can we learn from the first of the next generation STING agonist companies?

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Insights on the STING agonist landscape

We first wrote about this innate pathway back in early 2015 – before it became famous and controversial – when things seemed much simpler then.

Imagine the basic concept… add an immune agonist – this targets the innate immune system to jumpstart or wake up the immune system in colder tumours – to an established adaptive immune therapy such as checkpoint blockade and see whether any magic happens. In practice, this turned out to be much easier said than done, because in reality mouse and man have quite different immune systems and do not react in the exactly same way, which makes extrapolation from one to the other challenging at the best of times.

Still, back in 2015 there were barely a handful of STING agonists that anyone could really put a name too, now there’s 18 compounds in early pipelines and counting.

Not all the players are small biotechs either, as big Pharma is certainly paying attention to the smaller biotechs (both private and public) generating molecules, especially now that early clinical data (alone and in combination) is beginning to dribble out.

Aside from collaborations and licensing deals, there’s also an increase in patents in this niche, which is often a sign of competitive activity.

Four years on, how has the landscape changed, what does the data look like and what sort of issues need to be addressed?

In the first of our latest three-part mini series, we look at the competitive landscape and how it has changed (quite drastically since 2015, I can assure you!). In parts two and three, we look at two different up and coming players in the STING space with very different approaches.

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ASCO GU19 Renal Cancer Review

In the third part of our ASCO GU coverage from San Francisco, which includes previews and post-match commentary, it’s time to turn our attention to renal cancer. This isn’t one disease, but a broad tumour type with multiple subtypes, some based on histology, with perhaps others to emerge down the road as we learn more about the disease and immune profiling.

There’s quite a bit to discuss this year, some of it quite complex and nuanced.

In the old days, much of the focus was on sequencing single agent TKIs in clear cell carcinoma, now it’s getting much more complex as scientists and researchers figure out combinations and regimen approaches, never mind what to do with the various histologies.

We walk readers through the latest information as we await the data presentations coming out tomorrow…

 

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A look at what’s new in GU malignancies

Genito-urinary (GU) cancers are a diverse population of tumour types that run the gamut from prostate, bladder, penile, and renal cell carcinomas in the main, along with a variety of rare cancers thrown into the mix.

While much attention has tended to be focused on advanced and metastatic disease, for obvious reasons, there are plenty of new developments emerging in earlier stage disease.

This year things are looking up on several fronts, which is a great time to take a look at what to watch out for in GU malignancies…

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New developments in Prostate Cancer

At one point not too distant in the past, all the big news seemed to flow out of advanced prostate cancer with abiraterone and enzalutamide vying for attention, followed by occasional news on ARN–509, ODM–201, galeterone (remember that one from Tokai with all the AR-V7 kerfuffle?), radium Ra–223 dichloride, cabazitaxel, denosumab, ipilumumab, PROSTVAC, brachyury, and a few others. Predictably, not all were successful, and the count is still out on some.

San Francisco

In our latest conference coverage, we take a look at what we can learn from riding the prostate cancer train at ASCO GU ahead of the presentations in San Francisco tomorrow.

We will be updating this review as more data become available with the presentations, so do grab a cup of joe and settle down for some interesting reading ahead of time… this should get you all up to speed on the journey there!

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