Biotech Strategy Blog

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

Posts tagged ‘ADU-S100 STING agonist’

In the enlightened realm of phase 1 oncology trials there generally more unknown unknowns than there are known unknowns, especially with new target approaches.

Who knew it was so beautiful outside of the cold dark halls?!

You could say that makes for a more interesting world, but it also makes for more caution, especially when the FDA is considering agonists that induce stimulatory effects.  What it means is that you start off very low – in this latest example it was 50µg and going up to 1600µg to determine the safety profile of a combination.

We have covered the STING pathway quite extensively over the last four or five years now, so it’s time for a new update and a look at some of the much awaited combination data. What can we learn?

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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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Early morning starts for #ESMO18

Munchen – If you haven’t checked out yesterday’s live blog post, which is packed with numerous updates and highlights from various sessions and embargoed data releases throughout the day, you can check it out here.

There’s much more in store today as the conference gets deeper into the swing of the program.

We have also been busy with expert interviews – more on those later – as well as digging out gems from the poster halls.

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Aduro Biotech LogoWe’re almost at the end of our coverage of AACR 2016. Post number 30 (!!) is on Aduro Biotech ($ADRO) and their STING (Stimulator of interferon genes) agonist currently in development.

On the final day of AACR, in a packed session chaired by Tom Gajewski, MD PhD (Chicago), the meeting heard from Tom W. Dubensky, Jr, PhD Chief Scientific Officer of Aduro Biotech in a presentation (SY39-02) entitled:

“Direct activation of STING in the tumor microenvironment leads to potent and systemic tumor regression and immunity.”

Dr Tom Dubensky Aduro CSO

Dr Tom Dubensky, Aduro CSO

I spoke with Dr Dubensky (pictured) afterwards. In my interview recording you can hear Vice President Biden’s cavalcade arrive at the Ernest Morial convention center in New Orleans for his plenary presentation.

Since AACR 2016, Aduro announced that the first patient has been dosed with ADU-S100 (MIW815) in a May 12 press release.  This triggered a $35M milestone payment from Novartis, who are undertaking the clinical trial (NCT02675439).

In March 2015, Aduro entered a collaboration with Novartis that, according to the Aduro press release, led to an initial payment of $200M and an additional $50M in equity investment.

After the recent failure of their pancreatic cancer vaccine, announced in a May 16 press release, there is a lot riding on ADU-S100 for both Aduro and Novartis.

I had the privilege to interview Dr Gajewski last year at Immunity 2015, where we talked about his work on STING (see post: Tom Gajewski takes the STING out of cancer). You can hear a short excerpt from the interview on Episode 2 of the Novel Targets Podcast.

So a year later it’s a good time to return to the STING pathway and take a fresh look at what Aduro/Novartis are doing.

For this post, I’ve chosen to write this up as a SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis of ADU-S100 based on what I learnt at AACR from talking with Dr Dubensky and other experts.

Your SWOT analysis of ADU-S100 may be different from mine, you may have access to other sources of information, an alternative opinion, or reach an entirely different conclusion. There is no right or wrong answer. We all view the world through our own individual bias and lens.

Before you read this post, I heartily encourage you to map out on the “back of an envelope” – or as I’d say in England, on the “back of a fag packet” – what your SWOT analysis looks like. That way you can compare yours to mine.

By definition, we’re dealing with a new product in early clinical development, where many questions remain unanswered. It’s always easier to see the picture after all the cards have been dealt……

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