Biotech Strategy Blog

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

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Wiesbaden, Germany – Last night Bavarian Nordic dropped the unfortunate news that the phase 3 PROSPECT trial exploring the PROSTVAC vaccine in combination with GM-CSF in asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (CRPC) was futile.

Source: Bavarian Nordic

Once you miss the overall survival (OS) endpoint, that’s it folks – there’s no other choice but to say the therapy failed, harsh though that may sound.

There are, however, a number of important points to consider from here that are worthy of further discussion.

Here, we post an analytical review and look at a number of factors that could have impacted the outcome.  It’s rarely one simple thing because the immune system is highly complex and multi-faceted.

Hopefully there will be important learnings from this study that will advance the IO and prostate cancer fields.

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As we demonstrated in the recent Novel Targets podcast that opened Season 3, one topic that is a key focus for many in the IO space is addressing mechanisms of immune escape and acquired resistance to single agent treatment with immunotherapy.

We’ve seen several oncogenic escape mechanisms reported, included activation of the JAK/STAT pathways in some patients and loss of existing immunity when the tumour suddenly becomes cold or an immune dessert.

The good news is that there are a number of ideas that can be pursued, including activating the innate immune system in various combinations.

As we see more companies invest in the innate immunity space in order to have a rational partner with which to combine with their checkpoint inhibitor, it will be important to maintain focus on trial designs and synergistic mechanism of actions to improve efficacy while reducing the potential for overlapping or severe toxicities.

Here’s one intriguing and promising new approach that caught our eye this month that is worthy of researching and following over time…

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Greetings from continental Europe!

ESMO Madrid Conference Center

We have a LOT of data to discuss today from ESMO and have also included an interview with one expert that was conducted under embargo on an important topic.

Of course, the usual in-depth analyses on new targets and early compounds in development will duly follow in the post-meeting output, but there’s plenty of practice changing data to consider and also some results that may trigger alternative thinking from where we are now.

We also received questions from BSB readers on certain trials and some of these are answered in today’s update on the road…

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Sunday is usually a good day at ESMO congresses and 2017 was no different in that respect.

It does feel weird, however, to be seeing tweets about data from some studies hours before they are presented in that day’s Presidential Symposium, something oncologists attending have started to notice too:

Yesterday we had encouraging readouts from PACIFIC and FLAURA trials to discuss, so what’s in store for today? Are they mostly highights or lowlights?

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It really doesn’t feel like a year since we were at ESMO in Copenhagen, in what was probably the most exciting meeting of the year in many ways.

Packed audience!

With the ASCO abstract deadline being in Jan/Feb, ESMO offers a great opportunity for companies to have another major slot in the calendar to present ground breaking data. In some ways, having positive data at a European meeting can actually amplify positive studies that might otherwise get lost in the noise at ASCO, which is almost becoming too big.

So what’s in store now that the meeting is upon us?

There are some large and small trials with important data on the first two days that bear thinking about and further discussion.

Here’s our take on the first batch of readouts, including some surprises…

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This kind of positive news is always nice to wake up and read:

“Rucaparib maintenance therapy increases progression-free survival in BRCA mutant recurrent ovarian cancer by 77%, according to late-breaking results from the ARIEL3 trial reported today at the ESMO 2017 Congress in Madrid.”

Of course, it’s not the first PARP inhibitor to show a significant effect as maintenance therapy in ovarian cancer after initial platinum therapy and we shouldn’t assume that all drugs in the same class will have an equivalent effect until we see the data.

It is good to see confirmation of a positive impact after seeing the data from two plus lines of therapy at ESMO in Copenhagen last fall.

So what does the new readout look like, what can we learn from it, and what were thought leader reactions to the data?

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Madrid city center

Greetings from Vienna, Austria!  Fresh off a red eye… we’re en route to one European cancer conference in Germany, while writing about another one in Madrid.

This latest preview looks at some of the key IO studies that are either intriguing or have potentially interesting results that BSB readers have written in asking us about.

There are some targeted therapies thrown in too for good measure too, as there are some IO-targeted combos to look at, as well as IO-IO approaches.

What I want to accomplish in this latest preview is point out some elements of what we call ‘interestingness’ where people should be watch or wary of either jumping to conclusions or making comparisons across trials and arriving at assumptions that may not turn out to be valid. My best advice here is to always be sceptical and assume there’s no concordance and that way you won’t be caught unawares.  It’s easier said than done, though.

Indeed there were so many questions about ESMO that we needed two preview posts to cover many of the questions we received.

Part 2 should roll out tomorrow, wifi on the road permitting – stay tuned for more on ESMO17.

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Dr Bernie Fox (@BernardAFox) is a man on a mission to #FinishCancer, a Twitter hashtag he uses to reflect his vision.

A cancer immunotherapy rockstar, Bernard A Fox, PhD, is the Harder Family Endowed Chair for Cancer Research at Providence Center Center and Chief of the Laboratory of Molecular and Tumor Immunology at the Earle A. Chiles Research Institute in Portland, Oregon.

Fox is also a past president of the Society for Immunotherapy of Cancer (SITC) and CEO of UbiVac, a biotechnology company focused on therapeutic cancer vaccines.

Readers of the Blog and Novel Targets Podcast listeners will recall we had the privilege to interview Dr Fox back at the American Association for Cancer Research (AACR) annual meeting in New Orleans in 2016: “AACR Cancer Immunotherapy Insights from Dr Bernard Fox.”

Fast forward 18 months… it is now time for a detailed update on this issue, as a few interesting events have since come to light in this niche with Genentech/Roche abandoning development of their OX40 agonist, coupled with several new publications from different labs suggesting that concurrent administration of an anti-OX40 antibody with an anti-PD1 antibody attenuated the effect of anti-OX40 and resulted in poor treatment outcomes in mouse models.

Dr Fox kindly spoke to Biotech Strategy Blog about some of the key learnings from this research, where he sees the future potential for OX40, and what his vision for cancer immunotherapy is.

Here’s a short clip from the fireside chat…

 

He’s definitely a man on a mission to #FinishCancer!

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In our ESMO 2017 Preview series so far we covered our Top 5 immuno-oncology and targeted therapy abstracts to watch out for (the latter has been updated since it first posted so do check it out).

Now it’s time to turn to something completely different.

Castle Manzanares el Real, Madrid

Here we look at hepatocellular carcinoma (HCC), including Blueprint Medicines FGFR4 molecule, BLU–554.

We first covered Blueprint back in February this year with a particular focus on GIST.  Quite a bit has changed since then, so it’s a good time for an update, especially in HCC now that they have data in Madrid.

In the context of the HCC landscape, what’s changing in this niche, what should our expectations be, and how is this market evolving since our last update?

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