Biotech Strategy Blog

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

Posts from the ‘Biomarkers’ category

One of the things that I’ve heard repeatedly over the last year is that many researchers want a better biomarker of response for checkpoint therapies than PD-L1 expression by IHC.

National Harbor

Indeed, we could expand that statement more broadly to say that there’s a real need for a better predictive biomarker of response to any immunotherapy, since there are more approaches out there now and not just checkpoint blockade. Plus combinations are evolving, complicating things further.

Fair enough, but what’s happening in this space?  Anything, Bueller?

We’ve covered a few emerging ideas in the past, although they were based on retrospective analysis – usually with a small N – and remain to be validated in prospective clinical trials.

There’s quite a few groups now much more active in research in this space, from academia to industry.  This is a good time to take stock and look at some of the emerging technologies that might be making a splash later if the data pans out.

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One of the intriguing themes that emerged recently at ASCO from several cancer immunotherapy trials centred around whether any elicited immune responses actually correlated with outcomes and if so, why and how?

Gems from the ASCO17 poster hall

It sounds easy in practice, yet in reality the topic has been quite a controversial one that has been hotly debated for a while.

With a wealth of new cancer immunotherapy trials now undwerway and initial results trickling out, how do we start to make sense of the information and what do we learn that might be useful going forward for future trials and the field as a whole?

With the help of a renowned cancer immunologist, we explored this concept in more detail to determine what can be gleaned from the data available.

Today, we look at part one of our latest mini-series, with the second part to follow later this week.

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At AACR17 one of the fascinating topics that came up in several presentations was exosomes, what they are, and how the information they contain can be used to best effect.

One of the evangelists of exosomes, and their potential in cancer research is Theresa Whiteside, PhD who is a Professor of Pathology, Immunology and Otolaryngology at the University of Pittsburgh.

At the recent 2017 American Association for Cancer Research (AACR) annual meeting, Dr Whiteside gave two fascinating talks in education symposia.  Afterwards, she kindly spoke to BSB about her research.

Love them or hate them, exosomes were a hot topic in Washington DC and something you should be aware of, if you aren’t already.

This post continues our volley of expert interviews from AACR17 and is the ninth in the series.

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Today we continue the second of a two part interview with a global thought leader who is also a scientist-clinician and well versed in cancer research as well as clinical trials.

Old Town Hall, Munchen

We explore how we can do clinical trials better in order to learn via a more rigorous process what works, what doesn’t, and why. After all, we we don’t know why certain approaches didn’t work or what the mechanisms of resistance are, how can we possibly improve?

Randomness is not necessarily a good thing in clinical research, especially if you don’t know what target you’re actually trying to hit!

If you missed the first part of this latest KOL interview and want to catch up then you can find it here (Link).

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Two of the most intriguing developments in cancer research over the last 5 years have been checkpoint blockade and CAR T cell therapies. There’s no doubt that they work – in some patients – or that toxicities can be challenging to manage at times, but what has been very interesting to me has been physician reactions to the rise of immunotherapies.

There has been much noise about biomarkers, including whether they work or not in this niche, as well as how do we go about selecting patients for therapies and combinations?

Ultimately, immunotherapies will be no different from targeted therapies in that we need to better understand the underlying biology in order to move forward beyond the low hanging fruit and figure out how we can best select appropriate therapy for each individual based on their particular characteristics.

The worry that many researchers have is that we could end up making the same mistakes with immunotherapies as targeted therapies, i.e. treat them in a broad fashion akin to throwing mud at the wall. Indeed, some companies are already doing this, much to the consternation of the research community.

So how do we go about doing things better and thinking more strategically about what needs to be done?

Up next is the first in a two-part interview series with a global thought leader who is a scientist-clinician with expertise in both immunology and oncogenic pathways. What does he have to say about where we are now and importantly, what does the future hold?

This is the penultimate article in our coverage from the Triple meeting in Munich, held in November 2016.

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We’re continuing our series of posts from the 2016 San Antonio Breast Cancer Symposium (SABCS) with an expert interview on how circulating tumor DNA could change breast cancer treatment.

There has been a noticeable increase in attention and focus on the application of liquid tests – especially from blood – over the last five years, culminating in a spinoff company called Grail from the deep sequencing giant, Illumina, announcing a massive funding round earlier this month.

At the time of the BSB expert interview in San Antonio, we had no idea that the Grail news was going to hit just a couple of weeks later!

While much of the media attention surrounding Grail has focused on the early detection of cancer in apparently healthy individuals, there’s actually a much more useful application where it could be more immediately applied to great effect.

Circulating tumor DNA (ctDNA) or cell free DNA (cfDNA) has the potential to revolutionise and improve monitoring over time for people with cancer who are receiving therapy.

This is the third in our series of expert interviews from the 2016 San Antonio Breast Cancer Symposium (#SABCS16).

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BioTwitter is all a-flutter today with the announcement from BMS that the CheckMate–026 trial in first line non-small cell lung cancer (NSCLC) comparing nivolumab (Opdivo) to chemotherapy did NOT meet its primary endpoint of progression-free survival (PFS).

The news was not entirely a surprise to us at BSB, here’s why…

Figurative statute representing Science on Holborn Viaduct in City of London.

Figurative statute representing Science on Holborn Viaduct in City of London.

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Biomarkers are a hotly debated topic at the moment within the cancer immunotherapy field.

At the recent Society for Immunotherapy of Cancer annual meeting (SITC 2015), there was even a debate with industry representatives arguing the “pros” and “cons.” Daniel Chen, MD PhD from Genentech (pictured right) argued “pro” and Steven Averbuch MD (pictured left) from BMS argued “con.”

SITC 2015 Biomarker Debate

The challenging question for anyone at the moment is if your Parent, Spouse or Best Friend were PD-L1 negative, would you still want them to receive a PD-1/PD-L1 checkpoint inhibitor (presuming it was indicated for the disease) and have a chance of a response, even if their PD-L1 negativity would suggest only a slim chance of responding?

AT SITC 2015 we spoke with an industry expert who offered insights into a leading company’s biomarker strategy and what the future may look like in 5-7 years time.

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Several groups have banded together to produce the first CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (Twitter #cicon15) which focuses on the science underlying the immune system as it relates to cancer.  You can view the program agenda here.

These groups include the American Association for Cancer Research (AACR), Cancer Research Institute (CRI), Association for Cancer Immunotherapy (CIMT), the European Academy of Tumor Immunology (EATI).

We’ll hopefully be covering key abstracts at this event over the next few days and reporting on not only what the data is, but also the broader significance of the findings.

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It’s time for the August mailbag where we answer questions about cancer research and R&D from subscribers.

After the recent queries about immuno-oncology, it’s time to focus a little on targeted therapies again. Neither chemotherapies nor targeted therapies are going to go away – they are still the bedrock of many treatment approaches in the clinic today. Sadly though, much of the new data for the latter trials were easily swamped by the sheer tsunami of immunotherapy data in Philadelphia (AACR) and Chicago (ASCO).

One important area that we have been discussing on both blogs for some time is the value of well designed basket trials.  It’s time to revisit this concept in the light of new data relating to the BRAF V600 mutation outside of metastatic melanoma.

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