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

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After yesterday’s popular update on Ignyta where we posted our recent interview with the CEO, Dr Jonathan Lim prior to the 2Q conference call, a flood of questions have come in from eager beaver BSB readers.

Rather than add to an already lengthy article, this seemed a good opportunity to start afresh and do our latest Reader Q&A mailbag on a specific topic, namely the TRK/ROS1/ALK space.

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Tropomyosin receptor kinase (TRK) inhibitors are not a name that rolls off the tongue easily and yet this niche is attracting a lot of interest from observers curious to learn more about a highly targeted approach to rare oncogenes such as TRK, ROS1 and ALK that occur in several different tumour types.

Much of the focus has been on the more commonly expressed ALK-positive lung cancers with crizotinib, ceritinib, alectinib, brigatinib, lorlatinib and others. Crizotinib also targets ROS1 and is approved by the FDA in metastatic NSCLC whose tumors are ROS1-positive.

As the next part of the development in this sphere, TRK and ROS1 mutations are now in the spotlight. Indeed, we have been reporting on the data since 2014, which has been encouraging thus far, particularly from two companies, namely Ignyta and Loxo Oncology.  These two agents differ in that entrectinib targets TRK/ROS1/ALK whereas larotrectinib is a specific pan TRK inhibitor.

There was a new raft of data at the recent AACR annual meeting and more data is expected at the forthcoming ASCO conference.

Here, we take a look under the hood through the lens of one of the small biotechs in this space via a candid interview with Ignyta CEO, Dr Jonathan Lim.

Dr Jonathan Lim, CEO Ignyta

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Over the years we’ve interviewed folks from numerous pharma and biotech companies here on BSB, including those with targeted therapies (small and large), as well as immunotherapies.

Some companies have small pipelines and may be forced by circumstances to explore what they have or seek collaborations with bigger partners.

For big pharmas with large pockets plus broad and deeper pipelines, the challenge is quite different – how do you prioritise potential combinations and tumour targets given it is impossible to evaluate them all in the clinic? How do you create differential advantage and value when you’re relatively later to market compared to your competitors?

In the BSB spotlight this week we have two researchers in clinical development and R&D from the same company, who happen to have both elements in their pipeline in areas of high competition.

Part one of our latest mini-series explores the IO side of the business as we look ‘Through the Keyhole’ at what’s going on in terms of biomarkers, monotherapy trials, combination studies (both IO-IO and IO-targeted) and what to expect in the near-term future later this year. It’s a wide ranging, candid, and fascinating discussion that highlights a lot of potential in terms of what could happen with a large pipeline.

In all, it makes for rather interesting reading and certainly changed how I perceived the company’s efforts in the IO sphere (for the better, I might add).  So what’s fascinating about their approach and what can we learn from their progress to date?

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At the AACR 2017 annual meeting, there was a surprising amount of early clinical data on offer, particularly in the field of cancer immunotherapy.

A shortage of reliable preclinical models that predict human response to cancer immunotherapy has led to a mad rush to the clinic to do trials in man – thee are now over 800 combination trials – if anyone wants to try and follow them all!

If you missed it do listen to the Of Mice and Men” episode of the Novel Targets Podcast recorded at AACR 2016 that features experts such as Dr Bernard Fox (@BernardAFox) and Professor Cornelius “Kees” Melief (Leiden) who discuss the challenges of mouse models.

Several thought leaders at this year’s AACR annual meting described it as “mini ASCO” given the focus on clinical data, with several plenary sessions devoted to the results of early trials.

Dr Julie Brahmer at AACR17 in Washington DC

At AACR17, Dr Julie Brahmer, a leading lung cancer expert and an Associate Professor of Oncology at the Johns Hopkins Bloomberg Kimmel Institute presented long-term survival data for nivolumab in second-line non-small cell lung cancer (NSCLC).

The 5-year survival rate of 16% with a single agent checkpoint inhibitor, while better than historical data with chemotherapy (~4%), is far from being a home-run, illustrating what a dismal disease this is to treat.

One of the challenges that we are starting to see with checkpoint inhibitor cancer immunotherapy is immune escape or acquired resistance in some patients. They may have an objective or partial response, and then relapse and progress (acquired resistance), or they may not respond at all (primary resistance).

From our experience with targeted therapies, it should perhaps come as no surprise that cancers may evolve, adapt and seek to evade immune detection. There are also many inhibitory factors in the tumour microenvironment to overcome in order to enable an immune response.

At AACR17, Dr Brahmer kindly spoke to BSB about what researchers at Johns Hopkins have learnt about checkpoint inhibitor resistance in lung cancer so far. Her insights are both insightful and very useful when we consider what to watch out for at the forthcoming ASCO meeting.

This post is part of our on-going series of expert interviews from AACR17.

In the additional commentary, now that the ASCO17 abstract titles are publicly available, we’ve also highlighted a few that caught our attention.  This is the first in our series of previews of ASCO17. We’ll be rolling out more hybrid posts as we segue our coverage from AACR17 to ASCO17.

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The majority of patients do not respond to cancer immunotherapy. That’s a fact. If you don’t have an immune response to start with, there’s no point giving a checkpoint inhibitor on its own because there are no T cells present in the tumor.

Dr Bernie Fox (@BernardAFox), a world leading cancer immunotherapy expert from Earle Chiles Research Institute in Portland, nailed this a year ago on the Novel Targets Podcast:

“What I teach the first year medical students is that if you have metastatic cancer, the only thing that makes a difference in your life is whether you’ve got your immune system turned on. If it’s not turned on, it doesn’t make a difference what you get, chemo, radiation, surgery, you aren’t going to do well.”

Lincoln Memorial, Washington DC

As we have seen with targeted therapies, drugs can also stop working as a result of acquired resistance. This is also true with cancer immunotherapy treatment.  Cancer constantly evolves and finds ways to bypass or evade detection or ways to kill it.

Faced with a complex jigsaw where we only have some of the pieces in place and an evil double sided version as a model for sneaky advanced cancers, where are we in overcoming cancer immunotherapy resistance?

At the recent AACR annual meeting we spoke with a rising star – an up and coming thought leader in the field of cancer immunotherapy who has taken all the disparate information out there and come up with a perspective on where the field is at and where it needs to go.

Jason Luke MD FACP (@jasonlukemd) is an Assistant Professor at the University of Chicago where, as a medical oncologist, he leads multiple early stage cancer immunotherapy drug development trials and treats patients with melanoma.

Dr Jason Luke AACR17

Working with colleagues such as Dr Tom Gajewski, he has a unique perspective on cancer immunotherapy resistance, and how to overcome this. Dr Luke kindly spoke to BSB in Washington DC.

This is the 3rd post in our series of expert interviews from AACR17.

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AACR17 audience

AACR17 audience in Washington DC

Over the last few years we’ve written a tremendous about primary and acquired resistance, both in oncogenic and immunotherapies, as well as on combination strategies for turning non-responders into responders and overcoming acquired resistance that induces clinical relapse.

These concepts were still on display in Washington DC at the 2017 annual meeting for American Association for Cancer Research (AACR), but beyond those obvious top line points, what are the next round of ideas and tools that cancer researchers are focusing on?

Based on numerous presentations, ad hoc discussions, as well as over a dozen one to one interviews we completed with oncology thought leaders, some useful and encouraging trends emerged.

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We’ve been saying for a while that 2017 and onwards would be when we start to see a few IO combination trials start to shake out. Interestingly, that process seems to have already started, if recent news is any thing to go by.

With this in mind, the annual meeting of the American Association for Cancer Research (AACR) coming up this weekend gives us a timely moment to explore combinations that are looking interesting… or not.

In the last of our AACR 2017 Conference Previews, we take a look at what to expect on this year’s program in the IO and Checkpoint arena. In short, it’s quite a lot and not without some controversy either!

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It’s finally time…

US Capitol Building, DC

By popular request from BSB readers, we have a CAR T cell therapy preview of the main abstracts to watch out for, including talks and posters, and what emerging themes to expect are likely to be.

If you are registered on the AACR site and signed in, then clicking on any of the abstracts highlighted in this review will enable you to add any interesting ones you fancy to your conference itinerary.

There’s a surprising amount to cover this year, especially when we consider the incredible work that’s ongoing to address a number of suboptimal aspects in the construct developments.  It’s continuing to progress at warp speed, so hold onto your hats and buckle down for our latest rock around the AACR clock.

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Molecular biology was a hot new topic back in its infancy in the late 1980’s just as I was finishing my doctorate – cue moment of realising you’ve missed a big wave before it really even started!

Springtime in DC

These days scientists now delve in the realm of deeper molecular biology and go much further than mere genes… it’s all about transcription factors, super enhancers, chromatin complexes, bromodomains, and even chromodomains. In the past, many of these drivers were often considered ‘undruggable’ – think MYC or RAS, for example.

The world of molecular biology is rapidly changing as researchers understand pathways and processes associated with carcinogenesis better, thereby enabling new approaches to evolve and with it, valid new targets for therapeutic intervention.

This field is always one of my favourite ones to cover at AACR, where we not only learn about exciting new research from investigators, but also up and coming young biotech companies that are doing good work who deserve to be highlighted.

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The White House in spring, Washington DC

With spring in the air and the clock rapidly running down on the annual meeting of the American Association for Cancer Research (AACR) in Washington DC in just two weeks time, it’s time to take a look at the seventh topic in our Preview series.

What’s hot on deck to day?

With increasing competition in the metastatic breast cancer space, particularly in HR+ HER2- disease, it’s time to explore key issues around CDK4/6 inhibitors as there’s a lot going on here, including some important presentations ahead.

A road map of what to expect and what to watch out for is often valuable if you want to avoid surprises.

We also examine key issues the companies here are facing as well as highlighting emerging scientific and clinical data of note on several relevant fronts.

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