Today’s news that an FDA Oncologic Drugs Advisory Committee (ODAC) review will not be required for rucaparib is good news for Clovis Oncology. The company announced this via an SEC 8K filing:
“The Food and Drug Administration (“FDA”) has notified Clovis Oncology, Inc. that FDA is not currently planning to hold an advisory committee meeting to discuss the Company’s New Drug Application for rucaparib.”
However, given the unmet medical need in ovarian cancer, a lot of companies are targeting both platinum sensitive and platinum resistant disease.
In our fourth preview of the forthcoming European Society for Medical Oncology (#ESMO16) meeting we’re looking at 9 key ovarian cancer abstracts to watch out for at ESMO.
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This is the third in our mini-series previewing the forthcoming European Society for Medical Oncology 2016 Congress in Copenhagen (Twitter #ESMO16).
In this post we’re taking a look at what’s hot in head and neck cancer.
It’s not a cancer type we typically hear a lot about, but there’s an unmet medical need for effective new treatments.
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The 2016 Congress of the European Society for Medical Oncology (ESMO) is fast approaching. It takes place next month from October 7th to 11th and we will be on site covering the meeting for Biotech Strategy Blog. We’re looking forward to a great meeting!
If you are sitting on the fence as to whether you should go to Copenhagen, then hopefully our series of Previews will help you decide.
Be warned that accommodation is in already in short supply and ESMO are now putting people up across the Oresund bridge in Malmo, Sweden.
The Congress App has a lot of useful information and is well worth downloading, if you haven’t done so already.
Last week many of the late breaking abstract (LBA) titles were announced, although there are still some placeholders. While we won’t know the actual late-breaking data until the meeting, the LBA titles offer insights into what will be presented in Copenhagen.
In the second in our ESMO 2016 Preview series, we’re highlighting the lung cancer late breakers that we’re looking forward to hearing, providing some background on why they may be of interest, and a look at how some of subset landscapes may be a-changing in the future.
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September 1st… as the hot summer floats away from London town and cooler autumn days draw in, it’s time to think about the upcoming fall cancer conference season – it’s quite a busy one this year!
In the coming weeks, I will be rolling out our series on the ESMO 2016 Previews (Twitter #ESMO16) and taking a more in-depth look at various topics of interest. The Copenhagen meeting is later than usual and also more compressed, with numerous sessions now held simultaneously. It used to be that you could take a break between key sessions, but not any more – there’s a lot going on this year.
One of the things that jumped out to me from a preliminary review of this year’s hectic ESMO program is an interesting novel target that had some early preclinical data at AACR, but that sadly got lost in the tsunami of data there.
It is good to have that reminder and be able to return to it in the context of broader data because overcoming barriers to drug resistance with targeted therapies is still an important issue that is worth researching.
You likely won’t see it in many analyst reports or previews, however, although it’s a hidden gem of great interest and well worth exploring in terms of what we know so far. This means that readers will be both prepared and intrigued – don’t be surprised to hear about some BD&L deals in this niche in the future.
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The audience of Biotech Strategy Blog is a broad “church” (no pun intended) of professionals associated with cancer drug development.
Bridge of Sighs, Oxford
Some readers with a research focus noticed I was in Oxford recently then contacted me to ask what scientific papers I was reading and catching up on over the lazy summer months?
This got me thinking as I was vividly reminded of my days as a PhD student at King’s College London, where the department would regularly meet to discuss key papers and recent research.
If your work has a narrow focus, and that applies to industry too, it’s sometimes difficult to see what’s on the horizon or be stimulated by ideas outside your immediate field, yet cross-fertilisation is an important pillar of learning. That’s one of the advantages of BSB, we cover a wide range of topics, at varying levels of complexity.
Welcome to the BSB Journal Club!
In this inaugural post, I’ve selected several recently published cancer immunotherapy papers that caught my attention, also a couple of books for your summer reading.
In case you worry that the science is above your ‘pay grade,’ for each I’ve written a brief summary and highlighted what data means from a commercial/new product development persepctive. You are of course most welcome to agree/disagree and reach your own conclusions… I hope it will stimulate your thinking.
Science often moves forward and develops as people make connections from a broader perspective. I’m planning on running the “Journal Club” as a monthly ad hoc post to dovetail with the Reader Q&A Mailbag.
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When it comes to cancer immunotherapy drug development, one of the challenges is that we can’t accurately predict from preclinical mouse models what will happen in people. The result is a rush into the clinic to test in human subjects.
We do need better preclinical models, which is why it was interesting to hear recently on an episode of Health Check (BBC World Service) about a 3D tumour model that is being developed at Barts Cancer Institute.
Professor Fran Balkwill (pictured), who leads the Centre for Cancer and Inflammation, kindly spoke to BSB about the work she and colleagues are doing to model the tumour microenvironment (TME) in high-grade serous ovarian cancer.
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Like the Battle of Britain, the cancer immunotherapy landscape is a dynamic one where tactical decisions can make the difference between “winning” and “losing.”
As Bristol Myers recently found out in first-line NSCLC, if you choose the wrong trial design or adopt an overly-aggressive strategy, you can end up losing badly (see post: Detailed thoughts on BMS CheckMate 026 1L trial in NSCLC)
A recent trip to the operations bunker at former RAF Uxbridge, from where the fighters of 11 Group were directed, shows how close we came to losing the Battle of Britain. Had the German Luftwaffe continued to target RAF airfields instead of diverting their efforts on London, the outcome of the war is likely to have been quite different.
History provides a valuable lesson that strategy and tactics can and do matter; in R&D the targets you choose and how effectively you execute on a plan can make a big difference to outcome.
Pictured: the RAF 11 Group Operations plot as it looked on September 15, 1940.
In Part 2 of the BSB interview with PsiOxus Therapeutics CEO Dr John Beadle, we discuss corporate strategy, and some of the challenges faced by an emerging Biotech company, many of which are likely to be shared by other small companies in the field.
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To be successful as a cancer immunotherapy company, you not only have to be science driven (that’s a given) and offer an approach that could make a difference, you also need a vision and the ability to execute ahead of competitors in a fast moving and competitive landscape.
Dr John Beadle
We’re continuing our series on emerging cancer immunotherapy companies with an in-depth look at PsiOxus, and the vision of CEO Dr John Beadle (pictured right) for it to be a world-leading immuno-oncolytic virus company.
PsiOxus is based just outside of Oxford – it’s part of the so-called “golden triangle,” the area between London, Oxford and Cambridge in the South of England that is a driver of UK science and innovation.
The company is located in a nondescript business park 45 minutes by train from Paddington to Didcot Parkway, followed by a taxi or bus ride. You have to want to make the trip from London!
Dr Beadle kindly spoke to BSB about the competitive advantage the PsiOxus oncolytic virus platform offers, their path-to-market strategy and how he sees the company developing in the future.
With clinical data due in 2017, PsiOxus is a cancer immunotherapy company to watch out for.
Part 1 of the interview focuses on the scientific platform and cancer new products in development that are driving the company forward.
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Thankfully, the dog days of summer means that the Pharmaland conference season takes a much needed break and the intense news cycle tends to calm down somewhat (well a little, depending on your perspective). This gives us some breathing space to conduct and write up some CEO interviews, as well as publish in-depth thought pieces and op-eds on up and coming areas of interest in the broader cancer research field.
In last week’s surprisingly popular mini-series on neoantigens, we explored the concept in a three-part series comprising a primer on the topic, plus helpful insights from a thought leader in the field and a CEO/investor at an example company.
Here we explore the broader landscape beyond T-VEC through a primer, plus a fascinating two-part interview with a CEO in this space.
To begin with, we start off with a primer to get BSB readers on the same page.
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As we continue our journey exploring neoantigens in the context of novel cancer research in Part 3 of our latest mini-series, today we focus on the commercialisation side of the business through an interview with a leading investor, Dr Cary Pfeffer, who is a partner in Third Rock Ventures, as well as being ad interim CEO of Neon Therapeutics. We’ve written about other Third Rock companies in the past; Agios, Foundation Medicine and bluebird bio come to mind, for example.
How does an exciting early product in development move from academia to industry? There are many ways to do this, so here is the story through the eyes of one young company with strong academic connections, as a way to illustrate what can be done. It isn’t the only way, by any means.
To be sure, there are other competitor companies in the neoantigen space – Gritstone and Moderna come to mind as examples – we will cover companies in the broader landscape in a future post. There is also an incredible amount of promising research going on in academia right now, which may lead to more companies or products being licensed and developed.
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