Biotech Strategy Blog

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

While in Marseille for the scientific meeting to celebrate the 40th anniversary of the Centre d’Immunologie de Marseille-Luminy (CIML), I had the pleasure to interview Hervé Brailly PhD, the CEO of Innate Pharma, a leading biotech company in the Marseille Immunopôle.

dr-herve-brailly-innate-pharma-ceo

Innate Pharma (@InnatePharma) was founded in 1999 by six immunologists: Hervé Brailly, Eric Vivier, Marc Bonneville, Alessandro Moretta, Jean-Jacques Fournié and Francois Romagné.

Yesterday’s blog post on “Why Target the Innate Immune System? An interview with Eric Vivier” sets the scene for today’s post.

Innate Pharma, as the name suggests, has pioneered targeting the innate immune system. The company has leveraged the research undertaken at CIML by Professor Vivier and others in the field of innate immunity.

Innate is leading the way in immuno-oncology by targeting checkpoint receptors on natural killer (NK) cells. In 2011 Innate signed a licensing deal with Bristol-Myers Squibb for the development and potential commercialization of lirilumab.

In a recent financial report (link to Sept 8 press release) the company announced that several clinical trials would read-out in the forthcoming months.

Without disclosing any material non-public information, Dr Brailly kindly spoke with BSB and talked about his vision for Innate, what data readouts we are expecting, and the inflexion point the company is now at.

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Eric Vivier, DVM PhD (@EricVivier1) is a leading French immunologist whose research has focused on understanding the innate immune system, and in particular, the role natural killer (NK) cells and innate lymphoid cells (ILC) play.

prof-eric-vivier

He is Director of the Centre d’Immunologie de Marseille-Luminy (CIML) and a Professor of Immunology at Aix-Marseille University.

In addition to his academic work, he also co-founded the biotech company Innate Pharma back in 1999. Through the company, he is actively involved in the translation of basic research into new cancer immunotherapy treatments.

New clinical data is eagerly expected for one of these, a first-in-class monoclonal antibody against KIR (lirilumab). It is in phase 2 clinical trials with Innate Pharma and Bristol Myers Squibb.

At the recent scientific meeting to celebrate 40 years of CIML (#CIML40), Professor Vivier kindly spoke to BSB about his research into innate immunity and the Marseille Immunopôle, for which he is also a co-founder.

It is an immunology cluster that brings together academic/clinical research with innovative biotech companies looking to bring new drugs and diagnostics to market.

This is the second post in our mini-series from the Marseille Immunopôle and CIML40. It also sets the scene for forthcoming posts on targeting the innate immune system, something you can expect to hear a lot more about in cancer immunotherapy.

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Marseille – When it comes to biotech clusters for immunotherapy, Marseille, the second city of France, has to be right up there along with Boston, San Francisco in the United States and the “Golden Triangle” of Oxford, Cambridge and London in the UK.

ciml40I’m here in Marseille thanks to an invitation from Professor Eric Vivier to attend the 2-day scientific conference that the Centre d’Immunologie de Marseille-Luminy (CIML) have organized as part of their fortieth anniversary celebrations (1976-2016). It starts today (Twitter #CIML40).

Surrounding CIML in the picturesque national park (Parc National des Calanques), just outside the city, are innovative biotech companies focused on immunology and cancer immunotherapy. The combination of companies, research institutes and academic hospitals in the region has created the Marseille Immunopôle (@Immunopole). The area should already be on your radar if you are following the field.

haliodx

Yesterday, I visited HalioDx (@HalioDx), a start-up company a stone’s throw from CIML. It was founded in 2015 to commercialize Immunoscore, a novel biomarker in colon cancer that can be used to stage patients based on their immune response.

Vincent Fert CEO HalioDx

Vincent Fert, CEO of HalioDx

We’ve been following the work of Dr Jérôme Galon on the blog for some time (see posts from European Cancer Congress 2015 and ASCO 2016), so it was a pleasure to talk to Vincent Fert, CEO (pictured right) and co-founder of HalioDx, about his plans to commercialize Immunoscore in Europe and the United States.

If you want to know more about the science behind Immunoscore, do listen to the recent Novel Targets Podcast (@TargetsPodcast) interview with Dr Galon, where he talks about the data he presented at ASCO 2016 (link to Episode 13: Immunotherapy or Bust).

The field of cancer immunotherapy is making rapid progress. It is already reaching the point where — in order to optimize the chance of a durable response — doctors need to know what a patient’s underlying immune response to cancer is, in order to direct therapy.

Vincent Fert and HalioDx are leading the way with the commercialization of a new diagnostic approach for colon cancer based on a patient’s immune profile. He kindly spoke with BSB about his plans for the company and making Immunoscore available in the US and Europe.

haliodx-marseille-luminy

This is the first post in a mini-series from the Marseille Immunopôle.

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There was a time when it seemed that all the good news emerging in cancer research was on breast cancer, that is clearly no longer true as other tumour types have seen some leaps and bounds with different modalities, including areas previously thought to be a graveyard for big Pharma, such as metastatic melanoma, for example.

new-dawn-houses-of-parliament

New Dawn at the Houses of Parliament

That said, after the excellent developments in hormone-sensitive disease and the identification of the HER2 oncogene, we now have CDK4/6 as a validated target in metastatic breast cancer.

Pfizer’s palbociclib (Ibrance) lead the way, with two approvals in previously untreated and relapsed ER+ HER2- advanced breast cancer. Two other companies in this field are Novartis with ribociclib and Lilly with abemaciclib. Data is being presented on all three therapies at ESMO this year.

In addition, there are some other abstracts of note that are well worth discussing.

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In our ECCO Preview series last year (note: ESMO and ECCO have alternated the EU major cancer conference in the Fall for years), we highlighted several promising novel agents in development including the following:

  • StemCentRx’s anti-DLL3 inhibitor: rovalpituzumab tesirine (ROVA-T)
  • Ignyta’s Pan Trk, ROS1 and ALK inhibitor: entrectinib
  • Pfizer’s anti-NOTCH3 inhibitor: PF–06650808
  • Pfizer’s PTK7 ADC in TNBC: PF–06647020

What happened to them all? Were they good selections or not?

Well, AbbVie acquired StemCentRx in a $10.2B deal, Ignyta are busy advertising their new clinical trial enrollment for entrectinib as a non-chemotherapy and non-placebo controlled study on social media, suggesting that compound’s clinical development is still very much alive, while both the Pfizer compounds are also still active, as far as I know.

None have yet been consigned to dog drug heaven, which is quite something considering the failure rate in oncology drug pipelines!

Indeed, last year the Pfizer PTK7 ADC data was focused on triple negative breast cancer, where there is a solid rationale. This time around, the same research group explore the latest activity in advanced solid tumours, including ovarian cancer, as mentioned in the earlier Preview (See: 9 key abstracts in Ovarian Cancer).

sallys-barSo it’s time to sit down and chew the fat on one of my favourite topics at conferences – Development Therapeutics.

Here we consider which other compounds – other than the Pfizer ADC – that are worthy of highlighting and watching out for this year?

There are certainly some curious and quite different (i.e. novel) approaches to look at.

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westminster-embankmentToday’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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Iron Men of CrosbyThis 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!

ESMO 2016 CongressIf 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.

View of Thames BarrierOne 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.

Oxford Bridge of Sighs

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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