Biotech Strategy Blog

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

Posts tagged ‘Innate Pharma’

Head and Neck cancer – or to be more precise – squamous cell carcinoma of the head and neck (SCCHN) has joined the checkpoint inhibitor club with two FDA approvals this year. National Harbor Maryland

Firstly, we saw the accelerated approval of pembrolizumab (Merck) based on objective response rate on August 5, 2016 for patients with recurrent or metastatic head and neck squamous cell carcinoma (SCCHN) that has continued to progress despite standard-of-care treatment with chemotherapy.

It’s a dismal disease with a generally poor prognosis in advanced patients once initial therapy fails.

While some patients do benefit with anti-PD–1 checkpoint therapy, the overall response rate in the KEYNOTE–012 trial of 174 patients was pretty low, i.e. 16%. In other words, the majority of patients do not respond or receive any clinical benefit.

Secondly, last week on November 10 nivolumab (BMS) was approved by the FDA based on the phase 3 CheckMate–141 data presented at ASCO earlier this year. The data was published in the New England Journal of Medicine to coincide with the FDA approval.

There were no statistically significant differences between the two arms for median PFS (2.0 months with nivolumab versus 2.3 months with standard therapy, HR for disease progression or death, 0.89; P=0.32) or ORR (13.3% vs. 5.8%) for nivolumab versus investigator’s choice, respectively. There was, however, a clear benefit in favour of nivolumab in median overall survival (7.5 months in the nivolumab group versus 5.1 months in the control group; HR 0.70; P=0.01).

This effect on patient outcome is a classic pattern for cancer immunotherapy with checkpoint blockade. Response rate and PFS are measurements that are very relevant to chemotherapy, but they are not as relevant to cancer immunotherapies where what is impacted more noticeably is overall survival and the long tail of the curve.

With two approved anti-PD–1 monotherapies in SCCHN, the next challenge has now become how can we improve on monotherapy by boosting the number of PRs to CRs potentially improving long term outcomes and/or turn non-responders into responders? This is the stage we are at in many tumour types now.

Combination approaches are believed to be the way forward, which is why we anticipated with great interest the lirilumab plus nivolumab head & neck combination data presented this past weekend at the 2016 Society for Immunotherapy of Cancer (SITC) meeting at National Harbor, MD. The presentation is available for download on the Innate Pharma website. The data raises numerous questions and scenarios that can be considered…

  • Are the data exciting, encouraging or disappointing?
  • Are the results enough to give confidence if a phase 3 trial with the combination were to follow?
To address these questions and other critical issues – including red and green flags – we took a deep dive into the data in the context of scientific facts and explored the landscape carefully.

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Part 3 of our series on Gems from the Poster Halls at ESMO continues with a look at another four important combination studies that may be of keen interest to readers.

These include both targeted therapies as well as immunotherapies.

Some of the posters I was originally keen to write about turned out a little unexpectedly with some issues to address i.e. lack of efficacy or unwanted toxicities based on the dosing schedule used and may require tweaking of the dosing, schedule or trial design. Others will unfortunately be destined for dog drug heaven unless a new tumour type offers more promise. Such is the R&D roller coaster that is oncology – sometimes we forget that more compounds fail than make it market.

The good news is that there were plenty of promising approaches that are worthy of writing up and discussing. In the third part of our poster mini-series, we take another deeper dive with a careful look at some new data in Copenhagen.

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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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After looking at one important poster yesterday on multiple myeloma, it’s time to explore other equally interesting targets in other tumour types.

Some years reflect the inertia that hit oncology R&D with a lot of old data rehashed or they can be flooded with many me-too compounds.  Not this year, there’s a lot to talk about and review… so much so that we may well have enough for three rounds of Gems from the Poster Halls, time permitting as ASCO is fast approaching!

Without much further ado, for round 1 we have explored eight posters spanning four companies with a variety of different targets including chemotherapy, targeted therapies and immunotherapies.  I will say though, that the lines are being blurred as all of these modalities can impact the immune system, sometimes in unexpected ways.

What’s in store for today?  A focus on biotech companies doing intriguing cancer research.

Companies mentioned: Infinity, Innate, Incyte, Agenus

San Francisco JPM16 Day 1It’s Day 1 of the annual pilgrimage to San Francisco for the JP Morgan Healthcare conference. In light of the success of the daily rolling blogs we’ve done around the conferences we cover, for the first time we’re doing a rolling blog for each day of #JPM16.

Throughout the day (schedule permitting) we’ll be updating the post with commentary around noteworthy news.

Company presentations mentioned in this post include: $PBYI, $CELG, $GILD, $INCY, $SGEN, $MDVN. There’s also commentary on several of the deals announced by Roche, Juno, Novartis, Sanofi, AstraZeneca & Merck.

If you want to follow along yourself, here’s the link to the JPM16 webcasts & conference agenda.

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Immuno-oncology is one of the hottest topics, if not, the hottest in cancer drug development at the moment, and every conference seems to advance the field forward. The pace of progress is breathtaking as thought leaders and pharma & biotech seek to maximize how to leverage the body’s immune system in the fight against cancer. It’s exciting times!

Coming up next on the calendar are two cancer conferences, the Society for Immunotherapy of Cancer (SITC) held in Maryland later this week, followed swiftly by the EORTC-AACR-NCI Molecular Targets conference (often referred to as the Triple meeting by industry insiders) in Barcelona just before Thanksgiving.

SITC 2014 Immunotherapy Banner

Whoa, that’s a lot of data yet to come, and then in December we have the American Society of Hematology (ASH) and San Antonio Breast Cancer Symposium (SABCS).

Back home in the Blighty, November is often referred to as the ‘month of the drowned dog’ because it rains a lot… at this rate it’s more like raining data – let’s hope not too many agents are headed for dog drug heaven! The good news for subscribers is there’s a lot of conference coverage to come!

2014 ESMO Congress Poster HallSo here we are, after nearly two dozen posts, it’s time to close out the 2014 ESMO coverage with a final review of the immuno-oncology posters that piqued our interest.

There were 16 in all that fitted that category. Normally, we highlight three or four gems from the poster halls, so more than a baker’s dozen is quite a feast.

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In the past, I’ve sometimes been accused of being a bit of an immunotherapy bear for my dislike of cancer vaccines as a single agent therapy in advanced disease where the tumour burden is very high. That particular field has undoubtedly been a huge graveyard for many companies, much in the same way that metastatic melanoma was, until novel therapeutics and immunotherapeutics emerged to push through the envelope.

To be clear, I am though, a big fan of targeted immunotherapies such as checkpoint inhibitors and chimeric antigen receptor (CAR) T cell therapies, which have been very much to the forefront in immuno-oncology over the last two years and rightly so, with some initial trials showing some very promising results.

Both of those approaches are squarely part of the adaptive immune system and seek, in different ways, to retrain the bodies immune system to fight the tumour. More recently, the innate immune system has seen new advances as reearchers moved beyond simple vaccines to develop more thoughtful and innovative approaches that seek to outwit the very masking the cancer is trying to fool the immune system with. It’s no less exciting, just a different way of looking at the science and improving out understanding of the biology of the many diseases that cancer makes up.

In this AACR preview, I take a broad look at some innovative and novel scientific approaches, including targeting anti-CD47 and SIRPα (Stanford and Stem Cell Therapeutics), KIR and MICA (Innate Pharma) and neutrophils (Biothera).

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Beyond the noise of the exciting the data in CAR-T cells, CLL, NHL and multiple myeloma, one of my favourite pastimes at cancer conferences is to look out for up-and-coming gems in the poster halls.

By this I mean interesting novel targets or very active agents in the pipeline.

One of the most eagerly awaited targets on my list was the Killer Immunoglobulin-like Receptor (KIR). It may be a key part of overcoming lymphoma resistance and inducing cell death. If you don’t kill the cancer cells, you likely won’t see remissions occurring.

Companies mentioned: Innate Pharma, BMS, Roche

Products mentioned: IPH2101, IPH2102 (lirilumab), ipilimumab, rituximab, obinutuzumab, anti-PD-1, anti-PD-L1

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