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What I learnt at the recent AACR annual meeting in New Orleans is that cancer immunotherapy studies are requiring industry to think differently about clinical trial design.
As we move into combination trials of novel/novel combinations, how do we efficiently work out not only that each drug is safe, but in what patients they are likely to be most effective?
Readers who listened to the recent Novel Targets Podcast, “Of Mice and Men” will hear about some of the challenges associated with mouse models and how decisions are made moving into the clinic.
What I learnt from the podcast (and I hope you did too) is that if you are doing an immunotherapy trial in patients, the type of mouse model can really matter when it comes to interpretation of the preclinical data.
In response to a subscriber request, today’s post is about some of the statistical challenges in designing combination immunotherapy trials. To many, statistics is like voodoo, so this post does not go into any maths!
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One of the interesting immuno-oncology presentations at the recent ASCO Genitourinary Cancers Symposium held in San Francisco from Jan 7 – 9, 2016 was presented by Dr Matt Galsky (Mount Sinai, New York).
Dr Galsky presented the results of a phase II trial of gemcitabine plus cisplatin plus ipilimumab in patients with metastatic urothelial cancer: HCRN GU-148 (Abstract 357).
The trial failed to reach its primary endpoint of showing a 20% increase in 1 year overall survival by the addition of ipilimumab compared to historical data for Gem + Cis in this patient population.
Many in the media don’t write up what is in essence “negative” data, but this trial is highly informative for those with an interest in urothelial cancer and in the optimal strategy for cancer immunotherapy. The GU16 discussant Dr Elizabeth Plimack (Fox Chase) raised many questions that merit consideration by those in the field.
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A burning question in the field of cancer immunotherapy is how long do you have to give a checkpoint inhibitor for?
At the recent Society for Immunotherapy of Cancer (SITC) annual meeting, new data presented by one of the leaders in the field, offered insight (from an unexpected direction) into what the answer to this question may be.
It has huge implications for cancer immunotherapy treatment and the many companies involved in this space.
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Holbrook Kohrt MD PhD (pictured right) is a Stanford medical oncologist and clinical researcher who is leading the way in cancer immunotherapy combination strategies targeting CD137 (4-1BB).
He’s a speaker I greatly enjoy listening to at meetings. Earlier this year at The American Association of Immunologists (AAI) annual meeting (Immunology 2015) in New Orleans, he gave a noteworthy presentation on combination monoclonal antibody therapy.
The potential of a combination of an anti-CD137 monoclonal antibody such as urelumab plus an anti-CD20 such as rituximab, was one that he appeared to be particularly excited about.
Dr Kohrt kindly spoke with BSB and shared his thoughts on the potential of immune modulators, which instead of acting as inhibitors to “release the brake,” like checkpoint inhibitors, act as agonists to “step on the gas” and rev up the immune system. This is a concept that many Pharma companies are currently looking to explore for new drug development opportunities, for example:
Source: Roche Media Briefing at ESMO 2014 in Madrid
When it comes to combination strategies, the big unanswered questions are which ones will produce big gains in response rates and survival outcomes, and which ones will be duds?
After all, much like targeted therapies, not all targets will be relevant in all tumour types – it will depend on the underlying immune system.
In New Orleans, Dr Kohrt talked about the potential advantages and concerns around combination strategies and why he’s particularly interested in CD137 as a novel target for immunotherapy.
In-Memorium Holbrook Kohrt
It is with great sadness that we must report that Holbrook Kohrt is no longer with us. He died, aged 38, on February 24, 2016.
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Oxford based Immunocore is an emerging UK biotechnology company that should be on your radar if you’re following companies such as Kite Pharmaceuticals and Juno Therapeutics. If it isn’t already you can expect to hear a lot more about them in the forthcoming year as they start clinical trials with the many leading global pharma companies who have already partnered with them.
Dr Namir Hassan, Immunocore
Immunocore is an immuno-oncology company with an innovative approach to targeting T Cell Receptors (TCR) using their proprietary ImmTAC (Immune mobilising monoclonal TCRs against cancer) technology platform.
Namir Hassan, D.Phil (pictured right) is Director of Translational Research and Head of Development at Immunocore. BSB met with him and Chief Business Officer, Eva-Lotta Allan at the company offices located in a science and business park near Oxford.
Immunocore recently raised $320M in Europe’s largest private life sciences funding. (Link to Press Release)
Earlier this year preliminary clinical data for IMCgp100 their first-in-class novel immunotherapy was presented at the annual meeting of the American Association for Cancer Research (AACR) in Philadelphia by Mark Middleton, Professor of Experimental Cancer Medicine at the University of Oxford.
In the interview, excerpts of which you can read below, Dr Hassan explained why their exciting and innovative approach that targets the T Cell Receptor is different from other companies in the field, what they have learned from the preliminary clinical data, and the potential immTACs may offer in combination with other cancer immunotherapies.
If you’re not a cancer immunologist, this type of science is complex, so the aim of the interview was to put into context the data already in the public domain and gain some insights into the excitement behind ImmTACs and what immunocore are doing. If you don’t understand the potential of TCRs and ImmTACs as immunotherapies, this post is for you!
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Picture Credit: @gene_antibody
For much of the last two years, one of the hottest topics around has been T cell manipulation, which can happen in many different forms.
This is just one area that we have covered extensively in the immuno-oncology space from Chimeric Antigen Receptor (CAR) T cell therapies to checkpoint inhibitors, as well as various antibodies, including the first bispecific T-cell engager (BiTE) to CD19 that recently approved by the FDA called blinatumomab (Blincyto) from Amgen.
Not all cancer patients respond to all these approaches though.
Why is that and what approaches or novel targets can we explore next to address this vexing issue?
At the SITC and SABCS meetings, I saw some really interesting and unusual presentations, together with some recent publications on topic, that really piqued my interest in this challenge. They are early signs of the new directions some of the research in this field could go. Overcoming resistance and understanding different aspects of immune escape will likely be very instructive in developing the next generation of combination studies that could make a positive impact on patients.
Today’s post touches on some of these exciting developments and includes an in-depth interview with Dr Ira Mellman, the scientist behind Genentech’s immunology research program at gRED.
Interested readers can sign in or sign-up in the box below to read more about the exciting new developments that are happening with different types of antibodies in the immuno-oncology space.
The Society for Immunotherapy of Cancer (SITC) annual meeting promises to be a most interesting one, if the first day is anything to go by. It’s being held this week at National Harbor, Maryland on the banks of the Potomac River just south of Washington DC.
As the meeting started with some intensive workshops yesterday, the American Society for Hematology (ASH) annual meeting abstracts were released at 9am, giving up a choice between writing up SITC in situ or switching gears and analysing the initial hematology abstracts. In the interests of sanity, we have decided to focus on SITC for the next week, then move onto the AACR-NCI-EORTC conference, before reviewing the ASH data in detailed previews.
SITC is mostly a translational science meeting with a little bit of relevant clinical data through in here and there. It’s also not for the faint hearted, especially given the sheer intensity and pace of some of the talks – keeping up with pen and paper to hastily scribble notes is surprisingly quite hard!
It was an honour to attend as one of the few members of the media here. The excitement is palpable, with speakers reminding us of how only a few years ago, few people attended immunotherapy sessions at ASCO. SITC is rapidly becoming a major meeting with a record-breaking 1500 expected for the first time! It is the immuno-oncology meeting to attend for those interested in understanding the emerging trends, landscape and direction that research is taking us.
Yesterday SITC fielded two workshops with impressive line-ups from the immuno-oncology space that included Drs Carl June, James Allison, Tom Gajewski, Susan Topalian, Stephen Hodi and Mario Sznol, to name a few. The workshops focused on different topics:
- A basic one on understanding the immune system
- A more advanced one on combination strategies in immunotherapy
Rather than summarise all the talks from both sessions that ran a full day each, we’ve decided to focus on some themes, ideas and concepts that catch our attention each day. Here’s the first of our daily reviews from the SITC 2014 annual meeting. Thanks to all our subscribers whose support enabled us to attend this meeting for the first time.
To learn more about our impressions from the SITC immunotherapy workshops yesterday, you can sign in or sign up below.
Cellectis is a Paris based biotechnology company, (NYSE alternext: ALCLS.PA) with an aspiring “blue ocean” strategy that, if successful, could revolutionize cancer immunotherapy.
The potential of using engineered T-cells (known as chimeric antigen receptors) to fight cancer was highlighted by the impressive data presented at last year’s annual meeting of the American Society of Hematology (ASH 2013).
To many, the data for the U Penn/Novartis engineered T-Cell therapy (CTL019) in pediatric acute lymphoblastic leukemia (pALL) was worthy of presentation in the plenary session at the meeting.
Over the past year, investors have poured money into companies active in the field: we’ve written about the launch of Juno Therapeutics and their intellectual property (IP) dispute with Novartis. More recently Kite Pharma had a successful IPO.
Why was Biotech Strategy Blog keen to interview Cellectis Chief Scientific Officer (CSO) Philippe Duchateau, PhD and Chief Executive Officer (CEO) André Choulika, PhD (picture left and right respectively)?
The answer is they have a completely new and innovative approach to CAR-T cell therapy that in the long run could be a “game changer.” Their lead product (UCART19) is an allogeneic CAR T cell for ALL and CLL. Allogeneic means the T cells that are modified come from a donor. This is in contrast to the autologous approaches that Kite, Novartis and Juno are developing where the engineered CAR-T cells come from the patient themselves.
All credit to Pfizer for seeing the potential in a company that has been on our radar for a while. They recently announced a major collaboration with Cellectis that could turn both Cellectis and Pfizer into major players in the cancer immunotherapy space.
In this fast moving R&D space there are already signs of where competition to Cellectis may come from, and it’s not Novartis, Juno or Kite.
Subscribers and those with an interest in CAR-T cell immunotherapy can login or sign-up below to read more, including excerpts of the interview at Cellectis HQ in Paris: