Immunotherapy strategy | Biotech Strategy Blog

Statistical Challenges of Immunotherapy Clinical Trial Design

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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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Strategies to overcome CAR T cell therapy resistance

Some people may think that if you just give a whole boat load of engineered T cells, and in particular, those modified with a Chimeric Antigen Receptor (CAR), that responders are “cured.”

While some recipients of engineered T cells can have long-term, durable remissions, others may initially respond, only to subsequently relapse.

Resistance to CAR T cell therapy can and does occur.

In this post, we talked with a leading expert about the latest research on how resistance to cell therapy develops, and the potential strategies to overcome it.

CAR T cell therapy is exciting, but remains an emerging field with multiple ways in which the competitive landscape may be shaped moving forwards.

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Promise of Cancer Immunotherapy highlighted at Immunology 2015

New Orleans – At the 2015 annual meeting of the American Association of Immunologists (AAI) leading experts came together to share their insights on the “Promise of Cancer Immunotherapy.”

The audience at #AAI2015, in an artic chilled hall, heard from an outstanding panel of speakers, many of whom flew in specially:

Immunologic Checkpoint Blockade: Combinations and Mechanisms, Jedd Wolchok (MSKCC)
Immune Checkpoint Therapy: Clinical Success and Next Steps, Padmanee Sharma (MD Anderson)
Improving Cancer Treatment Through Immunotherapy Combinations: Combination MAb Therapy: Dual tumor & Immune Targeting, Holbrook Kohrt (Stanford Cancer Institute)
Curative Potential of T-Cell Transfer Immunotherapy for Cancer, Steven Rosenberg (Surgery Branch, NCI)
PD-1 pathway blockade in cancer therapy: new frontiers, Suzanne Topalian (Johns Hopkins)

Dr Steven Rosenberg (NCI)

Cancer Immunotherapy is such a fast-evolving field that at Immunology 2015, we heard data that wasn’t at the annual meeting of the American Association for Cancer Research (AACR), just a few weeks ago.

Several presenters also put in context data that will published at the forthcoming ASCO annual meeting.

If you’d like to hear more about some of the checkpoint inhibitor data at AACR15, do listen to the first episode of the Novel Targets podcast (if you haven’t already done so).

It’s available as a free download on SoundCloud and on iTunes.

This post offers a top-line summary of some of the key messages we heard in the #AAI2015 symposium.

To learn more insights on this intriguing topic, subscribers can log-in or you can purchase access to BSB Premium Content.

Next generation approaches to immuno-oncology – where next?

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 log-in to read more about the exciting new developments that are happening with different types of antibodies in the immuno-oncology space.

Can Cellectis Revolutionize CAR-T cell immunotherapy?

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 to read more, including excerpts of the interview at Cellectis HQ in Paris:

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Posts tagged ‘Immunotherapy strategy’