Biotech Strategy Blog

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

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Berlin: Checkpoint Charlie

With a series of inconsistent results involving phase 3 trials involving checkpoint antibody therapy, even in similar indications, it’s time to get down and dirty and look at some of the factors that might be influencing the outcomes since three of the five approved anti-PD(L)1 products have now been similarly affected.

It’s an interesting and intriguing conundrum, to be sure…

Instead of obeying traffic rules, with immune checkpoints maybe we need to consider following immunology rules instead 🙂

The potential hidden answers, however, might be surprising to some readers.

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The latest company immunotherapy announcement is from Lilly and Nektar Therapeutics, for a strategic collaboration to co-develop NKTR–358, which targets the IL–2 receptor complex, thereby impacting regulatory T cells (Tregs). It is thought that this target may have particular relevance to autoimmune disorders and other chronic inflammatory conditions. This agreement involves an initial payment of $150 million, with the potential for up to $250 million in additional development and regulatory milestones.

Source: Nektar Therapeutics

Preclinical data on this novel compound was recently presented on July 10th at the World Congress of Inflammation.

We first spoke to Nektar at SITC in November, including an interview with one of their leading scientists (Dr Jonathan Zalevsky) together with the academic PI (Dr Adi Diab), and I’m delighted to say that the dynamic duo graciously agreed to a follow-up discussion at ASCO last month on the emerging IO pipeline.

In our current analysis and commentary on the IO pipeline, we also look briefly at the Lilly deal with NKTR–358 in autoimmune disease.

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In our latest thought leader interview we explore the intersection between epigenetic therapy and immunotherapy.

Gems from the ASCO17 poster hall

Much of the IO focus to date has been on monotherapies rather than combos, although that situation is slowly changing.

What we can also expect to see are the emergence of regimens, long the bedrock of traditional cancer therapy approaches.

As we learn how to bucket more discrete populations based on the underlying biology of the tumour microenvironment, so we will see a more IFTTT (If this then that) approach evolve in order to fix or improve a situation before or after attempting the core therapy. It might require a focus on changing the immunosuppressive or inhibitory factors, for example, or addressing factors that induce primary resistance upfront. The possibilities are endless.

Obviously, there are a number of ways to do this from chemotherapy and radiotherapy to epigenetic agents to targeted therapies – these traditional treatments are not going to go away, but I can see a future where we see more integration based on a patient’s underlying immune status. It won’t be the zero sum game many analysts seem to think it might be.

In the past, we have covered chemotherapy, radiotherapy and targeted therapies and looked at how they might be employed with immunotherapies in various guises. In this latest thought leader interview, we look at a different approach, epigenetic therapy and other novel immunotherapies.

Here, we combine two popular types of posts – Gems from the Poster Halls with an Expert Interview  – for detailed look at one particular area of research that is beginning to look quite intriguing.

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Back in January this year, we posted an early look on what to expect from the evolving 1L NSCLC landscape following the controversial FDA submission of Merck’s pembrolizumab with chemotherapy. This lead to subsequent approval in May.

Checkpoint Charlie, Berlin July 2017

At that time, quite a few people were shocked and surprised that the phase 2 KEYNOTE–021 Cohort G data presented ESMO was neatly parlayed into accelerated approval in the US.

Since then, a lot has happened and now many readers are on tenterhooks as we await the next round of lung cancer trial results in the upfront setting.

First up is AstraZeneca’s MYSTIC trial exploring an IO-IO combination with durvalumab plus tremelimumab. Merck’s confirmatory trial for pembrolizumab plus chemo is also expected in the fall – will it support the accelarated approval – or not? Meanwhile, we also await Roche/Genentech’s IMpower150 study evaluating their checkpoint inhibitor, atezolizumab, in combination with chemotherapy by the year end.

These are quite different strategies with diverse endpoints so following them closely will be key to understanding what happens next.  Based on what we’ve seen in lung cancer to date, the roller coaster looks set to continue.  The C-suite shenanigans have only added to the intrigue and mystique – do they mean anything?  Who knows, but we’re focusing on the hard data i.e. science and the clinical clues that are available.

It’s all to play for and many readers wrote in asking for an update on the landscape and what to expect now that we’re much nearer to the shoes actually dropping.

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La Tour Eiffel par nuit

Paris, France:  It’s the dog days of summer and my reading stack of interesting science and cancer research papers is particularly high at the moment despite reading voraciously over the last few weeks…

So much excellent research keeps on piling up as fast as one can get through it.

It’s beginning to feel like Ravel’s Bolero…

Still, there’s one particular batch of important papers that draws together some interesting findings in an area we have been following for a little while now and these data most certainly advance the field in more ways than one.

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Traditionally we’ve seen the evolution of oncology companies with chemotherapies, then those with targeted therapies, whether TKIs or antibodies.

Increasingly, we’re seeing the rise of an entirely new empire – those with a raft of immunotherapies in their pipeline.

Gems from #ASCO17 Poster Halls

Then there are those with a more mixed portfolio approach of targeted compounds and novel immunotherapy agents… which leads to some interesting combination approaches that target the cancer immunity cycle and address issues that exert inhibitory factors dampening down the immune system responses.

Our latest fireside chat and expert interview focuses on an up and coming biotech company with a pipeline that combines protein targeted antibodies with novel approaches that can potentially reprogram various immune cells in the tumour microenvironment.

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Churchill College, Cambridge: Yesterday heralded the 4th and final day of the EACR Cancer Genomics conference with some invited speakers and proffered papers based on research from several groups and labs.

Churchill College, Cambridge

We got to see through the keyhole on several important areas of research that highlight both challenges and opportunities faced by the field.

The good news is that the opportunities provide insights into how we can learn from ongoing and optimise future clinical trials.

 

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Churchill College, Cambridge:  Yesterday, the main focus at the EACR Cancer Genomics conference was on immunology-related topics as they pertain to genomics.

A rainy day in the Fens for #CG17

Unfortunately, however, the Great British summer ended as almost as soon as it started – I can confirm that it started on a Wednesday this year and fizzled out by the following Tuesday!

Consider that on the first two days of the conference it was gloriously sunny and those wooden benches were full of scientists sitting outside eagerly discussing their research or various collaborations afoot.

A mere 24 hours later, the heavens opened and steadfastly drizzled all day long, much to the chagrin of the attendees.

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Cambridge: the third annual European Association for Cancer Research (EACR) conference on cancer genomics is underway at Churchill College in the UK. (Official Twitter hashtag: #CG17).

Churchill College, founded by the former Prime Minister, Sir Winston Churchill, is a short 15 minutes walk from the historic city centre and has an edgy modernist field to it, with thought provoking sculptures scattered throughout the grounds. It’s a far cry from the more romantic and dreamy spires of Oxford portrayed in the TV detective series, Morse and Lewis.

Despite all the interest in cancer immunotherapy and immuno-oncology, it’s important to remember that cancer remains a disease of the genome, which is why we decided to cover this meeting for the first time. It has an impressive line-up of keynote speakers, as well as researchers presenting posters.

All too often now on the cancer immunotherapy conference circuit, it’s the same thought leaders giving a repeat of their ‘party piece’ standard “keynote” talk so it’s refreshing to hear new voices who are at the leading edge of cancer research, albeit in a slightly different niche.

What we are starting to see is the convergence of cancer immunotherapy with genomics, and that was very evident in the posters that are directional of where the field is going. More on that later.

This is the first of three daily blogs that summarise some of the insights and take-home messages from the EACR Cancer Genomics conference at Churchill College, Cambridge.

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Yesterday, we had a sarcoma expert in the spotlight looking at the new developments from the American Society of Clinical Oncology (ASCO).

In part two of our sarcoma mini-series, we have another interview for our readers, this time from the perspective of the CEO, Dr Carlos Paya. They had some interesting data in Chicago so what was their reaction to it and where are they going next?

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