Biotech Strategy Blog

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

Posts tagged ‘bispecifics’

Not in Madrid – with the global pandemic continuing to exert a significant effect on the cancer conference season, the annual meetings continue apace virtually.

Plaza de Cibeles, Madrid

For this year’s ESMO meeting we have already covered immunotherapies, both early and late stage pipeline highlights and now it’s time to explore what to watch out for over the weekend on the early to mid stage targeted therapy front.

The good news is there is some potentially practice changing data being presented, as well as some novel approaches in preclinical development emerging. These should be hitting the clinic in the near to medium term future.  On the other extreme is the more common problem whereby a few agents are showing signs of not holding up to their early promise/hype.

Let’s now take a look at what we can learn in the fourth and final ESMO Preview for 2020…

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Remember the good old days at ESMO17 in Madrid? Sadly there’s no face to face networking at this year’s ESMO20 virtual meeting!

In this third ESMO 2020 Preview the focus is on early stage immunotherapies – we’ll cover targeted therapies in a separate review article.

As new regimens evolve involving multiple immune targets, this complexity brings with it a greater need to understand cell-cell interactions – not just immune cell relationships, but also oncogenic, metabolic, and even epigenetic ones. How do they all fit together and what happens when we interfere with those relationships therapeutically?

Often the simple answer is we don’t know until we head into the clinic, I’m afraid.

Beyond the obvious phase 3 IO readouts in the various Presidential symposia and Proffered oral sessions there are quite a few emerging ideas – old ones with a twist as well as entirely new ones – which we can consider and discuss.

Here, we highlight five key IO areas related to cancer immunotherapy and explore the various concepts as preparation for the upcoming meeting…

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Virtual meetings mean we miss the fun of German pop-up sausage stands and focus solely on the new emerging clinical data!

EHA25 Virtual, Not-In-Frankfurt – There’s a lot of commercial interest in CD20 x CD3 bispecifics, and in this post we’re taking a look at some of the latest clinical data presented at recent ASCO and EHA virtual meetings. Companies mentioned include Regeneron, Roche/Genentech, Genmab/Abbvie, Xencor, and IGM Biosciences.

Any analysis of a rapidly evolving and fast-moving landscape only represents a snapshot in time at the point it was taken, and this post is not intended to be a comprehensive landscape report, you’d pay a lot more than a yearly sub to BSB for that, but we’ve been following the field, and there are some trends emerging.

What makes it interesting is there is some nuance required in the interpretation of data, and with that in mind we spoke to an investigator at the forefront of clinical research who has done trials with several of the CD20 x CD3 bispecifics in development; the insights were quite illuminating.

This post offers an update on the CD20 bispecific landscape, analysis of some of the recent data at EHA and ASCO, as well as expert opinion, what more could you ask for?

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The B-cell maturation antigen (BCMA) is an oncogenic protein target relevant to multiple myeloma that we have been following for a while on BSB, including an expert interview with a global myeloma KOL at ASH last December as part of a wide ranging discussion and deeper look at the Future of Multiple Myeloma.

San Diego

This weekend I was following a myeloma workshop where quite a bit of teasing early data was presented that may give us clues about what’s likely to be interesting at ASH18.

I wasn’t the only one doing this judging by a raft of reader questions that came in, particularly on the topic of BCMA and other emerging targets in this disease.

Is one BCMA better or worse than another? Will antibodies take a BiTE out of the CAR-T cell therapy noise? We take a careful look at these issues to explore what’s what and what really matters in this niche.

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ASCO 2014 Chicago Contemplation

Contemplation in Chicago ahead of #ASCO17

As part of our ongoing American Society of Clinical Research (#ASCO17) Preview series (we’re on number 5 already), we turn our attention to an upcoming area of cancer research that is expected to play an important role in future clinical trials and combination regimens because of the mechanism of action involved.

It may also turn out to be a very handy and important approach for turning cold into hot tumours.

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We’ve come a long way over the last two years in the oncology market, with several novel approaches approved, numerous major phase 3 trials evolving and a huge turnaround for many companies in terms of early pipeline activity.

ASCO 2016 Posters 3

The melée at the ASCO 2016 Poster Hall

Unfortunately, this also means that the tendency of lemming activity also increases in the rush to copy everyone else and not be left behind.  Just a couple of years ago, some industry friends grumbled that there were over 20 checkpoint inhibitors chasing them in development; they may be surprised to know that now there are nearly 70!  This is both unprecedented and unsustainable, and yet it’s also a function of the perceived success these agents have had on the cancer R&D landscape to date.  Everyone wants one for fear of being left behind… except that many are indeed way behind already.

You can imagine the tall guy on the left of the picture looking at his watch and wondering, “Ah so many new posters, so little time!”

Meanwhile, as the rate of approved cancer therapies increases, so does the inexorable march in terms of hyper-aggressive basket pricing.  I would argue that at some point, it no longer acceptable or even conscionable to change a premium or even market rate for drugs that give an incremental improvement of a mere 2 months of extra life.

Equally, one thing that many industry observers and the media love to do, and wrongly in my view, is to compare the individual drug prices on an annualized basis.  This is silly for several reasons:

  1. So far, not all patients are treated for a full year
  2. If patients are treated until progression and that happens early, then therapy is stopped
  3. What people should be looking at is the average treatment cost based on the length of therapy – some people will receive a few months and some much more than that
  4. What’s the true cost of a cure or remission to a patient and their family?
  5. How do we quantify the impact of the long lasting durable remissions?

These questions will become increasingly important as we see a more aggregated therapy approach emerge over the next few years.

By this, I mean that we are now going beyond monotherapy and even combinations; those trials have already long started and are the low hanging fruit that has been rapidly snapped up by the early players, as we eagerly wait for their data readouts.

If you have new agents coming-out of preclinical and into phase 1 development over the next year, there are a number of important questions to consider:

  • What are you going to do and where do you start?
  • How do you gain an edge when coming from (way) behind?
  • How do you develop unique positioning that could sustain your molecule in a sea of similar competitors?
  • Is it realistic to expect the 17th and 50th checkpoint to have equivalent efficacy as what went on before and will all of these seriously make it to market?

You can see now why even the FDA’s Dr Richard Pazdur was moved to grumble about the surfeit of me-toos here and company expectations that the FDA should consider them – it’s on a massive scale that we haven’t seen before.  For once I agree and empathize with him over that dilemma, it’s madness to think they will all be as good as pembrolizumab or nivolumab.

What we are starting to see emerge now is a surprising synthesis of ideas and a merging of disparate approaches. How will this affect oncology R&D over the next 1–5 years?

A couple of smart readers wrote in asking about these emerging trends, what have we identified so far, and where do we see the oncology space going in the near to medium term future. Now that AACR and ASCO are behind us, what can we learn about the new developments and where they all fit in the oncology landscape strategically?

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