Biotech Strategy Blog

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

Posts tagged ‘TIM-3’

The start of a New Year is a good time to take stock of where we’ve come from and where we’re going in the fast-paced world of oncology new product development.

Upregulation doesn’t always mean a protein is a valid target, but in some cases it just might…

In this latest post, we’re revisiting T cell immunoglobulin and mucin domain-containing protein 3 – or TIM-3 in short – and taking a closer look at the evolving competitive landscape in this niche.

One company targeting it is Novartis, who have an anti-TIM–3 antibody MBG453 in development. In this post we have an expert interview with a scientist who is a pioneer in the emerging field of TIM-3 biology.

There’s also a review of some of the recent important scientific papers on TIM-3 biology, as well as commentary on data presented at ASH19 that we expect may feature in presentations at JPM20 next week, not to mention be the focus of future interim updates should the data turn out to show some promise in certain settings.

If you have an interest in targeting novel immune checkpoints and want to find out more about where the field is at with TIM-3, then this post is for you.

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Imagine being becalmed on boat in the doldrums patiently waiting for the wind to pick up…

Just as experienced sailers learn to make best use of the available knowledge on sea breezes, tides, tidal winds, catspaws, headsails, heels, genoa etc, so immunologists are experimenting with various modalities.

This enables them to develop a more extensive knowledge base before they can use all the available tools more effectively at their disposal in order to chart a course in each tumour type and setting.

That’s a tremendous amount of information and skills that needs to be gathered before we can even consider racing against competition. So it is with cancer immunotherapy, with all its different approaches that are available to combine or sequence in a multitude of tumour types. We are still largely in the unknown unknown stage of figuring things out.

That said, each cancer conference brings new nuggets and gems that on their own do not appear to offer much, but added together in the broader picture can contribute more than many observers realise.

That was certainly the case with our latest update on IO therapies, as you will see…

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SITC Phase 1 Review Part 1 – It’s time for a two-part mini-series on recent phase 1 clinical trials and how to interpret the findings.

Are we at a crosswords with IO combos?

As a former new products development professional, this is something that I’m particularly enthusiastic about.

While it is fascinating to see other people’s reactions to early oncology trials, these should often be taken with a very large pinch of salt, in my view.

In Part 1, it’s time to take a step back and understand not only what companies are doing, but also how they set the trials up and what they are looking for. We highlight some examples of data readouts to illustrate the points.

In Part 2 on Monday we take a rock around the clock at some of the other recent phase 1 readouts and explain what we can learn from what was presented. The devil is often in the small details that many observers miss at first glance.

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Heading Downtown for #CICON18

New York – It’s always good to see cancer researchers receive a Nobel prize.

I don’t think anyone at #CICON18 was surprised to see Dr Jim Allison as a recipient.  I’m delighted to see Prof Honjo was also recognised too, as he discovered the PD-1 checkpoint target:

Moving on it’s time for some highlights of the first day of the meeting – a couple of interesting findings emerged from the proceedings…

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Summer time always seems a good opportunity to explore new cancer targets or approaches on BSB and we’ve covered quite a few interesting concepts over the last couple of years.

ASCO18 Gems from the Poster Halls

This particular approach is an up and coming immuno-oncology target that I noticed is quietly gaining increased interest amongst pharma companies and not all the usual players either.

Consider typing in [target] + cancer in PubMed…

What I got was one single paper in 2000, nothing until 2006 (two more papers), then one to four new ones a year dribbled out until 2014 when nine appeared, followed by a big jump to 17 in 2015, over 20 the following year, then finally more than 30 last year.

At the current rate there will likely be 40–50 such articles in 2018, making for a typical sigmoid growth rate of interest.  Boom!

Clinical trials (montherapy and combinations) are already in early phase studies in the clinic, so this is a good time to take stock and look at progress to date. It also makes for interesting reading when put together as a whole!

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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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Iwakuni Bridge

Cherry Blossoms and Iwakuni Bridge

We’re continuing our countdown to the 2016 AACR annual meeting in New Orleans with a look at anti TIM-3 and LAG-3 inhibitory checkpoints and highlighting some of the companies with noteworthy abstracts.

In case you missed it, yesterday AACR announced that Vice President Biden will be delivering remarks on the final day of the meeting, Wednesday, April 20th in the “Highlights 2016: Vision for the Future” Plenary Session. As conference diehards, we will be there in person, but AACR have announced they plan to livestream it to the world. It’s a fitting finale to what is set to be a “must attend” meeting for those with an interest in cancer new product development and in particular, cancer immunotherapy.

What can we learn from AACR abstracts on TIM–3 and LAG–3?

There is some early clinical data that we will be checking out (no pun intended) on TIM-3 and LAG-3.

Subscribers can read Day 2 of our “Road to AACR 2016” coverage by logging in, or you can purchase access.

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Port Sunglight SpringSpring has arrived in many parts of the world, and with it I am always reminded of William Wordsworth’s classic poem, “I Wandered Lonely as a Cloud:”

I wandered lonely as a cloud 
That floats on high o’er vales and hills, 
When all at once I saw a crowd, 
A host, of golden daffodils; 
Beside the lake, beneath the trees, 
Fluttering and dancing in the breeze.

 

So what does the future hold for cancer immunotherapy?

Inspired by Wordsworth, I’ve sat on my cloud and have looked at some of the recent review papers and thought pieces published by experts in the field. Do they offer a Jerry Maguire – like mission statement: “The Things We Think and Do Not Say: The Future of Our Business” or will we have to wait till AACR 2016 in New Orleans to learn more?

 

This is the latest in our pre-AACR 2016 annual meeting series. Subscribers can login to read more or you can purchase access.

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One of the most important challenges in cancer immunotherapy is overcoming immune resistance. For example, even with the high response rates seen in acute lymphoblastic leukemia (ALL) with CAR – T cell therapy, a significant number of patients relapse after an initial response.

Chinatown Honolulu

Chinatown, Honolulu 2016

Could immune resistance be reversed or prevented by the addition of appropriate checkpoint blockade? Which ones matter though, that is the critical question?  Rather than randomly picking ones to try, we need scientific evidence regarding these choices.

This post explores some of the latest data presented at the BMT Tandem meeting on the role of T cell immunoglobulin mucin–3 (TIM–3) and PD–1 upregulation in causing resistance.

If you’re not already a sub and want to read our coverage of ASH, BMT Tandem and the forthcoming AACR 2016 annual meeting, you can purchase individual access below. This week only – inspired by the story of Eddie Aikau in Hawaii – we have a special offer that we’ve never done before (and may never do again) of $75 off a quarterly subscription. The deal ends tomorrow Friday March 4th at 12 noon HST. Check it out!

Subscribers can login to read more about the latest data on how alternative checkpoint inhibitors may have a role to play in cancer treatment.  Welcome to the new folks who signed up this week, good to see y’all!

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Vienna Torte

Which of these cakes will you choose?

Greetings from Vienna where we are gearing up for our coverage of the European Cancer Congress (Twitter #ECC2015).

We’ll be writing a “highlights” post for subscribers at the end of the day here on Saturday, Sunday and Monday, then will follow- up with more in-depth coverage after we have talked with experts about the data presented.

Checkpoint Inhibitors and Cancer Immunotherapy are not surprisingly hot topics at the meeting.

In case you missed it, this month’s episode of Novel Targets (are we really on show #6 already?!) takes us on a new branch of the journey looking at various aspects of cancer immunotherapy:

Boosting T cell production – Stepping on the Gas

In past shows, we’ve looked at unlocking the brakes (checkpoint inhibitors), immune biomarkers (MDSCs and STING pathway), an inflamed or immunologic tumour type (lung cancer), a non-inflamed tumour type (prostate cancer), adoptive cell therapies and now it’s time for something really different… what happens when we literally step on the gas with immune agonists?

That’s the theme of the latest show – listen to Episode 6 on SoundCloud or iTunes (open access thanks to our sponsors, Genentech).

This article focuses on more detailed background and show notes for BSB subscribers.

It’s an important topic that is both simple in concept to understand and yet highly complex in terms of optimising therapy.

It’s time to take a deeper dive…

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