Biotech Strategy Blog

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

Posts tagged ‘venetoclax’

Next generation of T and NK cell therapies

Taking a leaf out of Wayne Gretsky’s book, we’re continuing our theme round seeking to be inspired and highlighting another batch of early developments, which may offer promise in the future.

Don’t skate to where the puck is – skate to where it will be.

Some of the best innovations come about because scientists think deeply about the challenges and issues preventing therapies from working as they should and ignore dogma in their pursuit of innovation.

These may not necessarily be the most popular approaches of the day, yet they can yield satisfying rewards down the road. In fact, I’d argue it is often the few who go an entirely different way from the crowd who end up being successful in the long run.

In today’s post we highlight some of these enlightening developments, as well as others following solutions looking more obvious at first glance, yet could stumble down the road…

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Adding up the evidence

Is the emerging early stage myeloma landscape as bleak as Titan in Clydebank?

For years we have seen much of the therapeutic research in multiple myeloma concentrated on three main categories:

  • Proteasome inhibitors
  • IMiDs
  • Anti-CD38 antibodies

Then came a raft of anti- BCMA and GPRC5D targeted approaches in various forms, but what else should we be looking out for?

It turns out there’s quite a few contenders of interest – we cover some of them in our latest look at early stage compounds to watch out for…

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Thinking outside the Box

Innovation at the cutting edge, cube houses in Rotterdam designed by Piet Blom

Continuing our CAR-T cell therapy mini-series, we take a look at how some creative preclinical studies helped uncover a new mechanism of resistance to CAR-T therapy.

This then led to a novel enhancement or tweak in the engineering of the CAR-T cells in order to make them resistant to being killed themselves. These twin findings could lead to the enhancement of performance in the clinic for patients needing such treatment.

If we want to help more lymphoma patients get to the 6 month mark and beyond then we need greater understanding of the underlying issues combined with practical thinking skills.

In our latest expert interview, we discuss an innovative new cell therapy approach with an unusual strategy currently in preclinical development, which is heading towards the clinic …

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On the prickly issues facing the Menin inhibitors

Spotting some red and green flags in a subset of AML patients

In the battle of the Menin inhibitors in advanced AML, it’s all too easy to forget we are currently looking at early dose escalation data in the rush to declare one company is a winner or a loser in the category.

I repeat the same thing every time this happens – the goals of any phase 1 trial are nearly always the same, namely safety, MTD, DLTs, and the establishment of the recommended phase 2 dose (RP2D).

Anything else is incidental, including initials signs of activity.

This is precisely what phase 2 trials are for based on a selected dose where responses have been observed without too many serious adverse events.

Despite this obvious caveat, people will look at results and make conclusions based on skimpy data.

Here we highlight some important subtleties, nuances, and caveats to think about as the clinical development plans move forward for both Syndax and Kura Oncology.  Of course, there are other competitors always snapping at their heels, so don’t make the obvious mistake of assuming it’s an either / or situation at play…

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The Forgotten Checkpoints

Time to shine the light on alternative checkpoint targets

The annual meeting of the American Society of Clinical Oncology (ASCO) is always a great place to find hidden gems or off the radar molecules.

This year we’re going to highlight progress on two closely related IO targets to illustrate how perceptions may change from the pummelling several of them received at SITC a couple of years ago.

There’s always a danger in writing off initial very early and immature data based on a limited number of allcomers in relapsed/refractory solid tumour trials, where the focus is more on dose finding and safety signals before proceeding to more clearly defined tumour types in expansion cohorts.

Three or four years on, how are these hidden niches doing and what can we learn from the data to be presented?

To find out, we took a dive unto the breach…

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10 early phase ASH19 abstracts with a difference

ASH19 Targeted Therapies Preview: This year’s ASH in Orlando is very much dominated by new developments on the immunotherapy front in terms of both T and NK cell therapies, with some passing interest in BTK inhibitors as well.

It’s not always sunny in Florida…

What about targeted therapies and the science behind those developments?

It was not that long ago that these were the main lifeblood of the meeting across many, if not most, hematologic malignancies. How times have changed!

That said, outside of the CARs (T and NK cells), as well as bispecific immunotherapies, and BTK inhibitors there are still some gems to be found amongst the rest of the ASH19 abstracts.

Here we highlight an additional 10 abstracts involving early pipeline areas that encompass some novel targets, new combination approaches, or emerging science.

Please note that the novel targets can take the form of classic targets or IO ones since they didn’t fit in the prior ASH Preview topics already reviewed under separate cover…

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The science behind the venetoclax clinical trial strategy

Buried amongst the intense hurly burly of a major medical meeting such as the American Society of Hematology (ASH) are the unsung preclinical researchers whose work largely makes clinical development possible. After all, few sensible companies would bet on an expensive clinical trial program, especially in combination, without first knowing whether such an approach is rational or not and has a decent shot of working efficaciously.

At stake here is the potential for building a blockbuster cancer drug niche by niche.

Venetoclax (BCL-2 inhibitor) got off to a somewhat slow start compared to say, ibrutinib (BTK inhibitor), which had a much broader initial indication and a lower risk of tumour lysis syndrome (TLS), yet it may actually have a wider application across multiple hematologic malignancies. This could well end up as one of those classic tortoise versus hare stories in the long run.

Back in 2013, we posted five interviews conducted with a range of experts including:

  • Dr Oliver Sartor (prostate cancer)
  • Dr Susan O’Brien (CLL)
  • Dr Deepak Sampath (BCL-2 and ABT-199)
  • Dr John Jenkins (then deputy director at the FDA)
  • Dr Renier Brentjens (CAR-T cell therapy)

To put this in context, consider that we just recorded 15 interviews at ASH this year alone!

As regular readers know, we like to follow people and R&D stories over time, so while in Atlanta at ASH17 we took the opportunity to move a particular story forward – we wanted to learn where Dr Sampath and his colleagues are now and also where they are headed next. This gives readers a head start on anticipating what future clinical developments might be mentioned at JPM18 by either Genentech/Roche or AbbVie.

In our latest expert interview, we pick up and continue the discussion with Deepak Sampath to find out what’s happening with venetoclax four years on… it turns out quite a lot and makes for very interesting reading indeed.

Dr Deepak Sampath (Genentech)

Curious to now more about what this scientist and his work in BCL-2 targeting is all about?  Check out this short excerpt:

 

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ASH17 Will MURANO impact the CLL landscape?

As we continue rolling out our ASH coverage, we now move on to the in-depth analyses and thought leader interviews post meeting… What do experts really think about the critical questions that arise from new data? What is practice changing versus a nice to have in a small subset of people?

Someone said to me recently, “You seem very picky about who you interview. Why’s that?”

You betcha we are!

ASH17 in Atlanta

There are hem/oncs, thought leaders, and true experts whose opinions we value and know are solid and fair balanced in their commentary. There are also others who have major COI and will say whatever needs to be said about a particular individual study they are involved in, but are not reliable in a strategic perspective of the broader landscape or the impact of a study in terms of future trends.

I’d rather talk to people in the first category and learn from them – they don’t have to know everything or even agree with our own viewpoint, but they do need to be independent and fair balanced.

In the first of our ASH interview series, we posed some tough questions to a CLL expert and here’s a snippet on what he had to say:

Hah, at least we are thinking along the same lines!

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Top 10 #ASH17 abstracts to watch out for

No ASH pre-conference coverage would be the same without a shout out to Dr John Leonard (Weill Cornell). For 10 days prior to the annual meeting he counts down each day with a lymphoma study that caught his attention and tags it #LeonardList. The first one went up yesterday:

Do follow Dr Leonard and his lymphoma selections on Twitter – there are usually surprising ones in the middle that are quirky or interesting that makes you stop and think more carefully.

Our #ASH17 series we have already covered aggressive lymphomas and also developmental therapeutics.

Atlantic Olympic Sculpture

Up next in our third ASH17 Preview, we take a broad look at the wealth of abstracts available and highlight ten key presentations, irrespective of tumour type, which readers should be watching out for.

Some of these ‘Champions’ may not be immediately obvious and include interesting preclinical findings, intriguing new products in development, as well as eagerly awaited mature data from recently approved therapies. It’s an eclectic mix, to be sure.

There are definitely some early trends and interesting new molecules emerging from company R&D pipelines that are worthy of further consideration in this year’s batch of abstracts.

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ASH Preview 2 – Developmental Therapeutics

One of my favourite areas to follow in oncology research is Developmental Therapeutics, whether they be targeted, genomic, epigenetic or immune therapies. At some point, even currently approved products started off life in this category, either in preclinical research or in early phase 1 trials.

It’s almost like a primordial soup from which future pipelines spring.

Following these initial approaches over time can be useful in many ways – you can pick up new trends and emerging drugs earlier than most, and can also step back to see a broader picture of the landscape as it evolves.

While there are no formal developmental therapeutics sessions at the American Society for Hematology (ASH) annual meeting per se, that doesn’t stop the intrepid scientist from creating their own selection, in fact it’s a lot more fun this way!

That’s exactly what I’ve attempted here…

Be warned though, this year, the mix is much more complex and intriguing with a lot of interesting and, in some cases, novel targets to explore and consider, including the deeper and tricky protein-protein ones to hit, which are now receiving more attention as researchers find more creative and indirect ways to tackle the problem.

Our second ASH 2017 Preview goes deep into what for many BSB readers will be intriguing, yet for others… completely unknown.

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