Biotech Strategy Blog

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

About MaverickNY

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Posts by MaverickNY

ESMO24 Preview 2 – Hurdles and Prospects

The Basílica i Temple Expiatori de la Sagrada Família in Barcelona

I’ve always found Gaudi’s gothic cathedral in Barcelona beautiful and inspiring inside despite its ugly gothic facade.

The way the light and space combine to produce a sense of awe and wonder is a nice way to forget the trials and tribulations in the outside world.

In our latest ESMO Preview we look at a particular niche, which has seen many changes in its landscape over the last few years, including some ugly data as well as areas giving greater hope for investigators and patients alike.

This year looks like continuing both trends in equal measure…

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ESMO24 Preview 1 – ADC challenges and opportunities

What’s on the other side of the window in Barcelona?

With the initial ESMO abstract drop, it’s time for our first Preview of this year’s conference from Barcelona.

Spain as a venue is rather apt considering they just won the European finals against England in Germany.

They have a thrilling and highly talented young side, is the same equally true of early stage drug development?

Part of the fun of the first ‘data’ drop is there are no data since only the titles are available for the following:

  • Mini orals (95 abstracts)
  • Proffered papers (60)
  • Regular posters (1742)
  • Trial in progress posters (97)
  • Posters (1589)

We usually cover a wide variety of topics over the summer, so it’s time for the first one on deck – let’s roll!

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Novel strategies for taking on advanced cancers

Signalling intentions… Tall Ships Race 2024 Turku, Finland

It’s an unfortunate truth very few currently available cancer therapies are capable of inducing durable complete responses in people with advanced solid cancers.

This is largely due to challenges such as tumour heterogeneity and acquired resistance or immune escape.

How can we change this situation for the better?

There are only so many targets to go around and existing modalities have their limits, thus what we need is some more innovative and creative strategies.

In this post we hone in on two such examples to explore what they and how they might make a difference…

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Red and green flags for RevMed’s RMC-6236

Is everything as bright and sunny as it first appears?

One of the many challenges associated with oncology R&D is picking out the red and green flags associated with early stage trials in order to handicap phase 3 outcomes.

The road to success is paved with many failures along the way.

KRAS has been a hot topic for a while now, yet much of the initial enthusiasm has finally been tempered of late thanks to shorter outcomes than some folks expected with the first generation of targeted therapies – with monotherapy no less!

It’s all too easy to forget KRAS was widely considered ‘undruggable’ or intractable until recently. This doesn’t mean the agents in this space get an easy pass though, far from it.

With new data now out on the first RAS multi agent in the clinic, what’s the story behind the results and what should we be looking for or wary of?

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Postcards on early oncology drug development

Mailbox by the Polar Museum, Trømso

It is the dog days of summer in many places, and as thoughts turn to vacations and time away from the office it seemed a good idea to write five postcards around topics catching our attention in the science and biotech/pharma news this past week.

Issuing a press release on a phase 3 trial on July 4 in America is never a signal of good news and in this post we’ve some analysis and commentary on why the trial was doomed from the start and what lessons companies can learn from it.

For scientists among our readership we also have some thoughts on potential new targets and for those in translational research,there are some early data readouts to contemplate, as well as some heartwarming news to finish.

The postcards also span a variety of topics from CAR-T cells to epigenetics, IO, and protein degradation.

Happy reading!

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Ghosts in the Clinical Machine

With considerable attention having been placed on RAS(off) inhibitors and growing interest in the dual RAF/MEK agents and on/off state agents from Nested Therapeutics, Frontier Medicines and Quanta Therapeutics, respectively, it’s all too easy to forget about the RAS(ON) inhibitors.

Meanwhile Revolution Medicines have trodden a different path and focused their efforts on targeting the active state of KRAS.

With clinical data likely coming up soon, we take a look at some of the science behind the curtain to see what to watch out for, including some red flags…

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Sorting out the clunkers in a crowded field

Early last year I started tracking and coding the various elements as new ADC agents began emerging post JPM23 from various conference presentations and BD&L activity. I quickly ran out of colours!

A couple of trends quickly became apparent.

Big Pharma – needing to replenish pipelines – were gleefully snapping up topoisomerase-based ADCs and Asian countries who had a seemingly bottomless pit to supply their pent-up demand were the main beneficiaries.

Bergen harbour – where elegant ships and rusted clunkers rub should to shoulder

There are a number of reasons why this may not be the best idea in terms of R&D, however.

Some of them may do well, while many will turn out to be clunkers and likely fail.

This latest gold rush is not going to end well for some players and there will be many tears before bed time once everything shake out.

Today’s story adds some more evidence to the mix for consideration…

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Making mountains out of molehills

Early stage oncology new product development is a rather strange beast at times.

On the one hand is the tendency of small biotechs to over inflate their datasets or cherry pick subsets to try and make them more impressive than they really are…

And on the other is a real challenge in trying to pick out a clear signal from the noise.

In our latest review there are some cautionary examples from both extremes, as well as some intriguing novel targets to look at.

Some of these require zooming out for a better big picture perspective, while others deserve to be put under the microscope more critically.

These latest examples span the gamut from bispecifics and CAR-T cells to degraders in a range of hematologic malignancies and solid tumour types…

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When changing direction trials and tribulations are inevitable

One of the many challenges of going in new directions with targeting proteins in a totally different therapy area is things do not always progress as expected or hoped.

For some the journey is a smooth one, for others the path to success can be considerably bumpier.

In today’s story we look at different examples in the context of how drugs originally developed in oncology may also potentially have a key role to play in metabolic diseases.

Going from preclinical to clinical development is never easy, as these examples illustrate…

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The trouble with crowds

How do we go about distinguishing one therapy from another in an emerging niche?

It’s been fascinating to see many companies in the IO space trying to pivot from oncology to autoimmune disease, regardless of whether they have a CD19 or CD20 T cell bispecific or CAR-T cell therapy.

Someone presents some initial evidence of activity and suddenly, Bingo!  Everyone else rushes to try it out too.

It reminds me of those old medical jars at apothecaries in the 1700-1800s, like the one in Imola (right), which still stands today.

How do we pick out one from another though?

The obvious answer is… it depends.  On the data collected by disease setting, the line of therapy, disease burden, and so on.

This is going to take some time to gather before the dust settles.

In our latest review we chose eight different approaches and put them through their paces for a careful look at the evidence.

Did anything stand out?  Yes, it did…

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