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

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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A delicate balancing act

Kostis Georgiou: Eutopia and Corpus aluminium sculptures

One of the biggest challenges with drug development in many advanced cancers is finding the sweet spot between safety and activity…

And hoping it will be a wide one!

It’s a particularly delicate balancing act in hematologic malignancies, however.

In our latest review we explore an up and coming niche in acute leukemias and look at how well companies are doing, including some new and early entrants…

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New directions in a post IO apocalypse

New directions can take many forms when it comes to oncology these days

It’s been an interesting exercise of late to watch how companies in the oncology arena have been planning and tackling both their new strategic five year reviews, as well as upcoming patent expiries.

If they want to maintain or even improve on their current growth rate then they have to set out a realistic plan for the future.

Some have come across as panicked and unconvincing with that ‘deer in the headlights’ look, while other come across as calm and

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Bicycling to new heights

Tadej Pogačar in the Giro D’Italia TT 2024 in Foligno  Source: Blue Ice Publishing

The leader of the Giro d’Italia wears the iconic pink jersey or Magli Rosa.

Not only is it appropriate for cancer research, but we think a long distance cycle race has a lot in common with cancer research – think about racing in stages, in a dynamic environment, and overcoming adverse conditions.

In this post we take a closer look at an aptly named company Bicycle Therapeutics through the lens of an interview with their CEO, Dr Kevin Lee.

We also take a closer look at the science and what strategic opportunities their novel designs may offer.

Will their Bicycle Toxin Conjugates and Bicycle Radio Conjugates take the cancer new product development to new heights and end up being the “race” leader?

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Degraders and glues – time for a pitstop

With all the noise and attention on marquee trials involving targeted therapies and immuno-oncology at cancer conferences lately, it’s all to easy to forget about numerous early stage developments making stealthier progress.

In this review we highlight another half a dozen such developments, which may be worth taking note of.

Not all of them will successfully make it to phase 3 trials so what can we learn about the latest available clinical data?

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Revving up for next generation IO agents

Are the new crop of early IO agents revving up to go or are the wheels coming off already?

Early stage product development in oncology is fraught with many difficulties once it gets into first-in-human testing in the  clinic.

Balancing activity and toxities to finesse the therapeutic window is just one of the challenges to consider during dose escalation trials.

There’s also figuring out where these agents might perform best, in which line of therapy, with which combination partner, or how about the optimal dose/schedule?

In this review we explore half a dozen new products with different targets and modalities and put them through their paces.  What does the analysis tell us?

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