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

New opportunities for Menin inhibitors

Tree of Hope

Some recent research in a specific area has provided some helpful and stimulating findings, which may lead to some unexpected combination trials in the future.

We all know cancer is best beaten with combinations and regimen approaches, but a key question always remains the same no matter which company is doing the R&D – which are the best options to evaluate together given the limited time, resources, and budget available?

Even large pharmas cannot explore every single possibility.

Suppose a company has the luxury of five early stage agents either in-house or available to them in a partnership. This would give 10 potential phase 1 doublets they could evaluate. If we include triplets as an option then we can add a further 60 possibilities on top.

It might sound like a tree of hope, yet these are unrealistic scenarios because few companies will run 70 phase 1 trials just to figure out the optimal regimen to go forward with in a phase 3 study. In fact, I seriously doubt if anyone would seek to attempt this number in mice studies either!

Despite all the misgivings people have about translating preclinical data to humans with advanced cancers, we often need to be reminded to keep our feet on the ground.

It’s not a matter of alchemy where chemists and translational researchers seek the ’elixir of life,” or a pill that would cure all cancers. Instead we have to use some common sense based on what we know and how things might shake out.

In today’s post we look at what some future combinations might look like and who the key players might be…

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And the relentless ADC march goes on…

Are ADCs the new smart bomb or likely to blow up company pipelines without a bye or leave?

We highlighted a number of issues and challenges facing the ADC field in our first ESMO Preview last month.

I really wasn’t expecting to be covering the topic again before the conference next month – how wrong I was in this assumption!

This is an active niche with much going on from one month to the next.

Thie thing is are the next generation versions going to blast through sufficient cancer cells with less toxicities than before or are they going to blow up a few early stage pipelines instead?

After all, it’s easy to forget more early stage agents will fail than succeed.

What kind of features ought we to be looking for and what can we learn from the latest round of company announcements ahead of the ESMO meeting next month?

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Riding the next IO wave or a damp squib at ESMO24?

Old Post Office in Barcelona

We’ve reached the point in the oncology R&D conference season where it’s hard to predict the outcomes of quite a few trial readouts.

Some folks might well reckon a correction is needed while others are focused one future.

Either way, we put a baker’s doxer of studies under the microscope to see which ones are destined for good data while others crash and burn.

Which agents fall into into which category?

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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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