Biotech Strategy Blog

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

About MaverickNY

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Posts by MaverickNY

Expect the unexpected

While there has been much speculation and rah-rah over the supposed demise of oral therapies thanks to the introduction of the Inflation Reduction Act (IRA) of 2022 including the Part D Redesign, I’m increasingly finding important developments on the targeted therapies front to watch out for.

In the third part of our ongoing mini-series on the PI3K and PIK3CA landscape we’re going to switch to a different example in this niche.

There are some key clinical data due out later this year, which ought to bear watching out for.

The question though, is why – and what ought we to be thinking about in a broader context?

Our latest article reviews the science, the players, the drugs, and explains how we got here…

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Piking the winners and shipping the new combos

Picking the winners in the race

In the second part of this mini-series on an important oncogenic target, we’re going to explore some topics around the theme of coalescence.

This means we can look at how do cancers hijack multiple pathways or co-opt critical cell growth related genes to help drive their own growth, proliferation, and survival.

If we understand the processes involved then we can start thinking about what we can do to interrupt or shut them down then develop relevant therapeutic strategies to tackle them.

Additionally, several targets have now been made druggable where they were considered intractable when this pathway axis was at its peak.  This may offer some fresh opportunities for progress in ways which were not feasible before.

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The perils of misreading oncogenic signalling

The moon   Credit: NASA

There was a frustrating point during the development of today’s target focus when one harried researcher turned to me and drolly noted,

“It’s like trying to go to the moon with just a plastic rocket on hand!”

You could see where he was coming from… we had a oncogene, some nice preclinical data, numerous approaches to tackling the target in the clinic and yet none – not one of them – were panning out as expected.

Failure after failure hit the niche, not all for the same reasons…

Too toxic, not enough activity, narrow therapeutic window – it was all there and not all of the issues were predicted in preclinical experiments either.  Some observers even began to question whether the target was in fact, a valid oncogene.

Then came some success and the floodgates opened.

These days we know a lot more about what works, what doesn’t and where things are headed.  We might not be going to the moon yet, but things are headed in the right direction.

In the first of a four-part series we take a look at the troubled waters and learn how the situation was rescued by a few smart scientists and companies invested in finding the right cell/right compartment to aim at…

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Does a Gaudy Night for GSK stand up under scrutiny?

Many moons ago the famous English writer Dorothy L. Sawyers wrote a series of novels about an aristocratic amateur sleuth called Lord Peter Wimsey.

When Wimsey attended the Gaudy dinner at Harriet Vane’s Oxford women’s college, the last thing he expected was to get caught up in a murder mystery.

Similarly, we might well wonder if the FDA will be surprised to see GSK, the sponsor of belantamab mafodotin, show up with a re-submission filing in multiple myeloma in an earlier setting several years on, especially since the toxicity profile hasn’t changed.  

In our latest data takedown we explore whether the findings hold water or not, including some expert opinions on the DREAMM-7 readout…

 

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Exploring novel targets and modalities in advanced cancer

New waves or on the rocks

It’s not that long ago when a certain tumour type saw several waves of promising new agents emerge, quite a few of which made it past the finish line and commercial approval.

These included novel drugs, fast follow-ons, and even me-toos.

The next batch in new development pipelines were not so lucky with a series of disappointing phase 3 misses.

Then radio silence ensued.

As we take another look at this niche, there are a number of early stage agents being put through their paces – small molecule inhibitors, protein degraders, bispecifics, immunotherapies – they’re all there.

Are we going to see some new waves or will they crash and flounder on the rocks?

To find out, we delved into the latest data to determine the current status…

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Look for what is missing

A beautiful crystal structure at the heart of these pipeline agents    Source: Alphafold

All too often in oncology we look for where there is too much of something such as oncogenic signalling.

Rarely do we actually look at what is missing – and I don’t mean in the context of protein loss like tumour suppressors.

In this case, there is yin and yang at play in terms of R&D. The good old Chinese philosophical concept of dualism is a handy analogy for today’s drug development story.

As one leading big pharma drug in a particular class slinks away quietly – almost unnoticed – to dog drug heaven, another candidate from a small biotech is marching almost stealthily towards the clinic in 2024.

There’s a catch though – while they may share a common target, the fundamental mechanism of action is an entirely different one!

What this means is we may now need to consider additional potential opportunities and complications likely not present with the existing class of agents already in the clinic…

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Pointing the way in AML

Pointing the way from Balboa Park

We held off from discussing the Menin inhibitors in AML at ASH last month because we were waiting for Kura’s update in the relapsed/refractory and upfront settings, as well as their initial combination data.

Now is a good time to take another snapshot in time.

The good news is there are some initial data reported on the first twenty patients in Kura Oncology’s KOMET-007 trial, which includes a mix of Menin-naive, previously treated patients who have received Menin inhibitors, as well as those the front-line setting who received combination treatment with standard chemotherapy.

When looked in the context of the prior data, an intriguing body of evidence is now emerging in this space, where a raft of other competitors are also rapidly emerging to compete with Kura Oncology and Syndax.

I came away with a number of impressions from the webcast, here are our takeaways…

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Balderdash and Poppycock!

Dark storm cloud warning!

Every now and then we see in Pharmaland what I call ‘the dark storm cloud warning’.

This where things are obvious when you later look back on a small biotech company’s representation of their data and realise the information was right there front and centre for all to see, yet few took note at the time.

Why not?

Likely because you wanted to like something positive and cheering, much like the classic orange beach hut or the whiter clouds to the right in the photo shot on Miami Beach in pre-pandemic days.

Or like the surfer guy in the foreground blithely heading off to the waves, board in hand, seemingly oblivious of the incoming storm from the left – it was quite something that day, let me tell you.

This review is one of those examples…

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Kicking ADCs up a notch

Orchid at Vizcaya Museum in Miami – always thought they looked like chemical structures showing us the gaps!

We highlighted a number of different types of antibody drug conjugates (ADCs) recently – yes, there’s much more to this category than simply dropping a chemo cargo on cancer cells!

In this review, we explore one of those flexible functionalities in more depth.

The cool thing about having an antibody base is creative chemists can bolt different things onto them, depending on what their goal is.

There are some really cool technology ideas being explored in research right now, which may improve not only what we can do with ADCs but also another modality.

If we think of the ADC as a modern day Trojan Horse to hide or mask the real payload in some way, the possibilities become limited only by our imagination.

The good news is there’s more than one example of this new genre to explore…

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Shining a beacon

Shining a beacon on key GI trials

After covering a lot of science of late it’s now time to review some recent clinical data, discuss some of the implications of the findings, and their potential impact.

After all, science doesn’t exist in a vacuum and how it translates into outcomes in people living with cancer is an important part of the process.

Can we help them live longer and feel better are two important questions to ask when looking at study readouts.

Let’s not forget there’s quite a difference when considering the exposure of light from a lighthouse beacon versus a typical torch.

The former is designed to produce an extremely powerful, far-reaching beam that can propagate over long distances. A torch has much more modest lighting capabilities suitable for short-range use. The exact brightness difference depends on the specific lighthouse and torch, but it can reasonably be assumed the lighthouse beam is orders of magnitude more intense.

In a similar fashion, we need to look at phase 1 and 3 trials through different lenses, just as we ought to do with the potential 14th agent to market versus the first…

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