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

Keeping an eye on the ball in AML

Every once in a while a new approach comes along in acute leukemias, which turns everyone’s head.

CAR-T cell therapies certainly achieved this in pediatric ALL, as did the FLT3 and Bcl2 inhibitors in AML before them.

What are the next potential novel developments to think about?

Recently at ASH we explored progress with the Menin inhibitors, although they aren’t the only targeted therapy on the horizon.

In our latest in-depth analysis, we turn our attention to a very different kind of therapeutic intervention, which also happens to have a potential near-term binary event to consider.

This particular review includes an interview with company executives for their perspective on a late stage clinical program…

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Pointing the way forward

Continuing our series on Kaizen in cell therapy, we now switch both angles and companies to explore a different round early stage developments.

It was clear at ASH that to some, these were perceived as a head scratcher, while for others they were considered the best thing since sliced bread in the niche, so opinions on the controversy clearly differ quite broadly!

What’s the skinny then – and why does it all matter?

Curious to learn more?

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Kaizen in action

Taken on Jan 1st 2023 – a bright new path forward?

Kaizen is the Japanese word for continuous improvement.

It’s all very well companies producing their first blockbuster in oncology, but what then?

The real mark of success in my view is being able to sustain their effort to build a life cycle management portfolio lasting over time, so in effect you generate many more options and opportunities for success over the long run.  This is much harder to achieve.

I think many folks were quite curious to see what would happen to the promising early stage Celgene pipeline once it transferred to BMS. Would the march continue beyond the IMiDs, or would it all wither and die on the vine?

We last took stock of their progress at ASH20 prior to the approvals of ide-cel and liso-cel.  In the two years since then much has happened – both on the approval front and also with the products coming along further behind.

It’s time for a look at how things are progressing, with some surprises in store…

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Tipping the TIGIT balance

Are we experiencing a sunrise or sunset for TIGIT?

TIGIT has certainly generated significant positive and negative reactions over the last few years, as it wenders its way through the Gartner hype cycle.

Sometimes people think things are much more clear cut than they actually are in practice; the complex TIGIT pathway is a great example of this fallacy.

With targeted therapies we have consistently seen the emergence of acquired resistance over time – a similar phenomenon happens with immunotherapies too as the tumour adapts in response to selective pressure.  These changes can lead to immune evasion, which means less tumour cells are being killed, leading to relapse.

We haven’t seen much data on what the mechanisms of resistance are, in part because the anti-TIGIT trials are starting to read out and it takes time to figure out what’s happening.

There’s some new data from academia to consider, which may shine a light on one potential solution as well as offering an opportunity for another NewCo to rise.

Here’s a look at the science behind the story…

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Shining the light

Shining a light

There’s always a newcomer coming out of stealth in the oncology field given the sheer breadth and depth of novel research being published in academia of late.

The latest example has a dramatic name, which made me smile. It may well have come from the ancient Greek word meaning “burning”, “blazing” or “shining.”

I’m inclined to think the last one is particularly apt, since this approach essentially shines a beacon for T cells to see their way more accurately.

So what’s the story and why is this one a potential standout?

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Moving targets

As we head into the JPM conference next week, it’s a good time to reflect and take stock of where we might be headed during 2023. It’s also an opportunity for a look forward and think about some of the emerging trends and potential hot areas of focus for this year.

Some are old (revisited), some are novel, some might be considered quirky or unexpected.

If you have time on your hands aka a plane ride to San Francisco, this might be just the ticket to stimulate your strategic thinking ahead of the hullabaloo.

In this latest review, we kick off the new year highlighting ten key areas to watch out for in oncology new product development…

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Chasing the alpha

It’s time to switch horses again and turn our attention to the final ASCO Plenary series of the year with another look at an anti-TIGIT trial.

After all the attention on the Genentech/Roche CITYSCAPE and SKYSCRAPER trials evaluating tiragolumab plus atezolizumab in combination of late, this time around it’s the turn of Arcus and Gilead to be in the hot seat.

In this latest instance they have data from a three arm open label randomised phase 2 study (ARC-7) exploring the Fc silent anti-TIGIT antibody domvanalimab plus zimberelimab, with and without their adenosine axis therapy, etrumadenant, both compared with the anti-PD-1 antibody alone in 1L NSCLC.

The results turned out to be rather controversial for a number of reasons, so let’s take a deeper look at what can be learned and why it matters…

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The evolution of blind spots in hematologic malignancies

What’s ahead – a smooth journey or a slow moving train wreck?

One thought struck me quite vividly at ASH – what is old is new again.

This certainly seems to be the case in the niche at the centre of today’s story where we explore new developments emerging in the context of both what’s happening now and also what might lie ahead.

Pharma and biotech companies are always seeking to claim their sparkly new anti-cancer agent is both novel and better than what’s available, meeting some unmet medical need and improving on prior performance etc, but is the truth a reflection of their claims or not?

Positioning, as Ries and Trout taught us all years ago, isn’t so much about what companies try to spin tell us about their product, but rather it’s how a product’s identity is perceived in the mind of potential customers – in this case oncologists – in contrast to other products in the niche.

The way the problem itself is framed also tells us much about how the company view the situation, especially when they conveniently ignore other factors in their story.

There’s a lot going on this particular example, with various types of agents, different mechanisms of action, not to mention a variety of resistance patterns emerging.

Here we explore the latest clinical and translational data and evaluate where the opportunities are going forward…

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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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Caveat emptor

ESMO IO always seems a good place for finding tricky immunotherapy datasets and this year was no different with Mirati revealing their update adagrasib plus pembrolizumab data from the KRYSTAL 1 and 7 trials.

The KRAS G12C niche is not only becoming increasingly competitive, but also more controversial as time goes by.

The recently updated sotorasib data in 2L NSCLC caused some consternation and it seems the same is true for adagrasib, although in a quite different fashion.

Here we analyse the data and the clinical direction to critically assess the near to medium term opportunities, with some red and green flags to consider along the way…

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