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

Unveiling the science behind a new IO strategy

Fall forest trail

Today is one of those ‘welcome to the frontier of cancer therapeutics, where innovation meets possibility’ moments.

In the realm of cutting-edge biotech, a new IO player has emerged from the north east, charting a course to change cancer treatment for the better.

This biotech company is navigating uncharted territory, exploring novel approaches to enhance T cell interactions, with a specific focus on overcoming T cell exhaustion – a common hurdle in advanced cancers which often limits our ability to mount a sustained immune response.

Who are they and what precisely are they doing differently?

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Setting the scene

Can TIGIT stand out from the crowd in gastric cancer?

We have seen all sorts of molecules come along in gastric-esophageal carcinomas, from antibodies, ADCs, bispecifics, small molecules, even CAR-T cell therapies.  Some have been more successful than others.

As the competition heats up even in the expanding number of subniches, it’s going to take some stellar data to stand out from the crowd.

We’ve already seen several miss such as Beigene’s much touted Fc-competent anti-TIGIT antibody ociperlimab in the second line setting at ESMO23 last month, while pembrolizumab continued its onward march at the ESMO Plenary back in February.

Now we have three more earlier stage agents to look at across different modalities such as Akeso’s PD1xCTLA4 bispecific cadonilimab, Keymed/AstraZeneca’s Claudin 18.2 ADC CMG901 and Arcus/Gilead’s anti-TIGIT antibody, domvanalimab.

In our latest review, we take a look at how these agents are doing…

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SITC23 Scorecard for emerging novel IO therapies

Every year post SITC we offer a critique and short reviews with a running scorecard of some of the emerging new developments, which captured our attention.

Time for some new directions?

When going through this process some years we barely managed to find half a dozen promising yet early gems – the good news is we have ten to share plus four additional ones to be covered in separate company interviews.

So what was interesting this year – and just as importantly – why was it intrguing, and what does it all mean?

The good news is there are some really creative and fresh ideas coming down the pike replacing others likely to fade away quietly to dog drug heaven…

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Unexpected developments at SITC23

Gaslamp Quarter in San Diego

Every now and then you come across some initial phase 1 data which turns your head and makes you wonder why it is working so well in heavily pretreated patients and what’s different about its particular design?

This was my reaction last week reading a SITC abstract – I wanted to learn more about not only the molecule itself, but also the other early stage agents with different targets being presented.

And here we are because it turned out there’s some nifty reasons why it worked when a prior drug against the same target had already failed in some patients as we discovered when talking to the company in our latest in-depth interview…

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Tagging the Donkey

San Diego, California

It’s time for the infamous ASH Dash with the abstract drop today!

We’ll be posting our series of in-depth previews around various themes/tumour targets and annual trend analysis in due course.

For now we wanted to highlight an emerging approach, which may well turn out to be disruptive in certain hematologic malignancies.

The catch?  It could happen sooner than you think.

What’s more, there’s data at ASH – making this our first ASH Preview, albeit of a slightly different kind from prior years…

In our latest expert interview we learn how, why, and when this technology could change the way we treat patients and pave the way forward for a new wave of biotechs developing these products.

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Pointing the IO way

Pointing the way

A few years ago at SITC 2016, we wrote about a raft of early agents, which were then considered all the rage against a variety targets at the time…

  • Modulating MDSCs, M2 TAMs, Tregs
  • TLR agonists
  • Adding MEK or TIGIT to checkpoint blockade
  • Immune agonists from 4-1BB to VISTA
  • And so on…

While some of the trials are still ongoing, a few have fallen by the wayside and still other targets continue to receive sporadic attention.

This year’s crop of emerging agents and targets are a very different bunch altogether and the breathless hype has been replaced by much more quiet determination and optimism.

What to watch out for in 2023? 

We offer eight areas to explore and check out – most of them are up and coming small to medium biotechs focused on oncology rather than big pharma cos with money to burn…

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The Fall and Rise of Essa Pharma

Today’s post highlights the lessons learned as part of the trial and tribulations associated with oncology R&D, including a large dash from vibe of the famous British sitcom, “The Fall and Rise of Reginald Perrin.”

Madrid city centre at dusk

No matter what industry outsiders think, drug development very rarely goes in a straight line from A-Z since there are often many expected – and even unexpected – twists along the way.

The company we’re focusing on is Essa Pharma, and boy, do they have some challenges and unexpected plot twists as part of their corporate DNA!

I often hear from artistic friends paraphrasing Ursula Le Guin that it’s all about the journey, not the destination.

Except in business and especially in Pharmaland, however, it is entirely about the destination and how you get there doesn’t matter so much. After all, if a small biotech doesn’t get a product in development over the finish line (aka approval) and become a commercial success then it’s game over for everyone involved.

This is one of those kind of stories.

A tale of belief, tension, tenacity, re-tooling, and finally, renewed hope…

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Process is power

If you had to name one company who have executed well in the IO space, it’s hard to argue against Merck with their consistent and relentless efforts from the pembrolizumab clinical development program building a blockbuster niche by niche.

Dawn of a new IO era at ESMO23?

Beyond checkpoint blockade, what’s next?

Are they a sparkly one-horse wonder or are there real possibilities to build a kingdom based on rational combinations?

Not every phase 1 pipeline agent is going to make it to the next stage, never mind over the finish line to market – some folks might think of this as the funnel of shame. The indiscriminate mud flinging which follows an ‘as many shots on goal as possible’ winner takes-all-approach is limiting, however, when you realise it creates an achilles heel in strategic thinking.

Instead suppose you can build a linchpin to enable you to build on while offering a helping hand up to some of your other early products in combination? To do this you need optimised agents which play well when combined. Now you have a very different proposition while raising the bar to other competitors – who may not have similar agents with optimal properties.

In our latest company interview, we explore the progress with several of Merck’s early stage products, look from the lens of how they see them, and where they’re headed…

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Who’s waving the flag at ESMO 2023?

Plaza de Cibeles, Madrid

Our coverage of the annual meeting of the European Society of Medical Oncology (ESMO) continues with a discussion on how we might go about overcoming the development of resistance or immune escape.

In order to accomplish this herculean task we perhaps need to get better at selecting the optimal combination partners in different tumour types, rather than simply taking whatever pipeline agents are available in-house and throwing them together.

The good news is there were some elegant and unexpected successes reported over the last two days, although they were offset by a few trial oddities producing negative results.

In our latest coverage, we look at examples in each category to explore what lessons can be learned from the body of evidence presented so far…

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How bispecific antibodies are reshaping cancer treatment

Rolling into Madrid!

One of the challenges we are starting to see more attention on is what happens in later lines of treatment for advanced solid tumours, regardless of whether prior therapy involved chemotherapy, immunotherapy, or hormonal therapies.

How can we provide new options for treatment of refractory disease and help more people live longer?

Finding active drugs with both a reasonable safety profile and demonstrable solid activity in a situation with more complexity in terms of the underlying biology coupled with a much higher tumour burden has long been a challenge for many oncologists and companies.

In previous years we saw how poorly checkpoint inhibitors did in this setting compared to using them upfront and while chemotherapy is very effective at shrinking tumours, the effects are rarely long lasting.

What’s next then?

One approach involves bispecific antibodies where the tumour cells and T cells are literally dragged into closer proximity, enabling the serial killers to do their job more effectively.  They worked rather nicely in blood cancers, so why not in solid tumours?

After nearly a decade of trying out many permutations of this approach, we are finally starting to see some light at the end of the tunnel with several different agents in diverse tumour types…

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