Biotech Strategy Blog

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

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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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Tilting at windmills

Sometimes I wonder when we are faced with particularly difficult challenges in oncology – there are certainly plenty of these to go around – if people give up before they start and consider certain endeavours far too difficult and thus any emergent approaches are considered tilting at windmills.

What if we could isolate and define the problem more specifically, thereby identifying where new targets might lie and then go about designing ways to tackle them?

When we do this the problem at hand is much more specific and less amorphous.

Here, we highlight and explore a key topic likely to be lurking in many abstracts over the next week across both hematologic malignancies and solid tumours alike… it’s an important subject many will ignore at their peril.

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Emerging biotechs and novel IO concepts to watch out for

There are plenty of innovative and creative ideas coming to the fore in oncology R&D of late, many of which are quite different twists on what we currently have available.

Early oncology development is rarely plain sailing – some fly like the wind, others fall over

As Dr Dan Chen of Engenuity noted in his talk in the SITC22 preconference session on lessons learned from IO combinations, if we want to cut to the chase when looking at emerging agents then we need to ask ourselves whether any of the concepts are seeking to address the limitations of the current products, particularly those associated with either primary or secondary immune escape.

After all, repeating the same old, same old is probably not going to move the needle in any meaningful way.

In thinking about which biotechs to pick for the annual SITC review, I also asked myself a couple of additional provocative questions – how are they distinguished from the competition, and in what way are they particularly compelling?

We’ll discuss these as we go through the selections, which includes both some solid developments as well as others we ought to be much more wary of offering too much hype over hope…

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Dancing with Cancer Cells

Spotting the Baubles amongst the Glitter

Readers in the UK who follow the BBC show ‘Strictly Come Dancing’ will know this Saturday night the show returns to the iconic Tower Ballroom in Blackpool.  All the contestants wanted to make it to this stage of the competition.

To put this analogy in context, an oncology equivalent might be the prestige of giving an oral presentation at a major medical meeting, it’s something you definitely remember and want to do!

There are many metaphors related to dancing that can apply to cancer research e.g. we’ve heard one leading researcher describe how immune cells and cancer cells ‘dance’ together.  As they say, it takes two to tango…

How new products ’embrace’ and interact with cancer cells, their receptors and binding sites can be key to therapeutic success. There are a variety of ways to do this, one of which can lead to cancer cell death via synthetic lethality, a concept we’ve covered extensively over many years going back to the emergence of PARP inhibitors in 2006.

In this post, we’re taking a closer look at an emerging biotech company, their drug discovery pipeline, and some innovative targets that may enable their new drugs to better ‘dance’ with cancer cells in a way that interrupts their routine, and ultimately, leads to their death.

Keep on dancing!

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A novel molecule may lead to the Secret Garden

One of the joys of oncology research is that it’s data driven, which means companies can quite clearly see how others have fared, and where the gaps and opportunities lie for new product development.

There is always the potential to unlock the gates to the “secret garden,” whether it be targeting a tumour type previously considered intractable, treating an unmet medical need where there are few or no effective therapies, or in the case of immuno-oncology, manipulating the tumour microenvironment in a way that leads to an improvement in the long tail of survival we’re all looking for.

In addition to improved outcomes, you also need a safety profile with a favourable benefit/risk ratio, where there aren’t intolerable or life changing side effects or an increased risk of death. Who said it was easy?

Innovation takes many forms, and in this post we’re looking at how one biotech company may have unlocked the key to a secret garden through the optimised design of their molecule.  As always, it’s early days although it’s good to see companies looking to solve hard problems because the easy low hanging fruit wins in immuno-oncology went a long time ago.

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Leaves of grass

Fall leaves in Boston

Autumn (or Fall for our American readers) is a time of cyclical renewal as old leaves die off and fall by the wayside to make way for new growth to emerge.

It’s the same process in oncology R&D pipelines too; by 4th quarter earnings reports we start to see Product X or Y being officially discontinued/abandoned, or sent off silently to dog drug heaven without even an epitaph to claim.

What about the promised new growth opportunities or targets?

Well there are various cancer conferences either happening now or coming up, which should offer plenty of signals for hope amongst SITC, EBCC, SABCS, ESMO IO, with ASH signing off the final coverage of the year.

In our latest report, we highlight some key presentations to watch out for not covered in the earlier SITC previews.  Some look encouraging already, while others – in all fairness – may have some unexpected question marks to consider…

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