Blog | Biotech Strategy Blog

Cat amongst the pigeons

As we head into the data tsunami coming out of ASCO this weekend, it’s time to reflect on what Merck’s endometrial win with sacituzumab tirumotecan (sac-TMT) this month means for the broader ADC landscape.

The implications of this finding may well go far beyond the obvious.

In our final ASCO preview, we offer up some pointers and clues as to where things might be headed, with a few potential surprises in store…

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Reflections on potentially practice changing trials

Today is the big day the embargo on the ASCO 2026 regular abstracts lifts.

In our fifth Preview – you can read all of our ongoing coverage here – we take a look at some of the late stage developments to watch out for.

Reflections from Chicago

While there are the inevitable hits and misses, one aspect which will likely get lost in the noise is there are practice changing data coming out, which will raise the bar for future entrants.

Think about those studies merrily moving along only for the standard of care to change midway through.

For companies involved, this can be the stuff of nightmares. Sure you can argue with FDA about the standard of care at the time of the trial initiation, but commercially it can turn into a whole different ballgame if onologists become wedded to the new regimen and cannot envision how yours fits in.

Loss of relevancy can had a large impact on how well your product does in the marketplace.

2026 will go on record as one of the richest and deepest years for phase 3 trials across multiple tumour types at ASCO over the last decade, and I don’t say this lightly. Let’s take a look at a selection of some of the key examples coming up in Chicago this year…

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What if the first target was the problem?

The next wave may tell us whether the idea was wrong.

Are naked antibodies back in fashion?

Some areas of oncology acquire baggage. Macrophages have become one of them; a field where many people instinctively roll their eyes before the sentence is even finished.

Too much promise, too much money, too many elegant hypotheses, and not nearly enough clinical vindication. What followed was a bruising reminder of how elegant science does not always translate into a workable therapeutic window.

For many biotech observers, the whole niche still carries the faint whiff of a story expected to work better than it did in practice.

The question is whether the field picked the wrong target to prosecute first because other cleaner targets are now beginning to emerge…

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Beyond the Dance: Eric Vivier on rethinking the NK cell paradigm

Eight years ago, during our last sit down interview in 2018, Professor Eric Vivier used a beautiful metaphor to describe the cutting edge of innate immunotherapy; NK cells and T cells were “dancing together.”

Eric Vivier is a Professor of immunology at Marseille University, co-founder and former CSO of Innate Pharma, and currently President of the Paris Saclay Cancer Cluster. He is one of the world’s leading and most cited scientists as an expert on NK cell biology.

Back in 2017-2020, the biotech industry was riding a wave of immense hype around natural killer (NK) cells. The promise of a safer off-the-shelf alternative to CAR-T had investors flooding the space with capital.

Fast forward to mid-2026 and the landscape looks radically different. The field has hit what many call a strategic stall, marked by high profile clinical setbacks in solid tumors, persistent manufacturing hurdles, and the realisation NK cells are evolutionarily designed as rapid sprinters rather than marathon runners because their short half-life is not ideal for sustained cancer control.

Several CAR-NK cell therapy companies have gone by the wayside. So where is the NK field at, and where will it be in five years time?

Speaking with Prof. Vivier just after his educational session at the 2026 AACR Annual Meeting in San Diego, he shared his vision on how we need to rethink the NK cell paradigm…

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Putting the boat out at ASGCT26

Over the last couple of years we have seen a number of oncology CAR-T cell therapy companies who were either late or slow in clinical development pivot to autoimmune disease, especially after the proof of concept offered in refractory systemic erythematosus lupus (SLE) and lupus nephritis by Prof Georg Schett’s group in Erlangen.

On the lookout

On top of the autologous and allogeneic products, we have also seen a variety of in vivo approaches emerge in both oncology and autoimmune indications, often involving some form of RNA based approach with a lipid nanoparticle (LNP).

Several of the companies in this space have already been snapped up by big Pharma, including Capstan Therapeutics (AbbVie), Orna Therapeutics (Lilly), Esobiotec (AstraZeneca), and more recently, Kelonia Therapeutics (Lilly).

So who are the next tranche of companies coming up behind them we should be looking out for and how are they shaping out with the latest round of data reveals?

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Late line RCC: where darlifarnib fits and why LITESPARK-012 matters

We’ve been following various new developments in clear cell renal cell carcinoma (ccRCC) for a while now with the emergence of the HIF2α inhibitors belzutifan (Merck via Peloton), and more recently, casdatifan (Arcus Bio).

Musee D’orsay Paris, France

At the recent International Kidney Cancer Symposium in Paris, Kura presented updated phase 1 data for their next generation farnesyl transferase inhibitor (FTI) darlifarnib (KO-2806) combined with cabozantinib in ccRCC.

The response rate turned heads – 44% in patients who had already been treated with cabozantinib. It needs to be considered as an emerging signal since these data are still very early, the patient numbers small, and there are some important questions the poster cannot yet answer.

In this review, we take a look through the window at what the phase 1 data actually tells us and where the RCC field is likely heading in the near to medium term given other related and recent developments…

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The goalposts shifted in Berlin, your trial timeline didn’t

Molecule Man in Berlin is a landmark event

There’s a particular anxiety keeping biotech executives awake at night; watching your phase 3 trial run behind while the field keeps moving the finish line.

ESMO Breast 2026 is a reminder of why this anxiety is rational.

The latest clinical data presented in Berlin paint a picture of a field in motion. If your company is developing a breast cancer therapy, understanding these shifts isn’t optional.

Here’s what’s happening in Berlin and why it matters…

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Pointed ironies: SERD wars, ADC hype, and what really works in breast cancer

The rejection of camizestrant at ODAC last week was sharp and pointed.

Sharp Samurai swords. Source: Kyoto museum

Vepdegestrant’s FDA approval a day later was even sharper.

AstraZeneca challenged the paradigm, catching ESR1 mutations early via ctDNA in patients without radiographic progression, shifting treatment while still on the CDK4/6i backbone.

Arvinas played it safe with a more traditional 2L setting, but ended up with a lower PFS than what was already approved. The irony cuts both ways.

Welcome to the contradictions defining the breast cancer landscape where regulatory logic collides with clinical biology, and boldness gets punished while unremarkable gets the nod.

As we head into American Society of Clinical Oncology (ASCO) annual meeting, it’s time for another preview as we look at what stands out and which agents are emerging…

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A study in regulatory conservatism versus clinical innovation

This morning heralds the long awaited ODAC meeting for AstraZeneca’s oral SERD, camizestrant, for the treatment of HR+ HER2- breast cancer when given on biochemical relapse, as defined by the appearance of the ESR1 mutation.

All aboard! Which SERD train is racing ahead or being grounded?

While headline media reports usually focus on the 56% reduction in the risk of progression, characterising safety as “consistent with earlier findings,” or highlighting improvement in the patient reported outcomes (PROs), the actual regulatory tension is far more complex and centres on a number of complex issues.

After seeing a disconnect between clinical enthusiasm and FDA scepticism, I thought this would be a useful opportunity to offer a quick take on how this might go down later today by looking at some of the issues which have arisen…

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What your CD3 T cell engager is missing

Pointing the way forward

CD3 T cell engagers have come a long way over the last decade.

One signal may not be enough though since the immune system has a trick most developers are overlooking.

What’s more, it has absolutely nothing to do with CD28 or 4-1BB, or even having dual antigen targets built in…

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