Biotech Strategy Blog

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

Posts tagged ‘Gilead’

Bridge over troubled waters at ASCO24

The devil as they say is in the detail and teasing out what oncology clinical trial data really means can be challenging for the best of us.

In this post we take a look at several trials  reported out at ASCO24 and consider some of the nuances around the data, in particular what cancer new product professionals may need to think about in order to have an informed opinion.

For some, the data is a bridge over troubled waters, while for others the results were perhaps a bridge too far…

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A smorgasbord of new agents

Every now and then what seems like one player out in left field for the longest time suddenly balloons into a whole new class or niche of agents.

Such is the case for the target in the spotlight in today’s focused review.

Here we look at the challenges and opportunities provided within the emerging landscape, explore where the field is going, and what to watch out for because this is one you’re going to hear a lot more about going forward in a number of ways…

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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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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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Scaling the ESMO23 ramparts

Scaling the ramparts in Real Madrido

In our last ESMO23 Preview ahead of the live meeting starting on Friday, we highlight another eight targets to watch out for where there will be intriguing data dropping out from Madrid over the weekend.

More than just the data though, is consideration for the implications of the findings and how they can impact a particular tumour landscape.

One thing to note is just because a company highlights what they consider to be positive data doesn’t always mean it is actually so when you look carefully at the small print.

Not surprisingly there are a few examples of this genre at the forthcoming conference…

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Next generation CAR-T cell therapies for the future

Putting new CARs in the spotlight

As we move on from second generation CAR-T cell therapies and CRISPR gene editing as well as a DNA to RNA shift, there’s a noticeable coming together of these modalities in novel next generation ideas now entering early stage trials in the clinic.

Inevitably some will fail, others will meet with mixed reactions on modest data, but a few will succeed and inspire the next round of innovative approaches.

Are there early signs of which products/companies might fall into each bucket?

Here we highlight fourteen examples to watch out for across biotechs and pharma alike while discussing some of the opportunities and challenges they may face…

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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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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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ASH20 Preview 2 on Antibodies and ADCs

Upregulation of ligands and receptors provides handy targets for antibodies and ADCs

Anyone who has been casually following oncology R&D over the last five years might be forgiven for thinking the gold rush and panning for nuggets in IO might have overtaken company interest in targeted therapies, whether they be small molecules, antibodies, or ADCs.

As hematologic malignancies evolve, proteins are upregulated on the surface of the cancer cells, providing a variety of novel targets to aim at therapeutically.

For those in the know, however, the quality of research in the targeted niche remains at a very high level with some serious research going on behind the scenes in terms of novel targets, focused clinical developments (i.e. not treating a targeted agent in an untargeted fashion), and even enhanced design of next generation molecules coming to the fore…

To learn more from our oncology analysis and get a heads up on the latest insights and commentary pertaining to the ASH20 virtual conference — including our second meeting Preview — subscribers can log-in or you can click to gain access to BSB Premium Content.

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What’s the skinny on a new IO target in oncology R&D?

When the boat comes in

Much has been written about new and emerging immuno-oncology targets where we can add new targeted agents to existing immunotherapies – after all, quite a few have already tried and failed in clinical trials to shift the survival curve upwards and to the right.

Can it be done?

I firmly believe so, but this endeavour is going to take the whole field much time and energy, as well as quite a few iterations in molecule and trial design.  No one knows what the next big target is though, but when they do it will be a bit like when the boat comes in – you know it when you see it.

In the spotlight today is a relatively obscure target we have written about perhaps once or twice before and now there is suddenly burgeoning interest in this subniche with a couple of players already active in the space.  Will there be others? Maybe, it will likely depend on how the phase 1 trials pan out.

We have attempted to cover a couple of key questions:

  • What can we learn about the science and research conducted thus far?
  • Why is a big biotech company suddenly interested in this target?
  • Which tumour types look like being important?

Most importantly, though, a long time reader wrote in and asked why on earth is there sudden interest?  Will start a new stampede?  Who are the competition?

Good questions, and now we get to set the scene to explain what’s what and why the target matters…

To learn more from our oncology analysis and get a heads up on insights and commentary emerging on an emerging IO target, subscribers can log-in or you can click to gain access to BSB Premium Content.

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