Biotech Strategy Blog

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

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Posts by MaverickNY

Ivonescimab Opportunities and Challenges

Who’s stamping their authority in 1L NSCLC?

I can’t quite believe this is the second post in a week where we find a biotech company making a claim not fully borne out by the data.

Much depends upon what yardstick you use to make these claims and often, the devil is in the details, especially when it comes to IO trials.

In this review we explore the controversial phase 3 trial for ivonescimab in first-line non-small cell lung cancer (NSCLC) from Summit Therapeutics/Akeso Bio and whether it stands up under scrutiny.

As is often the case in these kind of situations, when every one zigs – zag!

Here we explain why things may not be all they seem…

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Pointers to consider in SCLC developments

Wait, what did you say?!

How many times in the past have we seen gaudy initial high response rates from traditional chemotherapies in small-cell lung cancer (SCLC) only for people to experience early relapse due to lack of persistence and durability?

Are we doomed to repeat this process with ADCs?

The initial attempts with Stemcentrx/AbbVie’s Rova-T, a DLL3 directed ADC ended in abject failure.  Proving the target wasn’t the issue, this hasn’t stopped a bispecific T cell engager (tarlatamab) from Amgen gaining approval in extensive stage disease (ES-SCLC).

Suppose we tweak a few elements with the next generation of ADCs and try swapping out the linker, payload, and antibody target – what then?

Perhaps another target with a chequered history to date has been B7-H3, with several modalities tested and a number of companies giving it a good go without much to show for their efforts.

This weekend we saw some new clinical data with a B7-H3 ADC. First reactions were positively rosy, yet there are a number of early warning signs and nuances to watch out for, as we explain in our latest review…

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New directions in autoimmune conditions

New directions coming up for a number of agents – who are the likely winners?

It’s nearly a decade since I was last in Copenhagen for a conference and oddly, it seems to be a venue signalling new directions are taking place for pipeline agents.

Last time around it was a watershed moment of sorts for the DDR niche with a raft of key data presented on PARP inhibitors in ovarian cancer.

This time around the focus is on a completely different niche and indication altogether!

Ahead of some key phase 2 and 3 clinical data coming up this month, here’s our latest conference preview with a look at what to expect and watch out for…

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ESMO24 Preview 7 – Lighting Up Early Stage Research

While many observers following ESMO and WCLC next month will be keen on watching the phase 3 trial readouts, there’s plenty of insights to be gleaned from other research too.

For example, if we want to maintain market share of existing therapies on the market then we may need to devise solid strategies for handling combinations in the face of new competitors.

Ideally, these should be rational based on information around acquired resistance or immune escape.

Increasingly research on biomarkers as well as genomic and even transcriptomic data is becoming more commonplace.

Here we shine a light on a number of key studies, which may help us move forward with future clinical trials…

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Early Developmental Therapeutics Trends from ESMO 2024

The ESMO 2024 database currently houses over 1,820 poster titles, with no abstracts available for review yet.

In the absence of detailed insights, sifting through the massive trove for gems in Developmental Therapeutics becomes both a challenge and an opportunity.

What’s cookin’ this week in the BSB kitchen?

We’ve scoured the listings and curated a selection of promising early-stage therapies that could signal emerging trends or novel approaches.

In this preview – our sixth from ESMO24 – we explore intriguing clinical leads in the ongoing quest to address unmet clinical needs in oncology…

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ESMO24 Preview 5 – Late Breaking standouts

Standing out from the crowd

In the fifth of our ESMO 2024 Previews we turn our attention to the late breaking abstracts since the majority of the titles were released this week.

The European Society for Medical Oncology has long been renowned for its late breakers and on clinical data, in particular.

Out of all of the available options – there were over 70 of them so far – which ones stood out from the crowd and why?

The selection chosen here are varied in nature and range across seven different categories…

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We may never know

Time for some quiet contemplation and reflection

One of the single biggest challenges we face in cancer research is what we don’t know – or the unknown unknowns.

This is especially true for companies either facing new targets or those cases where we have seen quite a few failures in the clinic despite a seemingly logical and rational target to aim at.

What gives and why don’t things always go to the clinical plan?

Here we take a look at what’s under the hood on some key IO programs and some of the scientific concepts which may have an impact on the outcomes…

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Breathing fire into novel combinations

Dragon sculpture at ⁨Kiyomizu-dera Temple⁩, ⁨Kyoto

Cancer cells can exhibit a dynamic ability to change their identity in response to environmental pressures or treatments. This flexibility allows them to adapt by taking on different characteristics, enabling them to survive in challenging conditions.

A tumour cell that initially depends on a specific growth pathway can shift its traits to rely on alternative mechanisms when the pathway is blocked therapeutically.

Much as a magician can conjure up an illusion, the nifty cellular shift can contribute to resistance to cancer treatment.

In some cases, tumour cells may alter their surface markers or acquire features typical of another cell type, making them less susceptible to targeted therapies.

Understanding this behaviour – and the molecular underpinnings of the changes – is crucial for developing more effective strategies to counteract tumour evolution, escape, and resistance.

What if the targets also change in the process?

Ah, but what if we can adapt a treatment regimen to aim at the evolved targets, assuming we know what they are?  After all, if we put a blindfold on an archer then he likely won’t be able to see what and where the target is, whereas if they can see then the chances of success is much higher.

In our latest review we look at a number of targets and novel combinations based on key findings around the underlying molecular changes…

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Pointing the way

Over the last decade chimeric antigen receptor (CAR) T cell therapies have demonstrated success in hematologic malignancies such as certain acute leukemias and lymphomas, yet they have struggled to gain traction in advanced solid tumours.

What can we learn from the ASCO Breakthrough meeting in Japan?

There are many reasons for this, not least are overcoming issues such as physical barriers, a hostile tumour environment, tumour heterogeneity, on-target, off-tumour toxicities, immune escape, difficulty in trafflicking and homing to the lesions, limited CAR-T cell persistence and exhaustion, etc.

It’s not all bad news though because there’s one tumour type where we are making some progress with CAR-T cells, namely gliomas.

What’s interesting is there has been a variety of tumour-associated antigens investigated in gliomas, including B7-H3, EGFRvIII, GD2, HER2, and IL–13Rα2.

Last week some new CAR-T cell therapy data of interest was presented at the ASCO Breakthrough meeting in Yokohama, Japan.

In this review we look at high grade gliomas in adults to explore how some new data against one target stacks up with what we’ve recently see reported for other targets. We also discuss future directions and where the field might be headed for further new product developments…

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New opportunities for Menin inhibitors

Tree of Hope

Some recent research in a specific area has provided some helpful and stimulating findings, which may lead to some unexpected combination trials in the future.

We all know cancer is best beaten with combinations and regimen approaches, but a key question always remains the same no matter which company is doing the R&D – which are the best options to evaluate together given the limited time, resources, and budget available?

Even large pharmas cannot explore every single possibility.

Suppose a company has the luxury of five early stage agents either in-house or available to them in a partnership. This would give 10 potential phase 1 doublets they could evaluate. If we include triplets as an option then we can add a further 60 possibilities on top.

It might sound like a tree of hope, yet these are unrealistic scenarios because few companies will run 70 phase 1 trials just to figure out the optimal regimen to go forward with in a phase 3 study. In fact, I seriously doubt if anyone would seek to attempt this number in mice studies either!

Despite all the misgivings people have about translating preclinical data to humans with advanced cancers, we often need to be reminded to keep our feet on the ground.

It’s not a matter of alchemy where chemists and translational researchers seek the ’elixir of life,” or a pill that would cure all cancers. Instead we have to use some common sense based on what we know and how things might shake out.

In today’s post we look at what some future combinations might look like and who the key players might be…

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