Biotech Strategy Blog

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

This is a story about how smart engineering and protocol innovation are reshaping T cell engager (TCE) – and potentially also antibody-drug conjugate (ADC) development.

To mask or not?

TCEs promised to bring the power of immunotherapy to solid tumours, but the story hasn’t been straightforward so far.

Despite compelling biology and mechanistic rationale, many promising agents have repeatedly stumbled over the same obstacle: a painfully narrow therapeutic window.

The culprit?

On-target/off-tumour effects triggering severe cytokine release and limiting dosing before efficacy can be fully realised. What if the solution wasn’t abandoning these targets altogether, but instead rethinking how we approach them?

Recent innovations in the HER2 space reveal three distinct strategies – clever sequencing protocols, avidity-driven engineering, and sophisticated masking approaches – which may finally crack this stubborn problem. The implications extend far beyond HER2 and could reshape development across multiple modalities, including ADCs.

For biotech strategists, the lessons here also challenge conventional portfolio wisdom about ‘over crowded targets’ and offer a roadmap for rescuing programs once deemed too toxic to pursue…

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In the whirlwind of presentations at this year’s AACR meeting in Chicago, some of the most valuable strategic insights may have gone unappreciated – pearls of wisdom cast before an audience often too overwhelmed with the sheer tsunami of data to fully grasp their significance.

Star of the show?

Dr Susan Galbraith at AstraZeneca delivered a masterclass in big pharma R&D strategy, which deserves careful examination.

Having developed 13 approved oncology drugs, including blockbuster therapies such olaparib, osimertinib, and durvalumab, Dr. Galbraith’s perspective carries exceptional weight.

This analysis distills not one, but twenty crucial lessons from her presentation.

These are strategic gems which could inform decision-making for biotech executives and scientists navigating their own oncology R&D processes.

From reframing competitive threats to challenging conventional thinking on established targets, these insights offer a roadmap for companies seeking to remain at the forefront of cancer therapeutic innovation…

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For decades, p53 – the ‘guardian of the genome’ – has been oncology’s great white shark: a critical tumour suppressor implicated in over 50% of cancers, yet stubbornly resistant to therapeutic intervention.

In a dramatic scientific plot twist, multiple companies are now racing to crack the code of the common Y220C mutation, with several novel approaches coming through. These range from non-covalent and covalent protein reactivators or stabilisers to heterobifunctional glues and even mRNA approaches.

The scientific breakthrough eluding researchers for generations may finally be within reach, potentially changing outcomes for many cancer patients who harbour this specific genetic alteration.

In a candid interview with one the companies actively involved in research in this niche, we learned more about what’s in store and what to watch out for…

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In the world of cancer therapeutics, transcription factors have long represented the ultimate challenge – critical drivers of disease, which have stubbornly resisted conventional drug discovery approaches.

At AACR 2025, an innovative US-based biotech revealed an elegant solution to one such notorious target: a molecular glue capable of hijacking natural cellular machinery to overcome what many considered impossible.

Their approach not only demonstrates a path forward for historically intractable targets, it also reminds us how in science, persistence and creative thinking can potentially transform today’s roadblocks into tomorrow’s clinical stage agents…

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It’s time to look at what I call the ‘ivonescimab puzzle’.

Last week when Summit Therapeutics announced the NMPA had approved their PD1xVEGF bispecific antibody ivonescimab, which showed “a clinically meaningful, positive trend” against pembrolizumab in a Chinese lung cancer trial, investors promptly responded by selling off the stock along with their German rival, BioNTech’s.

What could explain this seemingly paradoxical reaction to positive clinical data?

The answer lies in the complex interplay between several key factors and the critical question of whether a promising new drug in China can meet the considerably higher bar set by Western treatment protocols. After all, this could be as good as it gets.

As we’ll explore in today’s analysis, this case study offers a fascinating window into how savvy biotech watchers look beyond press releases to assess what really matters for global market potential…

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The FDA’s recent pivot away from mandatory animal testing marks a watershed moment for drug development, with patient-derived organoids (PDOs) poised to change how cancer therapeutics are evaluated and approved.

This regulatory sea change could dramatically compress timelines, reduce costs, and potentially improve predictive accuracy for human outcomes.

On the other hand, it could also lengthen filing timelines and costs for those companies who have not yet embraced the concept of organoids in early stage research.

For biotech and pharmaceutical companies navigating this sudden shift, understanding the practical applications of PDOs isn’t just academic interest – it’s becoming a strategic imperative.

The integration of organoid technology with real world data could transform how we identify, validate, and optimise new cancer therapies.

In this post, we discuss the pros and cons of the ‘lab-in-a-loop’ concept with one of the tech companies actively involved in this area of research…

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Amidst the bustling crowds and packed sessions of AACR’s 2025 annual meeting, two therapeutic modalities are quietly undergoing renaissance moments few investors have fully appreciated.

Chicago River Bridge

While antibody-drug conjugates (ADCs) have dominated headlines lately, a subtle revolution in their key design principles is rapidly unfolding.

Meanwhile, targeted protein degradation (TPD) – often dismissed after early clinical disappointments – is finding new life through innovative E3 ligase recruitment strategies.

Day one at AACR revealed critical insights around both approaches, which could reshape therapeutic landscapes in the coming years. Here’s what savvy observers should be watching out for…

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This is our first Preview from the ASCO 2025 annual meeting. It offers an initial analysis of a selection of the recently released titles, examining emerging trends in modalities and therapeutic approaches before detailed data are presented.

We highlight notable agents across different categories, track shifts in the competitive landscape, and consider what these selections might signal about the direction of oncology drug development.

While we’re working with limited information at this stage, certain patterns are already becoming clear…

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Dawn of a new era or a setting sun on a tricky approach…

Three is a magic number – except when it isn’t.

Trispecific antibodies are one of the emerging stars on the multispecific stage, promising to hit not one, not two, but three targets with a single swing. It’s a tempting idea – who doesn’t love a good triple play?

With great ambition also comes great complexity, and not every design is ready for primetime.

At this year’s AACR, the trispecific party got a little louder.

From PD-1/CTLA-4/VEGF mashups to CD3-based T cell whisperers, the posters are brimming with innovation – and more than a few eyebrow-raisers.

So before we get swept up in the hype, let’s pause and ask a provocative question: is this a triple threat or a triple headache waiting to happen?

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The KRAS field has undergone a remarkable transformation in recent years, evolving from ‘undruggable’ to a therapeutic playground with multiple innovative approaches.

Graffiti in Adams Morgan, Chicago

At AACR 2025, over 400 abstracts focus on KRAS alone, showcasing the impressive scientific momentum in this space.

While initial G12C inhibitors provided proof of concept with modest clinical benefit, the field has rapidly expanded to include mutation-specific inhibitors (G12D, G12V), dual-state inhibitors targeting both RAS(on) and RAS(off) conformations, and pan-KRAS approaches.

This preview highlights the most significant developments to watch for at this year’s meeting and what they might mean for overcoming the persistent challenge of KRAS-driven resistance.

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