Biotech Strategy Blog

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

About MaverickNY

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Posts by MaverickNY

Navigating the Complex Landscape of Next Gen Checkpoint Blockade Combos

In drug development, as in life, there’s often a high stakes race against time and complexity. Much like the legendary railroad engineers in the early 1900s, industry teams often charge full steam ahead in the quest towards developing novel therapies.

The thrill of progress continues to propel us forward, especially in the rapidly evolving world of cancer immunotherapy.

Checkpoint blockade therapies have certainly opened new avenues, empowering the immune system to recognise and fight cancer.

Despite their initial success, much like unexpected obstacles on a winding rail track, resistance and immune escape are persistent challenges over time.

Research teams are accelerating efforts to outmanoeuvre these barriers, exploring ADCs, multi-targeted combinations, as well as bispecific and trispecific antibodies.

In this article, we’ll examine new data on some these strategic efforts and the avenues emerging from the recent SITC presentations – advances which could either redefine the checkpoint blockade landscape for the future and keep our train moving steadily on the rails or end up in the graveyard known as dog drug heaven…

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Beyond the Topo-I Rush: Finding Space in a Crowded ADC Landscape

James Turrell’s Twilight Epiphany Skyspace in Houston

As a wave of me-too Topo-I antibody drug conjugates (ADCs) flood the oncology landscape, we interviewed a c-suite executive at Genmab who explains why successful ADC development requires much more than just picking the trendy payload.

There’s a critical look at why Topo-1 molecules alone won’t be enough to guarantee success in this complex and rapidly evolving field.

From the critical importance of antibody internalisation to the game-changing role of linker chemistry, we learn how Genmab is strategically positioning itself in an increasingly crowded space.

The company’s deep expertise in bispecific antibodies may provide unique insights into how future ADC development might evolve beyond traditional formats.

Through their ProfoundBio acquisition and sophisticated antibody platform, we discover why Genmab believes the future lies not just in conventional ADCs, but also in next-generation bispecific modalities, which could reshape how we look at targeted cancer therapy…

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ASH24 Preview 1 – Captivating CAR-T cell Developments

Time for some new directions?

The CAR-T cell field continue to develop apace with plenty of novel ideas and constructs coming down the pike, especially on the hematologic malignancies front.

It’s like the cycle of life – as some products fall by the wayside, so a raft of others emerge to replace them.

As we think ahead to the annual meeting for the American Society of Hematology (ASH) in San Diego next month, it’s time to showcase the work of a number of up and coming researchers and companies as well as the established ones.

What’s hot this year?  It turns out there’s quite a lot to watch out for…

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A Turning Point for IO at SITC 2024?

Choices, oh so many choices!

We’ve been following the IO wave for over a decade now and one of the questions that comes to my mind is whether we are about to experience what the Germans would call a change in times, or ‘Zeitenwende.’

The Duden German dictionary describes Zeitenwende as “the ending of an epoch or era and the beginning of a new time.”

Readers may recall it was famously used by Germany Chancellor Olaf Scholz after the Russian invasion of Ukraine in 2022 to describe how this was a turning point in European and Germany history, albeit in not necessarily a good way.

Are we at a turning point in IO for the better rather than worse?

After the initial wave of success with low hanging fruit, we’ve sadly seen more failures than successes although we’re starting to see signs that new strategies may yet deliver the promise and potential we all hoped for way back when.

In this post we take a look at 10 presentations to watch out for at SITC 2024 around the theme of Zeitenwende. Check it out!

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The Nexus Frontier

Futuristic image created with WALL-E   Source: Blue Ice Publishing

The Nexus Frontier stands as a bold and groovy movement at the intersection of discovery and understanding, where complexity meets clarity.

It’s a frontier where scientific rigour and human relatability converge.

In other words, it’s time for a collaborative guest post from a physician CMO to learn about his perspectives and reactions to recently presented data.

What jumped out?

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Lucky 7 – Meet the Cancer Drug Disruptors

How to stand out from the crowd

They say there’s more than one way to skin a cat.

In oncology’s latest chapter, a number of innovative compounds are proving there’s more than one way to shut down a cancer cell.

From molecular orchestration to cellular sleight-of-hand, these approaches are rewriting the traditional playbook of targeted therapy.

In our latest analysis, we offer seven up and up coming early stage targeted therapies to watch out for and explain why they may stand out from the competition going forward…

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RevMed’s approach to kicking KRAS to the kerb

Source: Dr Tillman Pearce, CMO at ALAFIA

It’s all too easy to take life for granted until one is faced with an unexpected devastating diagnosis such as a terminal Stage IV cancer – cholangiocarcinoma or pancreatic ductal adenocarcinoma (PDAC) come to mind, for example.

When we see new early stage agents emerge from Pharma pipelines showing a promising and different concept from what’s gone before then it’s hard to imagine anyone not wanting to see it break the mould and succeed, regardless of who the company is.

This doesn’t mean we should borrow a pair of Dame Edna Everage’s sparkly rose-tinted glasses and abandon common sense.

Last Friday we saw the first-in-human data from a phase 1 readout centred on Revolution Medicines new KRAS inhibitor, RMC-9805, in a presentation by Dr David Hong at the ENA Triple meeting in Barcelona.

The company also presented several posters on the pipeline agents and held a conference call to discuss their progress and next steps.  The PanCan community are naturally excited to see some progress with the early stage agents.

This is the second example we’ve seen this month where a company has publicly announced a phase 3 trial opening based almost entirely on phase 1 data.  Will it end well or flounder down the road?

In our latest analysis we take a look at some of the many challenges and opportunities to consider when handicapping the odds of success…

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Arcus takes aim at belzutifan in the HIF-2α arena

Once we have a new standard of care agent in a class the question is always how long can they hold it for?

Oncology R&D is a dynamic beast to watch – very little stands still or survives the test of time.

Once we have a new King anointed at the top of a mountain in a particular class of agents then there’s always a posse of others following in the wings to knock them off their perch.

If you’re not first-in-class to a given market then the race becomes very much one of who has the best-in-class potential and how long the mould-breaker will have on their perch.

We are currently watching to see who has the potential to become a best-in-class HIF-2α inhibitor beyond Merck’s belzutifan (Welireg) – or will they turn out to be similar and the first past the post reigns supreme?

The real test is never the initial preclinical or clinical data that comes out, but rather if any pretender to the throne continues to demonstrate favourable safety, higher selectivity, and durable activity in the form of improved survival over time.  After all, drug development is a marathon, not a sprint.

For later stage entrants such as Arcus’s casdatifan, the opportunity lies in differentiating themselves through improved outcomes and optimised combination strategies. As data mature, clearer insights into the overall survival and quality of life benefits will emerge, solidifying their role in the evolving RCC treatment paradigm.

Ironically we saw this same battle with the VEGF inhibitors in the same disease a decade ago.  Now it’s the turn of the HIF-2α inhibitors to follow the well-trodden path – there’s a lot to think about with new data coming out…

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An unexpected emerging onco landscape to watch out for

Which Thunderbirds are Go?

Whenever we see a novel emerging niche with a raft of early stage agents coming to the fore, I always remember the salutary lesson we learned from the rise and fall of the BET/Bromodomain landscape.

This particular development attracted a lot of companies – big and small – with various permutations (selective, dual, pan inhibitors) entering clinical pipelines.  It wasn’t to be though, for it all collapsed once it was realised they were toxic and numerous projects were suddenly abandoned left, right, and centre.

Of course, not all targeted agents go poof by the wayside in the same fashion – as the PD(L)1 checkpoint and CD19 CAR-T cell therapies will certainly attest!

In our latest landscape review we take a look at an emerging target with a dozen agents in competition, the majority of which are either in the clinic already or undergoing IND enabling studies.

The good news is they are not all based on the same modality, which only adds to the interestingness of the niche.

While it’s unlikely all of the current agents will successfully make it past the post, I have a strong intuition at least one of them will.  The question is, which one?

To learn more about these early stage oncology compounds, check out the links below…

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10 lessons on in vivo CAR-T cell therapies

Man measuring the clouds sculpture, Kanazawa

This summer I came across Jan Fabre’s fabulous bronze sculpture Man Measuring the Clouds (right) in Japan, of all places. It represents humanity’s ambition, idealism, and the pursuit of impossible goals.

The artwork depicts a life sized bronze figure of a man, often thought to be modelled after Fabre’s late brother, standing on a tall ladder and reaching upwards with a measuring rod as if trying to measure the sky. The piece captures a blend of optimism, futility, and persistence in the face of unattainable aspirations.

Similarly, we might consider the concept of tackling a variety of complex diseases from cancer and cardiac fibrosis to various genetic disorders with a tiny cell therapy involving a sample of just few millilitres seems equally apt and fitting.

Is it truly impossible though?

In our latest post, we argue no it’s not – and may actually be much closer to reality than many people realise.  What seemed like something on the distant horizon is likely to soon see not one, but multiple clinical trials opening up in other indications beyond blood cancers involving several cell therapy companies.

Following on from an inspiring talk this week, we offer 10 important lessons to think about and be challenged by – because the old yardsticks may well be a’changing sooner rather than later…

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