Biotech Strategy Blog

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

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Posts by MaverickNY

Precision vs Power – The Next Generation of Immune Reset

For over a decade, cell therapy in cancer has embraced a simple philosophy: maximum firepower to eliminate malignant cells.

As these powerful tools enter autoimmune disease trials, however, a fascinating evolution is underway as companies begin releasing research on their pipelines at conferences.

Are the data breathing fire – or even too much of it?

From the early groundbreaking lupus studies to more precision targeting tools coming through preclinical development, researchers are discovering that finesse may well trump force when it comes to treating chronic inflammatory conditions.

This shift – from indiscriminate B cell destruction to more selective targeting of disease-driving cells – could redefine how we reset dysfunctional immune systems.

New data from the American College of Rheumatology (ACR) meeting held this week in Washington DC showcases this transformation while highlighting innovative approaches under the radar, which may finally thread the needle between efficacy and safety.

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Upping the game in autoimmune disease

Choices, choices…

During the ongoing American College of Rheumatology (ACR24) conference held in Washington DC, there has been a wide choice of potential new treatments being investigated in refractory autoimmune diseases with several products from the oncology space.

These include bispecific T cell engagers, ex vivo and in vivo CAR-Ts, CAR-NKs, TCRs, and even ADCs.

There’s always more than one way to skin a cat – yet do they all look the same or even produce similar results?

In our latest in-depth look at the emerging preclinical and clinical data, we highlight quite a few red and green flags to watch out for in Part 1 of our ACR coverage…

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Adding up the evidence

The Fall conference season continues apace!

As the Fall conference season continues its rounds through various cancer meetings, it’s time to take stock for a moment and look at what an in vivo CAR-T cell therapy, a TCR therapy, and a dual checkpoint combination all have in common.

The answer may well surprise a few people.

In our latest analysis and discussion we highlight some early approaches, which could have an impact in phase 2 development given the encouraging data reported so far.  There’s also an intriguing biomarker that’s been identified, which could impact other IO combinations.

We’ve always argued in favour of waiting for more robust data at the recommended phase 2 dose (RP2D) because it’s much easier to judge activity and durability when you have an active dose, as opposed to many people receiving the early, suboptimal ones.

That said, there’s still quite a lot we can learn from the initial phase 1 evaluation in advanced solid tumours, particularly when the focus is deliberately narrowed to more rational and selective situations rather than random allcomers, as this report highlights…

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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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