Biotech Strategy Blog

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

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Posts by MaverickNY

A Critical Juncture

Time for some new directions?

The hematologic niche in the spotlight today at the American Society of Hematology (ASH) is at a critical juncture – while we’re increasingly seeing impressive efficacy with novel combinations, offset by both clinical and financial toxicity profiles presenting significant challenges.

The ultimate goal of moving away from traditional chemotherapy must be balanced against creating sustainable, accessible treatment options capable of optimising both safety and cost considerations.

After all, if we remove one backbone and replace it with another only to swap the nature of the serious adverse events then we’re not going to help as many people as we first supposed or claimed.

Another important aspect to consider is what should these new regimens even look like?

As we stand at the crossroads in novel cancer therapeutics, future trial designs and drug development strategies will both need to address these multiple competing factors, as well as proper sequencing of these regimens to truly advance the field.

In today’s post, we take a look at some important emerging trends, as well as some of the pitfalls and pressures facing companies and researchers in this space alike…

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Beyond R-CHOP: New Frontiers in Lymphoma Treatment at ASH 2024

Even the cars stand out in San Diego

After writing of some trials and tribulations in solid tumours earlier this week (see review of the Janux TRACTR here), it was rather nice to return to my old stamping ground of hematologic malignancies and feel soothed by both the familiar and also incoming novel approaches for a variety of different conditions.

It is exactly twenty five years since the initial phase 1 data for STI-571 (now known as imatinib or Gleevec) were first presented in an ASH Plenary.  31 out of 31 advanced CML patients responded and Dr Brian Druker received an outstanding ovation at the end of his presentation.  It was the kind of stuff that gave you goosebumps – despite the freezing cold hangar.

This is the kind of thing hematologists and companies alike live for; it’s what gets you jumping out of bed in the morning to help make a difference to the lives of cancer patients.

At ASH this year there are some encouraging data on early stage trials coming out in several hematologic malignancies, which kept me occupied and fascinated for most of the first day of the meeting.  There’ll be another detailed write up of one of these areas tomorrow morning, while a different condition offered a raft of choices across single agent therapy and combinations alike.

Here we highlight what to watch out for – both positive and negative – on five agents with encouraging early data, which caught out attention yesterday.  They include bispecific T cell engagers and cell therapies – what’s not to like?

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Death by a thousand cuts

Sharp, thorny plants for the unsuspecting visitor at the Vizcaya museum, Miami

In the fiercely competitive race to develop new treatments for metastatic castrate resistant prostate cancer (mCRPC), biotech companies must present compelling data to stand out from the pack.

However, as a recent example from Janux Therapeutics demonstrates, a closer look under the hood often reveals more spin than substance.

In this article, we’ll dissect Janux’s claims about their bispecific PSMA T cell engager JANX-007, and expose how cherry picking and selective data presentation can skew and even misrepresent a therapy’s true potential.

Read on to learn the red and green flags to watch out for and why extraordinary claims require extraordinary evidence…

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Innovator’s Dilemma – Promise and Potential of Bispecific Combination Strategies

Imagine a scenario… a symphony of therapeutic agents working in harmony, each contributing its part to achieve remission in even the most refractory hematologic malignancies. Yet, as with any great orchestra, a poorly tuned instrument – or in this case, a poorly considered combination – can disrupt the entire performance.

Bispecific T cell engagers have emerged as new virtuosos in cancer therapy especially in refractory settings involving hematologic malignancies such as lymphomas and myeloma, although their integration into combination regimens may be as challenging as it is promising.

Don’t be caught napping though!

In our latest ASH analysis, we’ll explore how some of these combinations perform, where they falter, and whether they can truly expand the therapeutic repertoire or simply shrink the index of possibilities.

In this review we will explore half a dozen different bispecifics when given in combination with an additional therapy to determine if:

  • They add anything to hematologic malignancies over what we would expect for monotherapy
  • Whether or not they shrink the therapeutic index
  • Whether anything else of note stood out (positive or negative)

If they fail on the first and negatively impact the second then they are highly unlikely to be a candidate for further clinical development!

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ASH24 Preview 2 – Early Stage Agents to Watch Out For

San Diego

In our latest ASH analysis, we’re going to focus on some key early stage oncology developments and their associated emerging strategic themes to watch out for.

After all, looking to see what’s coming behind you can be just as important as what’s in front of you.

In this latest review, we highlight and discuss 14 abstracts from a mix of pharma and biotech companies based across several continents, with various intriguing developments spanning preclinical to phase 2 involving a mix of targets and modalities…

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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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