Biotech Strategy Blog

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

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Posts by MaverickNY

Biotechs beating ADCs at the own game

For all the hullabaloo around M&A and licensing deals from China especially for antibody-drug conjugates (ADCs) of late, it’s easy to forget they have many inherent challenges in their design, which may lead quite a few to fall short down the road – despite high expectations.

Recently we asked ourselves is there a different way to go about killing cancer cells in late stage tumours more effectively?

In our latest company interview, the answer, at least in some instances could well be yes.

It’s also a lot of fun going off the reservation to hear more about next generation approaches from up and coming young biotech companies with well thought out approaches to watch out for…

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Three Times A Charm

Downtown San Francisco

The biotech industry kicked off the 2025 JP Morgan Healthcare conference this week with a flurry of major oncology deals totaling over $4.6 billion, highlighting both the sector’s continued appetite for innovative cancer therapeutics as well as its willingness to place big bets on clinical stage assets.

While Pericles reminds us that true value lies in impact rather than price tags, these deals offer some fascinating insights into current market dynamics, strategic priorities, and the evolving landscape of cancer treatment.

Let’s examine three notable transactions where each tell us a different story about the state of oncology drug development…

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A novel bispecific ADC to watch out for

Companies think they see gold in the distance, while ignoring the narrowing, darker hazards close by

If 2024 was the year of topoisomerase-I antibody-drug conjugates (ADCs) then 2025 is likely to herald a different series of trends within this niche.

Adding on extra payloads or targets may seem like a logical extension – as witnessed by the flurry of bispecific and dual-payload ADCs. This approach often ignores the many underlying complexities and challenges involved because these are highly complex and sophisticated agents to develop.  It’s not simply a matter of swapping out different elements akin to Lego bricks and hoping for the best.

In this article, we discuss a number of issues facing companies chasing the ADC dream, as well as an early example of an intriguing novel ADC target to pay attention to going forwards.

In the long run, the near and far might turn out to be relative, depending on your perspective…

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The Swiss Army Knife of Cancer Drugs

Image generated by Wall-E

Imagine an emerging and novel cancer agent which could be deployed as a versatile and multi-functional tool, akin to the dual-purpose nature of the novel bispecific ADC, with added bells and whistles.

Just as a Swiss army knife combines multiple tools in a single compact form, this new ADC represents an innovative convergence of two targets, two payloads, one mission.

Can it be done?

At least one company believes so – enough to collaborate on building a brand new product from scratch…

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Big Pharma’s Next Big Bet

Time to scale new heights or crash into the sea

As the pharma and biotech industry prepare to gather for the annual JP Morgan Healthcare Conference in San Francisco next week, all eyes are on potential deal announcements and strategic collaborations.

Among the hottest emerging areas of interest?

A new wave of engineered agents is emerging, which may potentially transform cancer treatment by addressing some of the weaknesses inherent with existing therapies.

If companies can solve some fundamental challenges – after all, no approach is without them – then this emerging class of agents could turn out to be an unexpected winner, winner chicken dinner.

It also has the propensity for high risk/high reward built in, which means either scaling new heights and blockbuster status or crashing into the sea below might be the spectacular end result either way…

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Degrading Expectations – BTK’s New Challenge

The importance of nuance when considering different subtle flavours

Just when we thought we had BTK inhibition figured out, along come the protein degraders to disrupt the party!

While covalent BTK inhibitors transformed CLL treatment and non-covalent inhibitors aimed to tackle resistance, a new class of drugs is taking a more radical approach: why just inhibit BTK when you can eliminate it entirely?

At ASH this month, two BTK degraders stepped into the spotlight. With response rates approaching 80% in heavily pretreated patients – including those with notorious resistance mutations – both BGB-16673 and NX-5948 are challenging our expectations of what’s possible in relapsed/refractory CLL.

As the dust settles on these early phase 1 results, the real story may lie in the nuances…

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The ADC Frontier: Are We Ready for the Next Leap?

The headline for today’s post reflects a mix of forward looking optimism with some (hopefully) balanced critical analysis.

The KA-pow! Effect – Created by DALL-E

Gone are the days of what I think of as the old school heavy handed antibody-drug conjugates (ADCs), where they were rather challenging to finesse in terms of the therapeutic window because you couldn’t dose high enough to exert the desired effect before the dreaded dose limiting toxicities whacked everything out of balance.

In the real life game of snakes and ladders, many an investigator would quickly become frustrated with too few little ladders up and long snakes back down trying to find an acceptable sweet spot in the dose schedules for their patients.

In terms of framing the new ADC frontier – these days things are a’changing much more rapidly when we consider the sheer number of novel molecules coming through company pipelines. Of course, not all agents in Phase 1 will succeed when considering there’s a long way to go to the approval line.

In this review we talk about some recent clinical and scientific developments, including two emerging and unexpected biomarkers of interest.

We thought about each update in the context of three key areas:

  • Innovations leading the charge
  • Challenges on the horizon
  • The ADC ecosystem in transition

As always, not all of the early promise in clinical trials will be completely rosy since there are tricky or unexpected hurdles to consider…

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Too Fragile to Succeed? Uncovering Hidden Weaknesses

When the crowd cheers the loudest, it’s often time to question the play.

Amid a wave of bullish investor enthusiasm for the Summit and BioNTech PD(L)1x VEGF bispecifics plus a raft of topo-I ADCs from China, the risks underpinning this rallying cry have been pushed to the shadows.

What if the foundations of the optimism are built on assumptions that don’t necessarily hold up to scrutiny?

In this analysis from the San Antonio Breast Cancer Symposium (SABCS), we unpack some of the overlooked vulnerabilities and present a case that might not win popularity contests, but could save companies and investors from costly missteps…

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Revolution and Rivalry: Anito-Cel Challenges Cilta-Cel in Myeloma

The ASH Dash continues apace!

Over the last decade CAR-T cell therapy has revolutionised the treatment landscape for relapsed/refractory multiple myeloma (RRMM), offering a lifeline to patients with few remaining options.

These engineered immune cells have demonstrated remarkable activity although their progress has also revealed a complex interplay of benefits and risks, which continue to evolve with longer follow up data and real world use.

As the field matures, new insights from clinical trials shape our understanding of these therapies and also serve to highlight critical distinctions between products.  By delving into these details, we can identify patterns, anticipate challenges, and explore opportunities to improve outcomes for patients.

There’s also the excitement of the proverbial ‘new kid on the block’ coming later behind the leaders.  ArcellX’s anitocabtagene autoleucel (anito-cel) is one we have been following since it was in preclinical development and were intrigued by their different scientific approach to tackling the same issues.

The big question was always going to be what happens in the clinic?

In the latest update, things are now getting interesting to say the least…

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ASH24 The Battle of Menin

The landscape of Menin inhibition in acute myeloid leukemia (AML) continues to evolve rapidly, with several competitors vying for position in this emerging therapeutic niche. At this year’s American Society of Hematology (ASH) meeting in San Diego, we saw important updates presented across the field, which shed new light on both the potential and challenges of targeting the Menin-MLL interaction in advanced disease.

San Diego street art

The therapeutic goals in advanced AML have always been clear – achieve deep remissions, bridge to transplant where possible, and ultimately extend survival. What makes the Menin inhibitor story particularly compelling is how these agents are reshaping our expectations for molecularly targeted therapy in AML, especially in difficult to treat populations harbouring KMT2A rearrangements or NPM1 mutations.

What’s also particularly striking about this year’s updates is the emerging differentiation between compounds in the class. While all share the core mechanism of disrupting the Menin-MLL interaction, we’re beginning to see distinct profiles emerge in terms of efficacy, safety, and potential positioning.

The battle lines are being drawn in what promises to be a fascinating commercial race as more clinical data become available over time.

In our latest review, we assess how revumenib, bleximenib, enzomenib, and ziftomenib are shaking out in the relapsed/refractory (R/R) setting and also take a look at ziftomenib and bleximenib in newly diagnosed AML…

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