Biotech Strategy Blog

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

Posts tagged ‘Innovent’

On monster molecules

For all our enthusiasm for novel early stage niches in oncology, let’s not forget the overall probability of success in preclinical and phase 1 development are both low.

When assessing these opportunities it is important to keep our feet on the ground and general perspectives on a sensible level.

Despite the risks, however, I can see this particular category seeing more activity from large pharmas once they have completed their annual strategic review periods going into AACR.

The good news is there is always another Gleevec, Avastin, Keytruda, Enhertu etc lurking in the wings somewhere.  The challenge is predicting where they might come from.

In this review we explore an emerging landscape and point out the potential upsides, downsides, and biotech players coming through because this isn’t a big Pharma space, at least for now…

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Why do T cell engagers succeed or fail?

Which flavour of tart, er TCE would you prefer?

The success or failure of T cell engagers (TCEs) represents billions in potential revenue and, more importantly, new treatment options for patients with limited alternatives.

With over 100 TCEs currently in clinical development and recent high profile approvals such as Roche’s Columvi, Genmab’s Epkinly and J&J’s Tecvayli, the stakes for getting the design right have never been higher.

Yet for every clinical success, there are numerous programs failing to advance beyond early phase trials, often for reasons not immediately apparent from traditional antibody design parameters.

Recent pipeline reshuffling – evident in announcements at JPM25 and in 4Q24 earnings calls – highlight a critical inflection point for the field.  Companies are making tough decisions about which TCE programs to license, advance or terminate, decisions which impact not just individual pipelines, but also broader investment and partnership strategies across the industry.

This post examines new insights into why some TCEs succeed while others fail. By understanding these molecular determinants of bispecific antibody performance, readers will:

  • Learn how physical properties impact TCE function
  • Understand why conventional optimisation approaches may miss critical success factors
  • Gain practical insights for evaluating TCE programs, particularly relevant for the wave of new candidates emerging from Western and Chinese biotechs
  • See how these principles apply to recent clinical successes and failures across the industry.

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What’s Being Lost in Translation?

Expected the unexpected: if it can snow in Florida, there’s hope for GI cancers yet!

The surge in ADC licensing deals from China has created a crowded development landscape where careful phase 1 evaluation risks being sacrificed for speed.

While the temptation to treat ADC development like traditional chemotherapy trials is strong, this approach overlooks crucial differences in therapeutic window optimisation, target expression validation, and resistance mechanisms. The recent flurry of ADCs (plain vanilla or Frankenstein versions) particularly highlights this challenge with multiple candidates racing through development, some with limited understanding of optimal dosing, target expression cutoffs, or sequencing strategies.

The following analysis examines five emerging new agents across ADCs, antibodies, and cell therapies where success may depend less on deal timing and more on thoughtful early phase development, particularly around patient selection and therapeutic index characterisation.

The historical pattern of failures in late stage oncology trials often traces back to inadequate phase 1/2 groundwork rather than target biology per se, making this distinction crucial for the field.

In this article it’s time to frame some specific examples, while highlighting the broader industry context and common development pitfalls…

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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 challenge with bispecifics and ADCs…

Seeing the wood from the trees

With all the breathless hype of late around the rise of ADCs and even some bispecifics, are the data likely to catapult these early stage agents into future stars?

Are there signals we can explore to try and answer this key question?

It’s easy to convince oneself something looks better than what went before – is this truly the case?

In this review we explore pros and cons around half a dozen early stage agents in clinical development and explain why some might go forward while others might experience future setbacks…

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Pointers to consider in SCLC developments

Wait, what did you say?!

How many times in the past have we seen gaudy initial high response rates from traditional chemotherapies in small-cell lung cancer (SCLC) only for people to experience early relapse due to lack of persistence and durability?

Are we doomed to repeat this process with ADCs?

The initial attempts with Stemcentrx/AbbVie’s Rova-T, a DLL3 directed ADC ended in abject failure.  Proving the target wasn’t the issue, this hasn’t stopped a bispecific T cell engager (tarlatamab) from Amgen gaining approval in extensive stage disease (ES-SCLC).

Suppose we tweak a few elements with the next generation of ADCs and try swapping out the linker, payload, and antibody target – what then?

Perhaps another target with a chequered history to date has been B7-H3, with several modalities tested and a number of companies giving it a good go without much to show for their efforts.

This weekend we saw some new clinical data with a B7-H3 ADC. First reactions were positively rosy, yet there are a number of early warning signs and nuances to watch out for, as we explain in our latest review…

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10 things I learned about ADCs at AACR 2024

San Diego bound for AACR 2024!

In our fourth AACR 2024 preview we’ve going to highlight some emerging trends you should watch out for. We took a look across over 130 abstracts and in an unbiased fashion, delved into the weeds to see what would shake out.

The findings were interesting to say the least:

Some expected, some unexpected surprises, others puzzling, a few provocative ones made me stop and think more about their approach.

It’s all here, black and white…

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Making sense of all the TIGIT data at ASCO23

Graffiti in Adams Morgan, Chicago

Continuing our coverage of the annual meeting of ASCO in Chicago I felt compelled to review the actual data presented at the meeting.

Regardless of whether you are bullish or bearish about the target – or even specific agents in the niche – there are some important subtleties and nuances to be aware of and take into consideration.

Here we offer a detailed look at key issues to think about in the broader context of new product development and early stage clinical trials…

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Intriguing progress on the KRAS front

Tackling intractable targets and tumour escape/evasion

Understanding clonal evolution ought to be an essential part of figuring out how to tackle intractable or tricky targets such as KRAS.

Inevitably chronic treatment with monotherapy will exert selective pressure on a given tumour so it reacts by escaping and signalling elsewhere in order to ensure its continued survival.

If we add in another agent, it may work for a while and then the same thing happens again.

What if we could break out of this cycle and try some novel approaches, find more potent agents, or even rational combinations to try and box in the resistance?

In our third ASCO Preview we take a look at some of the progress being made and where things might be headed in the near to medium term future…

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