Biotech Strategy Blog

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

Posts tagged ‘Chugai’

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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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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Lessons learned from AACR24 – Part 1

Sunny San Diego is full of surprises

The AACR annual meeting is an opportunity to challenge established paradigms and scientific dogma.

In this post, we’re highlighting some key learnings we’ve taken from the conference in San Diego, which others in oncology new product development might well want to think about.

Agree or disagree, part of what we do at BSB is challenge your thinking, and consider what we can learn, both good and bad, from researchers, industry executives, thought leaders, and regulatory agencies.

There’s certainly been a lot of inspiring science on show at AACR24 and we’ll have more of those learnings to share in part 2.

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Just can’t get enough

Gone Fishing!

The dawn of the 1980s represented a much more optimistic future than what it eventually turned out to be – will we see the same trend evolve with the seemingly myriad of attempts to box in certain cancer targets?

In some ways this has turned into a bit of a fishing expedition in several ways:

  • Uncovering mechanisms of resistance
  • Finding rational combinations with a decent therapeutic window
  • Developing next generation agents to address the limitations of the earlier versions

If we want to see success in the clinic then what might this look like in the next round of trials and who are the companies active in developing them?

It turns out there are a few surprises in store…

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Can Jonathan Lim ignite the TRK oncology space?

Tropomyosin receptor kinase (TRK) inhibitors are not a name that rolls off the tongue easily and yet this niche is attracting a lot of interest from observers curious to learn more about a highly targeted approach to rare oncogenes such as TRK, ROS1 and ALK that occur in several different tumour types.

Much of the focus has been on the more commonly expressed ALK-positive lung cancers with crizotinib, ceritinib, alectinib, brigatinib, lorlatinib and others. Crizotinib also targets ROS1 and is approved by the FDA in metastatic NSCLC whose tumors are ROS1-positive.

As the next part of the development in this sphere, TRK and ROS1 mutations are now in the spotlight. Indeed, we have been reporting on the data since 2014, which has been encouraging thus far, particularly from two companies, namely Ignyta and Loxo Oncology.  These two agents differ in that entrectinib targets TRK/ROS1/ALK whereas larotrectinib is a specific pan TRK inhibitor.

There was a new raft of data at the recent AACR annual meeting and more data is expected at the forthcoming ASCO conference.

Here, we take a look under the hood through the lens of one of the small biotechs in this space via a candid interview with Ignyta CEO, Dr Jonathan Lim.

Dr Jonathan Lim, CEO Ignyta

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Are targeted therapies now a thing of the past in the immunotherapy era?

With the sheer breadth and depth of immuno-oncology data being presented at even the American Association for Cancer Research (AACR), several readers were prompted to write in and ask:

“Is this the end of the road for TKI therapies? Should we even bother to continue working on these agents?”

Good question.

There was actually quite a bit of interesting data on regular novel targeted therapy to discuss, although I do concede that much of the mass media news focusing on the immuno-oncology tsunami in Philadelphia effectively drowned out targeted therapies and the results coming out in that space.

To maintain the balance between novel targeted agents and immunotherapy, here’s a review of some of the interesting new developments that I came across at AACR, from both the poster halls, as well as some of the thought leaders in this space.

When you stack up the emerging evidence in several tumour subsets, there are quite a few tasty morsels that are worthy of further discussion!

I’d like to take this opportunity to extend a warm welcome to all the new subscribers who took advantage of the AACR Special Offer to continue their education and learning about the exciting new developments in cancer research.  Thank you for joining our conference coverage service, we really appreciate it.

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