Biotech Strategy Blog

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

Posts tagged ‘Regeneron’

When the going gets tough

Walking into stormy waters may require some chutzpah

Sometimes oncology new product development can be fascinating to watch from the sidelines.  There are always up and downs as well as many hurdles and challenges to address.

In a relatively short time the B cell malignancy niche has become a highly crowded space full of tough competitors, with numerous T cell engagers and CAR-T cell therapies already approved and more coming along.

If you’re late to any given market then you will need to stand out as the best-in-class in order to succeed.

There are some companies who execute flawlessly, others well, they can have a rather bad habit of shooting themselves in the foot when least expected…

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A look at T cell therapies at ASH23

Next stop – the ASH convention center!

In our final Preview ahead of the annual meeting of the American Society of Hematology (ASH), we’re focusing on immunotherapies.

With thousands of abstracts to wade through, it’s all too easy to think either there isn’t much going on or worse, so much it’s too complicated to even think about parsing.

To make things easier we picked ten different approaches to discuss, mostly involving early stage developments across numerous companies (big and small), plus a variety of targets, modalities and even immune cell subsets.

The value of looking at these kind of approaches now is being more prepared later in anticipating evolving trends and competitors because the IO space moves fast – and stealthily…

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Unexpected developments at SITC23

Gaslamp Quarter in San Diego

Every now and then you come across some initial phase 1 data which turns your head and makes you wonder why it is working so well in heavily pretreated patients and what’s different about its particular design?

This was my reaction last week reading a SITC abstract – I wanted to learn more about not only the molecule itself, but also the other early stage agents with different targets being presented.

And here we are because it turned out there’s some nifty reasons why it worked when a prior drug against the same target had already failed in some patients as we discovered when talking to the company in our latest in-depth interview…

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Playing with fire

Are we playing with fire – again?

A few years ago, Dr Philippe Armand at Dana Farber used this very colourful phrase accompanied by ‘rip roaring toxicities’ when describing autoimmune type reactions his institution had seen in patients with hematologic malignancies who had received prior allo SCT (see more here).

Now we’re starting to see more evidence emerge for improved activity with next generation bispecifics accompanied by lethalities.

Finding the balance between the two is proving to be something akin to a tightrope across the Niagara Falls without a safety net.

With so many runners and riders in the IO niche, it’s often hard to tell who will be the winner

Checkpoint blockade, CAR-T cells and fusion proteins haven’t been the only ones to struggle with this challenge, since bispecifics are also an immunotherapy approach capable of inducing some potent, if unwanted immune effects.

Here we look at the challenge in the bispecific arena with a focus on some recent events…

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5 important topics to watch out for at AACR22 on bispecifics

In the first part of our bispecific antibody review from the AACR front (the second will post next week), we highlight some strategic issues of interest to the field through the lens of several company’s data being presented at the meeting.

When we look at the themes of the meeting (right) we learn about the focus for this year’s event:

  • Decoding cancer complexity
  • Integrating science
  • Transforming patient outcomes

These are all particularly relevant to the the bispecific niche because whilst there are many of them, not all will make it to the finish line if they fail to improve outcomes and some will be consigned to the dreaded dog drug heaven status.

Think about it – you can have the grooviest bispecific molecule design ever, but if people taking it don’t live longer then it will likely get canned down the road in order to make way for a new era of novel targets and agents.

It’s time for some weekend reading – in the first part of our look at the bispecific antibody space, we highlight five key elements (with examples) to watch out for…

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ASH20 Preview of progress with bispecific antibodies

After a totally crazy last week, I must say it’s a tremendous relief to get back to focusing on science and early stage clinical development!

Behind the all the ongoing political and Covid-19 furore, the ASH abstracts dropped unexpectedly early on November 4th instead of Bonfire Night and this week it’s the start of the SITC meeting with live presentations already starting.

Every year we post a series of Previews highlighting key data to watch out for on key selected topics. The focus varies with each meeting with a look at different targets, modalities, or tumour types. This year we’re kicking off our coverage with a focused look at bispecific antibodies in early development…

Are bispecifics flying high at ASH20?

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Who is winning the CD20xCD3 Bispecific Race to Market?

Virtual meetings mean we miss the fun of German pop-up sausage stands and focus solely on the new emerging clinical data!

EHA25 Virtual, Not-In-Frankfurt – There’s a lot of commercial interest in CD20 x CD3 bispecifics, and in this post we’re taking a look at some of the latest clinical data presented at recent ASCO and EHA virtual meetings. Companies mentioned include Regeneron, Roche/Genentech, Genmab/Abbvie, Xencor, and IGM Biosciences.

Any analysis of a rapidly evolving and fast-moving landscape only represents a snapshot in time at the point it was taken, and this post is not intended to be a comprehensive landscape report, you’d pay a lot more than a yearly sub to BSB for that, but we’ve been following the field, and there are some trends emerging.

What makes it interesting is there is some nuance required in the interpretation of data, and with that in mind we spoke to an investigator at the forefront of clinical research who has done trials with several of the CD20 x CD3 bispecifics in development; the insights were quite illuminating.

This post offers an update on the CD20 bispecific landscape, analysis of some of the recent data at EHA and ASCO, as well as expert opinion, what more could you ask for?

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ASCO20 Preview on the importance of modality in oncology R&D

Continuing our ASCO20 coverage with another Preview in the pre-meeting series, we turn our attention to a particular modality of keen interest to many of our readers.

In this latest article, we highlight ten areas within the niche and include an array of companies, both big and small, across Pharma and Biotechs.

Some of them have some nice data to share, others will be footnotes to the meeting, but who fits into what category and what can we learn from the abstracts upfront?

To find out more, we looked very carefully at the hints and nuance which inevitably grace the writer’s pen – it’s time to hone in on where are the flourishes and the crossings out this year?

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JPM20 Highlights from Day 1

San Francisco – This week is mostly about business news as pharma and biotech companies congregate around the JP Morgan Healthcare conference.

It’s JPM time!

As of today (January 13th) I think a lot of investor and journalistic observers have probably been rather disappointed with no news of any major M&A activity, as this seen as setting the tone for the year ahead. I don’t personally see things that way because there’s always plenty of interesting small deals, new early funding, new science and even newco’s forming.

Indeed, Allogene already announced a new clinical collaboration with SpringWorks Therapeutics to evaluate their investigational anti-BCMA allogeneic CAR-T cell wherapy with their gamma secretase inhibitor in multiple myeloma.  They clearly see this as one way to address the shedding problems that have led to relapse with BCMA therapies.

As in previous years, we have a rolling live blog each day at JPM to highlight some of the scientific and company findings that emerge during the meeting…

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Where’s the next exciting IO target coming from?

Following the success of anti-CTLA4 and PD(L)1 therapies over the last five years or so, there is much time and attention being focused on addressing a key question, namely – what’s the next viable checkpoint target?

There are quite a few possibilities emerging, although to be fair, some of them will no doubt go by the wayside over the next year or two.  There has already been quite a bit of attrition since 2015/16.  Figuring out which ones will be a target versus being a useful marker is also an important aspect of new product development.

Competition is a fine thing – as long as they’re going in the direction you want to go.

For most of our ASCO coverage over the last few years we have tended to include a variety of approaches in the pre-conference Preview series that can run from a tumour type, a up and coming modality, an emerging target, and various other ways of looking at or making sense of the sea of data.

Here, we take a look at an IO target that is receiving much interest and explore what we know and where this might be headed… and ask whether the early promise is living up to the billing in practice?

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