Biotech Strategy Blog

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

Posts tagged ‘mesothelin’

Continuing our up and coming biotech series, we now switch our focus from small molecules to immuno-oncology.

While big Pharma has garnered the lion’s share of attention (and revenues) from checkpoint inhibitors and CAR-T cell therapies, if we want to make a serious impact on solid tumours, especially the colder ones, then we are going to need to devise ways of jumpstarting the immune system where there are far fewer immune cells around to help do this.

There are many ways to achieve this aim, although the count is still out on how best to optimise combinations.

We’ve looked at various approaches over the last couple of years including chemotherapy, immune agonists, cytokines, STING/PARP/TLRs, NK cell checkpoints, T and NK cell bispecifics, and many many more.

Fortunately, most small biotechs have been focused on alternative targets that mght be seen as complementary to existing established therapeutics.

As we move forward towards a more regimen-based approach some of these will succeed while many will not, such are the challenges of oncology R&D where 90% of compounds unfortunately fail.

One challenge that has long been obvious though is that once clinical proof of concept has been established, another 10 companies will wade in quickly and dust down old molecules lurking in screening libraries that have been languishing in darkness waiting for their call-up. In the old days, a lead time of 5+ years before a competitor caught up with a rival drug was not uncommon.

Increasingly, it now seems there are mere months rather than years between approvals in the same class, an astonishing feat in a highly competitive and cut-throat business driven by generic erosion, noticeable pipeline gaps and the urgent need for continued topline sales growth.

In today’s hot seat, we have a small biotech CEO discussing his company’s IO pipeline and progress…. they caught my attention at AACR last year and I’m delighted to have the opportunity to learn more about what they are doing and how they are different from the existing competition.

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The immuno-oncology space continues to get both interesting and also very crowded with over 20 chimeric antigen receptor (CAR) T cell therapies now in development. Originally, the excitement began with the University of Pennsylvania’s dramatic announcement regarding the first two advanced CLL patients they successfully treated, leading to a collaboration with Novartis and spurring a new ‘arms race’ development in this niche.

While most of the CAR T cell therapy data since has largely focused on acute lymphoblastic leukemia (ALL) and to a lesser extent, non-Hodgkins lymphoma (NHL), many have been wondering what was happening on the CLL front?  Has hope been abandoned there or will we see a renaissance occur?  It is of particular relevance with the Abbvie/Genentech announcement that venetoclax has positive data in CLL patients who have the Del17p mutation and filing is likely here in this subset soon.  Therapies such as ibrutinib and idelalisib are already approved in refractory CLL and may also have a future role to play here.

Do we need suicide switches for CAR T cell therapies such as Bellicum and Cellectis are developing or not?

Meanwhile, other hematologic malignancies are also being explored, including multiple myeloma. Why would a CD19 CAR work in a disease long considered to be CD19-negative in advanced, refractory disease?

Carl June UPenn

Dr Carl June, U Penn

What about progress with solid tumours? Many commentators and investors have been highly sceptical of the chances of success here following the advent of positive checkpoint data beyond metastatic melanoma and early CAR data in mesothelin cancers.

To answer these questions and also get a flavour for where things are headed with CAR T cell therapies, we recently interviewed one of the leading experts in this field, Dr Carl June (U Penn).

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“You may say I’m a dreamer

But I’m not the only one.”

John Lennon, Imagine

As part of our ongoing series on the AACR Previews, today I want to take a closer look at some interesting scientific and clinical data in triple negative breast cancer (TNBC).  One reason for this is that we need to remember that the disease, as currently defined, is essentially what’s left after taking out the ER+, HER2+ and inflammatory breast cancer subsets. In other words, it’s a very heterogeneous catch-all population, making clinical trials rather challenging at best. It also means that the chances of success in general all-comer trials is rather low.

It is my hope that as we learn more about the biology of this disease, we may see further subsets be defined by molecular peculiarities, much in the same way that gastrointestinal stromal tumours (GIST) were defined by KIT expression and CD117. Once we have more homogenous subsets, it will be easier to conduct trials just looking at those specific patients, thereby improving the chances of clinical success with therapeutic intervention.

There’s been a lot of work focused on this area over the last few years, so it seems a good point to find out where the progress has got to.

Without much further ado, what can we learn about the biology of TNBC from AACR this year and which potential new targets might emerge?

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