Biotech Strategy Blog

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

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In this post, it’s time to put your thinking caps on and empty your minds of any pre-conceived bias in order to play the modern version of Star Trek tridimensional chess aka IO combination trials.

Gems from the Poster Halls

Here we weave now together some important themes and highlight intriguing ideas that at first seem dissimilar, but actually have much more in common than many realise.

Data from bone chillingly cold poster halls of conferences in the distant past can come back and reviewed afresh in the light of new developments. The seasoned observer discards neither these findings or thought leader snippets of insights within nor forgets them in an instant, as many do after the hum of instant live reactions passes.

With oncolytic viruses and cytokines being much in the news of late, what can we learn about where things are likely headed?

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A path through the CD47 wilderness?

Continuing the third part of our ongoing CD47-SIRPα mini-series, we move on from the science and the competitive landscape to look at what CEOs in this niche have to say. There are many different approaches being evaluated at present, mostly in preclinical development, which makes it an intriguing area to potentially follow over time as new data emerges.

Not all of these molecules will be successful and the target is certainly not the easiest to attempt, although not as diffcult as MYC or RAS either!

When all is said an done, what do key players in this field think when they are developing compounds and how do they see the emerging challenges?

In this latest post, we have not one, but two CEOs, who were willing who share their candid thoughts and perceptions on the CD47-SIRPα space…

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Choose your clinical gateway!

When an oncology R&D landscape starts getting crowded and highly competitive, how do you go about working out clinically meaningful differences between compounds in development?

After all, there are often a myriad of small differences and nuances in the preclinical approach that may or may not be useful when it comes to the clinic.

Sometimes design matters, whether this be in the way the molecules are built or function, perhaps in tumour types that are selected for study, while at other times trial design can impact outcome.  In short, much like a 3D chess game it can get complicated pretty fast.

One such area that has been receiving increased attention lately and also has a lot of complexity to consider is the CD47-SIRPα pathway.

Last week we covered some of the key basics in a primer exploring the science in Part 1 of this mini-series.

Tomorrow we will post Part 3, which focuses on candid comments from researchers and CEOs in this niche, but before we get there it’s time to look at key clinical perspectives, as well as some of the nuances from related pathways that may be important factors to consider.

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For what seems the longest time, we have seen the battle in metastatic clear cell renal cell carcinoma (ccRCC) being focused on various anti-VEGF TKIs, whether against interferon, mTOR inhibitors, and even each other.

Lately, anti-PD(L)1 antibodies have also come on the scene – both as monotherapy and in different combinations – so are things set to change?

Will it be plaining sailing or are there hidden dangers ahead for the unwary?

Here, we take a look at the ever evolving landscape in RCC and explore the issues and challenges surrounding some of the novel combination readouts, including a look at the role immuno-oncology might play going forward.

Not surprisingly, there’s a lot to consider, discuss and think about…

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San Francisco

San Francisco – Yesterday at the ASCO Genitourinary Symposium, Dr Kim Chi noted that emerging data suggests that ctDNA appears to give better picture of tumour mutations than biopsy and can also monitor tumour load. This is an encouraging development that may facilitate increased use of the diagnostic as a helpful biomarker of response in clinical trials with immune checkpoint blockade.

We also know that prostate cancer sits firmly in the middle of the now famous Alexandrov and colleagues tumour mutation burden (TMB) analysis, but what factors are important in our understanding of the underlying biology of the disease?

There are many inhibitory factors exerted on the tumour microenvironment and thase may vary not only by tumour type e.g. renal cell carcinoma may have a greater influence from VEGF than prostate cancer, but also in individual patients.

With this in mind, I wanted to explore some new combination data being presented at the meeting, as well as look aspirationally to some potential combinations currently in development that may have escaped many people’s attention.

In this post, we take a look at current and future implications that keen observers should be watching out for…

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If there is one topic that has proven to be rather controversial over the last decade or so, it has been the CD47 and signal-regulatory protein (SIRPα) pathway.

What originally started out as a basic research project at the NIH and then academia has long since morphed into a highly competitive mini landscape of its own with multiple small and large biotech companies pursuing preclinical and clinical research in the space.

Are they going to be flying high or experiencing a bumpy landing?

In our latest 3-part mini-series, we take a look at the underlying biology, followed by separate posts on the companies in the landscape and finally, a company interview to highlight this growing field of oncology R&D.

We first posted a snippet on this pathway back in 2009 and much has happened since then. How much of the attention is hype over hope? Is the target a valid one? Where is the research heading in 2018 and beyond?

To start the ball rolling, we begin at the beginning with a look at the science…

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It’s that time of the year again already… the ASCO GU Preview series!  The good news is that there is a bumper crop of intriguing data to discuss this year.

Golden Gate Bridge, San Francisco

With the ASCO embargo on the GU Symposium in San Francisco lifting at 5pm, there’s a lot to consider not merely in terms of the data itself, but more importantly, in terms of a broader context and the landscapes involved in prostate, renal and urothelial cancers.

Here we take a look at some of the key highlights to watch out for and what they mean in context.

A separate post on the phase 3 PROSPER data for enzalutamide in prostate cancer with a discussion on the ongoing enzalutamide/abiraterone/ADT/chemotherapy debate as part of the GU18 coverage is also available.

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BMS LogoThe big news of interest in the oncology landscape this morning is the BMS announcement that the CheckMate–227 study hit its primary endpoint of PFS under certain conditions in previously untreated non-small cell lung cancer (NSCLC).

We’ve been covering the 1L NSCLC landscape for a while now and this study was one that was less easy to predict than the others for a number of reasons. I’m pleased to say we got it right, although there are quite a few things to learn from this announcement, not to mention some important implications too.

Here, we continue our coverage on this topic with an analysis based on the latest information…

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How Will Adoptive Cell Therapy Crack Solid Tumours? – This was the provocative question raised by the title of Dr Malcolm Brenner’s keynote lecture at the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium held last week in San Francisco, ”Adoptive T cell Therapy: Target Solid Tumors by CARs or TCRs?”

Malcolm K Brenner, MD PhD is the Director of the Center for Cell and Gene Therapy at Baylor College of Medicine in Houston, Texas.

ASCO have just named CAR-T cell immunotherapy as its “2018 Cancer Advance of the Year” so it’s timely to take a look at where we are in the adoptive cell therapy field and where it may be going?

We’ve been writing about adoptive cell therapies (ACT) such as CAR T cell therapy since 2011.  Indeed, I vividly recall one of my early interviews about it at ASH 2013 (See post: Juno Therapeutics takes on Novartis and seeks to revolutionize the treatment of blood cancers – an interview with Renier Brentjens)”.

In recent years, CAR T cell therapy has made tremendous progress in hematologic malignancies, gaining FDA approval last year in relapsed/refratory paediatric ALL and non-Hodgkin lymphoma (NHL). We have not seen the same efficacy in solid tumours as yet, and this remains one of the key challenges in the field today.

In this post, we take a look at the perspectives Dr Brenner offered in his keynote lecture at ASCO-SITC and the potential impact they may have on the landscape.

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Bellicum have just announced that the FDA placed a clinical hold on BPX–501 clinical trials in the United States following three cases of encephalopathy “deemed as possibly related to” treatment with their new product in development, BPX–501.

The FDA clinical hold does not affect the ongoing BP–004 registration trial in Europe.

Here we take a look at some of the issues underlying the unfortunate news.

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