Biotech Strategy Blog

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

With so much data to cover recently, we haven’t have time for a perennial favourite, the monthly mailbag to answer BSB reader Q&A on hot oncology topics.

October has brought out quite a lot of controversy to consider, most of it happening in the last week!

Here, we consider questions on Immune Design’s phase 3 trial with their NY-ESO-1 vaccine, CMB305, which attracted both a lot of market attention and also questions from readers.

We also review a bunch of questions relating to 1L NSCLC and the upcoming readouts.  This niche is probably potentially one of the most competitive spaces in oncology R&D at present and readers seem almost insatiable for information on this topic.

It is quite a turnaround considering the last decade of numerous failed trials or even non-inferiority studies that were being conducted.

Like many readers, I can well remember sitting in freezing cold, half empty halls wondering if the latest chemo or targeted therapy doublet was going to offer a mere 2-3 months improvement in PFS and no OS benefit or not.  It was that binary and also depressing.

With the possibilities offered by immune checkpoint blockade, in a short space of time 1L NSCLC has gone from graveyard to uber intense with several companies vying to demonstrate improvements in overall survival by 6 months or more.

There’s a lot more to come here and not all of the lung trials will be positive – that’s expecting too much against the game of chance.  Here, we look at numerous factors that could make a difference, both positive and negative.

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One of the things that I’ve heard repeatedly over the last year is that many researchers want a better biomarker of response for checkpoint therapies than PD-L1 expression by IHC.

National Harbor

Indeed, we could expand that statement more broadly to say that there’s a real need for a better predictive biomarker of response to any immunotherapy, since there are more approaches out there now and not just checkpoint blockade. Plus combinations are evolving, complicating things further.

Fair enough, but what’s happening in this space?  Anything, Bueller?

We’ve covered a few emerging ideas in the past, although they were based on retrospective analysis – usually with a small N – and remain to be validated in prospective clinical trials.

There’s quite a few groups now much more active in research in this space, from academia to industry.  This is a good time to take stock and look at some of the emerging technologies that might be making a splash later if the data pans out.

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Coney Island Roller Coaster

In the roller coaster of life that is oncology R&D, molecules come and molecules go… a rare few reach blockbuster heights while many others are quietly packed off to dog drug heaven, never to be seen or heard of again.

This is also very true of targets as well…

What about the in-between space?

Unfortunately, that’s where most molecules and cancer targets end up – into a deep black nothingness where we seek the high affinity targets with low grade side effects – and fall short in some way. It’s a frustrating place to be, to be sure.

One of these conundrums is compounds against CD123 (IL3Rα), which have been in the spotlight on and off this year and are turning out to be a rather mixed bag.

After our recent update on Cellectis and their CD123 direct CAR T cell therapy (UCART123), I wasn’t expecting to write any more on this until ASH in mid December. How wrong that prediction turned out to be!

Today we have quite a few things to discuss on this topic, so if interested in CD123 in hematologic malignancies and going beyond that to find better targets in AML then this is the poster for you…

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Last week we reviewed some of the promising oral late breaking abstracts and highlighted what to watch out for (W2W4) from our key selections.

National Harbor, DC

This week, it’s the turn of the poster late breakers to be in the spotlight.

There are several approaches worthy of highlighting, but as always, there are also some potential pitfalls for readers to be aware of.

After all, life in the oncology R&D fast lane is as never easy or predictable as the changing of the seasons.

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One of the biggest challenges that many people have in cancer research is spottng opportunities in a cosntantly swelling sea of data.

That situation gets ever more difficult as the year and cancer conference season goes on and a raft of new data evolves from not just monotherapy studies, but also combination trials.

Add in numerous tumour types and patient subsets…

And then there’s another layer (or five) of additional sophistication from newly emerging targets, different approaches undertaken and novel ideas explored.

Who want’s to play 3D chess?

It’s a little bit like slowly peeling an onion, strip by strip, until we get to the heart of the matter. This can take time. Meanwhile, preclinical data at previous meetings that many barely noticed at the time comes back to be looked at in a fresh light with newly emerging clinical data. And we start to see things quite diffferently with this new information.

Talking on the onion, we decided to kick off our annual SITC series ahead of the event next month with a look at five key presentations that should be interesting and advance the field in terms of potential impact.

National Harbor Maryland

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Cancer immunotherapy has been very much focused on T cells of late, but perhaps we shouldn’t ignore the importance of the innate aspect of the immune system and how that might help generate cytolytic activity to help kill cancer cells.

Regular readers will know that we’ve been following the potential of Natural Killer (NK) cell therapy and targeting NK checkpoints.

Sculpture in Mainz

At the recent CRI-CIMT-EATI-AACR international cancer immunotherapy conference in Mainz, we spoke with a scientist active in NK cancer immunotherapy research.

Dr Nicholas Huntington (@Dr_Nick_Bikes) leads a laboratory at the Walter and Eliza Hall Institute (WEHI) of Medical Research in Melbourne, Australia.  He’s also co-founder of oNKo-innate, a startup company focused on developing innate immunotherapies.

After his presentation in Mainz, he kindly spoke to BSB about his NK cell research and its potential as a novel target for cancer immunotherapy.

Here’s a short excerpt from our discussion:

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Periodically, we post an analysis and look at a particular landscape and the leading competitors within. One area of rather intense interest that we have been following is the progress (or march might be more precise) of checkpoint blockade in previously untreated metastatic non-small cell lung cancer (1L NSCLC).

Our extensive reviews and discussions in this area have included a look at:

In addition, I last posted my recent predictions on this space in July this year and already quite a bit has happened since then!

With a bunch of other phase 3 trial readouts coming up over the next couple of months, it’s now time for another update on what to watch out for, what to expect and why some studies can be handicapped differently.

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Pancreatic adenocarcinoma is a tough disease to deal with given that it is portends poor clinical outcomes, aggressive tumour biology, and early metastatic spread. Not surprisingly, we have seen very little improvements in terms of clinical outcomes with anti-cancer therapeutics. Surgery (for early stage disease) and intense chemotherapy (for metastatic disease) remain the bedrocks of treatment to this day.

From an immunotherapy perspective, there are also additional barriers and hurdles to overcome including, for example, lack of high mutational load, a complex inhibitory tumour microenvironment, and even a physical barrier in the form of the stromal layer.

Not surprisingly, all of these factors combine to make companies reluctant to rush into clinical trials with immune checkpoint blockade, accepting that we really need to understand the underlying tumour biology better before attempting such an endeavour.

At a recent cancer conference we heard an uplifting talk from a research group who are attempting to tackle this issue and offer some pointers on where there may be some near-term opportunities that are worthy of discussion.

Before we can even consider what delivery system or adjuvant to use, we first have to do the scientific investigations into what’s special about exceptional responders and characterize those.

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Mainz – At the recent CRI-CIMT-EATI-AACR international cancer immunotherapy conference in Germany, one of the underlying themes of the conference that attracted considerable attention from speakers and poster presenters was neoantigens, and how to generate cancer vaccines directed against them.

One of the European leaders in the field is Professor George Coukos who is Director of the Department of Oncology at the University of Lausanne Hospital and Director of the Lausanne branch of the Ludwig Institute for Cancer Research.

Lausanne is an exciting place for innovative translational oncology work with the Swiss Cancer Center, that Coukos also directs, creating synergy between partner institutions co-located in the Lausanne University Hospital (CHUV).

Mainz, Germany

We last spoke to Prof Coukos 18 months ago and much has happened since then. In Mainz, he kindly agreed to speak to BSB again and provide an update on progress.

This time we talked about the cancer vaccine research that he and collaborators such as Dr Lana Kandalaft are pioneering in Lausanne, and how this could best be applied in ovarian cancer.  It was exciting to hear him discuss his vision and some of the ambitious goals he hopes will be possible within the field.

Here’s a short excerpt from the interview – he has an interesting story to tell:

This expert interview is part 5 of our onging mini-series on the Future of Cancer Vaccines.

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Mainz: At the third CRI-CIMT-EATI-AACR international cancer immunotherapy conference held in Mainz recently, one of the emerging themes from an exciting and interesting meeting was novel cancer vaccines.

Despite the announcement last month that the Bavarian-Nordic phase 3 PROSTVAC trial in prostate cancer was futile (See post: PROSPECTing for nuggets with PROSTVAC in CRPC), therapeutic cancer vaccine research is experiencing a renaissance.

In this new mini-series, we’re featuring interviews with leading scientists and clinical researchers at the forefront of cancer vaccine research.

Mainz, Germany

It’s not meant to be an exhaustive list of the “good and great,” as not all leaders in the field were actually in Mainz, but nonetheless we hope this series, like a series of postcards, captures some of the excitement along with challenges and opportunities facing researchers at present.

Up next is Professor Cornelius “Kees” Melief, who is Emeritus Professor at Leiden University in the Netherlands and Chief Scientific Officer of ISA Pharmaceuticals – where ISA stands for Immune System Activation.

Earlier this year, Professor Melief received a lifetime achievement award from the Association for Cancer Immunotherapy (CIMT) for his work in research in this niche.

He’s a global expert on cancer vaccine research.  Ironically, back in July he published an editorial in Nature entitled, “Cancer: Precision T-Cell therapy targets tumors” that discussed some two letters on neoantigen cancer vaccine research from other thought leaders we have interviewed in this current mini-series, namely Dr Cathy Wu (Link) and Prof Ugur Sahin (Link).

While, in Mainz, Professor Melief kindly shared his thoughts on the field, where it is going, and how ISA Pharmaceuticals are looking to make a difference.  Here’s an audio postcard for those interested in hearing a sample of what he had to say…

This is the fourth interview in our mini-series on the Future of Cancer Vaccines.

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