Biotech Strategy Blog

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

Paths to success in cancer research

It’s time to pull together some notes, ideas, and clinical data on various biomarkers based on data available from clinical studies in oncology R&D and see how much progress we are making.

Are biomarkers a good path to success in cancer research or are they a gloomy red herring to the road less travelled?

Both answers can be equally true, but how do we tell the difference?  Are there any clues that we can use ahead of time to avoid later disappointment?

There have been several early studies that we’ve been following lately with readouts available from numerous cancer conferences, both positive and negative.

Can we learn from the failures and successes of the past to better interpret outcomes from future trials?

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Hitching a ride on the Powell and Mason tram

Gastrointestinal (GI) cancers comprise quite a wide variety of different tumour types, including those of the oesophagus and stomach, pancreas, small bowel and hepatobiliary tract, as well as the colon, rectum and anus.

With the possible exception of oesophagus and gastric/stomach cancers, this bunch of tumour types are generally colld rather than hot tumours for various reasons.

Aside from some recent forays by immune checkpoint blockade in gastric cancer, this field hasn’t had a lot of startling new developments to get excited about of late.

Are things finally changing?

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Cancer cells Source: Dr. Cecil Fox, NCI

As part of our ongoing mini-series on small emerging companies to watch out for, we have two quite different biotechs focusing on different aspects of immunotherapy on deck today.

We look at what we know, what we recently learned and where things are likely headed in the near to medium term future.

As always, there’s good and bad news along the way, so what are the pitfalls and what’s to be cheerful or encouraged about?

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While much of the attention and news flow seems to be on the big companies at the JP Morgan Healthcare conference, I also wanted to take time to explore some early oncology developments coming out of small biotech companies.

Next Gen TKIs pointing the way?

TKIs are very much still alive and kicking in many pipelines and no, not everything is all about immuno-oncology, checkpoint blockade or CAR T cell therapies.

We still have to tackle the three horsemen of apocalyse, namely MYC, RAS and TP53, and find ways of making the undruggable finally druggable if we want to succeed in tumours where these driver mutations confer unrelenting oncogenic addiction.

With that in mind, here’s an interview with Dr Charles Baum of Mirati Therapeutics and what they are doing to address some of these challenging issues…

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Unlike last year, rain in San Francisco wasn’t a feature in 2019

If there’s anyone who hasn’t got fed up looking for somewhere to sit and chat or have a meeting in San Francisco at the 2019 JP Morgan Healthcare conference this week, then don’t be surprised…

With meeting space continually at a premium and many attendees unwilling to pay exhorbitant table rental prices, you now see people resorting to the lobby steps at the Sir Francis Drake, while the ladies have the advantage over the gents of access to the powder room in the Westin (with plugs!)

There’s also a movement from the chic to the shabby:

JPM is as much about informal meetings, pitches and confabs about new ideas, as it is about the actual CEO presentations, and so this situation is likely to continue in future years.

Meanwhile, we continue to dive in with our latest daily blog and put a bunch of companies through their paces.  If day 1 is all about the big pharmas, by day 3 the focus is much more on up and coming or mid sized biotechs…

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San Francisco

While much of the focus has been on the mergers and acquisitions at this year’s JP Morgan Healthcare conference, seeing what a few companies have up their sleeves is also intriguing.

In today’s round up we address reader Q&A as well as highlight some presentations and announcements of interest in the cancer research space.

2019 is going to turn out to be a rather critical year for some companies…

If you missed the first day’s highlights and lowlights – check them out here!

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Karl the Fog lifts in San Francisco

The annual JP Morgan Healthcare conference in San Francisco is upon us with a bunch of deals, acquisitions and mergers already announced ahead of the meeting with more today now the event has opened.

Some years this meeting sets the scene for a scintillating 12 months ahead for Pharmaland, other years it’s a damp squib highlighted by the fog and rain.

What will 2019 turn out to be? It’s too early to tell but there’s certainly some intriguing elements worthy of initial discussion and review.

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We’ve written extensively about various cellular therapy approaches in hematologic malignancies involving T cells and natural killer (NK) cells over the last few years, but if we are to see significant lasting success in solid tumours then we may need to consider the involvement of other immune cells.

Indeed, if they can be engineered in some way to enhance the anti-tumour response then they might turn out to rather useful in combination with existing established approaches such as checkpoint blockade as a way to generate more responses.

How do we go about achieving this state?

There are some very intriguing and different approaches in early development that we plan to follow over time. Here, we explore this potential and the possibilities through our latest in-depth expert interview…

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We tend to think of the Fall cancer conference season as full of hope for new molecules showcasing encouraging yet early new data.  Rarely does negative data or unexpected trial glitches immediately jump to mind, although it unfortunately happens with startling regularity!

We’ve received a few enquiries and questions about an update on the Macrogenics platform recently.

The company have what they call a Dual-Affinity Re-Targeting (DART) program that includes bispecifics, mostly with CD3 as a standard co-stimulatory domain, although some are dual inhibitory checkpoints instead.

After writing about rather modest clinical efficacy with enoblituzumab monotherapy (anti-B7-H3 antibody) at the SITC 2015 meeting, I suspect that few of the attendees were envisioning an unexpected side swipe after this year’s event with one of their bispecific molecules, but so it came to pass.

As always, there’s a lot more to the central issue of ‘raised liver enzymes’ than meets the eye, so by popular reader request we walked through the issues and evidence to take a look at what’s behind this phenomenon…

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Standing from the crowd in refractory CLL?

Last year the two FDA approvals of tisagenlecleucel (Novartis) and axicabtagene ciloleucel (Kite/Gilead) CAR T cell therapy for hematologic malignancies such as pediatric acute lymphoblastic leukemia (pALL) and non-Hodgkins lymphoma (NHL) have captured a lot of attention.

It’s worth remembering, however, that back in 2010 the first patient who had a dramatic response to CD19 targeted CAR T cell therapy was actually a gentleman with advanced chronic lymphocytic leukemia (CLL), the case study of which was subsequently published by Porter et al., (2011) in the New England Journal of Medicine.

We’ve been following CAR T cell therapy and its potential in CLL for some time now, with all the successes, trials and tribulations along the way.

Dr David Porter (Penn) told BSB earlier this month:

“The very first patients we treated are now eight years out from their infusion, a little over eight years, and still in remission, still doing extremely well with no evidence of disease or progression, never had any other therapy. So, I think it’s become very clear that for some patients this is effective in the far advanced setting.”

It’s now two years since we last spoke and it was a great pleasure to reconnect with Dr Porter. As he told BSB at ASH in San Diego:

“One way you make it better is to understand why it’s working and why it’s not.”

What have we since learnt about the potential for adoptive cellular therapy in CLL and what new insights did we gain from new data presented at ASH18? The answers may well surprise you.

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