Biotech Strategy Blog

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

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New developments in Multiple Myeloma

We have been following the progress of various classes of molecules in the myeloma space here on BSB since 2010. These include traditional approaches (e.g. HSCT and proteasome inhibitors/IMiDs and various antibodies or ADCs), as well as immunotherapy (checkpoint blockade, CAR T cell therapy, oncolytic viruses etc).

Brick Lane Grafitti

There’s much going on in this space and it’s not only becoming extremely crowded and competitive (akin to 1L NSCLC), but there is a gradual trend towards convergence on many fronts, be they targets or modalities.

In our latest look at the myeloma space, we focus on several key areas of development – antibodies, CARs, and also highlight a new target that may be of interest…

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Can we target p53 therapeutically?

The Francis Crick Institute in London has an admirable program of engagement with the public and external researchers.

Attending a Crick Lecture recently presented by Cancer Research UK (CRUK) Chief Scientific Officer, Prof Karen Vousden CBE FRS, reminded me of my days as a PhD student at nearby King’s College London.

Regular BSB readers will recall that Prof Charles Swanton FRS is the Chief Clinician of CRUK.

In her Crick lecture, Prof Vousden elegantly explained to the audience why p53 mattered and how it might be targeted by small molecules.

What is the potential of this research for translational drug development? In this post, we take a look at new developments in the basic understanding of what p53 does, the current state of targeting p53 and Prof Vousden’s latest approaches.

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Ever decreasing circles in oncology R&D

File under: intriguing binary events coming up of interest this quarter…

Source: BBC

There are a couple of phase 3 readouts likely due soon on two quite different oncology drugs in late stage development, namely Mirv and Marge, (aka mirvetuximab soravtansine and margetuximab).

For British readers, they remind me of Howard and Hilda Hughes (right) in the highly popular 1980’s comedy sitcom, lead by Richard Briers, Ever Decreasing Circles.

Aside from the fact that it’s an amusing historical analogy with more than a bit of whimsy, there are some strange parallels and hidden messages to be found here. For the record, the two characters had a penchance for wearing matching yet rather garish and ghastly jumpers.

You could either make a similar negative case for the rush from limited phase 2 data to pivotal registration study as for terribly ugly sweaters, with the reduced return on efficacy being alluded to from the show’s title.

The ripple effect – which way will it go?

Or on the other hand… the matchy matchy look could also play out the other way, in terms of positive forthcoming readouts validating phase 2 findings, so which case looks stronger overall for each agent?

To find out, we take a look at the history, what we know, and share our thoughts on how things might pan out – either way, major positive or negative outcomes can have a major ripple effect.

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New developments in cytokines as immune modulators

T lymphocyte    Source: Dr Triche, NCI

It’s time for an update on cytokines as there is a lot going on here across both academia and industry.

While the clinical proof of concept has been demonstrated for IL-2 with FDA approval going back to 1992, there’s still much that we don’t know when it comes to the telephone directory containing many of the others.

There’s quite a few questions that can be asked:

  • Which ones might be best in which tumour types?
  • What about timing, dosing, and sequencing?
  • Which early combinations look promising in terms of unleashing the T lymphocytes?

After all, let’s not forget that some cytokines will induce negative immunosuppression, while others might induce variable effects depending on what they encounter in the tumour microenvironment.  It’s certainly a lot more complicated than many people truly realise.

There’s also the much under-rated potential to combine cytokines with other approaches such as immune agonists in order to jumpstart the colder tumours.

In this latest update, we take a look at five very different approaches and see how much progress is being made with alternative forms of immune modulation – the resulting conclusions might well surprise quite a few readers!

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How do we improve on 1st Generation T cell bispecifics?

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 Yin and Yang of biomarkers in cancer research

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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Insights from the ASCO GI19 conference

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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A tale of two cities – a look at two small immunotherapy biotechs

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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TKIs are still alive and kicking!

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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JPM19 Day 3 Highlights

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.

You can check out all of our JPM19 coverage, analysis and discussions here.

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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