Biotech Strategy Blog

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

About MaverickNY

Here are my most recent posts

Posts by MaverickNY

AACR23 Preview 5 – an emerging landscape

Bridge over troubled waters or time to lay down?

In our latest preview, we’re taking a look at a pathway previously thought to be ‘undruggable’ – an awful term we increasingly should think carefully about using given it may only reflect the limitations of current science.

As we’ve seen with KRAS – and this piece is not about that pathway – innovative science can quickly turn the ‘undruggable’ into something much more ‘tractable’ with the right agents.

In our latest post we’re looking at the emerging landscape for a class of new agents in early development we expect to hear more about at the AACR23 annual meeting in Orlando.

Which companies will be the winners and losers is too early to tell, but much like crossing the bridge in Iwakuni, are you better off staying with the group, or taking an entirely different route to success?

To continue reading our latest highlights on oncology new product development including commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

AACR23 Preview 4 – Stepping It Up

Continuing our evaluation and exploration of another batch of early stage anti-cancer compounds either in late preclinical or phase 1 clinical development, there are some surprises in store this year.

While following the nth molecule in a given space may have utility for patients in the form of the improved design and superior outcomes, here at BSB we’re much more intrigued by uncovering and following novel targets.  Some of these we first wrote about in 2016 or earlier when they were little known and very much under the radar.

As we start to see more clinical data emerge how are things holding up and just as importantly, how is the field evolving in the context of different approaches to the same tumour target?

One of the biggest mistakes I see rookie industry folks commit is to only follow competitors with the same target as the one they have in house.  They’re so blinkered they don’t realise the standard of care can be changed by a completely different regimen from the one they are pursuing.  This means by the time they come to market they have to usurp something they don’t have data against.  It happens all the time, sadly, and can lead to a suboptimal post launch performance.  Oops.

New product development is never easy, although the good news is we have another group of targets/modalities/companies/tumour types to review and discuss – what’s not to like?!

To continue reading our latest highlights on oncology new product development including commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

AACR23 Preview 3 – Emerging agents with a different mechanism of action

As we continue our new products journey evaluating early stage agents in development with data at AACR23, it’s time to assess another batch of compounds in the context of the broader landscape.

What stands out and why does this or that agent matter?

Yes we all want to be able to tell the wood from the trees, but what are some of the critical questions needing to be asked and answered in order to be able to do this?

There’s a lot of intriguing and innovative drugs on the horizon at AACR23, so plenty to watch out for!

To continue reading our latest highlights on oncology new product development including commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

AACR23 Preview 2 – Seeing the wood from the trees

Seeing the wood from the trees

The annual AACR meetings are where we look for hidden gems, new trends, novel targets, as well as a raft of early stage agents coming out of company pipelines.

The problem is which ones stand out from the crowd and how do we attempt to see the solid wood from the mass of trees surrounding us?  Unfortunately, it isn’t always obvious and the first past the initial stage of development isn’t necessarily the best example or most optimised in the long run.

Let’s not also forget how a whole niche can also wither overnight based on the first company’s negative results, which can be in the form of lack of efficacy – Incyte’s IDO inhibitor was a good example causing a major sneeze – or severe toxicities viz BET/Bromodomains, which fizzled out almost overnight after a promising start and a long list of competitors vying for time, space, and attention gradually faded from view.

In our latest Preview, we take a look at four early stage new developments and highlight some potential opportunities and challenges to be addressed…

To continue reading our latest highlights on oncology new product development including commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

AACR23 Preview 1 – What to watch for

With the AACR abstract drop coming tomorrow, it’s a good opportunity to explore what are some of the important broader themes to watch out for at the annual meeting this year?

In the first of our conference preview series, we highlight six key areas to watch out for and why they’re important in the context of novel or early stage development molecules coming through in oncology pipelines.

Some of the selections may well cause a few surprises…

To continue reading our latest highlights on oncology new product development including commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

A lysing kind of winter

If we want to understand where the next generation of products are coming from we have to dive deep beyond the obvious to ‘see’ where the field is going and why.

Sometimes this might involve clever strategies for hiding or masking the ability of the killer cells to ‘see’ normal cells in order to reduce on-target/off-tumour toxicities, other times we may need to use creative synthetic enhancements to give the product more robust performance in some other shape or form.

How should we go about achieving this next stage of nirvana? Can it be done, and if so, how, where, and what’s involved?

In this latest post, we take a look at what lies beyond and explain why some of the emerging ideas with cool targets might either make it through or fall at the cell therapy equivalent of Becher’s Brook at the Aintree Grand National…

To continue reading our latest highlights on oncology new product development including commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

New progress in tackling intractable cancer targets

125th St subway in Harlem

It’s all too easy to think of New Jersey as the behemoth of Pharmaland in the north east, while biology dominates in nearby Boston and Cambridge, yet Manhattan is rapidly turning out to be a nice home for quite a few young biotechs with a ready made source of talent and technology.

We’ve covered several of these companies over the last couple of years, including Volastra Therapeutics in Harlem.

What’s more, they’re working on a pipeline focused on chromosomal instability (CIN).

While many companies are getting into replication stress and synthetic lethality, CIN is a specific niche referring to genomic instability where chromosomes become unstable, such that either whole chromosomes or parts of chromosomes are duplicated or deleted (aneuploidy) such as point mutations or chromosome rearrangements.

Much of the genetic heterogeneity we see in tumours is largely due to chromosomal instability.

One of the up and coming areas in cancer research is CIN and the impacts of these changes and we may be able to address them with therapeutic interventions.

We’ve been following the progress of Volastra for a couple of years now so with their latest news centred around an in-licensing deal and closing on Series A financing, this is an excellent opportunity to provide an update and discuss what these developments mean in context…

To continue reading our latest highlights on oncology new product development including commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

Dark Knight Rising

Rotterdam harbour

In the latest installment of our CAR-T cell mini-series, we take a look on the ‘dark side’ as we switch from liquid to solid tumours.

We have made some great progress in leukemia, lymphomas, and even multiple myeloma while solid tumours have presented a much greater challenge for the field.

There have been some helpful developments over the last few years relevant to this front, however, although when each is seen in isolation, the potential may not be apparent.

Here we look at the bigger picture and highlight important areas, which could lead to some surprising new developments emerging over the next few years…

To continue reading our latest highlights on oncology new product development, including an expert interview plus commentary and analysis BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

Changing of the guard

A frequent challenge in oncology R&D is the fast paced nature of pipeline development such that there’s always something cool or new coming along nipping at the heels of those further ahead in clinical development coupled with the changing of the broader landscape before you even get to market.

What this means is companies with agents in phase 2 development can frequently feel rather squeezed between the two extremes.

This can lead to a lot of pondering on whether they will have enough innovation to make an impact on whatever are the favoured approaches by the time they might get to market, while at the same time offering sufficient protection against the novel compounds coming along behind.  Obviously no one drug is perfect and each will have their own achilles heels, to add to the mix and uncertainty.

For some time now there hasn’t been much in the form of new approaches in prostate cancer beyond the myriad of androgen receptor antagonists in various treatment niches plus the PARP inhibitors in a select population of men with BRCA mutations… what then?

A big question targeted therapies often have to address is their impressive initial response rates and PFS based on RECIST measurements don’t always translate into people living longer, as measured by overall survival.  No drug is without toxicities either, which means these need to be factored into the final clinical decision making and can make or break early uptake more than initially realised.

In our latest review we highlight some examples of where the field might be headed next (or not), based on some new preclinical and clinical data presented…

To continue reading our latest highlights on oncology new product development including commentary and analysis, BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

The near term future in CAR-T cells is a’changing!

It’s hard to imagine It’s now almost a decade on since eagerly reading the seminal CRISPR papers from the Doudna/Charpentier and Zhang labs in Science, but what a ride it’s been!

The cool thing here is we’re now getting closer to seeing clinical grade oncology products using base editing, a next generation approach with greater precision in terms of the cuts achieved.

This technology has important implications, not only for novel CAR-T cell therapy developments (which we will be covering in more detail going forward), but also other diseases where base pair changes are necessary to address the underlying root cause of the disease.

In our latest expert interview, we caught up with the CEO of one of the ompanies active in this space for a fun science discussion about the potential implications for new product development in a variety of key topics….

To continue reading our latest highlights on oncology new product development including an expert interview, BSB subscribers can log-in or you can click to access the content.

This content is restricted to subscribers

error: Content is protected !!