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

Arcus takes aim at belzutifan in the HIF-2α arena

Once we have a new standard of care agent in a class the question is always how long can they hold it for?

Oncology R&D is a dynamic beast to watch – very little stands still or survives the test of time.

Once we have a new King anointed at the top of a mountain in a particular class of agents then there’s always a posse of others following in the wings to knock them off their perch.

If you’re not first-in-class to a given market then the race becomes very much one of who has the best-in-class potential and how long the mould-breaker will have on their perch.

We are currently watching to see who has the potential to become a best-in-class HIF-2α inhibitor beyond Merck’s belzutifan (Welireg) – or will they turn out to be similar and the first past the post reigns supreme?

The real test is never the initial preclinical or clinical data that comes out, but rather if any pretender to the throne continues to demonstrate favourable safety, higher selectivity, and durable activity in the form of improved survival over time.  After all, drug development is a marathon, not a sprint.

For later stage entrants such as Arcus’s casdatifan, the opportunity lies in differentiating themselves through improved outcomes and optimised combination strategies. As data mature, clearer insights into the overall survival and quality of life benefits will emerge, solidifying their role in the evolving RCC treatment paradigm.

Ironically we saw this same battle with the VEGF inhibitors in the same disease a decade ago.  Now it’s the turn of the HIF-2α inhibitors to follow the well-trodden path – there’s a lot to think about with new data coming out…

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

An unexpected emerging onco landscape to watch out for

Which Thunderbirds are Go?

Whenever we see a novel emerging niche with a raft of early stage agents coming to the fore, I always remember the salutary lesson we learned from the rise and fall of the BET/Bromodomain landscape.

This particular development attracted a lot of companies – big and small – with various permutations (selective, dual, pan inhibitors) entering clinical pipelines.  It wasn’t to be though, for it all collapsed once it was realised they were toxic and numerous projects were suddenly abandoned left, right, and centre.

Of course, not all targeted agents go poof by the wayside in the same fashion – as the PD(L)1 checkpoint and CD19 CAR-T cell therapies will certainly attest!

In our latest landscape review we take a look at an emerging target with a dozen agents in competition, the majority of which are either in the clinic already or undergoing IND enabling studies.

The good news is they are not all based on the same modality, which only adds to the interestingness of the niche.

While it’s unlikely all of the current agents will successfully make it past the post, I have a strong intuition at least one of them will.  The question is, which one?

To learn more about these early stage oncology compounds, check out the links below…

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

10 lessons on in vivo CAR-T cell therapies

Man measuring the clouds sculpture, Kanazawa

This summer I came across Jan Fabre’s fabulous bronze sculpture Man Measuring the Clouds (right) in Japan, of all places. It represents humanity’s ambition, idealism, and the pursuit of impossible goals.

The artwork depicts a life sized bronze figure of a man, often thought to be modelled after Fabre’s late brother, standing on a tall ladder and reaching upwards with a measuring rod as if trying to measure the sky. The piece captures a blend of optimism, futility, and persistence in the face of unattainable aspirations.

Similarly, we might consider the concept of tackling a variety of complex diseases from cancer and cardiac fibrosis to various genetic disorders with a tiny cell therapy involving a sample of just few millilitres seems equally apt and fitting.

Is it truly impossible though?

In our latest post, we argue no it’s not – and may actually be much closer to reality than many people realise.  What seemed like something on the distant horizon is likely to soon see not one, but multiple clinical trials opening up in other indications beyond blood cancers involving several cell therapy companies.

Following on from an inspiring talk this week, we offer 10 important lessons to think about and be challenged by – because the old yardsticks may well be a’changing sooner rather than later…

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 Future of Fratricide-Resistant CAR-T Cell Therapy

Over the last couple of years there have been numerous examples of novel CAR-T cell therapies going into initial phase 1 testing in oncology indications beyond B cell ALL/NHL and multiple myeloma from a variety of research groups as well as industry.

Masking may become important in new CAR-T cell products

An interesting trend to watch is the rise in gene edited CARs – via CRISPR or base editing – to either delete or knockdown various genes in an effort to improve the performance of the product in some way.

What if we could go beyond gene editing and employ creative masking strategies instead, especially in a broader array of tumour types?

Two obvious benefits would be lower risk from immunogenicity and also potentially lower cost of goods involved in the manufacturing process.

In this review we explore some new approaches coming out in the CAR-T cell therapy space and assess their strengths and weaknesses…

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

What can aviation teach us about ADCs and bispecific antibodies?

Blue Angels at Pensacola NAS

The aviation industry is a great example of innovation in practice, both in terms of incremental progress and truly revolutionary breakthroughs over the last few decades.

Think how far we have come since the first flight of an engine-powered heavier-than-air aircraft by the Wright Brothers at Kitty Hawk in December 1903.

Like the pharma industry, aviation is highly regulated and during the design of a new aircraft tradeoffs must be made in terms of the features and benefits, as well as weight, range, and performance.

So what can we learn from the aviation industry when it comes to oncology product development?

Quite a lot actually! I recently spent a morning at the National Naval Aviation museum in Pensacola, Florida and was inspired by what I learned to pen this post.

As an aside – if you are ever in the area, the museum is world class and definitely well worth a visit!

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

Stacking up the evidence

Sake drums, Takayama

If you are in Pharma business development and licensing (BD&L) then one of the things you may be looking for is opportunity gaps in the market. This means you can either license in new drugs in or partner with other companies to generate optimal combination opportunities for drugs in your pipeline. It’s becoming a real challenge, however, given few companies have all the products they need in their own portfolio.

The risk of signing an expensive deal that doesn’t pan out in the long term, even if heavily milestone orientated, is always there.

Here we highlight an under-rated cancer niche where there is a clear gap in the market.

It discusses how several companies are looking to tackle what could be a commercial opportunity. Will some of the one/two knockout punches proposed stack up when we see the data, or will the companies end up drinking sake to down their sorrows if it doesn’t work out?

This post also analyses some of the recent company news and data then looks at how we see the landscape as it currently stands, and where the future opportunities may lie.

In today’s world where the cost of capital is high – who can’t forget the concept of weighted average cost of capital (WACC) from their MBA case studies – emerging biotech companies can’t afford to make expensive mistakes.

Not only do you need to be science driven, but you have to be commercially aware in how you focus your oncology new products and BD&L activity…

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

Dramatic new paths being taken in autoimmune diseases

The road to enlightenment or an uphill struggle?

Five years ago when CD19 bispecifics and CAR-T cell therapies were all the rage, I doubt few people anticipated these agents would wind up being evaluated outside of cancer indications in areas such as autoimmune diseases.

Part of the reason, I suspect, lies in the very Yin and Yang nature of the underlying biology.

Chemists creating antibodies against targets relevant to both often create agonists and antagonists, reflecting different opportunities in each.

With CD19/CD20/BCMA CAR-Ts and bispecifics, however, the same product can be used for both because the initial goal is to simply wipe out all the pathogenic B cells or plasma cells and reset the immune system. Nifty, eh?

In our latest conference preview we highlight over a dozen different products to watch out for and look at some of the novel and emerging early stage approaches coming through beyond the obvious.

While there have been some dramatic and encouraging early signs in clinical trials, the road to approval success might be longer than some observers expect because there’s still a matter of phase 2 and 3 trials to go where long term follow-up might shake out some unexpected findings. “Optimistically cautious” is how one expert described his view of this fledgling world to BSB.

Curious to learn more?  Check out the article below…

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

Decoding CD123 CAR-T cells in AML

Some reflections on success and failure of CAR-T cell therapy in AML

I can’t quite recall who first offered this sage advice; it might have been Michael Caine as he often comes up with excellent practical if pithy advice such as ‘use the difficulty’:

If you want to find the solution to a complex problem then turn the problem upside down.

This is a great idea because it offers an opportunity to look at things from an entirely different perspective with fresh eyes.

Some new clinical and translational data has recently been published where the researchers did exactly that and came up with some intriguing findings. The outcome of which could prove to be helpful in prospective clinical trials…

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 challenge with bispecifics and ADCs…

Seeing the wood from the trees

With all the breathless hype of late around the rise of ADCs and even some bispecifics, are the data likely to catapult these early stage agents into future stars?

Are there signals we can explore to try and answer this key question?

It’s easy to convince oneself something looks better than what went before – is this truly the case?

In this review we explore pros and cons around half a dozen early stage agents in clinical development and explain why some might go forward while others might experience future setbacks…

To learn more from our latest oncology review and get a heads up on key cancer research insights, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

ESMO24 Reflections on early-stage standouts and wipeouts

It’s ceratinly been an intense and busy weekend covering early-stage new product developments at ESMO this year.

As with every new crop of agents, some look more promising than others with the abstract drops only to fizzle when we see the presentations, while other seem nondescript initially then provide hidden depths with the data reveal.

This year’s meeting from Barcelona is no different, offering highs and lows in equal measure.

In our latest review, we put half a dozen agents through their paces and explain the whys and wherefores to watch out for…

To learn more from our latest oncology review and get a heads up on key cancer research insights, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

error: Content is protected !!