Biotech Strategy Blog

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

About MaverickNY

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Posts by MaverickNY

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…

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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!

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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…

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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…

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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…

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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…

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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…

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Breathing fire into early onco pipelines

Dragon outside ‎⁨Kiyomizu-dera Temple⁩, ⁨Kyoto⁩

It’s time to review some key highlights from ESMO in the early stage pipeline products.

There were so many on our list this year we split the review into two parts.

One challenge many biotechs face is the decision on whether or not to present initial clinical data before the full cohort has completed enrolled.

Do they go for a quick snapshot demonstrating some activity in a truncated waterfall plot as an ‘encouraging sign’ or wait for the full picture and hope it holds up over time?

It’s interesting to see this played out every year at ESMO.

At ASH and ASCO an early look will likely end up in a poster, but at ESMO there are far more slots available for developmental therapeutics, even in tumour type oral proferred papers or mini-oral sessions.

If the reaction isn’t what you expect then it can unwittingly become an actionable event for a public company.  This comes with both blessings and a curse so choose wisely.

In this review we have a mix of small and large companies, as well as regional diversity from UK/EU, US,  and Asia…

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A tale of two cities

The Tree of Life, Kenrokuen Gaden, Kanazawa

We can easily imagine a ‘tree of life’ metaphor to illustrate the philosophical idea of how advancements in cancer therapeutics can represent a growing, intricate system with many branches.

While these branches – representing novel therapies – can offer hope and potential for improved outcomes, the complexity and resource requirements might not reach all branches of the population equally.

Increasingly there is disparity between those who benefit from cutting edge treatments and those who, due to geographic or systemic barriers, remain underserved.

In today’s post from the annual meeting of the European Society of Medical Oncology (ESMO), we highlight a couple of developments where the results might factually be considered practice changing owing to improvements in outcomes, yet for various reasons may not actually move the needle in the real world…

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IO bispecifics compete with ADCs and make an impact

Bridging between cancer conferences

For all the breathless hype and attention focused on antibody-drug conjugates (ADCs) of late, you might well be forgiven in thinking other modalities have been broadly abandoned or forgotten completely.

This isn’t actually the case since there are quite a few developments on the bispecific front, which are quietly moving along and showing some intriguing data in certain areas.

As we bridge between World Lung and the ESMO meeting this weeknd, this is a good opportunity to take a look at some of the progress being made off many people’s radar…

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