Biotech Strategy Blog

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

Posts tagged ‘GSK’

Molecular Jiu-Jitsu – Turning Cancer’s Mistakes Against Itself

What’s emerging next from the AACR box?

Synthetic lethality has always seemed a great idea on paper, yet the very nature of tumour complexity has frequently hampered our efforts to make the most of the scientific premise.

There’s a new kid on the block now with an altogether much clearer proposition on offer.

There are also several of these compounds already in the clinic with a raft of others pursuing them in preclinical development.

What’s not to like?

In our second major update on this class of agents, today’s story takes a look at where we are, what’s coming up, and where we’re headed in the context of what needs to be accomplished…

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Does a Gaudy Night for GSK stand up under scrutiny?

Many moons ago the famous English writer Dorothy L. Sawyers wrote a series of novels about an aristocratic amateur sleuth called Lord Peter Wimsey.

When Wimsey attended the Gaudy dinner at Harriet Vane’s Oxford women’s college, the last thing he expected was to get caught up in a murder mystery.

Similarly, we might well wonder if the FDA will be surprised to see GSK, the sponsor of belantamab mafodotin, show up with a re-submission filing in multiple myeloma in an earlier setting several years on, especially since the toxicity profile hasn’t changed.  

In our latest data takedown we explore whether the findings hold water or not, including some expert opinions on the DREAMM-7 readout…

 

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Wrestling an intractable cancer target into submission

Santa Fe, NM

When it comes to intractable or tricky to drug targets, I’ve always thought this is where companies should put their best people on these projects and give them space and creativity to come up with new solutions to an age old problem.

There is both beauty and opportunity in either being first or best to a previously untamed oncology niche.

Why chase the herd of me-toos when you can conquer what was previously considered impossible?

After all, this is where there is advantage to be gained, especially if you have a head start then it’s up to everyone else to define how they are different and better than the first to the frontier land.

In our latest review, we explore the fresh opportunities to be had for savvy companies who have created novel pipeline agents in an early, yet emerging niche…

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Tipping the TIGIT balance

Are we experiencing a sunrise or sunset for TIGIT?

TIGIT has certainly generated significant positive and negative reactions over the last few years, as it wenders its way through the Gartner hype cycle.

Sometimes people think things are much more clear cut than they actually are in practice; the complex TIGIT pathway is a great example of this fallacy.

With targeted therapies we have consistently seen the emergence of acquired resistance over time – a similar phenomenon happens with immunotherapies too as the tumour adapts in response to selective pressure.  These changes can lead to immune evasion, which means less tumour cells are being killed, leading to relapse.

We haven’t seen much data on what the mechanisms of resistance are, in part because the anti-TIGIT trials are starting to read out and it takes time to figure out what’s happening.

There’s some new data from academia to consider, which may shine a light on one potential solution as well as offering an opportunity for another NewCo to rise.

Here’s a look at the science behind the story…

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Take the high road

We’re at the point in time in the cancer conference calendar where we are rolling out AACR analyses and interviews while also highlighting relevant ASCO abstracts to watch out for.

As a result, I always tend to think of May as the ‘mish mash’ month, to put things in Brit speak.

This isn’t necessarily a negative connotation, by the by, rather it’s a great opportunity to highlight some developments in different niches which tended to be overlooked.

Sometimes new data allows us to put a more coherent picture together or set boundaries around the corporate messaging.

To kick start our ASCO coverage, we’ve taken five phase 1 trials and looked at the pros and cons of each in the context of the underlying science – some come out strongly or understated, others much less so.  It’s important to understand the underpinnings in order to avoid being sucked into the inevitable hype machine accompanying abstracts at this event…

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An interesting turn of events for GSK and the BCMA niche

All aboard the BCMA train – or not?

No matter, this was an interesting one with a few twists in the tale. It also offers some additional context as to why GSK’s experimental BCMA ADC therapy, belantamab vedotin, missed out on a late breaker at ASH.

When you read the briefing documents you can quickly see why this might have been the case.

In the latest installment of this story – the last one was the late breaker than wasn’t at ASH19 – things turned out to be rather more intriguing than many may have initially realised…

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Flying high in the DDR oncology niche

Recently, PARP inhibitors have been back in the news for several reasons, including the publication of the olaparib (AstraZenca/Merck) advanced mCRPC data in the New England Journal of Medicine from the phase 3 PROfound trial and the announcement regarding achievement of the key secondary endpoint of overall survival. As Dr José Baselga quite rightly noted, this is very good news indeed because:

“Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve.”

We’ve rather more trial misses in this disease setting than successes from various therapies over the last few years including ipilimumab, PROSTVAC, alisertib, and atezolizumab, to name a few off the top of my head.

Related to mCRPC, let’s also not forget the upcoming PDUFA date later this month for Clovis’s rucaparib in the very same indication.

Not to be outdone on the PARP front, just a few days GSK received FDA approval for niraparib as first-line monotherapy maintenance therapy for women with platinum-responsive advanced ovarian cancer – regardless of biomarker status – based on the phase 3 PRIMA study presented at ESMO last year and simultaneously published in the NEJM. Recall that the majority of women (51%) had homologous-recombination deficiency (HRD) and this subset saw the greatest benefit.

Flying high in the DDR space?

We have now seen clinical benefit in the PARP inhibitors in four tumour types driven by DNA damage repair (DDR) deficiencies, namely ovarian, breast, pancreatic, and prostate cancers.

How do we go about extending the concept of DDR in terms of the biology of other tumour types?

A number of related pathway targets have been investigated, including ATM/ATR, Chk1, Wee–1 and others, with mixed success.

It’s not the nature of oncology R&D to stand still, however; what if we could turn things on their head and think creatively about the problems still to be addressed?

One particular new company to the PARP space is doing just that… so what are they doing and what’s different about their approach?

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JPM20 Highlights from Day 2

San Francisco – the 2020 JP Morgan Healthcare conference is now in full swing, and we’re continuing our coverage with another rolling blog that provides review and analysis of company presentations, deals, and plans for the coming year.

Some of the companies featured in yesterday’s commentary were: BMS, Incyte, Novartis, Deciphera, Allogene, Nektar, Seattle Genetics, Mirati, and Clovis.

While our focus on BSB is mainly writing about the science driving innovation and new product development, especially in oncology and immunology, it’s good to hear what companies are looking to accomplish in the coming year and then put that in context.

Cancer drug development, whether it be with targeted therapies or immuno-oncology remains a fast moving and continually evolving field, and one you have to keep your finger on the pulse of if you don’t want to be left behind.

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The dog that didn’t bark

What do cancer drug development and Sherlock Holmes have in common?

The simple answer is that sometimes you can gain insights by looking at what did not happen.

Will belantamab mafadotin stand out in the crowded BCMA space?

In 1892 Sir Arthur Conan Doyle wrote a short story about the disappearance of a famous racehorse the night before a race. What was curious about the incident was that there was no barking from the watchdog when you might otherwise have expected it, suggesting the dog knew the thief…

Can we follow the same inductive reasoning when it comes to cancer drug development? Are there things we would expect to see, but don’t? If so, what inferences can we draw from them?

In this post we’re taking a closer look at the latest data for GSK2857916 (now belantamab mafadotin), which in many ways was “the dog that didn’t bark” at ASH19.

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PARP inhibition in metastatic prostate cancer

Who’s King of the PARP castle?

After yesterday’s review and expert commentary on the phase 3 PROfound trial presented in the Presidential Session at ESMO 2019, we’re continuing our look at PARP inhibitors in advanced prostate cancer.

Perhaps surprisingly, there were a lot of insights to be found in the posters that were presented and discussed at the meeting for other PARPs in clinical development.

How do these stack up against olaparib? We’re not fans of cross-trial comparisons as they always come with a mandatory health warning, but if you want to consider the emerging landscape, it is important to be aware of the different patient populations, lines of therapy, and details of the trial designs.

For additional perspective at ESMO19, we spoke to a European prostate cancer expert who kindly talked about his clinical practice and also offered insights into a PARP clinical trial he and colleagues presented in Barcelona.

Who will be King of the PARP castle in advanced prostate cancer?

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