Biotech Strategy Blog

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

Posts tagged ‘AbbVie’

Thinking outside the box

I’ve heard quite a few people frequently exclaim of late how “ADCs are hot!” Alrighty then, yet this is really only the end of the beginning because old hands know they have actually been around for quite a while.

If one was cynically minded then there’s an obvious reason – chemotherapies are usually generic these days, while ADCs bring in much higher ticket prices.

They won’t all succeed though – we’ve already seen a steadily growing graveyard of failures, which started out promising on paper then unfortunately flopped in the clinic.  Just because an area is suddenly declared hot (again) doesn’t guarantee success because these are complex molecules to design compared to small molecules with a lot of factors impinging on their performance.

What many observers have missed, however, is the deeper and broader opportunities offered beyond the often plain vanilla examples.

This is because the modality has greater flexibility than chemotherapies – you can design them such that other things can be bolted on or even hidden, Trojan horse style.

In other words, what we are seeing is an early trend with few enlightened companies starting to ‘think outside the box’ in this niche.

In the near to medium future we will see a greater volume of clinical data on these emerging approaches, which could lead to improved outcomes and longer lives for people living with cancer.

So what are these new fangled things, how do they work, and which companies are active in the futuristic ADC markets?

In this review we highlight half a dozen emerging areas around ADC technology with examples of products and companies active in these niches…

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AACR22 Part 2 of the RASpalooza

Voodoo in NOLA? Say it ain’t so!

A few years ago long before the advent of the KRASG12C inhibitors, a scientist once drolly stated to me that trying to drug RAS, and KRAS in particular, was akin to the med-chemist’s version of voodoo. Hah!

Fast forward a few years to AACR in New Orleans and we have a veritable feast of RAS targeted agents now coming through quite a few company pipelines in all shapes and forms from covalent and non-covalent inhibitors to molecular glues, and even bifunctional degraders.

Some voodoo, man.

In this review, we look carefully at three different companies (including biotechs and big pharma) who are actively developing various inhibitors in the RAS niche with early stage developments and look at what’s coming along behind Amgen and Mirati… the first isn’t always the best in the long run, so what should we be looking at and learning from in the next tranche?

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Who is winning the CD20xCD3 Bispecific Race to Market?

Virtual meetings mean we miss the fun of German pop-up sausage stands and focus solely on the new emerging clinical data!

EHA25 Virtual, Not-In-Frankfurt – There’s a lot of commercial interest in CD20 x CD3 bispecifics, and in this post we’re taking a look at some of the latest clinical data presented at recent ASCO and EHA virtual meetings. Companies mentioned include Regeneron, Roche/Genentech, Genmab/Abbvie, Xencor, and IGM Biosciences.

Any analysis of a rapidly evolving and fast-moving landscape only represents a snapshot in time at the point it was taken, and this post is not intended to be a comprehensive landscape report, you’d pay a lot more than a yearly sub to BSB for that, but we’ve been following the field, and there are some trends emerging.

What makes it interesting is there is some nuance required in the interpretation of data, and with that in mind we spoke to an investigator at the forefront of clinical research who has done trials with several of the CD20 x CD3 bispecifics in development; the insights were quite illuminating.

This post offers an update on the CD20 bispecific landscape, analysis of some of the recent data at EHA and ASCO, as well as expert opinion, what more could you ask for?

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Is there a silver lining in SCLC?

Last October I posted two updates on small cell lung cancer (SCLC). One explored the broad SCLC landscape, while the second was a detailed analysis highlighting the red and green flags to watch out for in the Rova-T TRINITY study.

My sombre conclusion or prediction, if you will, was not particularly well received at that time:

“My sense is that the median PFS and OS in the allcomer ITT population will remain modest and in line with what we might expect from historical chemos in 3L SCLC.”

Dismal happenings are to be expected…

This morning AbbVie announced that they will not be filing for accelerated approval of Rova-T in 3L SCLC based on the interim analysis.  In other words my expectations for this trial were met, although there are many who will be very disappointed at the results.

What matters though is not just how disappointing topline results might be per se, but why they occurred, what we can do about it, and most importantly, where we go next.  There’s a lot more to this than might initially be obvious from the press release.

That’s what this new post is all about… first a post mortem, then the obstacles to be addressed, and finally, what we can look forward to in SCLC…

On a happier note: there may be some surprises ahead!

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SCLC – An in-depth look at ROVA-T and TRINITY

Yesterday in part 1 (Link) of our latest mini-series, we looked at the SCLC landscape and some of the key background issues to think about.

This time around in part 2 we drill down focus more specifically on Rova-T, including physician and patient sentiments and in particular, what to watch out for with the upcoming phase 2 TRINITY readout.   There’s a lot to consider here so we’ve broken the analysis down to five key areas.

Mystic Meg is also back with her canny predictions – what does the crystal ball portend for Rova-T and the TRINITY trial?  Caveat: she’s been on a tear of late; this situation will not continue forever.

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A look at the SCLC Landscape and Rova-T

Many of the questions we received from BSB readers this month was a plea from several folks to answer numerous queries about small cell lung cancer (SCLC) and the anti-DLL3 ADC, Rova-T, in particular.

Of course I’m happy to oblige, but this was way too big a topic for inclusion in Friday’s mailbag.

Cornish Tin Mine

What makes a lot more sense here is a short two-part mini series where we look at the dismal landscape of the disease and then consider the red and green flags that arise from the Rova-T development.

With the interim results expected from the phase 2 TRINITY trial in 2H17, this is a timely moment to sit down and reflect on what to expect.

In the first part of the series, we walk through SCLC as a disease, including what is known and what to consider when contemplating a new therapy here.

In the second part tomorrow we will focus more specifically on Rova-T and what to watch out for.

So let’s rock and roll with a look at the SCLC landscape…

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JPM17 Healthcare Conference Day 3 Highlights

It’s Wednesday at the 2017 JP Morgan Healthcare Conference and the last full day of the meeting. 

SF Streetcar at Pine StIt’s also our last day for a rolling blog; we hope you’ve enjoyed our coverage and commentary this year.

If you want to catch up on what we’ve written about, do check out our posts form Day 1 (Link) and Day 2 of JPM17 (Link).

Yesterday also included some thoughts on the latest Merck pembrolizumab filing announcement in 1L NSCLC, which has certainly had a dramatic impact on the market, even for big pharma (MRK +$4.9B, BMY -$3.3B).

Companies we’ve covered so far include: Celgene, Incyte, Seattle Genetics, Clovis, Puma, BMS, Five Prime, Nektar, Juno and others.

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ASH16 Preview on Acute Myeloid Leukemia AML

Post 2016 US Election, we move on and get back to business with an in-depth review of some new science and clinical data.

ash-2015Yes, it’s time for another Bushidō – “Way of the Warrior” – guide to the key ASH abstracts!

Here we focus on acute myeloid leukemia (AML), a difficult and challenging disease to treat with a high unmet medical need for new effective therapies.

In this Preview we look at key companies in the AML space, as well as a look at what’s happening in classic targets and also some new ones that are receiving notable attention, both preclinically and also in the clinic.

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ASCO 2016 Monday Blog #ASCO16

Chicago ArchitectureChicago – the ASCO 2016 annual meeting is in full swing. This is the third and last day of our rolling blog where we’re providing updates with top-line commentary throughout the data.

If interested, you can also check out the many updates from Day 1 and Day 2.

There’s a lot happening at ASCO today, including a presentation by Vice President Joe Biden later this morning. Allow extra time for security checks if you plan to listen to him in person, and I expect there’ll be delays to the hotel shuttle buses around Chicago as roads are closed to accommodate the VP’s motorcade.

Many people chose not to come to ASCO this year – but it’s turned out to be a great meeting. We’ve heard a lot of new data which are likely to have an impact on future clinical trial strategy, as companies look to bring new products to market in what is a competitive field, particularly in cancer immunotherapy. There are how many PD-1 checkpoints in development now?

A word of warning to the wise – not all these IO molecules are going to win – some are going to fail, some will be useful tools in various subsets and some are going to be new home runs.

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The BET Bromodomain Landscape in Cancer Research

The BET Bromodomain market is a meaty epigenetics topic we have followed for several years now, including a look at the space back in 2013 on the old Pharma Strategy Blog (Link). The last update on this was ironically at AACR last year when we discussed MYC and bromodomains (Link).

Nawlins Mardi GrasIn a remarkable tale of two cities in real life, two companies we discussed in those posts – Constellation Pharma and Tensha Therapeutics – have had markedly different fortunes since then. Roche decided to end their collaboration with the former and went on to acquire the latter instead.

Since we first wrote about bromodomains and BET inhibitors, the niche has exploded in a wildly stunning way… More drugs in the pipeline, more tumour targets being explored, and even novel combinations being evaluated preclinically for synergistic or additive effects. Even I was surprised by how competitive this niche has become based on the offerings at AACR this year.

With all the wealth of new data at the AACR annual meeting and also some other recent presentations I’ve attended elsewhere, it’s time for a more in-depth look at the BET/Bromodomain landscape.

Who are the new players, which tumour targets are now being evaluated, which combinations might be useful?

A word to the wise – this is neither a nerdy science post nor a comprehensive literature review – instead we take a look at the emerging landscape from a new product development perspective.

Science has been absolutely critical to success in all of the cancer therapeutics from targeted therapies to immunotherapies that have emerged in the last decade.

It really doesn’t matter whether you come from a marketing and commercial organisation or the investment community – if you want to make great decisions, you need to understand the basics of the science underpinning the R&D, where the strengths and weaknesses are. The alternative is play Roulette and put everything on Black 11 as a euphemism for whichever company/product/target you have an interest in.

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