Biotech Strategy Blog

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

Posts tagged ‘daratumumab’

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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Challenges and opportunities with CAR-T cell therapies

Are we putting the cart before the horse – yea or neigh?

We’ve been following and writing about the CAR-T cell therapy space for over a decade now, with plenty of trials and tribulations along the way for both products and companies alike.

With the fanfare around the latest Penn data on Friday, we’re going to take a slightly different approach from the lay media and explore some of the ins and outs around the big strategic picture.

We’ll also be looking at some new data on multiple myeloma and CAR-T cell therapies. The latter are seeing the emergence of some interesting early studies of late…

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When PARP and immunotherapy worlds collide

Picking a PARPi – what can the biology tell us?

How many observers realised there’s more than one member of the PARP family?

There’s quite a bit to be learned in the DNA damage repair (DDR) and replication stress niche, especially when it’s new targets, new tumour types and even new companies to look at.

In our latest post on this space we switch horses from big Pharma and continue the story with some interesting findings from the biotech side of the R&D fence.

This is a key trend we’ll be following going into ASCO next month as we start to see the layers peeled off the onion and get a lot at what’s working, where it’s working and just as importantly, what’s not…

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Strategic direction and future impacts in multiple myeloma

Shining a light on hidden gems in the myeloma niche

If we want to go beyond the proteasome inhibitors, IMiDs and anti-CD38 antibodies in multiple myeloma, there are plenty of emerging candidates these days.

This is excellent news, but how will it all fit together, and which gems were under-rated at the recent ASH meeting?

The latter may catch a few people by surprise when the clinical aspects are considered in the totality of what needs to be done and in which patient subsets.

We discuss near and medium term aspects, which may have a lasting impact and also talk about why they matter.

To find out, the final part of our myeloma mini-series offers an engaging and thoughtful fireside chat with a global thought leader in this niche…

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How bispecifics will make an impact in myeloma

With all the time and attention surrounding the BCMA-based products in multiple myeloma, including ADCs and CAR-T cell therapies, it’s easy to forget there are other approaches coming down the pike.

Building new mosaics and novel regimens in myeloma is coming

Beyond the hullabaloo there are various bispecific antibodies and T cell engagers in early stage development – not only is the modality different, but the targets might differ too.

How are all of these novel approaches doing in the clinic and how might they all fit together in future regimens? The myeloma world as we know it of proteasome inhibitors and IMiDs may not yet be a thing of the past, but the landscape is certainly changing.

In our third installment of the myeloma mini-series, we tackle these issues and look at near and medium term strategic directions, which can be considered and how these might impact different combination approaches and lines of therapy in order to further improve outcomes in this disease.

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10 early phase ASH19 abstracts with a difference

ASH19 Targeted Therapies Preview: This year’s ASH in Orlando is very much dominated by new developments on the immunotherapy front in terms of both T and NK cell therapies, with some passing interest in BTK inhibitors as well.

It’s not always sunny in Florida…

What about targeted therapies and the science behind those developments?

It was not that long ago that these were the main lifeblood of the meeting across many, if not most, hematologic malignancies. How times have changed!

That said, outside of the CARs (T and NK cells), as well as bispecific immunotherapies, and BTK inhibitors there are still some gems to be found amongst the rest of the ASH19 abstracts.

Here we highlight an additional 10 abstracts involving early pipeline areas that encompass some novel targets, new combination approaches, or emerging science.

Please note that the novel targets can take the form of classic targets or IO ones since they didn’t fit in the prior ASH Preview topics already reviewed under separate cover…

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Highlights from Plenary Sunday at ASCO19

Chicago: We’ve heard a lot of people say how they think this year’s annual meeting ASCO19 is not as good for data as previous years, and we’re going to have to respectfully disagree.

On Sunday at ASCO19 there was a wealth of data on display in multiple sessions with some noticeable “winners and losers” when it comes to drugs in development.

Dr Hedy Kindler presents phase III POLO trial in Plenary Session at ASCO19. Data simultaneously published in NEJM.

In this post, we’ve some top-line commentary on some of the Sunday sessions we covered, and what caught our attention. As always our detailed analysis comes after the meeting in the “post-game” show.

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New developments in Multiple Myeloma

We have been following the progress of various classes of molecules in the myeloma space here on BSB since 2010. These include traditional approaches (e.g. HSCT and proteasome inhibitors/IMiDs and various antibodies or ADCs), as well as immunotherapy (checkpoint blockade, CAR T cell therapy, oncolytic viruses etc).

Brick Lane Grafitti

There’s much going on in this space and it’s not only becoming extremely crowded and competitive (akin to 1L NSCLC), but there is a gradual trend towards convergence on many fronts, be they targets or modalities.

In our latest look at the myeloma space, we focus on several key areas of development – antibodies, CARs, and also highlight a new target that may be of interest…

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Learning from IO-IO combo misses

In the frantic rush to the clinic with various IO-IO combinations, many people seem to have forgotten that these have an increased risk of failure than say, combining one IO molecule with chemotherapy.

This risk can take the form of increased toxicities, as well as lack of efficacy, especially if you are giving an unknown therapy instead of one that is known to be effective in controlling the tumour.

We look at a tale of two cities in lung cancer; there are some interesting lessons to be learned here…

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Syros CEO Nancy Simonian looks forward to an exciting 2018

As part of our #JPM18 coverage we like to feature up and coming companies to watch out for, one of these is Syros Pharmaceuticals (NASDAQ: SYRS). In this post we take a look at what’s on the horizon for the company in 2018?

Myelofibrosis has certainly been in the news this week with Celgene acquiring Impact Biosciences for fedratinib and both Celgene and Incyte presenting their annual update at the JP Morgan Healthcare conference in San Francisco.

Yesterday at JPM, Syros and Incyte announced a new collaboration to explore myeloproliferative neoplasms (MPN):

“… The companies have entered into a target discovery, research collaboration and option agreement. Under the agreement, Syros will use its proprietary gene control platform to identify novel therapeutic targets with a focus in myeloproliferative neoplasms (MPNs), and Incyte will receive options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets. Incyte will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets.”

Given the need to find new targets and potential combination agents to partner with JAK2 inhibitors such as ruxolitinib (Jakafi), this deal makes a lot of sense.

It also leaves Syros and Incyte with space to continue developing their existing pipelines in the usual fashion without any undue commitment or conflict.

Syros are a company we have been following for three years now, with several updates on BSB, including thought leader and C-suite interviews.

With new data presented at ASH and SABCS last month, it was a good time for an update on this topic, so we sat down with Dr Nancy Simonian (CEO) for a chat about where they are and where they are going with their current small molecule pipeline ahead of their presentation at JPM18.

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