Biotech Strategy Blog

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

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Challenges and Opportunities in the evolving 1L NSCLC Landscape

Rolling English Landscape in Devon

Following a series of events – from BMS’s failure with nivolumab monotherapy… to Merck’s sudden announcement to file their combination of pembrolizumab plus chemotherapy… to AstraZeneca’s delay of the MYSTIC trial exploring durvalumab plus tremelimumab this week, there’s never a dull moment in lung cancer!

So can we expect some more surprises in store in 1L NSCLC?

I say yes we can!  

The big questions are what are they and what impact will they have?

2017 is ironically, the year of the Rooster – so who’s going to crow loudly at dawn and who is going to get strangled in the process?

In the world of cancer research it is unlikely that everything wins or is successful, so figuring out the early signs and hints is an important part of the process.

One thing I learned early in this business is that it pays for companies to be humble, flexible and open minded rather than arrogant and dogmatic in their thinking… otherwise you can easily be blindsided.

There were a few examples of that in oncology R&D last year, a repeat could very well follow in 2017 for the unwary.

Here we look at 1L NSCLC in the context of multiple phase 3 trials that are slated to read out… from AstraZeneca, BMS, Merck and Genentech.

If you want to know what the potential impact of these events are on the landscape, including what we can expect from MYSTIC, CheckMate-227 and several others, then this is the post for you because some surprises are likely in store.

We cut through the chase to explain the what and the why in clear simple language.

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View of Cambridge and Charles River

Neon Therapeutics is based in Cambridge, MA

One of the much anticipated cancer immunotherapy presentations at the 2017 JP Morgan Healthcare conference was by Neon Therapeutics CEO Hugh O’Dowd.

As readers know we’re riding the Immuno-Oncology wave on Biotech Strategy Blog, and one of the exciting new topics to emerge is whether we can target neoantigens to create personalized immunotherapy.

Our mini-series last year on neonatigens received a lot of attention. It included a primer and three interviews. We were very much of the opinion that Neon Therapeutics is a company to watch out for.

In case you missed them, here are the links:

I highly recommending reading these articles as background on the science and new product development as a prelude to the latest commercialisation update we will cover in today’s post.

What did we learn from the 2017 JP Morgan presentation of the Neon Therapeutics corporate strategy?

If you didn’t make it to the presentation at JPM17 in San Francisco (it wasn’t webcast), you may be interested in this post. This is the latest update in our on-going series on neoantigens and why they matter in cancer immunotherapy.

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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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It’s Tuesday at the 2017 JP Morgan Healthcare conference in San Francisco.

San Francisco Streetcar in RainEach day of #JPM17 we’re doing a rolling blog post which we’re updating throughout the day with commentary and insights on the company presentations we’re covering.

While we’re not giving a blow-by-blow account, many companies have the slides readily available, we will be commenting on noteworthy news, and what we learn about pharma/biotech corporate strategy going into 2017.

For those of you who like to catch up with the final summary of each day’s highlights, you can read our post around Day 1 here (Link).

Yesterday we also published a thought leader interview we did with Dr Stephan Grupp, Director of the Cancer Immunotherapy Program at CHOP about some of the latest CAR T cell data and emerging issues we heard at #ASH16 last month (Link).  Do check it out!

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It’s Day 1 of the 2017 JP Morgan Healthcare Conference in San Francisco…

San Francisco StreetcarDespite the travel challenges associated with the cold weather hitting much of the United States, many have made [or are in the process of making] the “pilgrimage” to hear leading pharma and emerging biotech companies lay out their strategy and goals for the coming year.

Every company that presents at #JPM17 has made their New Year’s resolutions… and like the ones we make personally, some will work out, while others will fall short.

In light of the success of our rolling blog from last years’ JPM conference (link to #JPM16 coverage), we’ve decided to repeat the concept again this year. Throughout the day (schedule permitting) we’ll be updating the post with commentary around news that catches our attention.

If you want to follow along yourself and listen to the company presentations, here’s the link to the JPM17 webcasts and conference agenda (link).

As an aside, in our coverage we will be using JPM followed by the last two digits of the year of the meeting i.e. #JPM17, last year it was #JPM16. This is how the “BioTwitter” community commonly refers to the meeting, and we will be continuing that tradition, notwithstanding the fact that JP Morgan have announced the “official” Twitter hashtag is awkward and long winded #JPMHC35.

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One of the pioneers of CAR T cell therapy in children is Dr Stephan Grupp, who is Director of the Cancer Immunotherapy Program at The Children’s Hospital of Philadelphia (CHOP).

Dr Stephan Grupp ASH16

He led the way in developing ways of treating cytokine release (CRS) syndrome through the use of tocilizumab. At the recent American Society of Hematology annual meeting, Dr Grupp presented the results of the ELIANA study, the first global, multi-center clinical trial with CTL019 (Novartis) in pediatric acute lymphoblastic leukemia (p-ALL).

What was surprising to many at ASH was that despite the fact that CAR T cell therapy is one of the hottest topics in hematology (if not the hottest), many presentations were in small (tiny) meeting rooms, which many people could not get into. Several overflow rooms were rapidly opened up, but still people were left out. Someone clearly did not get the memo!

If you didn’t make into the meeting room at ASH to hear Dr Grupp, he kindly spoke to BSB about the data he presented and also shared his perspective of what the future may hold for CAR T cell therapy in pediatric ALL.

There’s also additional commentary on some of the other key CAR T cell presentations that caught our attention at ASH.

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Over the last five years the face of the chronic lymphocytic leukemia (CLL) landscape has changed quite dramatically with the advent of new approvals in several categories. These include anti-CD20 antibodies, BTK inhibitors, PI3K inhibitors and apoptotic Bcl–2 inhibitors.

In yesterday’s wide ranging interview we explored in-depth how these therapies are impacting the broader landscape, as well as emerging trends in how these regimens might be used.

In Part 2 of the ongoing series, we spoke with another CLL expert and explored promising new and earlier agents in development for a different perspective on how outcomes might be improved further.

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Targeted therapy and Chemo-Immunotherapy in CLL

At last December’s 2016 annual meeting of the American Society of Hematology, one of the areas that attracted attention was the latest clinical data on the treatment of chronic lymphocytic leukemia (CLL).

ASH 2016 in San Diego

In recent years, we’ve seen tremendous advances in the field with several new agents approved such as obintuzumab, ibrutinib, idelalisib, and venetoclax. There are also new treatment options available for CLL patients with high risk disease such as 17p deletions (Del17p).

Other new targeted therapies such as acalabrutinib are now in clinical development, plus we have CAR T cell therapies and combination strategies also being evaluated in the clinic.

So what was the hot news from #ASH16 in CLL?

  • Does chemotherapy still have a role or is it a targeted therapy world?
  • Are we further forward towards a cure?
  • Have we worked out how to identify those at risk of relapse?
  • Will CAR T cell therapy be a game changer in CLL?
  • Is financial toxicity going to be an issue with combination strategies?

BSB interviewed two experts in CLL while in San Diego who kindly shared their thoughts on which CLL data impressed them at the ASH annual meeting and discussed some of the big strategic issues facing the field right now. These interviews are being posted in a two-part series.

Part 1 today answers some of the questions highlighted above and explores the changing face of the broader CLL landscape.

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One of the interesting and exciting parts of major medical meetings such as the ASH annual meeting, held last month in San Diego, is hearing about new compounds in development.

When it comes to the treatment of aggressive lymphomas, there remains a high unmet medical need to improve the response rate to first line treatment, as well as offer better outcomes post relapse.

At #ASH16, we heard more about a novel ADC called polatuzumab vedotin (Genentech/Roche).

Preliminary safety and clinical data for polatuzumab plus obinituzumab in relapsed or refractory Non-Hodgkin Lymphoma (NHL) was presented in an oral session by Dr Tycel Phillips (University of Michigan).

Three posters were also presented showing early data in combination trials in R/R follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL), as well as in first line DLBCL.

To find out more about the potential of this novel ADC, BSB spoke with Dr Michael Wenger, Senior Group Medical Director at Roche Genentech.

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The Future of our (cancer research) Business

Happy New Year! No one really wants to spend too much time in the past dwelling on the negatives, what didn’t work, and in some spectacular cases, who’s to blame for it.

What we do want to know is what are the learnings from such endeavours and where are we going next.

Let’s look forward rather than backwards then and see what the Maverick’s crystal ball is showing in terms of fresh clarity and new trends we can learn from …

In today’s post I want to take a moment to look at some of the trends we can expect to see occuring in cancer research in 2017.

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