Biotech Strategy Blog

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

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Thankfully, the dog days of summer means that the Pharmaland conference season takes a much needed break and the intense news cycle tends to calm down somewhat (well a little, depending on your perspective). This gives us some breathing space to conduct and write up some CEO interviews, as well as publish in-depth thought pieces and op-eds on up and coming areas of interest in the broader cancer research field.

In last week’s surprisingly popular mini-series on neoantigens, we explored the concept in a three-part series comprising a primer on the topic, plus helpful insights from a thought leader in the field and a CEO/investor at an example company.

Dawlish High Speed Train

Here we explore the broader landscape beyond T-VEC through a primer, plus a fascinating two-part interview with a CEO in this space.

To begin with, we start off with a primer to get BSB readers on the same page.

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As we continue our journey exploring neoantigens in the context of novel cancer research in Part 3 of our latest mini-series, today we focus on the commercialisation side of the business through an interview with a leading investor, Dr Cary Pfeffer, who is a partner in Third Rock Ventures, as well as being ad interim CEO of Neon Therapeutics.  We’ve written about other Third Rock companies in the past; Agios, Foundation Medicine and bluebird bio come to mind, for example.

neonlogoHow does an exciting early product in development move from academia to industry? There are many ways to do this, so here is the story through the eyes of one young company with strong academic connections, as a way to illustrate what can be done. It isn’t the only way, by any means.

To be sure, there are other competitor companies in the neoantigen space – Gritstone and Moderna come to mind as examples – we will cover companies in the broader landscape in a future post. There is also an incredible amount of promising research going on in academia right now, which may lead to more companies or products being licensed and developed.

To learn more about what Cary Pfeffer had to say on Neon Therapeutics and neoantigens, subscribers can log-in or you can sign up in the blue box below:

Westminster Hall Stained GlassThis week we’re focusing on neoantigens, what role they have to play in cancer immunotherapy and novel approaches that identify and use them as a therapeutic modality.

When you look at the cancer immunotherapy landscape it’s like looking at a stained glass window – it’s not only about the light but seeing the patterns and way the glass is aesthetically arranged in order to make it effective.

Today’s post, the second in a mini-series of three, features an interview with a thought leader doing pioneering work at the forefront of how neoantigen based vaccines can be used to target solid tumors.

The field of vaccine based cancer immunotherapy research is attracting renewed interest from VCs, angel investors and academics because of it’s potential to be used in combination with other immunotherapies.

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Great Fire MonumentThe Great Fire of London started 350 years ago in September 1666 following a fire in a Pudding Lane bakery.  It highlights the potential of what a small fire can do once it takes hold – over the course of 3 days, 13,000 houses and 436 acres were destroyed.  It forever changed the landscape of medieval London.

The Monument (pictured right) to commemorate the Great Fire was designed by Sir Christopher Wren. Constructed from 1671 – 1677, it is 202 feet in height, the distance to the bakery where the fire started. You can even walk up it, if you are in the area.

When we think about cancer immunotherapy, one of the emerging important trends is the need to “inflame” or set fire to the immune system, especially in those cancer patients who don’t have a pre-existing immune response.

We want to ignite the immune system, in the hope that it will create the equivalent of the Great Fire…

Great Fire of London Plaque

In this post we’re starting at mini-series looking at neoantigens, beginning with a primer on what they are and why they matter in cancer immunotherapy.  In subsequent posts we’ll look at some of the innovative ways companies are identifying and targeting them.

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BioTwitter is all a-flutter today with the announcement from BMS that the CheckMate–026 trial in first line non-small cell lung cancer (NSCLC) comparing nivolumab (Opdivo) to chemotherapy did NOT meet its primary endpoint of progression-free survival (PFS).

The news was not entirely a surprise to us at BSB, here’s why…

Figurative statute representing Science on Holborn Viaduct in City of London.

Figurative statute representing Science on Holborn Viaduct in City of London.

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HMS VictoryThe dog days of summer are usually quiet on the Pharmaland front, although this year has been a bit of an exception, being notable for a batch of deals being completed and announced already.

The cell therapy space is one area that has courted both controversy and new collaborations, for example. Nary a week seems to pass without something appearing in the news! This has proven pretty interesting for a number of subscribers, who write in asking plenty of astute questions.

Today’s questions from BSB readers therefore encompass allogeneic cell therapies and what’s going on in that fast moving dynamic space.  Not all of the announcements may be what they seem though, and some are much more riskier than others.

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The Shard from River ThamesMuch has been written about the impact of cancer immunotherapies, particularly the twin pillars of checkpoint blockade and CAR T cell therapies, but beyond that lies a huge wealth of alternative approaches that may come in very useful indeed.

Just as we have seen oncogenic escape witth targeted therapies, there is also a related phenomenon called immune escape. Likewise, this can occur as either primary or secondary resistance.

It’s very important to consider this issue, because, after all, the vast majority of cancer patients with solid tumours do NOT see durable clinical benefit with immunotherapies when given as single agents. Some don’t respond at all (primary resistance), while others may see an initial response, then relapse (secondary resistance).

Understanding the mechanisms involved in resistance may help us design better combination trials to address the underlying biology as well as develop biomarkers to help select appropriate patients for each regimen. Clearly resistance can vary, not only by tumour type, but also by lesion and patient, making it a very complex situation to research.

Some interesting new information has recently come to light that is worthy of futher discussion and analysis, particularly in the context of other published data in this niche.

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The race to the be first to market in the United States with a CD19 directed CAR-T cell therapy is a bit like the America’s Cup Challenge Race Series – one boat/company is ahead and then another is ahead, it’s an ever changing and fluid situation…

Americas Cup Portsmouth

In this post, we’re looking at questions from subscribers – so what’s in the July BSB mailbag?

* CAR T Cell Therapy: Is the recent FDA hold – that came and went in record time, a setback to Juno? Who will win the CAR-T race to market in the United States? What is the market opportunity in Europe?
* Jounce/Celgene Deal: Celgene have a reputation for doing deals with innovative biotech companies, but then what? Is the Jounce deal a good one, or is it a value destroyer?

There are a few other questions in the mail bag, but the above gives you a flavour of some of the commentary in this post.

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Yesterday, Lilly and Boehringer Ingelheim announced a clinical trial collaboration in metastatic breast cancer with the CDK4/6 inhibitor, abemaciclib, and the IGF antibody, BI 836845. The goal of the phase Ib study is to evaluate potential of combination therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer (mBC).

Braving the ASCO 2016 Poster Hall

Braving the ASCO 2016 Poster Hall

A couple of BSB readers wasted no time and wrote in asking what we thought of this development, so this presents an excellent opportunity to turn the spotlight on combining targeted therapies in a rational fashion, especially as there was data presented on these agents at the recent ASCO annual meeting.

There are ceratinly a number of important considerations to explore with this type of approach.

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It’s been very clear for over four years now that combinations were going to be necessary if we want to a larger number of deeper and more durable responses than can attained with monotherapy.  Gradually, we are starting to see early and very preliminary readouts with some of the trials in progress.

We are also learning very quickly that it’s going to be a case of #notalltumours and #notallsubsets.

ASCO 2016 Posters 2

Another very busy poster session at #ASCO16!

By this, I mean we obviously can’t take a one-combination-fits-all approach for all tumour types.

We need to be able to classify patients into more homogenous subsets and then devise different combinations or even sequences that address the underlying biology of both the cancer itself and also the tumour microenvironment.  That’s going to take a while to sort out, perhaps even years.

Let’s not forget though that in the meantime, we can gather information quite a few clues both preclinically, as well as from initial clinical studies.  Sometimes, after all, we even learn more from negative trials than positive ones. This is an area that is ripe for combinations with traditional targeted therapies, the question is which ones are promising and why?

We took a look at the landscape in SCCH&N and how this might evolve over time in the medium term, with future opportunities, that can be explored in rational combination approaches.

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