Biotech Strategy Blog

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

Posts tagged ‘nivolumab’

After some relatively quiet summer months, we have been deluged with questions and requests this month for commentary on some hot topics of late. This seems like a good time to take stock and reflect on some of most frequent ones sent in.

west-acton-tubeThe original Journal Club post slated for today will appear next week instead.

Here, we address numerous queries on the following five topics readers are interested in:

  • APHINITY trial in HER2+ adjuvant breast cancer
  • Array’s BRAF plus MEK data in metastatic melanoma
  • Kite’s interim ZUMA–1 phase 2 announcement
  • Amgen’s Kyprolis in newly diagnosed multiple myeloma
  • BMS nivolumab data in 1L lung cancer (CheckMate-026)

The last two in particular seem to be causing a lot of hand-wringing!

To learn more about our insights, subscribers can log-in or you can sign up in the blue box below…

Iron Men of CrosbyThis is the third in our mini-series previewing the forthcoming European Society for Medical Oncology 2016 Congress in Copenhagen (Twitter #ESMO16).

In this post we’re taking a look at what’s hot in head and neck cancer.

It’s not a cancer type we typically hear a lot about, but there’s an unmet medical need for effective new treatments.

To learn more about our insights on this intriguing topic, subscribers can log-in or you can sign up via the blue box below…

The 2016 Congress of the European Society for Medical Oncology (ESMO) is fast approaching. It takes place next month from October 7th to 11th and we will be on site covering the meeting for Biotech Strategy Blog. We’re looking forward to a great meeting!

ESMO 2016 CongressIf you are sitting on the fence as to whether you should go to Copenhagen, then hopefully our series of Previews will help you decide.

Be warned that accommodation is in already in short supply and ESMO are now putting people up across the Oresund bridge in Malmo, Sweden.

The Congress App has a lot of useful information and is well worth downloading, if you haven’t done so already.

Last week many of the late breaking abstract (LBA) titles were announced, although there are still some placeholders. While we won’t know the actual late-breaking data until the meeting, the LBA titles offer insights into what will be presented in Copenhagen.

In the second in our ESMO 2016 Preview series, we’re highlighting the lung cancer late breakers that we’re looking forward to hearing, providing some background on why they may be of interest, and a look at how some of subset landscapes may be a-changing in the future.

Subscribers can login to learn more insights or you can purchase access below via the blue button…

To be successful as a cancer immunotherapy company, you not only have to be science driven (that’s a given) and offer an approach that could make a difference, you also need a vision and the ability to execute ahead of competitors in a fast moving and competitive landscape.

Dr John Beadle

Dr John Beadle

We’re continuing our series on emerging cancer immunotherapy companies with an in-depth look at PsiOxus, and the vision of CEO Dr John Beadle (pictured right) for it to be a world-leading immuno-oncolytic virus company.

PsiOxus is based just outside of Oxford – it’s part of the so-called “golden triangle,” the area between London, Oxford and Cambridge in the South of England that is a driver of UK science and innovation.

The company is located in a nondescript business park 45 minutes by train from Paddington to Didcot Parkway, followed by a taxi or bus ride. You have to want to make the trip from London!

Dr Beadle kindly spoke to BSB about the competitive advantage the PsiOxus oncolytic virus platform offers, their path-to-market strategy and how he sees the company developing in the future.

With clinical data due in 2017, PsiOxus is a cancer immunotherapy company to watch out for.

Part 1 of the interview focuses on the scientific platform and cancer new products in development that are driving the company forward.

Subscribers can login to read more or you can purchase access via the blue box below.

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:

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.

To learn more, you can log-in or sign up in the blue box below:

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.

Subscribers can login to read more or you can purchase access in the blue box below.

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.

To learn more, subscribers can log-in below or you can sign-up to join the ever-growing BSB club by clicking on the Blue Box:

We’ve noticed for a while now that trials involving immunotherapies have not just standard adverse events reported, but also immune related adverse events (irAEs).  We saw these articulately in combination trials at ASCO earlier this month.

Most of these have involved colitis, hepatitis, pneumonitis and such like. If the signs and symptoms are picked up early through careful monitoring and education, these can be more easily managed and controlled.

What about auto-immune diseases?

Is there a risk of auto-immune disease with long term use usage of checkpoint blockade, especially in situations where patients may be treated until progression, which could be a long time if the patient is one of the lucky ones who get a durable complete response?

In today’s post we take a look at these issues. To learn more, subscribers can log in or you can sign up in the blue box below:

ASCO 2016 Collective WisdomContinuing part two of our mini-series on colorectal cancer, today we move from the big scale Immunoscore study to small subsets of disease that are looking interesting in several ways.

For years, advanced colorectal cancer has been dominated by chemotherapy (FOLFOX or FOLFIRI) with and without targeted therapies (VEGF and EGFR antibodies), with very little new to talk about. Part of the challenge here is how do you add something the existing standard of care and move the needle significantly. In front-line, for example, the OS is already out 2-plus years, so these are long and risky trials to undertake. Not surpisingly, many companies have sought to evaluate their agents in tumour types where they consider the risk of development to be lower.

Unless… we can find creative approaches that turn the paradigm on its head and identify a clearly defined niche that can be carved out separately from allcomers.

This is where we’re at now – identifying subsets that might respond exquisitely to novel approaches based on a rational understanding of the underlying biology.  One obvious subset might be BRAF, which can be treated with a BRAF inhibitor with or without other targeted therapies as Dr Pietrantonio and colleagues (2016) literally just showed for example, but what about others of potential interest?

Colorectal cancer with microsatellite stable (MSS) disease represents 95% of metastatic patients. These are people whose mismatched repair system is proficient and actively functional in fixing the DNA strand breaks that occur during the course of life.

In contrast, those with microsatellite instability (MSI) are the minority of people with colon cancer (and some other cancers too) whose mismatched repair system is deficient and unable to adequately repair the DNA strand breaks. Ironically, this leads to thousands of mutations that can be recognised by the immune system to help detect the presence of cancer. It also tends to occur in hereditary cancers such as Lynch Syndrome.

We’ve been following the MSI vs MSS story for a while now, but at ASCO this year there was more data available and things appear to be getting clearer on the commercial front too.

To learn more, subscribers can log-in or you can sign up via the blue box below to join the ever-growing BSB Club of enthusiastic readers…

error: Content is protected !!