Biotech Strategy Blog

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

Posts tagged ‘Pharma CI’

Munich – the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics conference is one of my favourite meetings on the cancer circuit. It’s small enough that you can catch people in the corridor and have a quick chat, while at the same time large enough that it attracts quality data. It’s also the place where you find people who think outside the box.

I want to hear from thought leaders who have the potential to be disrupters.

feuerwurstTalking of another kind of disruption, sadly the travel chaos caused by the Lufthansa pilot’s strike(s) meant some people didn’t make it to the meeting or arrived late. Despite the best efforts of Lufthansa, there was still a good turnout of posters today and several caught my attention!

Those who follow our cancer conference coverage know that the poster hall is often where the gems and insights are to be found, particularly when it comes to early drug development.

If you couldn’t make it to Munich, this post has commentary on four gems from the Wednesday poster session at EORTC-NCI-AACR that caught my attention. I’ve chosen to focus on novel targets and novel combination approaches…

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The first day of the 2016 EORTC-NCI-EORTC Molecular Targets meeting brought us chilly weather and a frozen lake outside the conference centre in Munich.  Brrrr!

gluhwein-munchenIt also heralded a great lineup of cancer researchers largely characterised by unconventional thinking. This, of course, is a good thing because it is only by dismissing dogma that a field can move forward unconstrained.

There were several talks that I will come back to in a separate post, but here I wanted to focus on one particularly good talk on breast cancer, something we haven’t covered in a while.

A decade or two ago, breast cancer made a lot of progress – we saw the emergence of gene expression profiling, the identification of different histology types, treatments for hormonal sensitivity or HER2-positivity and then… nothing.  Meanwhile, the issue of drug resistance plagued researchers – why don’t all women respond and why do they become resistant?

In the meantime, we’ve seen a wealth of progress in melanoma, lung, kidney and bladder cancers, enormous strides in hematologic malignancies and many other areas.  Breast cancer, the early star, seems to have faded and we haven’t had much to be cheerful about aside from a few isolated cases.

The good news is that things are a-changin’ though and research is looking more promising as we learn from lessons in basic and translational research and how they can be applied to new therapeutics and drug resistance.

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Having heard about a one day symposium on immunotherapy organised by Charles River, I headed over to Munich and the EORTC-NCI-AACR conference a day early… Providentially it seems, as the Lufthansa strike will likely affect a few travellers en route to the Triple and ASH/WCLC/SABCS conferences.

cr-ena2016The focus of this excellent one day event was on ‘Mapping the future of cancer drug discovery.’

So what stood out as interesting and intriguing?

Quite a few things, as it turned out, including a novel target in cancer research that I haven’t come across before.

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The 2016 annual meeting of The American Society of Hematology (ASH) is rapidly approaching and starts later this week on Friday in San Diego (Twitter #ASH16).

ASH15 Late Breaker Session“Super Friday” at ASH, as it’s commonly known, is a day typically associated with satellite symposia, where company’s and organisations sponsor or give unrestricted grants for continuing medical education (CME) around a specific topic or theme. These are professionally produced events that offer fair balance and a line up of experts.

There are also scientific workshops and unofficial meetings not part of ASH….so if you have plans to be in San Diego on Friday where should you be? 

I’m flying in late Thursday and have carefully reviewed all my options for Friday, of which there were many.

ks-beerdetail-2016-03-rtaOne now jumps out to me as a “must attend” and I’m afraid it’s not drinking a Red Trolley…. You’re welcome to join me or can maximise your mileage by going to another event and avoiding duplication of coverage.

Tomorrow @MaverickNY will be kicking off her coverage from Munich and the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium (Twitter #ENA2016) before flying to San Diego on Friday.

If you’re hoping for coverage of World Lung from Vienna, I’m afraid that fell through the cracks thanks to it’s change of date from September to December and the clash with ASH who always hold their annual meeting around the same time.

After #ASH16 I’ll be doing the “on, on, on” to San Antonio for #SABCS16. It’s going to be a busy 2 weeks!

Happy Cyber Monday! Subscribers can login to read my ASH16 Super Friday Preview or you can purchase access below. 

Juno Therapeutics LogoThis is an important and necessary follow-up to the ongoing Juno JCAR015 story in July after three patients had died due to complications associated with cerebral oedema. At that time, the company attributed the deaths to the inclusion of fludarabine in the lymphodepletion given prior to CAR T cell therapy infusion, leading to severe neurotoxicity, and clinical hold was lifted by FDA after the protocol was subsequently amended.

This morning came the dramatic announcement that following the protocol amendment, Juno has voluntarily placed the ROCKET trial on clinical hold again following another two deaths from cerebral oedema.

What gives and what are the consequences here?

We take a joint look at some of the issues that arise from this situation in terms of the CAR T cell therapy market and also pen thoughts from the analyst call this morning.

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gaylord-national-harbour-md

National Harbor, MD

Despite remarkable results with cancer immunotherapy to date, we do need to keep out feet on the ground and remember that response rates are relatively low to modest (10–30%) and the majority of patients do not respond or see a benefit with these approaches.

As we start moving beyond checkpoint monotherapy, the realisation has fast hit many researchers and companies that we really don’t know as much about the tumour microenvironment (TME) as we would like.

No doubt we will learn a lot more about it from the combinatory approaches, but be aware that this also means higher risk associated with such developments – we will likely see a lot of failures – and hopefully, some successes too.

This is where the little biotech companies have an opportunity to shine… they may have some intriguing IO compounds in development but not an anti-PD1/L1 backbone, meaning they can collaborate with a big pharma company to explore novel combinations in small phase 1/2 trials to determine what works or not. This is much lower risk (and R&D costs) for both parties and we get to see more quickly where things shake out.

At the annual Society for Immunotherapy of Cancer (SITC) meeting last week, there was a whole day devoted to New Immunotherapy Drug Development.  

Some of these agents look worthy of watching out for and following their progress.  A variety of data in different targets and MOA were presented from big and small companies alike.  We selected a few of the promising ones for further review and discussion.

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national-harbor-sunset

National Harbor, MD

Bladder cancer is the most common of the urothelial cancers and is the 9th most common cancer globally, with over 400,000 new cases each year and around 165,000 deaths. In the US, approximately 76,000 Americans will be diagnosed with bladder cancer in 2016 and ~11% of new diagnoses are made when bladder cancer is in advanced stages.

Unlike tumour types such as ovarian and pancreatic cancers, the majority of bladder and urothelial cancers are diagnosed at an earlier stage. The rates of recurrence and disease progression, however, are high and approx. 78% will recur within 5 years while the 5-year survival for stage IV bladder cancer is pretty dismal at 15%.

Earlier this year, Genentech/Roche’s anti-PDL1 antibody atezolizumab (Tecentriq) was approved by the FDA in the second line setting and was the first such new approval in this disease for 30 years.

Since then, there has been heightened interest in urothelial and bladder cancers in multiple settings, with several companies rushing to play catch up, including Merck and BMS.

We’ve been following the steady progress of checkpoint blockade this year at AACR, ASCO, ESMO and now SITC – amazingly, what was once a graveyard for Pharmaland has now become a hypercompetitive niche in a very short time.

Here, we take a look at the latest data in advanced urothelial cancers and explore the landscape in the context of rapidly increasing competition.

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Head and Neck cancer – or to be more precise – squamous cell carcinoma of the head and neck (SCCHN) has joined the checkpoint inhibitor club with two FDA approvals this year. National Harbor Maryland

Firstly, we saw the accelerated approval of pembrolizumab (Merck) based on objective response rate on August 5, 2016 for patients with recurrent or metastatic head and neck squamous cell carcinoma (SCCHN) that has continued to progress despite standard-of-care treatment with chemotherapy.

It’s a dismal disease with a generally poor prognosis in advanced patients once initial therapy fails.

While some patients do benefit with anti-PD–1 checkpoint therapy, the overall response rate in the KEYNOTE–012 trial of 174 patients was pretty low, i.e. 16%. In other words, the majority of patients do not respond or receive any clinical benefit.

Secondly, last week on November 10 nivolumab (BMS) was approved by the FDA based on the phase 3 CheckMate–141 data presented at ASCO earlier this year. The data was published in the New England Journal of Medicine to coincide with the FDA approval.

There were no statistically significant differences between the two arms for median PFS (2.0 months with nivolumab versus 2.3 months with standard therapy, HR for disease progression or death, 0.89; P=0.32) or ORR (13.3% vs. 5.8%) for nivolumab versus investigator’s choice, respectively. There was, however, a clear benefit in favour of nivolumab in median overall survival (7.5 months in the nivolumab group versus 5.1 months in the control group; HR 0.70; P=0.01).

This effect on patient outcome is a classic pattern for cancer immunotherapy with checkpoint blockade. Response rate and PFS are measurements that are very relevant to chemotherapy, but they are not as relevant to cancer immunotherapies where what is impacted more noticeably is overall survival and the long tail of the curve.

With two approved anti-PD–1 monotherapies in SCCHN, the next challenge has now become how can we improve on monotherapy by boosting the number of PRs to CRs potentially improving long term outcomes and/or turn non-responders into responders? This is the stage we are at in many tumour types now.

Combination approaches are believed to be the way forward, which is why we anticipated with great interest the lirilumab plus nivolumab head & neck combination data presented this past weekend at the 2016 Society for Immunotherapy of Cancer (SITC) meeting at National Harbor, MD. The presentation is available for download on the Innate Pharma website. The data raises numerous questions and scenarios that can be considered…

  • Are the data exciting, encouraging or disappointing?
  • Are the results enough to give confidence if a phase 3 trial with the combination were to follow?
To address these questions and other critical issues – including red and green flags – we took a deep dive into the data in the context of scientific facts and explored the landscape carefully.

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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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It was only five years ago that the number of abstracts on CAR T cell therapies at the American Society of Hematology (ASH) ran to a dozen or less. Fast forward to 2016 and we now have tens of them, almost too many to count, let along review quickly and easily.

ash-annual-meeting

A scene from ASH 2015…

To give you an idea of the staggering speed of progress, in 2010 it took me less than half an hour to search and read all the CAR T cell abstracts, now it takes nearly a whole day to peruse and review them carefully.

We can’t resist a challenge…

As usual, we will write in more depth from the meeting as the data emerges in real time since many of the abstracts are often placeholders with updated information provided at the conference itself.

For now, here we provide an in-depth preview of the CAR T cell landscape in terms of the players, the products, new scientific research, biomarkers, emerging trends and more in a handy What to Watch For (W2W4) guide on key areas to expect at ASH to enable better enjoyment and awareness as the data rolls out next month.

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