Biotech Strategy Blog

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

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Chicago RiverChicago – the annual meeting of the American Society for Clinical Oncology (Twitter #ASCO16) starts in earnest today, yesterday was primarily education sessions and a travel day for many.

Starting today and for tomorrow and Monday, we’ll be producing a daily rolling blog with top-line commentary around sessions we attend, experts we talk to and what captures our interest and attention at the meeting. It won’t be real-time, but schedule and wi-fi permitting, we’ll be providing updates throughout the day.

It really kills us to do a semi-live blog, but our subscribers love it – they tell us that even if they’re not at ASCO, they feel like they are with us following along remotely. We’ll of course be generating a series of posts with more in-depth coverage after the meeting when we’ve heard the data.

If you’d like to join an exclusive club of companies and individuals, you can purchase a subscription below.

As a special offer throughout ASCO 2016, if you buy a quarterly subscription and then want to upgrade to an annual subscription, all you have to do pay the difference before your quarter expires. Offer to new subscribers and new purchases only. Buying a quarter is a great way to check out what we do!

Aduro Biotech LogoWe’re almost at the end of our coverage of AACR 2016. Post number 30 (!!) is on Aduro Biotech ($ADRO) and their STING (Stimulator of interferon genes) agonist currently in development.

On the final day of AACR, in a packed session chaired by Tom Gajewski, MD PhD (Chicago), the meeting heard from Tom W. Dubensky, Jr, PhD Chief Scientific Officer of Aduro Biotech in a presentation (SY39-02) entitled:

“Direct activation of STING in the tumor microenvironment leads to potent and systemic tumor regression and immunity.”

Dr Tom Dubensky Aduro CSO

Dr Tom Dubensky, Aduro CSO

I spoke with Dr Dubensky (pictured) afterwards. In my interview recording you can hear Vice President Biden’s cavalcade arrive at the Ernest Morial convention center in New Orleans for his plenary presentation.

Since AACR 2016, Aduro announced that the first patient has been dosed with ADU-S100 (MIW815) in a May 12 press release.  This triggered a $35M milestone payment from Novartis, who are undertaking the clinical trial (NCT02675439).

In March 2015, Aduro entered a collaboration with Novartis that, according to the Aduro press release, led to an initial payment of $200M and an additional $50M in equity investment.

After the recent failure of their pancreatic cancer vaccine, announced in a May 16 press release, there is a lot riding on ADU-S100 for both Aduro and Novartis.

I had the privilege to interview Dr Gajewski last year at Immunity 2015, where we talked about his work on STING (see post: Tom Gajewski takes the STING out of cancer). You can hear a short excerpt from the interview on Episode 2 of the Novel Targets Podcast.

So a year later it’s a good time to return to the STING pathway and take a fresh look at what Aduro/Novartis are doing.

For this post, I’ve chosen to write this up as a SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis of ADU-S100 based on what I learnt at AACR from talking with Dr Dubensky and other experts.

Your SWOT analysis of ADU-S100 may be different from mine, you may have access to other sources of information, an alternative opinion, or reach an entirely different conclusion. There is no right or wrong answer. We all view the world through our own individual bias and lens.

Before you read this post, I heartily encourage you to map out on the “back of an envelope” – or as I’d say in England, on the “back of a fag packet” – what your SWOT analysis looks like. That way you can compare yours to mine.

By definition, we’re dealing with a new product in early clinical development, where many questions remain unanswered. It’s always easier to see the picture after all the cards have been dealt……

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New Orleans Sign advertising Voodoo

New Orleans Sign Advertising Voodoo

What I learnt at the recent AACR annual meeting in New Orleans is that cancer immunotherapy studies are requiring industry to think differently about clinical trial design.

As we move into combination trials of novel/novel combinations, how do we efficiently work out not only that each drug is safe, but in what patients they are likely to be most effective?

Readers who listened to the recent Novel Targets Podcast, “Of Mice and Men” will hear about some of the challenges associated with mouse models and how decisions are made moving into the clinic.

What I learnt from the podcast (and I hope you did too) is that if you are doing an immunotherapy trial in patients, the type of mouse model can really matter when it comes to interpretation of the preclinical data.

In response to a subscriber request, today’s post is about some of the statistical challenges in designing combination immunotherapy trials. To many, statistics is like voodoo, so this post does not go into any maths!

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One of the (many) highlights for me at the recent annual meeting of the American Association for Cancer Research (AACR) was a “Meet the Expert” session presented by Professor George Coukos.

Prof George Coukos AACR 2016

Prof George Coukos AACR 2016

Professor Coukos is Director of Oncology at the University Hospital of Lausanne and Director of the Ludwig Institute for Cancer Research in Switzerland.

Ovarian cancer is becoming a fascinating battleground for cancer immunotherapy, with multiple challenges that must be overcome before we see improvements in outcomes, especially for women advanced disease.

The interview with Prof Coukos is a follow-on to the one we did on advanced ovarian cancer and checkpoint blockade at ECCO 2015 in Vienna with Dr Nora Disis (Link).

If you missed it, you can still listen to highlights in Episode 7 of the Novel Targets Podcast (Link).

After his AACR presentation, Prof Coukos kindly spoke with BSB and in a wide ranging discussion, highlighted some of the innovative clinical trial strategies he is working on to move the cancer immunotherapy field forward in ovarian cancer.

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Dr Michel Sadelain AACR 2016

Dr Michel Sadelain at AACR 2016

Dr Michel Sadelain, Director of Cell Engineering at Memorial Sloan Kettering Cancer Center in New York is a pioneer in the field of adoptive cell therapy.

Without his contribution, it is unlikely CAR T cell therapy would be where it is today.

He’s also President of the American Society of Gene and Cell Therapy (ASGCT), whose annual meeting is currently underway in Washington DC from May 4 to 7 (Twitter #ASGCT16).

Recently at the annual meeting of the American Association for Cancer Research (AACR), Dr Sadelain gave an outstanding presentation on turbo-charged CAR T cells, and shared some of his ideas on how to move the field forward.

In New Orleans, he also kindly spoke to BSB, and discussed how he thinks cell therapy researchers may obtain the “holy grail” of getting CAR T cell therapies to work effectively in solid tumors.

Dr Sadelin is someone who wants to break the immunology rules!

Not surprisingly, Dr Sadelain is optimistic and doesn’t share the view expressed by Dr Steven Rosenberg on CAR T cell therapies being limited to mostly hematologic malignancies when we interviewed him a year ago at last year’s ASGCT meeting.  There’s nothing like a friendly controversy to spice the field up!

If you haven’t already done so, do listen to Dr Rosenberg on Episode 5 of the Novel Targets Podcast (@TargetsPodcast).

Subscribers can log-in or you can purchase access below to read more about what Dr Sadelain told BSB at AACR…

AACR 2016 PostersNew Orleans – Tuesday is the last full day of the 2016 annual meeting of the American Association for Cancer Research (AACR), and the last day of our #AACR16 rolling blog posts.

What struck me at this meeting has been the explosion in cancer immunotherapy research. It’s worth remembering that where we are today is the result of pioneering work done over the last 15 years by researchers, many of whom struggled for funding and recognition as they laid the foundation for where we are today.

Tomorrow, the Vice President of the United States, Joe Biden, will fly in to address the closing plenary session of the meeting. Mr Biden’s remarks will be live streamed by AACR (link to information).

There’s a lot happening at AACR today and tomorrow; and as conference die-hards we’ll be here to the end in order to capture some really interesting data that’s on the program.

Subscribers can login to read our AACR Day 4 commentary or you can purchase access in the blue box below.

AACR16 RegistrationNew Orleans – it’s Day 3, Monday, at the 2016 annual meeting of the American Association for Cancer Research (AACR). Attending AACR for the first time can be a daunting prospect, with a full program of activities from dawn to dusk.

For those of who don’t regularly go to large medical meetings, it’s all too easy to forget the sheer scale of the event and how mach walking is involved up and down long corridors – it’s easy to clock up 15,000+ steps on your Fitbit!

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New Orleans AACR 2016New Orleans – here at the annual meeting of the American Association for Cancer Research (AACR), the emphasis has shifted from yesterday’s education program to the start of the scientific programme.

If you didn’t make it to the Cell Press/Nanostring, “What’s Next: Bit Topics in Cancer Immunology” event yesterday evening at the Bourbon Orleans hotel in the heart of the French Quarter, you missed a great unofficial AACR16 event that featured a panel of leading experts:

  • Aviv Regev, PhD (Broad Institute of MIT and Harvard)
  • Tom Gajewski, MD, PhD (University of Chicago)
  • Dan Chen, MD, PhD (Genentech)
  • Pam Sharma, MD, PhD (University of Texas MD Anderson Cancer Center)
  • Michel Sadelain, MD, PhD (Memorial Sloan Kettering Cancer Center)
  • Jerome Galon, PhD (INSERM)
  • Ira Mellman, PhD (Genentech)
  • Catherine Wu, MD (Dana Farber Cancer Institute)

Throughout the day, schedule permitting, we’ll be posting top-line commentary from the sessions we’ve been in.

You can also catch up with the commentary from the Day 1 Live Blog, which has several updates from yesterday (Link).

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New Orleans StreetCarNew Orleans – the annual meeting of the American Association for Cancer Research (AACR) starts in earnest today with a full program of educational sessions presented by leading experts in different fields.

There’s a lot going on at AACR, with many sessions in parallel, so always remember the “law of two feet” – if the session you are in isn’t interesting, what you expected or isn’t meeting your needs – get up and go to another one!

Starting today and through Tuesday will be posting a daily blog with commentary around the sessions we attend and the people we speak to. It won’t be real-time, but to the extent possible we’ll be providing updates during the day.

It kills us to do semi-live posts from conferences, but they’re popular with subscribers, many of whom enjoy reading top-line commentary during the meeting, then our in-depth pieces later.

If you’d like to join the club of readers who enjoy access to our content, much of which by definition is exclusive – we don’t think anybody else does what we do or talks to as many thought leaders….

The good news is that a quarterly subscription will also cover you for ASCO 2016 in Chicago.  If you’d like to support our conference coverage, you can purchase access below. Subscribers can login to read more.

European Lung Cancer Conference 2016

European Lung Cancer Conference 2016

Geneva – At the 2016 European Lung Cancer Conference (ELCC) today, one of the highlights to watch out for is the presentation of first-line data for AstraZeneca’s ($AZN) third generation EGFR inhibitor osimertinib (Tagrisso), formerly known as AZD9291.

At 3.30pm in Geneva (9.30am on the East Coast of the United States), Dr Suresh Ramalingam (Winship Cancer Institute, Emory) will present updated data from two expansion cohorts of the AURA phase 1 trial (NCT01802632) with updated results on the use of osimertinib in the first-line setting:

LBA1_PR: Osimertinib as first-line treatment for EGFR mutation-positive advanced NSCLC: updated efficacy and safety results from two Phase I expansion cohorts. S. Ramalingam, J.C.-H. Yang, C.K. Lee, T. Kurata, D.-W. Kim, T. John, N. Nogami, Y. Ohe, P.A. Jänne

Do follow tweets from the conference (#ELCC16).

As Dr Ramalingam noted in a press release issued by the European Society for Medical Oncology (ESMO):

“The overall response rate was among the best reported for first-line therapy of EGFR mutated NSCLC. The PFS results are exciting, well exceeding the historical control rates of 10 to 13 months with first or second generation drugs. Many of the patients have not had disease progression on the study and are still benefitting from treatment.”

Readers will recall osimertinib was approved by the FDA last November (link to press release) for the treatment of advanced non-small cell lung cancer (NSCLC) in patients who test positive for an epidermal growth factor receptor (EGFR) T790M mutation following prior treatment with an EGFR tyrosine kinase inhibitor (TKI).

Nearly two-thirds of patients who receive an EGFR-TKI develop a T790M mutation, and until the approval of osimertinib, there were no approved treatment options.

I vividly remember being in the audience at the European Cancer Congress in Amsterdam back in September 2013 and listening to Professor Malcolm Ranson (Christie, Manchester) present the first clinical data from the phase 1 study, which at that time was only a single center. See post: ECCO 2013: AZD9291 shows early promise in NSCLC.

Dr Ross Camidge (Denver), who was the discussant in Amsterdam, concluded his discussion with a picture of the first step on the moon. Cancer metaphors around the moon and moonshots have since become overused, but I think this one was justified at the time:

“By addressing acquired resistance at the molecular level potentially creating one small step in the EGFR treatment paradigm, third-generation inhibitors like 9291 are likely to represent one giant leap forward in the treatment of EGFR mutant disease.”

~ Dr Ross Camidge at ECC 2013.

Whatever the role we play in cancer drug development, and most of us are but bit players, we live for moments like that. Dr Camidge’s visual metaphor remains etched on my memory as a landmark moment when all in the audience saw the first glimpse of a drug that could make a difference.

We’ve been following the development of osimertinib over the past 3 years and the race to market with Clovis Oncology’s rociletinib (formerly known as CO-1686). See e.g. AstraZeneca ramps up AZD9291 lung cancer clinical development, AstraZeneca leaps over Clovis with AZD9291 data at World Lung Conference.

Looking back, when you compare the development of osimertinib to rociletinib, it is a “Tale of Two Cities,” to paraphrase the title of a novel by Charles Dickens.

In a recent article (open access) published in Annals of Oncology, Dr Antoine Yver, Senior VP at AstraZeneca described how fast the development of osimertinib was:

“The development programme for osimertinib is the most rapid to date, taking just 24 months from filing the FDA Investigational New Drug Application to submitting the FDA New Drug Application and just 2 years 8 months and 1 week from the first patient dosed to the first approval.”

To put this in context, the speed of the osimertinib development rivals – and perhaps even just beats – the accelerated development of imatinib (Gleevec) by Novartis from Feb 1998, when the first patient was dosed, to approval in May 2001, a tremendous achievement.

Key to AstraZeneca’s success was the company’s previous experience in bringing gefitinib (IRESSA) to market in EGFR lung cancer.

The development of osimertinib by AstraZeneca offers a new case study to other companies in how to bring a drug to market.

Sadly, the drug development by Clovis Oncology offers the exact opposite, as evidenced by the recent meeting of the FDA Oncology Drugs Advisory Committee, which recommended (12 to 1) against accelerated approval of rociletinib for the same indication as osimertinib. See FDA ODAC meeting briefing documents (link).

So what do we learn from the first-line osimertinib data presented at European Lung?

Dr Pasi Jänne at ASCO 2014

Dr Pasi Jänne, Dana-Farber Cancer Institute pictured at ASCO 2014

I spoke with the senior author of the LBA_1 PR abstract at European Lung, Dr Pasi Jänne, who is Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute (DFCI) and Professor of Medicine, Harvard Medical School about the significance of the data presented at European Lung.

During the interview, excerpts of which I’ve posted for subscribers, we touched on acquired resistance to osimertinib and whether rociletinib has any future in the treatment of EGFR positive NSCLC.

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