Biotech Strategy Blog

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

San Francisco JPM16 Day 1It’s Day 1 of the annual pilgrimage to San Francisco for the JP Morgan Healthcare conference. In light of the success of the daily rolling blogs we’ve done around the conferences we cover, for the first time we’re doing a rolling blog for each day of #JPM16.

Throughout the day (schedule permitting) we’ll be updating the post with commentary around noteworthy news.

Company presentations mentioned in this post include: $PBYI, $CELG, $GILD, $INCY, $SGEN, $MDVN. There’s also commentary on several of the deals announced by Roche, Juno, Novartis, Sanofi, AstraZeneca & Merck.

If you want to follow along yourself, here’s the link to the JPM16 webcasts & conference agenda.

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SGEN Booth ASH15

Seattle Genetics ASH 2015 Exhibit – photo with permission

San Francisco – Seattle Genetics are presenting later today at the JP Morgan Healthcare conference (2.30pm PST) and we’ll be covering this as part of our daily rolling blog.

As blog subscribers already know, one of the presentations that caught our attention at ASH 2015 was the updated phase 1 data for Seattle Genetics latest ADC, denintuzumab mafodotin (SGN-CD19A) in B-cell malignancies, including diffuse large B-Cell lymphoma (DLBCL).

Unlike with brentuximab vedotin, where one of the main side effects seen is peripheral neuropathy, with 19A, as it’s commonly known, there is ocular toxicity. Will this toxicity bring the house of cards down for Seattle Genetics?

I spoke to President and CEO Clay Siegall, PhD about this, the company’s corporate strategy moving forwards in 2016 and how checkpoint inhibitors may impact classical Hodgkin’s Lymphoma (cHL).

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Acute Myeloid Leukemia (AML) is challenging disease to treat and quite distinctly different from its cousin, acute lymphoblastic leukemia (ALL).  The first is more common in adults, while the second is more prevalent in children.  Success rates with pediatric ALL have far outstripped what we have achieved with adults in AML to date, partly due to the elderly nature of the disease making for poorer outcomes with stem cell transplants (SCT), as well as increased clonal heterogeneity and cytogenetic complexity with age.

Quite a few FLT3 inhibitors have come and gone over the years – many keen observers will remember Cephalon’s (now Teva) TKI called CEP-701, which was tested in relapsed/refractory disease and Elderly AML, for example, and slid off largely unnoticed to dog drug heaven.

How much does clinical trial design impact a drug’s success or failure?

Sometimes quite a bit, as this story with midostaurin demonstrates; limited activity in advanced disease but much more dramatic results in the upfront setting.  Clearly, sometimes testing drugs in later disease does not predict their future performance elsewhere!

To put more colour on the data presented at ASH, we interviewed a thought leader in adult AML for his perspective on the FLT3 R&D developments.

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ASH Exhibit HallIn recent years, there’s been a lot of progress in the treatment of chronic lymphocytic leukemia (CLL). New targeted therapies such as ibrutinib (Imbruvica) and idelalisib (Zydelig) have been approved and have helped extend the lives of patients with this disease further. However, there still remains a need for new treatment options.

Several new drugs are on the horizon for CLL.  At ASH there were a number of presentations for venetoclax, formerly known as ABT-199/GDC-0199, it’s a BCL-2 inhibitor, which is being co-developed by AbbVie and Genentech.  We’ve written extensively about it on the blog.  One of the challenges with venetoclax is the potential for Tumor Lysis Syndrome (TLS) – we heard at ASH that starting a patient on the drug needs to be carefully managed and monitored, with high risk patients hospitalized.

Other new drugs on the longer term horizon for CLL include acalabrutinib (Acerta) and BGB-3111 (BeiGene), both next generation BTK inhibitors and potential competitive threats to ibrutinib. The CLL market is becoming interesting again!

At ASH 2015, I spoke with Ian W. Flinn, MD, PhD. Director, Blood Cancer Research Program at the Sarah Cannon Research Institute in Nashville, TN. At ASH, Dr Flinn presented data for a CLL trial of venetoclax combined with obinutuzumab, a CD20 targeted monoclonal antibody; data was obtained in both the upfront and relapsed/refractory setting.

In a wide ranging conversation, we talked about some of the data of note in Orlando, what the future direction is in CLL, and what to look forward to at ASH 2016.

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ASH15 LBA Session

ASH 2015 LBA Session

The annual meeting of the American Society of Hematology (ASH) has a few quirks compared to other meetings. One of these is that all the “Late Breakers” are presented together on the last morning of the meeting.

It’s a rather unfortunate time given many have already headed back to their busy clinics or left for SABCS in San Antonio and ‘late breakers’ by definition, often offer new data that’s really noteworthy.

The result can also be a bit of a hodgepodge session that you have sit to listen through to get to those presentations you really want to hear.

At ASH this year there were two late breakers on new treatment options for CLL patients with a 17p deletion (Del17p). This is a pretty challenging group to treat.  Although ibrutinib is indicated for this patient group, many sadly relapse. There’s an unmet medical need for new treatment options. At ASH we heard data for idelalisib (PI3K-delta) and venetoclax (Bcl2).

After the session, I briefly spoke with Dr Kanti Rai (New York) for his reaction to the data. Dr Rai (pictured below) received the 2014 Wallace H. Coulter Award for Lifetime Achievement in Hematology.

Dr Kanti Rai receives 2014 ASH Lifetime Achievement Award

Dr Kanti Rai receives 2014 ASH Lifetime Achievement Award

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Prof Qasim ASH 2015 posterPart 2 of the ASH 2015 interview Professor Waseem Qasim kindly gave BSB at the American Society of Hematology (ASH) discusses the poster he presented at the meeting (Abstract 2046:) “First Clinical Application of Talen Engineered Universal CAR19 T Cells in B-ALL.”

Prof Qasim is a Consultant in Paediatric Immunology and Bone Marrow Transplantation at Great Ormond Street Hospital (GOSH) and Professor of Cell & Gene Therapy at the Institute of Child Health which is part of University College London (UCL).

The “devil is in the detail” so it was a privilege to be taken through the case by Prof Qasim, and in the process, better understand the treatment rational, as well some of the challenges and unanswered questions that will need to be addressed moving forwards.

The first-in-man use of the UCART19 allogeneic CAR T cell therapy from Cellectis was done under the Compassionate Use guidelines of the UK Medicines and Health Products Regulatory Agency (MHRA). A phase 1 clinical trial is planned for early 2016.

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Prof Qasim UCART19 ASH 2015 PosterMy highlight of the 2015 annual meeting of the American Society of Hematology (ASH) was interviewing Professor Waseem Qasim, who is a Consultant in Paediatric Immunology and Bone Marrow Transplantation at Great Ormond Street Hospital (GOSH) and Professor of Cell & Gene Therapy at the Institute of Child Health, which is part of University College London (UCL).

In a poster presented at ASH 2015, Prof Qasim together with colleagues from GOSH & UCL reported the “first in man” use of a gene edited, off-the-shelf, allogeneic CAR T cell from Cellectis, a company we have written extensively about on the blog. It was probably one of the leading posters at the meeting, at least in terms of the amount of interest it generated, and the crowds I saw reading it.

There was far too much content in the interview for one blog post, so we’ve split into two, with Part 1 focusing on gene editing and Part 2 discussing in detail the case reported in the poster.

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We’ve had a couple of requests come in for a revival of the old conference series… ‘Gems from the poster halls’ because quite a few folks are interested in the up and coming data from small to medium biotechs.

SABCS San Antonio CrowdA bunch of my Post Doc chums in this field were at the San Antonio Breast Cancer Symposium (SABCS) meeting and gleefully highlighted mobbed posters or areas where they thought the data looked potentially interesting.

From these, we selected a few for review in today’s look at the nuggets that can be gleaned from cool and intriguing trials or preclinical research that may influence future trials.

Companies covered in this article include Seattle Genetics, Jounce, Immunomedics, Syndax and MedImmune.

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Today the immunotherapy and related data flooding out of the annual meeting of the San Antonio Breast Cancer Symposium (SABCS) is pretty exciting!

Data was presented on a number of drugs including pembrolizumab, avelumab and atezolizumab, which put together with some recent publications, highlights some potentially exciting opportunities in this fast moving space.

Here, we explore the potential for checkpoint therapy combinations in TNBC, HER2 and even the ER+ subsets.  There’s a lot of new findings to take in and contemplate here.

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ASH 2015 Manic Monday

The #ASH15 wall of people marching to the poster hall just after 5pm

Orlando – it’s Monday at the annual meeting of the American Society of Hematology (ASH) annual meeting, a day I call “Manic Monday” because there are so many simultaneous sessions, you end up running around frazzled, in/out of sessions, in the hope of catching all the presentations of interest.

It’s particularly challenging if you are in a full session — you won’t be able to get back in if you leave — which results in having to make difficult choices on what to see and where to run to.  Some of the myeloma thought leaders were urging colleagues to tweet sessions they couldn’t be in, so “Manic Monday” may be a good time to contribute to the collective ASH Twittersphere.

We’re starting today’s rolling post with my notes from the lymphoma New Drugs session yesterday, then we’ll be updating the blog as the day goes by, as the opportunity permits.

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