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San Francisco JPM16 Day 3It’s Day 3 of the JP Morgan Healthcare Conference in San Francisco, and we hope that you’re enjoying our commentary and analysis around some of the presentations & news each day. If you’re reading this and aren’t a subscriber already, then why not become one?

We’re not offering a substitute for watching a company presentation yourself, they’re freely available by webcast and several companies have also put up their presentations up on their websites, but in a world awash with information competing for time and attention, we hope we’ve teased out a few of the noteworthy points.

Yesterday, on the Day 2 post we commented on $AMGN, $RHBBY, $BMY, $SGMO, $IMGN and more.

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San Francisco JPM16 Day 2It’s Tuesday at the 2016 JP Morgan Healthcare conference in San Francisco (Twitter #JPM16).

Each day of #JPM16 we’re doing a rolling blog post which we’re updating throughout the day with commentary and insights on the company presentations we’re covering.

While we’re not giving a blow-by-blow account, many companies have the slides readily available, we will be commenting on noteworthy news, and what we learn about corporate strategy going into 2016.

For those of you who like to catch up with the final summary of each day’s highlights, you can read yesterday’s Day 1 synopsis here and our interview with Seattle Genetics CEO, Clay Siegall here.

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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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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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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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ASH 2015 Hematology Orlando

ASH 2015 — taken before 7am!

Orlando – a presentation in the plenary session at #ASH15, the 2015 annual meeting of the American Society of Hematology, is the pinnacle of any doctor or researcher working in the hematology field.

Yesterday, we had the privilege to interview Dr Richard Stone (Dana-Farber Cancer Institute) ahead of his plenary presentation at ASH:

Abstract 6: The Multi-Kinase Inhibitor Midostaurin (M) Prolongs Survival Compared with Placebo (P) in Combination with Daunorubicin (D)/Cytarabine (C) Induction (ind), High-Dose C Consolidation (consol), and As Maintenance (maint) Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients (pts) Age 18-60 with FLT3 Mutations (muts): An International Prospective Randomized (rand) P-Controlled Double-Blind Trial (CALGB 10603/RATIFY [Alliance])

Anyone who has been to an ASH education session on AML knows how hard a nut it is to crack, so it’s wonderful to see some positive data, in what is commonly considered to be a “graveyard” disease.

The trial has taken a long time to come to fruition, so all credit to Dr Stone and colleagues. We’ll be writing up more about the data in our post meeting coverage.  For additional background, you can also check out our FLT3 preview in AML, which details some of the history and context for this study. The data from the phase 3 study is likely to form the backbone of a registration filing for Novartis with this compound in the near future based on successfully meeting the trial endpoints.

We also kick off today’s highlights with quick reflections on some of the hot topics that emerged yesterday including Bluebird Bio’s lentiglobin, Bellicum’s pipeline and .

During the day, as the opportunity presents, we’ll also be providing commentary on sessions we attend.

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