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ASH 2014 Day 2 Live Blog #ASH14

San Francisco – it’s day 2 of the annual meeting of the American Society of Hematology. Yesterday, data was presented to the media on “Directing the Immune System to Attack Hard-to-Treat Blood Cancers.”

The press briefing included four presentations on some the latest developments in blood cancer immunotherapy:

  • Phase 1 trial of nivolumab in classical Hodgkin Lymphoma (cHL) – Abstract 289.
  • Phase 1 trial of pembrolizumab in classical Hodgkin Lymphoma (cHL) – Abstract 290.
  • Phase 2 trial of blinatumomab in acute Lymphoblastic Leukemia (ALL) – Abstract 379
  • Phase 2 trial of CTL019 CAR-T therapy in children with acute lymphoblastic leukemia (ALL) – Abstract 380

Delegates to the meeting will hear the above abstracts presented in oral sessions tomorrow. However the media heard the results yesterday which led to stories being published about data that “researchers reported on Saturday” and described the “results presented at the American Society of Hematology,” not the results to be presented!

We also saw the publication of two New England Journal of Medicine papers to coincide with the presentations to the media yesterday.

The New England Journal published the nivolumab data in cHL. BMS seem to have a talent for obtaining publication of early PD-1 clinical trial data in the NEJM to coincide with meeting presentations.

Irrespective of when data is presented at ASH or how it is shared, data on its own is meaningless without context and interpretation. The majority of our conference coverage will be after we have heard the full presentations of data, talked to experts and can do in-depth pieces.

However, on our daily live blog (or as live as we can make it) we will be sharing rolling insights from the sessions we are in and top line thoughts on what captures our attention.

Today, for those of you looking for a photo with our antibuddies (@gene_antibody), they are having a photo opportunity – do check it out, they will be at the Genentech booth 1909 from 12 -1.30.

What Genentech are doing is fun and educational – but do remember to brush up on your antibody structures before asking for a photo, you wouldn’t want the embarrassment of not knowing which was which would you?

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ASH 2014 Day 1 Live Blog #ASH14

San Francisco – the 2014 annual meeting of the American Society of Hematology kicks off today. Yesterday was “Super Friday” –  a day when the non-profit and industry sponsored satellite symposia and other ancillary meetings, take center stage.

Each day (Sat – Mon) at the ASH meeting here in San Francisco, we we’ll be sharing information on which sessions we are in. For all those who have asked how do we get a photo with our antibuddies: @gene_antibody, we’ll mention where they are if we see them 🙂

By the way to get a photo you have to be able to identify which one is which – tip: there’s a monoclonal, bispecific, ADC and glycoengineered. Can you work out which is which from the picture? If not, it’s time to brush up on your antibody structures!

In addition, throughout the day (schedule and wifi permitting) we’ll be updating the rolling blog with short comments on the oral sessions and posters we’ve been in and what’s captured our attention. The hematology community has embraced Twitter, with many of the leading experts in the field sharing commentary and insights on their specialized area. ASH is also particularly welcoming to patient advocates who will be live-tweeting too. Expect the #ASH14 Twitter hashtag to generate a lot of information. If you’d like to share the ASH journey with us over the next 3 days, you can purchase access by clicking on the blue icon at the end of the post.

Existing subscribers already know how to login. Let the meeting commence!

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ASH 2014 Annual Meeting Multiple Myeloma Preview

The 2014 American Society of Hematology (ASH) annual meeting starts later this week in San Francisco. #ASH14 is a “must attend” given the innovation that has taken place in recent years for new treatments of blood related cancers.

One of the highlights of last year’s ASH was the data for CTL019 Chimeric Antigen Receptor CAR-T in children with acute lymphoblastic leukemia (ALL) presented by Stephan Grupp (CHOP). The data, in the opinion of many, was worthy of presentation in the plenary session of the meeting.

CAR-T cell therapy remains in the news, with the recent announcement that Seattle based Juno Therapeutics have an initial public offering (IPO) planned, and last week Kite Pharmaceuticals announced a secondary offering to raise additional funds. Last month, Houston based Bellicum Pharmaceuticals also filed an IPO to raise funds for development of their GvHD and CAR-T therapies.

It already looks a highly competitive marketplace and nobody is yet in phase 3 development. In addition to Juno, Kite, Novartis/UPenn and Bellicum, the Chinese also have CAR-T therapies in development. Other companies in the field include Cellectis, who have partnerships with Servier and Pfizer. On top of all this activity, only a week ago Janssen announced they had partnered with Transposagen Biopharmaceuticals. Wow!

In addition to ALL, CLL, and NHL, new developments are starting to emerge in myeloma, not just with CAR T cell therapies, but also checkpoint inhibitors and modified measles virus therapy.

Investor interest in immuno-oncology is certainly very high, and one has to question whether it is beginning to border on “tulip mania”? As we’ve written about on the blog, there remain a number of challenges that have to be overcome with CAR-T therapy, particularly in adults, and at the moment it’s still very much an experimental therapy.

In this post, we offer some top line thoughts on what to expect and look out for at ASH14 in Multiple Myeloma. It is consistently an area that attracts a lot of interest at the meeting and this year promises not to disappoint.

If you have to plans to be in San Francisco, do say “hello.”

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Can you reduce Graft versus Host Disease GvHD by regulating gut bacteria?

At the 2014 Society for Immunotherapy of Cancer (SITC) annual meeting at National Harbor, MD, one of the presentations that caught my attention was by Marcel van den Brink MD PhD (@DrMvandenBrink), pictured right, from Memorial Sloan-Kettering Cancer Center in New York. (picture courtesy of MSKCC with permission).

Dr van den Brink, who is Head of the Division of Hematologic Oncology and Alan.N. Houghton Chair, gave a fascinating talk entitled, “The role of the Intestinal Microbiome on GvHD” (Graft versus Host Disease).

Think of the yogurt pots and probiotic drinks we see in the supermarket with “beneficial” bacteria. We’re familiar with the idea that the make up of the millions of bacteria in our gut can make a difference to our digestion and health.

Well, it turns out it can make a difference to our immune system too. Research presented at the recent SITC meeting by Dr van den Brink showed that manipulating the bacteria in the gut could potentially help the thousands of patients around the world who receive a bone marrow transplant (BMT).  BMT is a gruelling procedure that many leukemia, myeloma and lymphoma patients have to face as part of their treatment protocol.

Sadly, about 20%* of people who receive an allogeneic bone marrow transplant from an unmatched donor die from Graft versus host disease (GvHD)

* According to 2010-2011 data from the Center for International Blood and Marrow Transport (CIBMTR), GvHD was the cause of death in 19-23% of people who received an allogeneic hematopoietic stem cell transplant.

After his informative and interesting presentation at SITC, Dr van den Brink spoke with BSB about his findings and what’s on the horizon for the treatment of GvHD.

Over the course of a half hour conversation, he covered some of the new treatment options, one of which may change the standard of care, and the rational some companies are pursuing by targeting the innate immune system.

For those interested in CAR-T cell therapy and the promise of allogeneic CAR-T cells, Dr van den Brink kindly talked about some unpublished data from MSKCC about why we have not seen GvHD in patients who receive allogeneic CAR-T cells.

GvHD is an important topic, and one that deserves more attention. I expect we will here a lot more about it at ASH this year so reading this interview will, hopefully, help you better put that data in context.

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SITC 2014 Cancer Immunotherapy Day 1

National Harbor, MD – The 2014 Society for Immunotherapy of Cancer (SITC) annual meeting officially kicked off today, with a record-breaking 1,500 attendees. The organization has grown by 33% over the past year highlighting the explosive progress in the field, and the growing importance of SITC!

There was a lot of thought provoking science on display as researchers and translational scientists came from all around the world to share results and talk about the future.

What struck me at the meeting today was the collegiality and friendliness of all who are here. It’s exciting times in immunotherapy and immuno-oncology and everyone at the meeting is bound by a common goal of making a difference to the lives of cancer patients.

The President of SITC, Francesco Marincola (Sidra) quoted Winston Churchill in his introductory address:

“Now this is not the end.

It is not even the beginning of the end.

But, perhaps it is the end of the beginning.”

Dr Marincola’s choice of quote seemed to strike the right balance of where we are at today: there’s still a long way to go to optimize cancer immunotherapy treatments, but equally there’s been tremendous progress to reach the point we are at where there are durable long-term responses in many patients who would otherwise not be alive today.

What was the highlight of Day 1 of SITC 2014?

For me, this morning, it was the presentation by Marcel van den Brink (MSKCC) on the influence of the microbiome on graft-versus-host disease (GvHD) for which there’s been no effective new treatment for over 25 years:

In the afternoon, it was the presentation by Roy Herbst (Yale) on the top ten lessons learned about immunotherapy for NSCLC.

It’s unfair to single out two presenters when there were multiple presentations and posters of note, but they stood out for me. If you’d like to read our more detailed notes from the road after Day 1 of SITC 2014, do log-in if you are already a subscriber.

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SITC 2014 Cancer Immunotherapy Annual Meeting Preview

This week sees the start of the 2014 annual meeting of the Society for Immunotherapy of Cancer (SITC) at National Harbor, MD.

Given the rapid progress that is taking place in the field of cancer immunotherapy, we’re excited to be flying up to DC to attend the meeting for the first time as part of our conference coverage.

Many of the leading translational scientists in immuno-oncology will be at SITC to discuss the current landscape, challenges and opportunities.

For all the promising results we’ve seen so far, harnessing the body’s immune system to fight cancer is very much a work a progress.

Don’t expect much from SITC on social media, most of the data is likely to be unpublished, which is why you have to go to meetings like SITC, ARVO and AACR in person. An important part of attending is the in-person conversations and connections that take place.

You can download the preliminary program on the SITC 2014 Annual meeting website. There’s also an iphone/android app for those attending.

Conference Highlights: 

  • Addresses by the 2014 Richard V. Smalley, MD Memorial Award recipient, Giorgio Trinchieri, MD – National Cancer Institute and the Annual Meeting keynote speaker, Olivera J. Finn, PhD – University of Pittsburgh
  • News on important initiatives and updates in cancer immunotherapy by key stakeholders in the field
  • Workshop on Combination Immunotherapy: Where Do We Go From Here?
  • Primer on Tumor Immunology and Cancer Immunotherapy™
  • Hot Topic Symposia on Managing Engineered T-Cell Toxicities & Accelerating Tumor Immunity with Agonist Antibodies.

If you haven’t already seen it, this educational video from Roche/Genentech, narrated by Dan Chen MD PhD (Cancer Immunotherapy Franchise Head) is not only educational in discussing the mechanism of action of their anti-PDL1 monoclonal antibody, MPDL3280A, but is highly fun and entertaining to watch. Enjoy!

Sally interviewed Dr Chen at ASCO this year for a blog post from the meeting on “Making a difference in advanced bladder cancer.”

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Breathing New Life into Bladder Cancer Treatment

Cancer immunotherapy, the ability to harness the body’s own immune system to fight cancer, is showing early promise in bladder cancer.

“Breathing new life into bladder cancer treatment” was the title of the excellent discussion by Maria De Dantis (Vienna) of data presented at the recent ESMO Congress in Madrid.

Advanced bladder cancer has a particularly poor prognosis. Once the cancer has spread in the body, according to Cancer Research UK, the average survival time is approximately a year to 18 months.

There is clearly an unmet medical need for effective new treatments, with no major treatment advances for over 30 years. To date, targeted agents in the second-line setting have shown only incremental progression free survival and generally low overall response rates.

Which is why it’s exciting to see hope for patients with urothelial bladder cancer from new inhibitors of the PD-1 immune checkpoint signalling pathway.

At ASCO this year, data for Roche/Genentech’s anti PD-L1 (MPDL3280A) was presented (Abstract 5011) by Thomas Powles (Barts, London). Commenting on the data, in her post “Making a difference in advanced bladder cancer” Sally noted, “it wouldn’t have been out of place in the Plenary session, frankly.”

Recognizing the potential based on the promise of the early clinical data, on May 31st the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to MPDL3280A in bladder cancer.

If you need to catch up on immuno-oncology, we have a growing library of posts on Biotech Strategy Blog, and we’ll be continuing our coverage of the rapid progress in this area at the forthcoming annual meeting of the Society for Immunotherapy of Cancer (SITC), which takes place at National Harbor, MD from Nov 6 -9.

At ESMO 2014, phase 1 clinical trial data in bladder cancer was presented for both Pembrolizumab (Merck) and MPDL3280A (Roche/Genentech).

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ESMO Posters Highlight New Cancer Drugs in Development

We spend a lot of time in the poster halls at scientific and medical meetings such as European Society for Medical Oncology (ESMO) Congress in Madrid because that’s where the action is in terms of finding nuggets of promising preclinical and early clinical data. You can also spot new trends emerging earlier this way.

 

At large meetings run by the American Society of Hematology (ASH) and American Association for Research (AACR) there are literally thousands of posters, all of which have passed the grade to merit presentation.

Gaining insights from posters, and in particular, picking those that really matter is often an art rather than a science – a lot of intuition is involved.

This post discusses a few of the posters presented in the developmental therapeutic session at ESMO this year. It focuses on non-immunotherapy topics, i.e. traditional TKIs and monoclonal antibodies to specific mutations or other targets.

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New drug targets may change Colorectal Cancer Landscape

One of the sessions that stood out for me at the recent European Society for Medical Oncology (ESMO) Congress in Madrid was a Special Symposium on “Advances in Precision Medicine of Metastatic Colorectal Cancer.”

This blog post focuses on two presentations in the symposium:

  • “Emerging druggable targets in colorectal Cancer” by Federica Di Nicolantonio (Candiolo Cancer Institute, University of Torino, Italy).
  • “Signal Transduction Inhibitors and Pipeline Drugs” by Josep Tabernero MD PhD (Vall d’Hebron University Hospital, Barcelona)

Dr Nicolantonio, pictured right, is active on Twitter (@fdinicolantonio) and well worth a follow!

Since the advent of VEGF (Avastin) and EGFR (Erbitux) inhibitors way back in 2004, there haven’t been any new developments in this cancer type other than more of the same (Zaltrap and Vectibix, respectively), so I was particularly excited to see progress in colorectal cancer, and the promise of new drug targets on the horizon that may change the treatment landscape.

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Did Galeterone ARMOR2 Prostate Cancer Data Impress at ESMO 2014?

At the 2014 ESMO Congress in Madrid, Mary-Ellen Taplin, MD (Dana-Farber Cancer Institute, Boston) presented the results of the Tokai Pharmaceuticals (NASDAQ $TKAI) ARMOR2 clinical trial of galeterone in men with advanced prostate cancer.

 

Galeterone has a novel triple mechanism of action. In effect, it is a CYP17 lyase inhibitor (like abiraterone) that has additional anti-prostate cancer actions including androgen receptor (AR) inhibition (like enzalutamide). It also causes AR degradation that decreases AR levels.

Tokai’s IPO last month is reported by Renaissance Capital to have raised $98M for the company, with most of the funds going to prior investors including Novartis Bioventures which owned 28 percent.

Shares in $TKAI were initially priced at $15. They soared to a high of $30 thanks to high insider buying and a high trading volume. Novartis Bioventures were reported by Renaissance to have bought $20M.

As of publishing this post, the stock is now trading at $15.40, slightly above it’s IPO price. So have Novartis and others made a good investment?

The market cap of $TKAI, according to their Investor Relations page (screenshot pre-market Oct 3, 2014 shown above) is $336M – not high for a company about to enter phase III drug development.

Readers are no doubt aware of the Feuerstein-Ratain rule that predicts a phase III cancer trial will be a failure when undertaken by a company with a market cap less than $300M. As Adam noted in his May 6 story on The Street earlier this year, “For companies with market caps between $300 million and $1 billion, the oncology phase III success rate is 59%.”

The big questions now are did the data for galeterone from the ARMOR2 trial impress at ESMO 2014 in Madrid and what are the challenges and opportunities in the planned phase III ARMOR3-SV trial? 

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DISCLAIMER: Please note this piece offers no stock advice, is not a solicitation to invest in $TKAI and makes no recommendation on whether to buy or sell. It merely offers commentary and analysis of the data presented at ESMO 2014. Readers should do their own due diligence prior to making any investment decision.

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