Biotech Strategy Blog

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

Posts tagged ‘CTL019’

ASH15 Preview on Aggressive Lymphomas

Aggressive lymphoma… the very phrase is enough to send chills down your spine!

ASH Annual MeetingIn the past, much of the focus at previous American Society of Hematology (ASH) meetings in this area has focused on the myriad of chemotherapy regimens and dose/schedule optimisations that followed in trying to boost patient outcomes.

This year, I’m pleased to say that things have quite a different flavour with numerous new therapeutics and promising combinations in development.

Some of these are inevitably hypothesis testing, while others will be up-levelling to large randomised controlled multi-centre trials.

As part of our ongoing preview series, we take a look at the different categories to watch out for beyond chemotherapy.  These include monoclonal antibodies, antibody drug conjugates, targeted therapies and yes, even immunotherapies.

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New therapies for multiple myeloma may make an impact

Multiple myeloma (MM) has been very much in the news this week after the American Society of Clinical Oncology (ASCO) abstracts were released to much anticipation.

Myeloma is largely thought to be an incurable disease despite the option of an autologous stem cell transplant for newly diagnosed patients. That said, I have actually met some people who have had two or 3 transplants over several decades, a testament to their strength and fortitude in enduring such a challenging procedure.

This year, the news media have focused on elotuzumab (BMS/AbbVie), a CS1/SLAMF7 inhibitor that has previously shown clinical activity in earlier trials, after it was showcased in the ASCO Presscast last week. This why you see many articles on the data reported from this particular abstract.

New Orleans American QueenIt’s not the most exciting new data in this disease for me though, that honour goes to two other therapeutics of an entirely different kind. They come completely out of left field and what we saw over the last two months really caught our attention and may surprise you too.

Indeed, we saw hints of some of this data at the American Society for Gene and Cell Therapy (ASGCT) meeting last week in New Orleans.

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ASCO 2014 blinatumomab in B cell ALL

A regular reader of BSB wrote in asking for an update on Amgen’s blinatumomab, an anti CD3/CD19 bispecific antibody being investigated in B cell adult acute lymphoblastic leukemia (B-ALL) and Non Hodgkins Lymphoma (NHL). It has orphan designation for both indications.

Amgen acquired Micromet and their BiTE program way back in January 2012. At the time, the R&D head, Roger Perlmutter, referred to the exploratory phase II results as being a key driver for their interest in the technology. Like many, I too, was initially enthusiastic about the bispecific antibody when it was with Micromet, since those were very encouraging results in refractory adult ALL, a particularly hard to treat malignancy with a generally poor prognosis.

Unfortunately, since then we’ve heard very little about the program, which seems to have languished in the Amgen portfolio, a not uncommon occurrence when big Pharma/Biotech take over small biotech programs. In the meantime, chimeric antigen receptor (CAR) T cell therapies have arrived to much fanfare, and with it, even more dramatic results that have caught people’s attention.

Is there still a future for blinatumomab and BiTE technology?

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ASCO 2014 CLL and iNHL Preview #ASCO14

Chronic lymphocytic leukemia (CLL) and indolent non-Hodgkins Lymphoma (iNHL) have received significant attention over the last two years. More exciting new therapies than ever before – with multiple different mechanisms of action – have either recently come to market or are in development.

There is an ongoing revolution in the CLL landscape and treatment of the disease, which above all else is good news for patients! As part of our ongoing longitudinal coverage, there’s a lot to discuss and catch up on in Chicago at the annual meeting of the American Society of Clinical Oncology (ASCO).

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6 important things I learned from AACR 2014 on immuno-oncology

 

“Nothing lasts forever, because nothing ever has.”

James Shelley, The Caesura Letters

This year’s annual AACR meeting was so good, we could probably write another 50 posts and still not be done! With ASCO fast approaching, however, it’s almost time to draw it to a close and the final post conference note will be published on Monday.

Today is the penultimate report and focuses on the key highlights that caught my attention in immuno-oncology, which covers the gamut from checkpoint inhibitors, co-stimulants, innate immunotherapy and CAR T cell therapy to bispecific antibody TCRs.

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ASH 2013 Stunning ALL data with Novartis CTL019 CAR Therapy

One of the fun aspects of the American Society of Hematology (ASH) conference last month was interviewing several thought leaders and CEOs about the latest developments that were emerging rapidly almost every single day.  Now, some medical meetings can be rather dreary if there’s no new or exciting data to pique the interest of the foot weary attendees, who tend to run on coffee and adrenalin for four days, but this ASH was rather different.

Looking at the program the first morning, I realised that I hadn’t felt so much anticipation since the 1999 meeting, when the phase I imatinib (Gleevec) data was presented in the plenary session by Brian Druker.  This time around there was a lot of buzz in so many areas from CLL and NHL to myeloma and ALL, it was pretty exciting to run from session to and see many packed rooms filled with an air of expectancy.  One evening, I hesitated at the top of an escalator and dithered over which of three very interesting sessions to dash to, as a bunch of researchers crashed into me all distracted by the exactly same dilemma!

If many of us could have made one request of the ASH organising committee it was clearly start offering a virtual meeting for all the oral sessions, something ASCO do incredibly well.

At ASH if you miss a presentation, it’s gone forever.

This is quite a pain if you really wanted to see the data from Agent X in CLL, Compound Y in CAR T cells and Drug Z in myeloma, as well as the one you actually attended.  All those sessions ran simultaneously.  It also means the sessions are still running at 7pm (yes, they were still packed even at that hour!) and many of us had an early start with 7am sessions or meetings.

The huge distances between rooms (#blisterruns), coupled with a stubborn insistence in putting almost all the oral sessions on Monday and Tuesday, together with long waits between interesting sessions over the weekend, makes for a very frazzled and disjointed schedule. Patience and stamina are the name of the game here.

Here we highlight our latest thought leader interview on CAR T cell therapy.

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Juno Therapeutics takes on Penn in dispute over St Jude Chimeric Antigen Receptor Patent

The Inquirer yesterday reported on Philly.com that start-up Juno Therapeutics (Juno) are now in control of a legal dispute between St Jude Children’s Hospital (St Jude) and the University of Pennsylvania (Penn) over chimeric antigen receptor (CAR) intellectual property that contributed to the development of CTL019, licensed by Penn to Novartis. Thanks to @lomu_j for sharing this news on Twitter.

According to the Inquirer, last month Juno entered an agreement with St Jude to commercialize their CAR T-cell technology, which gave them the right to “control, pursue and defend” the dispute between Penn and St Jude.  On December 18, Juno’s intervention was approved in Federal District Court in Philadelphia.

(Update Jan 10: Zack Seward (@ZackSeward) provides additional commentary on WHYY Philadelphia newsworks on “The high-stakes legal fight over a ‘cancer cure from Penn.’ He reports that St Jude have every confidence in their patent.

 

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Winners and Losers in CLL at American Society of Hematology

Now that the last of the 2013 cancer conference season is finally over, we’re going to run a couple of post meeting summaries this week from ASH as a few subscribers have asked for the Cliff Notes version of what was hot – or not in the context of the market.

New treatments for Chronic Lymphocytic Leukemia (CLL) was one of the hot topics at the recent annual meeting of the American Society of Hematology in New Orleans.

Hot on the heels of Roche’s recent FDA approval for Gazyva (obinutuzumab/GA101) in CLL, other companies in the race to market including:

  • Pharmacyclics and Johnson & Johnson (ibrutinib)
  • Gilead (idelalisib, GS-9973)
  • Infinity (IPI-145)
  • AbbVie and Roche (ABT-199/GDC-0199)
  • Novartis (CTL019).

Here’s my subjective and personal assessment of the winners and losers based on the data presented:

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ASH 2013 Novel Treatments for CLL – notes from the road

New Orleans – the hematology diehards were up early yesterday for the 7.30 am oral session on some of the most interesting data at the annual meeting of the American Society of Hematology (ASH) on potential new treatments for Chronic Lymphocytic Leukemia (CLL).

Just to make sure everyone’s Fitbits were well exercised, the organizers put the session in the farthest end of the Convention center! Like many of the CLL sessions, it was a full house with multiple financial analysts sitting in the row behind me taking copious notes and pictures.  Unlike at ASCO, there is no virtual meeting, so you can’t replay any of the oral scientific sessions at a later date. If you didn’t see it, you missed it! There’s no substitute for boots on the ground.

What this post is about is my subjective opinion and top-line impressions of the information presented and some of the key strategic issues and challenges that came across listening to a full presentation of the latest data. I’m not going to rehash the press releases and the abstract data, most readers have already assimilated that.

It is what it says — notes from the road — the kind of things I’d write in a trip report if I were in a company.

The four presentations covered in this post are:

Abstract 871: Dinaciclib (SCH 727965) Is a Novel Cyclin-Dependent Kinase (CDK) Inhibitor That Exhibits Activity In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia (CLL).

Abstract 872: Bcl-2 Inhibitor ABT-199 (GDC-0199) Monotherapy Shows Anti-Tumor Activity Including Complete Remissions In High-Risk Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL).

Abstract 873: Randomized, Phase II Dose Optimization Study Of Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) In Patients With Relapsed, Refractory CLL.

Abstract 874: Phase I Trial Of Autologous CD19-Targeted CAR-Modified T Cells As Consolidation After Purine Analog-Based First-Line Therapy In Patients With Previously Untreated CLL.

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ASH 2013 Preview: will new Seattle startup Juno Therapeutics push Novartis and U Penn in CART?

Last night Luke Timmerman of Xconomy posted a nice article on the formation of a new Seattle startup, Juno Therapeutics, which aims to develop the chimeric antigen receptor T cell therapy (CAR-T) based on autologous T cells developed by Memorial Sloan Kettering (MSK) in New York, Fred Hutchinson Cancer Center (FHCC) and the Seattle Children’s Hospital, both in Seattle.

Juno secured $120M in Series A funding, which is pretty good for a two month old startup and shows how much excitement there is for this exciting technology.

How does this new development impact the CART landscape and in particular, the U Penn and Novartis partnership?

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