Biotech Strategy Blog

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

Posts tagged ‘immuno-oncology’

Some people may think that if you just give a whole boat load of engineered T cells, and in particular, those modified with a Chimeric Antigen Receptor (CAR), that responders are “cured.”

While some recipients of engineered T cells can have long-term, durable remissions, others may initially respond, only to subsequently relapse.

Resistance to CAR T cell therapy can and does occur.

In this post, we talked with a leading expert about the latest research on how resistance to cell therapy develops, and the potential strategies to overcome it.

CAR T cell therapy is exciting, but remains an emerging field with multiple ways in which the competitive landscape may be shaped moving forwards.

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The 30th anniversary meeting of the Society for Immunotherapy of Cancer (Twitter #SITC2015) starts today at National Harbor, MD just outside of Washington DC.

Congratulations to SITC on 30 years of Advancing Cancer Immunotherapy Worldwide!

National Harbor MD SITC

It’s an unusually packed conference season this month with the AACR-NCI-EORTC Molecular Targets (#Targets15) meeting in Boston unfortunately clashing with SITC 2015.  In previous years, the Triple meeting has been held in late October, something we hope it will return to in future.

Many of the leading cancer immunologists are at National Harbor…

In our latest conference preview post, we’ve taken a quick look at some of the late breaker and poster abstracts of note and will cover the main oral presentations at the end of each day, so do check back daily for more news and views.

As subscribers already know, we generally provide most of our commentary and analysis after a meeting when we’ve had a chance to hear the data, “kick the tyres” and talk to researchers. However, for those who can’t be at SITC, we will be writing a “top-line”post at the end of each day to give you a flavor of what’s hot at SITC 2015 and our initial impressions of the data we heard.

We typically generate a separate page for each conference we cover, so you can find the SITC 2015 coverage here; it includes some additional posts that make for background reading.

Wednesday’s program at National Harbor starts off with a Global Regulatory Summit (which we’ll miss due to travel) and an International Symposium on Cancer Immunotherapy later in the afternoon.

The weather looks like it’s going to be quite delightful at National Harbor – hopefully the meeting room won’t be as frigid as last year – and in addition to the great science, we’re look forward to meeting up with those of our subs who are here too!

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Some really intriguing news was announced this morning, with Aduro Biotech issuing a press release on their new global collaboration with Novartis for their “immuno-oncology products derived from its proprietary STING-targeted CDN platform technology.”

Many readers will recall Aduro for its program that inserts genetically engineered lysteria into therapeutics aka the LADD regimen. The lead program, CRS–207, in combination with GVAX Pancreas in pancreatic cancer previously received Breakthrough Therapy designation from the FDA. Their scientific advisers include Drew Pardoll and Frank McCormick, who are immunotherapy and protein pathway specialists, respectively.

The collaboration with Novartis is for a completely different platform based on cyclic dinucleotides (CDNs), which are small molecules that are naturally expressed by bacteria and immune cells and have been recently shown to activate the STING (Stimulator of Interferon Genes) signaling pathway in immune cells.

So what’s the significance of this exciting deal and why does it matter?

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It’s time to answer some more subscriber questions. Several readers wrote in and asked about the anti-PD1 checkpoint data that was presented at the recent American Society of Hematology (ASH) meeting in classic Hodgkin’s lymphoma (cHL):

What did we think of it?

Well, for starters it was one of our highlights of the ASH 2014 conference (see quick write-up, open access), with an impressive 87% response rate for nivolumab in refractory cHL. Many of these patients had failed both autologous stem cell transplant and brentuximab (Adcetris), for which FDA granted breakthrough therapy designation.

ASH14 CHECKPOINTSOverall, I agreed with Ron Levy (Stanford) when he noted in the packed Special Session on Checkpoint inhibitors in Hematology that there were only 4 or 5 abstracts to actually discuss (he didn’t spend much time on the preliminary data) and that the results are still very early without seeing how good the durability will be.

As he observed in the session, which was standing room only, figuring out how best to integrate these new agents into clinical practice with other successful approaches will be most interesting.

That said, there are some new data that have emerged since ASH that are worthy of discussion in terms of potential future directions and how they could impact the checkpoint landscape in both hematologic malignancies and even solid tumours.

This is part of our ongoing immuno-oncology series on how we can manipulate T cells in creative ways to kill the cancer cells.  The findings discussed in this article are completely new and have not been discussed here before.

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Picture Credit: @gene_antibody

Picture Credit: @gene_antibody

For much of the last two years, one of the hottest topics around has been T cell manipulation, which can happen in many different forms.

This is just one area that we have covered extensively in the immuno-oncology space from Chimeric Antigen Receptor (CAR) T cell therapies to checkpoint inhibitors, as well as various antibodies, including the first bispecific T-cell engager (BiTE) to CD19 that recently approved by the FDA called blinatumomab (Blincyto) from Amgen.

Not all cancer patients respond to all these approaches though.

Why is that and what approaches or novel targets can we explore next to address this vexing issue?

At the SITC and SABCS meetings, I saw some really interesting and unusual presentations, together with some recent publications on topic, that really piqued my interest in this challenge. They are early signs of the new directions some of the research in this field could go. Overcoming resistance and understanding different aspects of immune escape will likely be very instructive in developing the next generation of combination studies that could make a positive impact on patients.

Today’s post touches on some of these exciting developments and includes an in-depth interview with Dr Ira Mellman, the scientist behind Genentech’s immunology research program at gRED.

Interested readers can log-in to read more about the exciting new developments that are happening with different types of antibodies in the immuno-oncology space.

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Madrid – it’s Day 2 of the European Society for Medical Oncology (Twitter #ESMO14) annual meeting and the Congress is now in full swing. Today one of the highlights is the Presidential Session that takes place this afternoon. It’s where all attendees have the opportunity to hear what ESMO think is the most noteworthy data at the meeting, irrespective of the type of cancer.

Yesterday, we launched our Live ESMO blog series for Day 1, with commentary and insights posted throughout the day. If you missed the afternoon and evening notes, you can check them out.

Meanwhile, we’re really looking forward to hearing the CLEOPATRA trial overall survival (OS) data in HER2+ metastatic breast cancer at 4pm CET this afternoon.

CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, Phase III, randomised, double-blind, placebo-controlled study. The study evaluated the efficacy and safety profile of pertuzumab (Perjeta) combined with trastuzumab (Herceptin) and docetaxel chemotherapy compared to trastuzumab and chemotherapy plus placebo in 808 women with previously untreated HER2-positive metastatic breast cancer (mBC) or with HER2-positive mBC that that had recurred after prior therapy in the adjuvant or neo-adjuvant setting.

Sally wrote on Pharma Strategy Blog about the PFS data for the trial which was first presented at the 2011 San Antonio Breast Cancer Symposium (SABCS).

As Sally noted back in 2011:

“The idea behind combining pertuzumab (Perjeta) and trastuzumab (Herceptin) upfront is to enable a more comprehensive shut down of the HER2 pathway and delay resistance setting in.”

We’re now looking forward to the final overall survival data that will be presented for the first time at a conference by Dr Sandra Swain (Washington DC) in the Presidential Session at ESMO this afternoon.

There’s a press briefing between 8 and 9 where this data will be featured, so expect news releases to follow soon after this. Out of respect to researchers and those who come to these meetings to hear the data, we typically don’t write about data until after it’s been presented, so expect our initial commentary and analysis to follow later in the day on the blog.

What else are we looking out for at the Congress today and which sessions will the Mav be in?

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Over the last few days, we’ve covered data from the leading checkpoint inhibitors from BMS, Merck and Roche, but what about other agents in development in immuno-oncology? One of the companies that burst on the scene in Chicago at ASCO 2014 with solid data was AstraZeneca with their anti-PD-L1, MEDI4736.

To put progress in context, last year Merck had one single abstract for MK–3475 (pembrolizumab), whereas this year MEDI4736 debuted with 7 abstracts, including several Trials in Progress posters in combination with their anti-CTLA4, tremelimumab, plus some important oral presentations too.

The last morning of the final day of the ASCO conference has not exactly been well attended in past years, especially in Developmental Therapeutics. This year was different – the large hall was jam packed and it was standing room only. I was lucky to get one of the last seats in the front row a good 15–20 mins early!

As we were waiting for the proceedings to start, the Japanese doctor sitting next to me turned and said:

“What do you think of this compound? I’m not expecting much, and they are behind the others already!”

To learn more about my insights from ASCO 2014, you can log-in to read the full article.

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Chicago – it’s the last day of the American Society of Clinical Oncology (ASCO) annual meeting. There’s been a record attendance this year with over 30,000 people coming to Chicago to hear the latest news and research on cancer treatments.

The message I am left with is the considerable hope it offers cancer patients around the well as researchers harness the latest techniques in genome sequencing and through a deeper understanding of cancer biology, develop new targets and ways of attacking this disease. Attacking the immune system (immuno-oncology) is one of the most exciting areas in cancer drug development.

I only wish other areas of biomedical research where there is an unmet need e.g. new and effective treatments for neuro-degenerative diseases such as Alzheimers, offered such hope and focused research activity.

It’s the final day of ASCO 2014 and only the diehards are left (or those who couldn’t get a plane out early).  We hope you’ve enjoyed the “live” blog and our notes from the road each day.

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Today I thought it would be a good idea to answer a question sent in by a premium subscriber.  He asked,

“What’s the deal with TIL and how does that relate to checkpoint inhibitors and PD-L1 expression?”

This is a good question and there were some interesting top-line debates about this at AACR recently, which are well worth discussing and highlighting.

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Today, I’m going to summarise some of my notes on what we learned about lung cancer and immunotherapy at AACR. The burgeoning immuno-oncology topic is way too big to do justice in one single post, so over the next couple of days, you’ll find a mini series evolving here on BSB to cover many of the points relating to checkpoint inhibitors from AACR. It was the first time in 15 years I’ve seen immunotherapy dominate a basic scientific meeting and it was good to see it happen. It is definitely very much the focus – and excitement – of many major cancer centres in the US.

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