Biotech Strategy Blog

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

Posts tagged ‘Pharma CI’

Things we need to think about ahead of ASCO17

We are finally at the end of our AACR 2017 post meeting analysis and coverage with the final interview from Washington DC on deck. Timely wise, it’s actually quite a relevant one given the news last week on mixed results with clinical trials involving checkpoint blockade.

Dr Jeff Engelman AACR17

Just as we learned that immunotherapy agents can stop working over time, as well as the majority of patients don’t respond at all to begin with, there are concerted research efforts ongoing by both academia and industry to explore mechanisms of immune escape, resistance and modulating the tumour microenvironment.

Here we explore the intersection of targeted therapy-IO combinations, resistance and immune escape, transcription factors and other interesting new areas of development.

Also included is commentary from a leading KOL, which is NOT available on the recent Novel Targets podcast episode on overcoming immunotherapy resistance – readers should check that out first before reading this article, as this is more advanced.

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Can AstraZeneca leapfrog the competition in lung cancer AGAIN?

Until recently, we followed the race to market in EGFR T790M lung cancer with Clovis’s rociletinib and AstraZeneca’s osimertinib (Tagrisso).  In phase 2, AstraZeneca caused quite a stir when they came from behind and leapfrogged their biotech rival with a large global randomized controlled trial seemingly out of nowhere.  They never looked back.

Can they do the same thing with durvalumab (Imfinzi), one of their IO therapies that targets PD-L1?

If there’s one thing that many astute observers of the IO space have learned this week it’s that irrational exuberance and the hopeful sentiment that ‘everything’ will just tweak the immune system and work positively no matter what has thankfully come to an end.

We’ve seen several highs and lows already with Merck’s pembrolizumab gaining accelerated approval in 1L NSCLC in allcomers when combined with chemotherapy and AstraZeneca reporting positive phase 3 data for durvalumab in unresectable (stage 3) NSCLC based on meeting the study endpoint (PFS).

There is much to be learned because the nivolumab disaster in 1L NSCLC last year was not a singular aberration given that durvalumab has seen some missteps in the past and even atezolizumab had some unexpected news with urothelial cancer this week (Check out our insights), as compared to chemo in the second line setting. Just like mutations, there will be many more to come, perhaps even some additional ones before the year is out.

What about today’s news from AstraZeneca in unresectable NSCLC?

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On Kite’s cerebral edema and Genentech’s IMvigor211 miss

We’re overdue a roundup and discussion on various key topics of interest to BSB readers, so here goes…

Today’s topics include an in-depth look at the impact of some negative events:

  • Kite and the cerebral oedema death with axi-cel
  • Genentech’s atezolizumab OS miss in urothelial cancer

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Going Beyond PARP in DNA Damage Repair

We now turn our sights to targeted therapies and DNA Damage Repair (DDR). This is an important topic that has seen much focus in ovarian cancer of late and will likely see renewed interest in breast cancer at the forthcoming ASCO meeting next month. As we segue from one set of conference coverage to the next, there is inevitably going to be overlap, which is a good thing here as it helps with background and preparation in getting up to speed.

There is no doubt that DDR has had a bit of chequered history over the last decade, whether it be the spectacular (and sadly predictable) flop of Sanofi’s iniparib in triple negative breast cancer (TNBC), the negative ODAC incurred by AstraZeneca’s olaparib in ovarian cancer, or AbbVie’s more recent veliparib failures, to the much more positive events such as three PARP drugs now approved in different lines of therapy in ovarian cancer (olaparib, rucaparib and niraparib).

If ever there was a niche for the roller coaster ride that is oncology R&D, it has to be PARP inhibitors.  There’s much more to DDR than just PARP though.

Indeed, there are multiple intriguing targets to explore and also the potential for combinations with cancer immunotherapy approaches that may yield encouraging results in the future.

Can we go beyond ovarian cancer into other tumour types and if so, which ones look encouraging and how woluld we go about exploring those idesa? What makes one approach more successful than another?

Here we explore the world of DDR through the lens one company’s approach and look at what they’ve done, where are they now and where they hope to be. It certainly makes for an intriguing and candid fireside chat.

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On Gritstone and neoantigens

Gritstone Oncology hit the ground running with a $102M Series A financing round back in October 2015. Any company that raises that amount of initial funding is on the radar as a company to watch, especially one in the cancer immunotherapy space.

Since the AACR meeting in DC, Gritstone have also hired Genentech’s Dr Raphael Rousseau as CMO (Link) and appear to be an exciting young company going places.

As attention on neoantigens increases, what is Gritstone’s strategy and where could they fit into the cancer immunotherapy landcaspe?

At AACR17 in DC last month, Dr Andrew Allen, President and CEO of Gritstone Oncology kindly spoke to BSB about his vision for the company.

This post is part of expert interview series (Link) and also forms part of our ongoing series on neonatigen based immuno-oncology.

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Do Exosomes Matter?

At AACR17 one of the fascinating topics that came up in several presentations was exosomes, what they are, and how the information they contain can be used to best effect.

One of the evangelists of exosomes, and their potential in cancer research is Theresa Whiteside, PhD who is a Professor of Pathology, Immunology and Otolaryngology at the University of Pittsburgh.

At the recent 2017 American Association for Cancer Research (AACR) annual meeting, Dr Whiteside gave two fascinating talks in education symposia.  Afterwards, she kindly spoke to BSB about her research.

Love them or hate them, exosomes were a hot topic in Washington DC and something you should be aware of, if you aren’t already.

This post continues our volley of expert interviews from AACR17 and is the ninth in the series.

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How do we get cancer immunotherapy to work in Prostate Cancer?

Dr James Gulley is Chief of the Genito-Urinary malignancies branch and Director of the Medical Oncology service at the National Cancer Institute (NCI) in the National Institutes of Health. He’s a world-leading GU cancer expert and at the forefront of pioneering research to make cancer immunotherapy work in prostate cancer.

We last spoke to him at ASCO 2015 (See post: The future of prostate cancer immunotherapy).

Almost two years on, and new research by Dr Gulley and colleagues from the NCI shows that the STING pathway may have an important role to play in prostate cancer immunotherapy. Activation of this pathway through a novel mechanism could turn a cold non-inflamed tumor into a more inflamed or hotter one in men with advanced prostate cancer. How cool is that?!

At the 2017 annual meeting of the American Association for Cancer Research (AACR) that was recently held in Washington DC, Dr Gulley graciously spoke to BSB about some of the novel trials that are underway at the NCI, with the aim of making cancer immunotherapy work in men with advanced prostate cancer.

Dr Jim Gulley, NCI at AACR17

This is the seventh expert interviews in our series from AACR17 where we explore the conundrum:

How does Dr Gulley plan to light the immune camp fire in prostate cancer?

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BSB Mailbag on ROS1, ALK and TRK inhibitors

After yesterday’s popular update on Ignyta where we posted our recent interview with the CEO, Dr Jonathan Lim prior to the 2Q conference call, a flood of questions have come in from eager beaver BSB readers.

Rather than add to an already lengthy article, this seemed a good opportunity to start afresh and do our latest Reader Q&A mailbag on a specific topic, namely the TRK/ROS1/ALK space.

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Can Jonathan Lim ignite the TRK oncology space?

Tropomyosin receptor kinase (TRK) inhibitors are not a name that rolls off the tongue easily and yet this niche is attracting a lot of interest from observers curious to learn more about a highly targeted approach to rare oncogenes such as TRK, ROS1 and ALK that occur in several different tumour types.

Much of the focus has been on the more commonly expressed ALK-positive lung cancers with crizotinib, ceritinib, alectinib, brigatinib, lorlatinib and others. Crizotinib also targets ROS1 and is approved by the FDA in metastatic NSCLC whose tumors are ROS1-positive.

As the next part of the development in this sphere, TRK and ROS1 mutations are now in the spotlight. Indeed, we have been reporting on the data since 2014, which has been encouraging thus far, particularly from two companies, namely Ignyta and Loxo Oncology.  These two agents differ in that entrectinib targets TRK/ROS1/ALK whereas larotrectinib is a specific pan TRK inhibitor.

There was a new raft of data at the recent AACR annual meeting and more data is expected at the forthcoming ASCO conference.

Here, we take a look under the hood through the lens of one of the small biotechs in this space via a candid interview with Ignyta CEO, Dr Jonathan Lim.

Dr Jonathan Lim, CEO Ignyta

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Can AZN take immuno-oncology to the next level?

Over the years we’ve interviewed folks from numerous pharma and biotech companies here on BSB, including those with targeted therapies (small and large), as well as immunotherapies.

Some companies have small pipelines and may be forced by circumstances to explore what they have or seek collaborations with bigger partners.

For big pharmas with large pockets plus broad and deeper pipelines, the challenge is quite different – how do you prioritise potential combinations and tumour targets given it is impossible to evaluate them all in the clinic? How do you create differential advantage and value when you’re relatively later to market compared to your competitors?

In the BSB spotlight this week we have two researchers in clinical development and R&D from the same company, who happen to have both elements in their pipeline in areas of high competition.

Part one of our latest mini-series explores the IO side of the business as we look ‘Through the Keyhole’ at what’s going on in terms of biomarkers, monotherapy trials, combination studies (both IO-IO and IO-targeted) and what to expect in the near-term future later this year. It’s a wide ranging, candid, and fascinating discussion that highlights a lot of potential in terms of what could happen with a large pipeline.

In all, it makes for rather interesting reading and certainly changed how I perceived the company’s efforts in the IO sphere (for the better, I might add).  So what’s fascinating about their approach and what can we learn from their progress to date?

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