Biotech Strategy Blog

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

Posts tagged ‘Novartis’

After some relatively quiet summer months, we have been deluged with questions and requests this month for commentary on some hot topics of late. This seems like a good time to take stock and reflect on some of most frequent ones sent in.

west-acton-tubeThe original Journal Club post slated for today will appear next week instead.

Here, we address numerous queries on the following five topics readers are interested in:

  • APHINITY trial in HER2+ adjuvant breast cancer
  • Array’s BRAF plus MEK data in metastatic melanoma
  • Kite’s interim ZUMA–1 phase 2 announcement
  • Amgen’s Kyprolis in newly diagnosed multiple myeloma
  • BMS nivolumab data in 1L lung cancer (CheckMate-026)

The last two in particular seem to be causing a lot of hand-wringing!

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There was a time when it seemed that all the good news emerging in cancer research was on breast cancer, that is clearly no longer true as other tumour types have seen some leaps and bounds with different modalities, including areas previously thought to be a graveyard for big Pharma, such as metastatic melanoma, for example.

new-dawn-houses-of-parliament

New Dawn at the Houses of Parliament

That said, after the excellent developments in hormone-sensitive disease and the identification of the HER2 oncogene, we now have CDK4/6 as a validated target in metastatic breast cancer.

Pfizer’s palbociclib (Ibrance) lead the way, with two approvals in previously untreated and relapsed ER+ HER2- advanced breast cancer. Two other companies in this field are Novartis with ribociclib and Lilly with abemaciclib. Data is being presented on all three therapies at ESMO this year.

In addition, there are some other abstracts of note that are well worth discussing.

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In our ECCO Preview series last year (note: ESMO and ECCO have alternated the EU major cancer conference in the Fall for years), we highlighted several promising novel agents in development including the following:

  • StemCentRx’s anti-DLL3 inhibitor: rovalpituzumab tesirine (ROVA-T)
  • Ignyta’s Pan Trk, ROS1 and ALK inhibitor: entrectinib
  • Pfizer’s anti-NOTCH3 inhibitor: PF–06650808
  • Pfizer’s PTK7 ADC in TNBC: PF–06647020

What happened to them all? Were they good selections or not?

Well, AbbVie acquired StemCentRx in a $10.2B deal, Ignyta are busy advertising their new clinical trial enrollment for entrectinib as a non-chemotherapy and non-placebo controlled study on social media, suggesting that compound’s clinical development is still very much alive, while both the Pfizer compounds are also still active, as far as I know.

None have yet been consigned to dog drug heaven, which is quite something considering the failure rate in oncology drug pipelines!

Indeed, last year the Pfizer PTK7 ADC data was focused on triple negative breast cancer, where there is a solid rationale. This time around, the same research group explore the latest activity in advanced solid tumours, including ovarian cancer, as mentioned in the earlier Preview (See: 9 key abstracts in Ovarian Cancer).

sallys-barSo it’s time to sit down and chew the fat on one of my favourite topics at conferences – Development Therapeutics.

Here we consider which other compounds – other than the Pfizer ADC – that are worthy of highlighting and watching out for this year?

There are certainly some curious and quite different (i.e. novel) approaches to look at.

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September 1st… as the hot summer floats away from London town and cooler autumn days draw in, it’s time to think about the upcoming fall cancer conference season – it’s quite a busy one this year!

In the coming weeks, I will be rolling out our series on the ESMO 2016 Previews (Twitter #ESMO16) and taking a more in-depth look at various topics of interest. The Copenhagen meeting is later than usual and also more compressed, with numerous sessions now held simultaneously. It used to be that you could take a break between key sessions, but not any more – there’s a lot going on this year.

View of Thames BarrierOne of the things that jumped out to me from a preliminary review of this year’s hectic ESMO program is an interesting novel target that had some early preclinical data at AACR, but that sadly got lost in the tsunami of data there.

It is good to have that reminder and be able to return to it in the context of broader data because overcoming barriers to drug resistance with targeted therapies is still an important issue that is worth researching.

You likely won’t see it in many analyst reports or previews, however, although it’s a hidden gem of great interest and well worth exploring in terms of what we know so far. This means that readers will be both prepared and intrigued – don’t be surprised to hear about some BD&L deals in this niche in the future.

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The race to the be first to market in the United States with a CD19 directed CAR-T cell therapy is a bit like the America’s Cup Challenge Race Series – one boat/company is ahead and then another is ahead, it’s an ever changing and fluid situation…

Americas Cup Portsmouth

In this post, we’re looking at questions from subscribers – so what’s in the July BSB mailbag?

* CAR T Cell Therapy: Is the recent FDA hold – that came and went in record time, a setback to Juno? Who will win the CAR-T race to market in the United States? What is the market opportunity in Europe?
* Jounce/Celgene Deal: Celgene have a reputation for doing deals with innovative biotech companies, but then what? Is the Jounce deal a good one, or is it a value destroyer?

There are a few other questions in the mail bag, but the above gives you a flavour of some of the commentary in this post.

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No CyclingLate this afternoon, Juno Therapeutics ($JUNO) announced (link to press release) that the FDA had put a clinical hold on enrollment into a phase 2 trial of their JCAR015 construct in relapsed refractory acute lymphoblastic leukaemia (ALL) in adults in the ROCKET Trial: NCT02535364.

The decision by the FDA was as a result of three recent patient deaths reported to be due to neurotoxicity. In after-hours trading the stock dropped 30% from a market close of $40.82, reaching an after hours low at time of writing of $26.66 at 4.43pm ET.

In this post we look at what happened, the possible reasons behind it, and what it may mean for other CAR T companies. A leading CAR-T cell expert also provided BSB with some commentary after the news broke.

Good News: Post now updated following FDA lifting hold on ROCKET trial.

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This morning, like many folks, I woke up to the latest immuno-oncology news on the bispecific front that Xencor, a Los Angeles based biotech, announced their latest collaboration, this time with Novartis.

Over the last few years, we have seen a surfeit of bispecifics emerge that are focused on stimulating the immune system, particularly with regard to T cells and natural killer (NK) cells, as well as antigen targets on the surface of tumours. The first one approved was Amgen’s blinatumomab (Blincyto), a CD19 targeted bispecific for the treatment of acute lymphoblastic leukemia (ALL), which we have written extensively about.

Xencor logoThe Xencor/Novartis deal has a number of interesting implications that are well worth exploring in more depth that go far beyond the information provided in the press release.

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After a long lull on the targeted therapies front – outside of EGFR T790M in lung cancer – this year’s ASCO has plenty to be cheerful about with new data across multiple tumour types.  We can’t cover them all here, but more will be discussed in the Daily Live Blogs starting on Saturday.

Which drugs are going to be in roaring back after a quiet period?  Which ones will be having a more muted meeting?

ASCO16 Chicago 4For those of you who are working in the targeting therapy world, take heart, there is a future beyond cancer immunotherapy; it is not the universal panacea and will likely not cure every cancer, at least for now.

There’s still a market opportunity for targeted therapies in cancer, and as we mentioned in yesterday’s ASCO Preview, there is also potential for the combination of targeted therapies with immunotherapies, so long as the combined toxicity is manageable and doesn’t outweigh the benefits.

In this post we’re looking at a selection of targeted therapies in a variety of tumour types. There’s a lot to choose from at ASCO this year.

Here’s a few we think are worth highlighting upfront.

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Aduro Biotech LogoWe’re almost at the end of our coverage of AACR 2016. Post number 30 (!!) is on Aduro Biotech ($ADRO) and their STING (Stimulator of interferon genes) agonist currently in development.

On the final day of AACR, in a packed session chaired by Tom Gajewski, MD PhD (Chicago), the meeting heard from Tom W. Dubensky, Jr, PhD Chief Scientific Officer of Aduro Biotech in a presentation (SY39-02) entitled:

“Direct activation of STING in the tumor microenvironment leads to potent and systemic tumor regression and immunity.”

Dr Tom Dubensky Aduro CSO

Dr Tom Dubensky, Aduro CSO

I spoke with Dr Dubensky (pictured) afterwards. In my interview recording you can hear Vice President Biden’s cavalcade arrive at the Ernest Morial convention center in New Orleans for his plenary presentation.

Since AACR 2016, Aduro announced that the first patient has been dosed with ADU-S100 (MIW815) in a May 12 press release.  This triggered a $35M milestone payment from Novartis, who are undertaking the clinical trial (NCT02675439).

In March 2015, Aduro entered a collaboration with Novartis that, according to the Aduro press release, led to an initial payment of $200M and an additional $50M in equity investment.

After the recent failure of their pancreatic cancer vaccine, announced in a May 16 press release, there is a lot riding on ADU-S100 for both Aduro and Novartis.

I had the privilege to interview Dr Gajewski last year at Immunity 2015, where we talked about his work on STING (see post: Tom Gajewski takes the STING out of cancer). You can hear a short excerpt from the interview on Episode 2 of the Novel Targets Podcast.

So a year later it’s a good time to return to the STING pathway and take a fresh look at what Aduro/Novartis are doing.

For this post, I’ve chosen to write this up as a SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis of ADU-S100 based on what I learnt at AACR from talking with Dr Dubensky and other experts.

Your SWOT analysis of ADU-S100 may be different from mine, you may have access to other sources of information, an alternative opinion, or reach an entirely different conclusion. There is no right or wrong answer. We all view the world through our own individual bias and lens.

Before you read this post, I heartily encourage you to map out on the “back of an envelope” – or as I’d say in England, on the “back of a fag packet” – what your SWOT analysis looks like. That way you can compare yours to mine.

By definition, we’re dealing with a new product in early clinical development, where many questions remain unanswered. It’s always easier to see the picture after all the cards have been dealt……

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If you had told me several weeks ago that we would write over 28 posts on #AACR16 and become very interested in mouse models, then most likely I would have laughed out loud and told you not to be so ridiculous!  Here we are with the 29th one and, another, on the bromododomain landscape yet to go.  Such was the vast richness of data and concepts being discussed or presented in New Orleans for those who chose to look.

Today, I want to start the segue from AACR to ASCO coverage.

Nawlins MGRAS FIOne way to do that is through the second part of the Gems from the Post Hall series. This latest one looks at a range of intriguing new targeted therapies and novel targets that are emerging, including a pharma company with a particularly interesting early pipeline.

Several pharma companies presented interesting data on their very early compounds currently in development, plus I noticed a trend for a new class of targeted therapies to emerge, MNK inhibitors, which we will also discuss.

Companies mentioned: Bayer, Orion Pharma, Lilly, Novartis, Pfizer, Agios.

Targets mentioned: PI3K, CDK, Akt, TWEAK, FGFR, BUB1, IDH1, SMYD2, MNK

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