Biotech Strategy Blog

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

Posts tagged ‘Amgen’

How do we improve on 1st Generation T cell bispecifics?

Continuing our up and coming biotech series, we now switch our focus from small molecules to immuno-oncology.

While big Pharma has garnered the lion’s share of attention (and revenues) from checkpoint inhibitors and CAR-T cell therapies, if we want to make a serious impact on solid tumours, especially the colder ones, then we are going to need to devise ways of jumpstarting the immune system where there are far fewer immune cells around to help do this.

There are many ways to achieve this aim, although the count is still out on how best to optimise combinations.

We’ve looked at various approaches over the last couple of years including chemotherapy, immune agonists, cytokines, STING/PARP/TLRs, NK cell checkpoints, T and NK cell bispecifics, and many many more.

Fortunately, most small biotechs have been focused on alternative targets that mght be seen as complementary to existing established therapeutics.

As we move forward towards a more regimen-based approach some of these will succeed while many will not, such are the challenges of oncology R&D where 90% of compounds unfortunately fail.

One challenge that has long been obvious though is that once clinical proof of concept has been established, another 10 companies will wade in quickly and dust down old molecules lurking in screening libraries that have been languishing in darkness waiting for their call-up. In the old days, a lead time of 5+ years before a competitor caught up with a rival drug was not uncommon.

Increasingly, it now seems there are mere months rather than years between approvals in the same class, an astonishing feat in a highly competitive and cut-throat business driven by generic erosion, noticeable pipeline gaps and the urgent need for continued topline sales growth.

In today’s hot seat, we have a small biotech CEO discussing his company’s IO pipeline and progress…. they caught my attention at AACR last year and I’m delighted to have the opportunity to learn more about what they are doing and how they are different from the existing competition.

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JPM19 Highlights from Day 2

San Francisco

While much of the focus has been on the mergers and acquisitions at this year’s JP Morgan Healthcare conference, seeing what a few companies have up their sleeves is also intriguing.

In today’s round up we address reader Q&A as well as highlight some presentations and announcements of interest in the cancer research space.

2019 is going to turn out to be a rather critical year for some companies…

If you missed the first day’s highlights and lowlights – check them out here!

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5 key abstracts to consider from ASCO 2017

As we all wearily trawl through the huge mountain of data for ASCO 2017, what stands out – and more importantly – what matters and why?

Before we get into our in-depth coverage based on the tumour type, target and modality landscapes, I wanted to take a moment to highlight five key abstracts that stood out for me as worthy of checking out in more detail once we get to Chicago.

Interestingly, only one of them is from big Pharma!

At least one had some negatives associated with it as we’re not all happy clappy everything is great enthusiasts here at BSB.  We do try to be fair minded and objective as possible about data.

So what’s in store and why do these five matter?

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September BSB Reader Mailbag

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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Can PsiOxus become a world leading immuno-oncolytic virus company?

To be successful as a cancer immunotherapy company, you not only have to be science driven (that’s a given) and offer an approach that could make a difference, you also need a vision and the ability to execute ahead of competitors in a fast moving and competitive landscape.

Dr John Beadle

Dr John Beadle

We’re continuing our series on emerging cancer immunotherapy companies with an in-depth look at PsiOxus, and the vision of CEO Dr John Beadle (pictured right) for it to be a world-leading immuno-oncolytic virus company.

PsiOxus is based just outside of Oxford – it’s part of the so-called “golden triangle,” the area between London, Oxford and Cambridge in the South of England that is a driver of UK science and innovation.

The company is located in a nondescript business park 45 minutes by train from Paddington to Didcot Parkway, followed by a taxi or bus ride. You have to want to make the trip from London!

Dr Beadle kindly spoke to BSB about the competitive advantage the PsiOxus oncolytic virus platform offers, their path-to-market strategy and how he sees the company developing in the future.

With clinical data due in 2017, PsiOxus is a cancer immunotherapy company to watch out for.

Part 1 of the interview focuses on the scientific platform and cancer new products in development that are driving the company forward.

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Beyond T-VEC – a look at oncolytic viral immunotherapy

Thankfully, the dog days of summer means that the Pharmaland conference season takes a much needed break and the intense news cycle tends to calm down somewhat (well a little, depending on your perspective). This gives us some breathing space to conduct and write up some CEO interviews, as well as publish in-depth thought pieces and op-eds on up and coming areas of interest in the broader cancer research field.

In last week’s surprisingly popular mini-series on neoantigens, we explored the concept in a three-part series comprising a primer on the topic, plus helpful insights from a thought leader in the field and a CEO/investor at an example company.

Dawlish High Speed Train

Here we explore the broader landscape beyond T-VEC through a primer, plus a fascinating two-part interview with a CEO in this space.

To begin with, we start off with a primer to get BSB readers on the same page.

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Beyond Blinatumomab – Update on Bispecific T cell Engagers

Washington DC Cherry Blossoms

Spring cherry blossoms

It’s twelve working days until the start of the annual meeting of the American Association for Cancer Research (AACR) in New Orleans. This is a meeting we’re especially looking forward to this year, not only for the cool science on offer, but also the Louisiana Coastal Cuisine!

Next year, AACR 2017 returns to Washington DC, at what hopefully will be a perfect time for cherry blossoms along the Tidal Basin.

In this post, I’ve taken a closer look at one cancer immunotherapy approach with new data at AACR – bispecific T cell engagers.  Amgen’s blinatumomab (Blincyto) is interesting because it was the first T cell engager antibody to be approved by the FDA for the treatment of Philadelphia-negative ALL and refractory B-cell precursor ALL, thereby offering proof of concept that such an approach could be safe and effective. There are, however, some challenges associated with it (which you’ll read about).

Can we improve on blinatumomab?

This post will address the question in three parts:

  • A look at what we know about blinatumomab to date
  • Where the competitive landscape is evolving with potential solutions
  • An interview with a scientist actively working in this field for their perspective.

For those attending AACR, I’ve put in links to some of the sessions and presentations to watch out for if you have an interest in bispecifics (there are a surprising number of them in R&D) – we’ll be writing more about some of the noteworthy data after it has been presented.

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Highlights of #JPM16 Healthcare Conference Day 2

San Francisco JPM16 Day 2It’s Tuesday at the 2016 JP Morgan Healthcare conference in San Francisco (Twitter #JPM16).

Each day of #JPM16 we’re doing a rolling blog post which we’re updating throughout the day with commentary and insights on the company presentations we’re covering.

While we’re not giving a blow-by-blow account, many companies have the slides readily available, we will be commenting on noteworthy news, and what we learn about corporate strategy going into 2016.

For those of you who like to catch up with the final summary of each day’s highlights, you can read yesterday’s Day 1 synopsis here and our interview with Seattle Genetics CEO, Clay Siegall here.

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Oncolytic viruses – are they ready for prime time?

William Coley first used live bacteria as an immune stimulant to treat cancer way back in 1893. Since then, however, progress with innate immunotherapy has been surprisingly very slow.

English Roses

Queen Mary Rose Garden, Regents Park, Summer 2015

Indeed, to date only one therapeutic cancer vaccine has actually been approved by the FDA (Sipuleucel-T, Provenge, Dendreon), one oncolytic virus was approved in China back in 2006 (H101, a direct derivative of the E1B55k-deleted Onyx-015 that had modest activity at best) and another could soon be approved by the FDA later this year (T-VEC, Amgen).

In today’s review, we take a look at the oncolytic viral space and explore the issues, challenges and companies involved. Is this all set to be a bed of roses, or is a thorny future predicted?

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Carfilzomib fails in refractory myeloma FOCUS trial

The big news yesterday evening was that Amgen’s phase III FOCUS trial in relapsed/refractory multiple myeloma failed to meet its primary endpoint of overall survival (HR=0.975).

Kyprolis logoSuch a marginal hazard ratio (HR) tells us that the risk of death was not reduced by taking carfilzomib over best supportive care.

According to the company:

“The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry.”

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Recall the PANORAMA-1 trial for panobinostat with Velcade plus dex versus Velcade + dec alone was presented at ASCO and achieved positive PFS and OS. The patients in this study were refractory to 1-4 or 1-3 lines of prior therapy respectively, with nearly half (48.4%) receiving ≥ 2 prior therapeutic regimens. To put this in context, this was a much less heavily pretreated/refractory group overall than the FOCUS trial in comparison.

At ASCO, opinions from experts I spoke to regarding the likelihood of a successful result from FOCUS were evenly divided, while ASPIRE was widely expected to succeed. As one well respected European thought leader – who erred on the side of caution – pointed out to me:

“Low dose dex (with or without cyclophosphamide) is an active, but fairly low hurdle to beat, even for salvage therapy. In this situation, you do need a gentle, well tolerated regimen to stand a chance of a successful outcome. Carfilzomib is neither of those things, so no, I won’t be at all surprised if it fails.”

Add this latest finding to the results from the ASPIRE study last week, where the PFS was met and OS was not yet mature, makes for a very tricky time for Amgen should they wish to seek EU approval and reimbursement. It is likely that a solid positive result for OS from the ASPIRE study may well be necessary now for EU success.  If a therapy or regimen does not convincingly improve patient outcome, then it is unlikely to obtain reimbursement in Europe given the current economic environment.

The ASPIRE data alone may possibly be enough for confirmatory approval of carfilzomib in relapsed/refractory myeloma in the US because it was conducted under an SPA, but this is not a guarantee of success given other uncertainties surrounding the carfilzomib data and the secondary endpoint (OS).

What about adverse events?

Recall that with the ASPIRE data, the rate of cardiac events observed in the carfilzomib arm were consistent with the current label approved by FDA. Discussion on the rate of cardiac events have dogged the drug since accelerated approval by the FDA and the black box warning that accompanied the label.

However, in the FOCUS study an increase in the incidence of renal adverse events of all grades was observed in the carfilzomib arm compared to both the active control arm AND the label.

This is a new finding and of particular concern because myeloma patients do tend to experience more severe renal impairment with worsening disease, thus any therapy that hastens or worsens that situation is clearly not a good thing.

Overall

One thing is very clear from these recent data announcements – the mature ASPIRE data is now going to be very keenly watched at ASH this year. The Kaplan-Meier curves could well make or break the chances for Kyprolis in Europe and a miss on OS could possibly jeopardize the US confirmation, if the curves cross-over or do not have a compelling readout.

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