Biotech Strategy Blog

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

Posts tagged ‘Amgen’

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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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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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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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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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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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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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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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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In today’s post, we discuss multiple myeloma and the proteasome inhibitors (bortezomib, carfilzomib and ixazomib), in particular. One of the ongoing debates concerns the toxicities and how the drugs in this class might differ. Whereas melphalan and the immunomodulatory drugs or IMiDs (lenalidomide, pomalidomide and thalidomide) have both been associated with secondary primary malignancies including AML and MDS, especially in combination, cardiotoxicity has been the main focus of debate for the proteasome inhibitors.

Is this a fair rap though?

We should remember that people with multiple myeloma typically tend to be around age 70. Think of Tom Brokaw, the famous newscaster, who was recently diagnosed with the condition aged 74 and is in the median age range, for example. In general, most people over 65 tend to have an increased incidence of cardiovascular disease and myeloma patients also tend to have a slightly higher risk due to disease factors, so there is a background effect that needs to be taken into account.

We should be mindful of the recent scare with cardiovascular events associated with ponatinib (Iclusig) in relapsed/refractory CML, which led to a temporary suspension from the US market and subsequent re-instation with a narrower license, appeared to unnerve both the FDA and investors alike.

At the American Society of Hematology (ASH) meeting in Decemeber, there were some interesting posters, presentations and debates on the proteasome inhibitors in myeloma that are worthy of further discussion. In addition, I sought some thought leader opinions and curated some of the interactions on this topic to add some colour commentary.

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As 2013 draws to a close, I though it would be a good time to add one last ASH post before finishing for the year. More to come in the form of the tumour summaries in January.

One of my favourite activities at conferences is finding interesting gems in the poster hall. In New Orleans this year there were not one, but two huge halls! That’s a lot of shoe leather involved in order to browse, chat with investigators or researchers and cover them all.

So what nuggets stood out to me this year?

Companies mentioned: KBIO, Gilead, Incyte, Seattle Genetics, Array, Amgen
Drugs covered: KB004, momelotinib, ruxolitinib, idelalisib, brentuximab (Adcetris), filanesib (ARRY-520), carfilzomib

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