Biotech Strategy Blog

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

Posts tagged ‘Pfizer’

We’re at the time of year where we can cheerfully draw on numerous lessons learned from preclinical research and start applying them to the clinic.

Today’s adventure in the time and space continuum takes us on a brief journey from one solid tumour to potentially several others.

This is an emerging new niche with both small and large players already actively conducting R&D with implications for some interesting future combinations…

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River Walk, San Antonio, Texas

The famous colourful umbrellas on the San Antonio river walk always remind me of cute little hats, which is a rather apt metaphor for today’s post on an emerging new target for breast cancer.

We have seen some success in ER+/HER2-negative breast cancers with the aromatase inhibitors and CDK4/6 inhibitors in first-line treatment of the disease and the SERDs elacestrant and fulvestrant in earlier and later lines, respectively, but there is still plenty of room for improvement.

If we want to seek out new targets to address either resistance or even synthetic lethal relationships, how might we go about finding them?

In our latest post on this niche, we discuss an emerging target of interest, highlight the competitors in the early landscape and also offer some commentary from a couple of the companies involved…

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This post is a consideration of a novel target and the promise, opportunities, and lessons learned from recent translational research as well as early phase clinical trials.

In exploring different modalities – can we expect to see different results?

Several companies have attempted to therapeutically drug this target with an array of agents, including ADCs, antibodies, vaccines, and even CAR-T cell therapy, raising the critical question of whether bispecifics can succeed where ADCs and others have failed?

Where does this target now stand from both a new product development and BD&L perspective?

Like fantasy football, if you have it in your portfolio, should you play it, bench it, waive it or trade it for something else?

In this case study, we’re offering our analysis, commentary, and conclusions…

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For what seems the longest time, we have seen the battle in metastatic clear cell renal cell carcinoma (ccRCC) being focused on various anti-VEGF TKIs, whether against interferon, mTOR inhibitors, and even each other.

Lately, anti-PD(L)1 antibodies have also come on the scene – both as monotherapy and in different combinations – so are things set to change?

Will it be plaining sailing or are there hidden dangers ahead for the unwary?

Here, we take a look at the ever evolving landscape in RCC and explore the issues and challenges surrounding some of the novel combination readouts, including a look at the role immuno-oncology might play going forward.

Not surprisingly, there’s a lot to consider, discuss and think about…

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San Francisco

San Francisco – Yesterday at the ASCO Genitourinary Symposium, Dr Kim Chi noted that emerging data suggests that ctDNA appears to give better picture of tumour mutations than biopsy and can also monitor tumour load. This is an encouraging development that may facilitate increased use of the diagnostic as a helpful biomarker of response in clinical trials with immune checkpoint blockade.

We also know that prostate cancer sits firmly in the middle of the now famous Alexandrov and colleagues tumour mutation burden (TMB) analysis, but what factors are important in our understanding of the underlying biology of the disease?

There are many inhibitory factors exerted on the tumour microenvironment and thase may vary not only by tumour type e.g. renal cell carcinoma may have a greater influence from VEGF than prostate cancer, but also in individual patients.

With this in mind, I wanted to explore some new combination data being presented at the meeting, as well as look aspirationally to some potential combinations currently in development that may have escaped many people’s attention.

In this post, we take a look at current and future implications that keen observers should be watching out for…

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Red Bull Air Race NYC

San Francisco: Today at the 2018 American Society for Clinical Oncology Genitourinary Cancer Symposium, commonly known as ASCO GU (Twitter #GU18), Dr Eric Small (UCSF) will present the results of the SPARTAN phase 3 trial (Link to abstract):

SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).

Despite the fact this is a positive trial and apalutumide will most likely gain regulatory approval for this indication in the United States, the data presented at ASCO GU is not a winner when viewed in the broader context of the prostate cancer landscape.

BSB subscribers can login to understand why, and also gain the perspective of a global thought leader familiar with both the SPARTAN and PROSPER trial data.

On a day when J&J have just announced that abiraterone (in combination with prednisone) provides a new treatment option for patients with metastatic high-risk castration-sensitive prostate cancer based on the results from the randomised phase 3 LATITUDE study, everyone’s attention is focused on the battle between SPARTAN (apalutamide) and PROSPER (enzalutamide) in M0 disease.

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For the last couple of years at every annual meeting of the American Society of Hematology (ASH) conference, I have posted an extensive Preview of the CAR T cell therapy landscape and looked at which abstracts piqued my interest.

The roaring 30s CAR

This year the review is the most extensive to date, with more companies, more research groups, more tumour types and way more preclinical research coming through. It’s like a kaleidoscope of ideas cascading through R&D.

The other thing to take note is how fast the field is moving – it’s warp speed now and so much comes through the literature every month on top of that.

So here we go – hold onto your hats as there is a LOT to contemplate this year!

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As we move from monotherapies to combinations in the immuno-oncology space, we start to see some intriguing ideas being explored from additional checkpoints to vaccines to neoantigens to immune agonists to oncolytic viruses. There are numerous ways to evaluate how to boost or jumpstart more immune cells upfront in the hope of seeing better efficacy.

One way to do this is to better understand the tumour microenvironment.

Wall of people at ASH16 in San Diego

If we know what’s wrong under the hood, we might be better able to make the immune system get going… more gas, faulty starter motor, dead battery, loose wire, broken fan belt? All these things and more might be a problem so you can see that diagnosing the issue up from from basic and translational work might be instructive for clinical trials.

If you don’t know what problem you’re trying to fix or repair then you might as well be throwing mud at the wall. Just as we don’t expect a car mechanic to suggest changing the battery or starter-motor without first diagnosing the issue, so understanding the tumour microenvironment in each different cancer or disease might also be a helpful strategy.

At the recent American Society of Hematology annual meeting (#ASH16), there was a fascinating sceintifc workshop that focused on this very concept – what’s going on under the hood and how do we go about fixing it?

Here we explore these ideas via an interview with a thought leader and specialist in the field. What he had to say was very interesting and candid indeed.

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Some cancer conferences attract more questions and queries than others.

Old Town San Diego

Interestingly, ASH is always a popular meeting for attendees and readers alike, so it is good to see another batch of critical questions come in so soon after the last one. It’s a while since we did two BSB reader Q&A mailbags from a single meeting!

Not surprisingly, there were also a bunch of questions on CAR T cell therapies, which continue to dominate readers minds, as well as related issues. Here, we answer the most pressing questions that have come in over the last week.

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San Diego – after “Flying Friday” where I flew from Munich to San Diego, Biotech Strategy Blog coverage of the 2016 annual meeting of the American Society of Hematology (ASH) is now done for another year.

Downtown San Diego during ASH 2016 With over 27,000 attendees – it’s the largest ASH annual meeting I’ve seen in 20 years of coming here!  ASH is definitely the pre-eminent global meeting for hematology and blood cancers.

As you might expect, the thought leaders at this event are super-busy, but we’ve already managed to catch up with a few, and we’ll be rolling out interviews in the “post-game show.”

Subscribers have been asking what’s really hot at ASH this weekend, so reflecting my interests and the sessions I went to, here are my seven highlights/learnings of ASH 2016 (so far). There’s a lot more data to come!

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