Biotech Strategy Blog

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

Posts tagged ‘New Product Development’

As we kick off a busy new year with plenty of new companies, new themes, new approaches, and new data to think about and synthesise, we decided to reflect, not backwards, but rather forwards in our intentions.

Here we kick off 2022 with a philosophical look at what may be needed if we want to move the chains in a meaningful way.

Think about it – we can just as easily shine the light on a more hopeful future or shutter any aspirational dreams simply by changing the attitude.

Each and every one of us can play a part in this movement – are you one of them?

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There’s always a lot of time and attention focused around phase 3 clinical trial readouts at ASCO, but what about some of the hidden gems where we can learn quite a bit from earlier developments?

This is a two-part series this week where we go off the beaten track on the road less travelled to explore some novel approaches, which may or may not make an impact.

Don’t forget we can often learn as much from negative studies as we do from positive ones because they can teach us what not to do in terms of future design of anti-cancer therapies.

New product development is very much a process of Kaizen, or continuous improvement where we adapt both from what went less well as well as what worked really well.

This year’s ASCO data drop has some important lessons embedded within for those intrigued to dig deeper and pay attention to the finer details…

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What stood out at AACR20?

With every cancer conference ‘attended’ – this includes the ubiquitous virtual meetings these days – I usually ask myself a couple of simple, yet key questions:

  1. Did we see any promising new targets or agents in early development emerge?
  2. Did any one talk or concept stand out from everything else?

Sometimes the answer is an emphatic ‘no!’ to both, sometimes a ‘maybe’ to either, while at other times, one thing clearly stands out head and shoulders from the rest.

At AACR20, one particular development stood out clearly for me as being novel and innovative, as well as encouraging on several fronts, so let’s take a look at what’s different about it and why a KOL we interviewed was quietly excited…

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“Find a bit of beauty in the world today. Share it. If you can’t find it, create it. Some days this may be hard to do. Persevere.”  ~ Lisa B. Adams

In the first part of the review on novel targets in hematologic malignancies, we covered five key areas in detail relating to emerging new agents around BTK, BRD, BET, and E3 ligase modulators (CELMoDs).

Continuing our look at some additional novel targets and agents in early development in hematologic malignancies, in part two of this series we explore four additional areas that piqued our interest.

These mostly involve either small molecules or monoclonal antibodies.

In the next series, we shall look at emerging immunotherapy related targets, but for now there’s plenty of targeted therapies to focus on!

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Is the dragon roaring back?

It’s a while since we last looked at new developments in a rare group of cancers called sarcoma so this is a good time to stake stock and explore the positive and negative trial results, as well as look at some of the emerging targets that are being investigated.

Not all of them will likely pan out given the nature of the disease, but some might turn out to be hidden gems.

We’ve had a few negative trial readouts in sarcomas and plenty of new trials with a variety of agents in early development – is the dragon roaring back or whimpering?

Aside from our top 10 review, we also have a thought leader interview to share with commentary from a sarcoma specialist…

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The lull before the Monday storm hits…

One of the highlights every year at the annual meeting of the American Association for Cancer Research (AACR) for me is catching up on new product development and finding out which molecules are moving along and which have encountered unexpected issues and most importantly, why. Drug development is an inexact science, after all, and sometimes it is more akin to art.

Sometimes you hear of a promising new or very early molecule in these sessions and follow them all the way to the market, while other times they get touted as such and then flame and burn out later.  Some years are also better than others, for obvious reasons.

How did 2018 turn out?  What’s to watch out for this time around?  A couple of years ago we had a dismal session here with the majority of agents clearly destined to the scrapheap and the poor researcher was dutifully performing the office of last rites. This year I’m pleased to say was quite different and there was much to be encouraged by…

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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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The Boston Globe today reported that Blueprint Medicines had received $40M in Series A venture funding.

The VC funding from Third Rock Ventures to the Boston/Cambridge based company is reported to be the largest early-stage funding for a New England life sciences start-up.

Many thanks to @rndubois for his tweets about this that drew it to my attention. You can read more about the financing in Blueprint’s press release.

What makes this exciting news?  First it adds to the growing reputation of Boston/Cambridge as a hot-spot for cancer research.  Blueprint Medicines will be focused on translational medicine and the development of new kinase inhibitors for the treatment of cancer.

Secondly, it confirms what is taught at business school, that investors back management expertise and their belief in the entrepreneurs ability to execute.  In the case of Blueprint Medicines the scientific co-founders are Dr Nicholas Lyndon and Dr Brian Druker, who were instrumental in the development of imatinib (Gleevec/Glivec), a tyrosine kinase inhibitor that revolutionized the treatment of chronic myeloid leukemia (CML).

Blueprint Medicines is a company to watch for the future and Biotech Strategy Blog wishes it well in the quest for personalized medicine and more effective cancer treatments.

The launch of the company in Boston/Cambridge adds to my view that Boston is emerging as the premier biotech region on the East Coast for start-ups interested in oncology and translational medicine.

Today at the European Association of Urology (EAU) annual meeting in Vienna, the big news was that 2010 was a “Grand Cru” year for new treatments for advanced prostate cancer.  Not only that, but sanofi-aventis announced that they had received European marketing approval for cabazitaxel (Jevtana®) in metastatic hormone resistance prostate cancer mHRPC.

The fact that there are now several new treatments available (or expected to be available in the not too distant future) is good news for patients and physicians.

What is interesting about prostate cancer is that it in terms of incidence it is comparable to breast cancer, yet seems to end up with far fewer resources and publicity.  Prostate cancer is to men, what breast cancer is to women.

The EAU 2011 Congress website has a variety of podcasts and webcasts of presentations, and I encourage anyone interested in the latest developments to check out the wealth of information they offer.  In particular, the presentation by Professor Johann De Bono from the Royal Marsden in the high risk prostate cancer plenary session today was one of my highlights of the meeting.

The take home message I obtained from EAU in Vienna is the excitement of new treatment options for castration resistant prostate cancer (CRPC) such as cabazitaxel, sipuleucel-T and abiraterone.  The challenge may well be to work out how best to use these new therapies, ie in what sequence and what potential combinations may evolve in the future.

However, as Professor Bertrand Tombal from Louvain in Belgium declared, 2010 was a Grand Cru for new prostate cancer treatments.  That is good news indeed.

 

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Nanotechnology is set to have a major impact on drug development and new products for the diagnosis and treatment of cancer.  Research from UCSF and Northwestern University published earlier this year in “Science Translational Medicine” shows this potential.

Edward Chow and colleagues describe how binding the cancer chemotherapy doxorubicin (DOX) to carbon nanoparticles 2-8nm in diameter in the form of a diamond, “nanodiamond” (ND), improved drug efficacy and overcame drug resistance.  Although this pre-clinical animal research has not yet been confirmed in humans, it raises the possibility of more efficient chemotherapies and the hope of increased survival rates as a result.

The conclusion from this research is that nanodiamonds may be a viable drug delivery platform for small molecules, proteins and nucleic acids. This technology could have an application in wide range of diseases.

Why is nanoparticle-mediated drug delivery more effective? The paper suggests one reason is that the nanodiamond-doxorubicin complex (NDX) allows for a more gradual release of DOX, allowing for increased tumor retention and increased circulation time.

It’s important to note that the NDX complex does not specifically target the drug efflux pumps, such as MDR1 and ABCG2 transporter proteins, responsible for chemoresistance. Instead the NDX complex appears to overcome drug resistance passively by the way DOX is released from the nanodiamond.

This research shows that taking old drugs and combining them with new drug delivery technology may offer therapeutic benefits.  The authors conclude that this research, “serves as a promising foundation for continued NDX development and potential clinical application.”

If successful in humans, it will translate into new product development and market opportunities for emerging biotechnology and biopharmaceutical companies.

 

ResearchBlogging.orgChow, E., Zhang, X., Chen, M., Lam, R., Robinson, E., Huang, H., Schaffer, D., Osawa, E., Goga, A., & Ho, D. (2011). Nanodiamond Therapeutic Delivery Agents Mediate Enhanced Chemoresistant Tumor Treatment Science Translational Medicine, 3 (73), 73-73 DOI: 10.1126/scitranslmed.3001713

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