Biotech Strategy Blog

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

Two of the most intriguing developments in cancer research over the last 5 years have been checkpoint blockade and CAR T cell therapies. There’s no doubt that they work – in some patients – or that toxicities can be challenging to manage at times, but what has been very interesting to me has been physician reactions to the rise of immunotherapies.

There has been much noise about biomarkers, including whether they work or not in this niche, as well as how do we go about selecting patients for therapies and combinations?

Ultimately, immunotherapies will be no different from targeted therapies in that we need to better understand the underlying biology in order to move forward beyond the low hanging fruit and figure out how we can best select appropriate therapy for each individual based on their particular characteristics.

The worry that many researchers have is that we could end up making the same mistakes with immunotherapies as targeted therapies, i.e. treat them in a broad fashion akin to throwing mud at the wall. Indeed, some companies are already doing this, much to the consternation of the research community.

So how do we go about doing things better and thinking more strategically about what needs to be done?

Up next is the first in a two-part interview series with a global thought leader who is a scientist-clinician with expertise in both immunology and oncogenic pathways. What does he have to say about where we are now and importantly, what does the future hold?

This is the penultimate article in our coverage from the Triple meeting in Munich, held in November 2016.

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At the recent 2016 San Antonio Breast Cancer Symposium (SABCS16), Cascadian Therapeutics (NASDAQ: CASC) presented a poster (Abstract #P4–21–01) on:

“Efficacy Results of a Phase 1b Study of Tucatinib (ONT–380), an Oral HER2-Specific Inhibitor, in Combination With Capecitabine and Trastuzumab in HER2+ Metastatic Breast Cancer, Including Patients with Brain Metastases.”

Tucatinib is an oral tyrosine kinase inhibitor that is highly selective for HER2.

Cascadian’s tucatinib poster at #SABCS16

We’ve seen several new treatments approved for HER2 positive breast cancers in recent years including four targeted treatments: trastuzumab, pertuzumab, lapatinib and T-DM1.

Other companies such as Puma Biotech (NASDAQ: PBYI) also have oral TKIs in development. Puma’s drug, neratinib has, however been shown to have a high incidence of grade 3+ diarrhea, raising questions about its tolerance.

At SABCS16 (Abstract P02–11–03), the company presented the interim analysis of an open-label, multicenter phase 2 trial, which explored their compound:

“Incidence and severity of diarrhea with neratinib + intensive loperamide prophylaxis in patients (pts) with HER2+ early-stage breast cancer (EBC).”

There has been a lot of interest and controversy in this space, so it’s time to take a look at the latest events in HER2+ breast cancer and consider the ramifications since there are a number of new developments that are well worth following, including neratinib (Puma Biotech) and pertuzumab (Genentech).

This is our final expert interview from SABCS – if you missed it you can catch up with the rest of the conference coverage and thought leader sentiments here.

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San Francisco: In the final post of the week, it’s time to focus on some of the interesting concepts and early ideas being explored in GI tumours such as pancreatic and colorectal carcinomas.

Gems from the Poster Hall or what Dog Drug Heaven really looks like?

Despite the image implied by the used poster bins (right), there were actually several encouraging signs from emerging IO approaches as well as some surprising results that lead to some compounds – or at least some indications – going off to dog drug heaven.

There were also some salutory lessons to be learned in terms of understanding biomarkers and useful these can be.

After years of incremental improvements with targeted therapies, it’s time to look at whether some immunotherapy combinations can make an impact in what is known as cold tumours.

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San Francisco: ASCO Gastrointestinal symposium 2017 – Update on metastatic colorectal cancer

It might surprise quite a few people that colorectal cancer (CRC) is the third most commonly diagnosed cancer globally, especially in the western hemisphere where hereditary, dietary and lifestyle factors can be important.

The bedrock of therapeutic approaches in this disease have largely centred around chemotherapy (FOLFOX or FOLFIRI) along with targeted therapies against EGFR (cetuximab, panitumumab) or VEGF (bevacizumab, ziv-aflibercept, regorafenib etc).

In our second report from #GI17, we take a look at some of the emerging monotherapy and combination approaches that are showing early signs of moving the needle in advanced CRC, an area that has been relatively dormant of late.  This is partly because it’s a cold tumour and with the focus on cancer immunotherapies, it’s not the first tumour type that companies will necessarily rush to evaluate.

Things are changing though, even in colorectal cancer so it’s time to look at some key studies that may teach us more about this disease.

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San Francisco: A look at what’s new in gastric cancer (GC) from the 2017 ASCO GI meeting.

Day 1 of #GI17 is filling up…

There were several phase 3 trials presented in GC and gastro-esophageal junction (GEJ) carcinoma in both targeted therapies and immunotherapies this past weekend.

  • When we look carefully at the latest data, what do we find?
  • Where are the opportunities and challenges in this niche?

Another critical question that many observers will be interested in is…

Will BMS’s checkpoint inhibitor, nivolumab (Opdivo), overcome recent setbacks in lung cancer and make a mark in stomach cancer to challenge approved targeted therapies such as ramucirumab (Cyramza)?

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The most common cause of breast cancer death is when metastatic ER+ tumors develop resistance to treatment.  There remains an huge unmet medical need for new effective treatment options.

One translational clinical researcher leading the way in understanding the molecular and genomic landscape in ER+ metastatic breast cancer is Nikhil Wagle, MD (@Nikhilwagle), Deputy Director, Center for Cancer Precision Medicine at the Dana-Farber Cancer Institute (DFCI).

He’s shown the power of partnering with patients via social media to speed research, with over 3,000 men and women joining the Metastatic Breast Cancer Project that launched in October 2015.

At the 2016 San Antonio Breast Cancer Symposium, Dr Wagle kindly spoke to BSB about the genomics research that he and colleagues are undertaking, and what this may mean for how metastatic breast cancer is treated:

  • What if you could help accelerate clinical trial enrollment via a network of educated and empowered patients?
  • What if you could access real world data to help learn about exceptional responders?

For those of you in Pharmaland, here’s one approach that should captivate the imagination of what’s possible.

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Dr Max Wicha is the 2016 recipient of the AACR Distinguished Lectureship in Breast Cancer Research. At the 2016 San Antonio Breast Cancer Symposium (SABCS16) he gave his award lecture, “Targeting Breast Cancer Stem Cells: Challenges and Opportunities.”

SABC16 Dr Max Wicha Award Lecture

As the AACR press release notes, “This lectureship recognizes an outstanding scientist whose work has inspired or has the potential to inspire new perspectives on the etiology, diagnosis, treatment or prevention of breast cancer.”

Dr Wicha is a pioneer in the field of cancer stem cells, and is Director Emeritus of the University of Michigan Comprenhensive Cancer Center and a co-founder of OncoMed Pharmaceuticals (NASDAQ: OMED).

Targeting cancer stem cells is an area I expect we will hear a lot more about, particularly in breast cancer. Dr Wicha kindly spoke to BSB after his award lecture, which was one of my highlights of SABCS16.

In case you missed it, do check out the post from the 2016 EORTC-NCI-AACR Molecular Targets Symposium in Munich that featured Dr Mina Bisell (Berkeley), who was a previous recipient of the AACR Distinguished Lectureship in Breast Cancer Research award in 2012 (Link.)

This is the fifth in our series of expert interviews from the 2016 San Antonio Breast Cancer Symposium.

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Challenges and Opportunities in the evolving 1L NSCLC Landscape

Rolling English Landscape in Devon

Following a series of events – from BMS’s failure with nivolumab monotherapy… to Merck’s sudden announcement to file their combination of pembrolizumab plus chemotherapy… to AstraZeneca’s delay of the MYSTIC trial exploring durvalumab plus tremelimumab this week, there’s never a dull moment in lung cancer!

So can we expect some more surprises in store in 1L NSCLC?

I say yes we can!  

The big questions are what are they and what impact will they have?

2017 is ironically, the year of the Rooster – so who’s going to crow loudly at dawn and who is going to get strangled in the process?

In the world of cancer research it is unlikely that everything wins or is successful, so figuring out the early signs and hints is an important part of the process.

One thing I learned early in this business is that it pays for companies to be humble, flexible and open minded rather than arrogant and dogmatic in their thinking… otherwise you can easily be blindsided.

There were a few examples of that in oncology R&D last year, a repeat could very well follow in 2017 for the unwary.

Here we look at 1L NSCLC in the context of multiple phase 3 trials that are slated to read out… from AstraZeneca, BMS, Merck and Genentech.

If you want to know what the potential impact of these events are on the landscape, including what we can expect from MYSTIC, CheckMate-227 and several others, then this is the post for you because some surprises are likely in store.

We cut through the chase to explain the what and the why in clear simple language.

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At the 2016 San Antonio Breast Cancer Symposium (SABCS16), I had the great pleasure to talk with a leading inflammatory breast cancer expert and translational researcher, Naoto T. Ueno MD PhD.

Dr Naoto Ueno at SABCS16

Dr Ueno is Executive Director of the Morgan Welch Inflammatory Breast Cancer Research Program and Clinic at the University of Texas MD Anderson Cancer Center.

He’s active on Twitter where, as @teamoncology, he shares information on the latest developments in breast cancer, often writing in Japanese for his followers.

A cancer survivor himself, he also brings an empathy to patient care through his own treatment experience.

Anyone who follows him on Twitter, will also know he is a “foodie.”  Prior to our chat, I joked he should write the definitive guide to San Antonio restaurants for attendees… he definitely ate better than I did at the meeting!

MD Anderson also has an IBC conference coming up next month for those interested in the area:

What caught my attention at SABCS16 were posters from MD Anderson researchers that offered insight into the challenges and opportunities in targeting this rare form of breast cancer, something we don’t hear a lot about.

Subscribers can login to read the interview Dr Ueno kindly gave BSB or you can gain access via the blue button below… this is the fourth in our series of expert interviews from San Antonio.

If you have a keen interest in IBC, do follow @teamoncology – if you don’t already!

We’re continuing our series of posts from the 2016 San Antonio Breast Cancer Symposium (SABCS) with an expert interview on how circulating tumor DNA could change breast cancer treatment.

There has been a noticeable increase in attention and focus on the application of liquid tests – especially from blood – over the last five years, culminating in a spinoff company called Grail from the deep sequencing giant, Illumina, announcing a massive funding round earlier this month.

At the time of the BSB expert interview in San Antonio, we had no idea that the Grail news was going to hit just a couple of weeks later!

While much of the media attention surrounding Grail has focused on the early detection of cancer in apparently healthy individuals, there’s actually a much more useful application where it could be more immediately applied to great effect.

Circulating tumor DNA (ctDNA) or cell free DNA (cfDNA) has the potential to revolutionise and improve monitoring over time for people with cancer who are receiving therapy.

This is the third in our series of expert interviews from the 2016 San Antonio Breast Cancer Symposium (#SABCS16).

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