Biotech Strategy Blog

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

About Pieter Droppert

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Posts by Pieter Droppert

Following the recent approval of Clovis’s rucaparib (Rubraca) by FDA under priority review as monotherapy for the treatment of women with certain types of advanced ovarian cancer, then impressive SOLO-2 maintenance data after initial chemotherapy at SGO earlier this month, PARP inhibitors continue to be in the news.

There’s always more though!

This afternoon saw the approval of Tesaro’s PARP inhibitor niraparib (Zejula) by the US Food and Drug Administration (FDA) for maintenance treatment of women with ovarian cancer who are in a complete or partial response to platinum-based chemotherapy (Link to label).

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We’re continuing our coverage of highlights from the inaugural ASCO-SITC Clinical Immuno-Oncology Symposium with a look at a novel way to potentially improve the efficacy of checkpoint inhibitors.

It’s not something we’ve previously written about, nor is it included in the recent Chen & Mellman Nature paper that discusses “factors that influence the cancer-immune set point.

So there’s a good chance it may not be on your radar either.

Given the commercial stakes at play in improving checkpoint efficacy, combination strategies that could have an impact are worth thinking about when it comes to designing clinical trials.

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Much of the focus in multiple myeloma over the last decade has focused on two key drug classes – proteasome inhibitors and IMiDs – with some recent approvals for monoclonal antibodies targeting key proteins on the surface of malignant myeloma cells such as CD38.

#ASH16 in San Diego

Combinations of these core therapies have lead to a noticeable improvement in outcomes for people living with the disease – from 3-4 years over a decade ago to now approaching 10 years post diagnosis.

If we want to continuously beat the status quo and improve on the chronicity, however, it is likely that several things will need to happen:

  • Better understand mechanisms of resistance that induce relapse
  • Develop predictive biomarkers of response
  • Identify novel therapeutic targets

Here. we focus on the latest preclinical findings that were recently presented at the American Society of Hematology (ASH) in San Diego and explore where the future might be headed in this disease.

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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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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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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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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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At the 2016 San Antonio Breast Cancer Symposium (#SABCS16) one of the mini-symposia that caught my attention was on “Harnessing the Immune System in Breast Cancer.”

A line-up of top researchers and clinicians shared the latest on breast cancer immunotherapy:

  • Laurence Zitvogel MD PhD (Gustave Roussy), “From Breast Cancer Surveillance to Immunotherapy
  • Leisha Emens MD PhD (Johns Hopkins), “Breast Cancer Immunotherapy: Building on Clinical Success”
  • Andy Minn MD PhD (Univ of Pennsylvania): “Identification of Resistance Mechanisms to Checkpoint Blockade for Cancer”
Dr Laurence Zitvogel SABCS16

Dr Laurence Zitvogel at SABCS16

Readers of the blog will recall we last spoke with Dr Emens at the AACR 2015 annual meeting (is it really that long ago?!) where she presented the first data for the PD-L1 checkpoint inhibitor atezolizumab in Triple Negative Breast Cancer (TNBC). See post: “Checkpoint data rocks AACR 2015.”

You can also hear Dr Emens talk about the data on Episode 1 of the Novel Targets Podcast.

What’s new in breast cancer immunotherapy and how have things advanced since then?

At SABCS16, we heard about a novel immunotherapy strategy targeting adenosine in breast cancer, and the trial with an adenonsine antagonist, CPI-444 (Corvus Pharmaceuticals, NASDAQ: CRVS) that’s now underway.

Last September, Corvus senior scientist Stephen Willingham, PhD and Chief Business Officer, Jason Coloma, PhD spoke to BSB about the data they were presenting at the 2016 CRI-CIMT-EATI-AACR Cancer Immunotherapy Conference in New York. See post: “Corvus moves fast to target the tumor microenvironment and improve checkpoint responses.

Corvus had a presentation at the 2017 JP Morgan Healthcare conference (#JPM17) yesterday, and we’ve included some additional commentary on that in this post.

After the SABCS16 cancer immunotherapy mini-symposium, Dr Leisha Emens, Associate Professor of Oncology at the Johns Hopkins School of Medicine, kindly spoke to BSB.

Dr Leisha Emens SABCS16

Dr Leisha Emens at SABCS16

She’s one of the rock stars of breast cancer immunotherapy, and it was truly a pleasure to catch up with her again in San Antonio.

This is the second in our series of expert interviews from #SABCS16. In case you missed the prior posts and want to bookmark for the upcoming ones, you will find them on the conference page (Link).

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We’re kicking off the first in a mini-series of expert interviews from the 2016 San Antonio Breast Cancer Symposium #SABCS16 with a leading researcher who has discovered a first-in-class compound that shows preclinical promise in several cancers including multi-drug resistant metastatic breast cancer.

It has a novel mechanism of action: 

“Interestingly, it was the only molecule, out of the 150,000 we screened that seemed to work through this pathway.”

To go from “bench to bedside,” and take this drug into the clinic now requires funding beyond what academia can provide.

If you’re at #JPM17 and into early stage VC funding or are in pharma/biotech business development BD&L and are on the look out for an innovative new licensing/investment deal, this post is for you.

What makes this a great story is I heard that one “missing piece of the jigsaw” in working out the pathway through which the drug worked came from unrelated research presented at a seminar on wound healing in zebrafish!

As a 2013 article by Robin McKie in The Observer notes, zebrafish (Danio rerio) share 70% of our genes, which makes them pretty cool research models. They are also transparent.

Hearing this anecdote reminded me of my conversation with Dr William Pao that you can hear on Episode 3 of the Novel Targets Podcast where he astutely said:

 “You never know where things are going to lead, you just have to be able to take advantage of them.”

That could also be a metaphor for life.

Science is about making sense of connections and patterns, which is why funding of basic science is so important. A piece of work by one researcher can unlock a breakthrough by another in a totally unrelated area.

While I was doing this SABCS16 interview, I was also reminded of the story behind the development of enzalutamide, and how AACR past-president Dr Charles Sawyers pitched his UCLA drug discovery work to several major pharma companies, without success, until Dr David Hung at Medivation took the risk… and the rest is history.

What makes that story so surprising is at the time Dr Sawyers already had a track record of success with his work on the development of imatinib!

It was a privilege to talk with a senior scientist at #SABCS16 who has thought outside of the box, made scientific connections, and in the process developed a new drug that shows exciting preclinical promise.

Improving the outcome for cancer patients requires the translation of basic science into new products that enter clinical trials.

I do hope funding will be forthcoming to move this first-in-class drug into the clinic so that’s its potential can be fully evaluated.

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If you’re at #JPM17, it’s a great time to buy a sub to BSB and put it on your expenses!

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