Biotech Strategy Blog

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

About Pieter Droppert

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Posts by Pieter Droppert

ASCO GU 2014: Will Galeterone make it to market in Prostate Cancer?

San Francisco – Tokai Pharmaceuticals is a case study in how not to do drug development.

A company, founded in 2004, with a novel prostate cancer drug has taken 10 years to make it to phase II drug development while competitors such as Medivation and Johnson & Johnson have brought similar new drugs to market in multiple prostate cancer indications.

At ASCO GU this week (Abstract 71), Tokai reported part 1 of their phase 2 ARMOR2 trial with reformulated galeterone (TOK-001) in men with prostate cancer at various stages of the disease in a poster.  Part 2 of the study will enrol 136 patients with a once daily dose of 2550 mg.

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ASCO GU 2014: Why does the Medivation PREVAIL trial matter?

This week sees the start of the American Society of Clinical Oncology Symposium on Genitourinary Cancers (ASCO GU) in San Francisco.

Prostate cancer has certainly been in the minds of investors the past few weeks in anticipation of the COMET-1 prostate cancer trial results for cabozantinib (Cometriq).

The share price went on a run-up until Exelixis CEO Michael Morrissey took yet another trip to the biotech ATM machine.  Somehow, this doesn’t come as any surprise given past performance.  The key issue at stake here, however, is will the COMET-1 trial be positive or negative?  The outcome is much anticipated and will no doubt influence the chances of successful approval for cabozantinib in advanced prostate cancer.  Data is expected sometime in first half of this year.

What we can expect in the media this week is more news on the Medivation and Astellas phase 3 trial PREVAIL clinical trial of enzalutamide (Xtandi) in men with advanced prostate cancer who had not yet received chemotherapy.  The ASCO GU abstracts are publicly available at 5pm on Tuesday.

Currently, the key data from oncology medical conferences is focused squarely on Medivation’s enzalutamide and the PREVAIL data.  It seems a good idea to discuss what are the key things to watch out for?

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Update on CO-1686 and AZD9291 race to market in T790M NSCLC

Clovis Oncology ($CLVS) is one of the winners at the JPM Morgan Healthcare conference (#JPM14) in San Francisco with a dramatic increase in share price over the past several days.

The presentation by Clovis CEO Patrick Mahaffy laid out an aggressive growth plan for drugs in development such as CO-1686 and was clearly well received by analysts and investors alike.

CO-1686 is a third-generation EGFR inhibitor with early data showing that is effective in many non-small cell lung cancer (NSCLC) patients who have developed acquired resistance to existing EGFR TKIs.

There are currently no approved treatments for patients who develop a T790 mutation. This unmet medical need offers a sizeable market opportunity as the commercial landscape currently stands.

Clovis, however, are in a race to market with AstraZeneca, who also have an exciting new drug in development, AZD9291.  Preliminary data has shown the agent to also be effective in NSCLC patients with the T790M mutation.

Both companies presented data at the World Lung Conference in Sydney at the end of October last year for their phase 1 trials.

As to which company will get to market first and which product is the best, the race to market is now too close to call and we don’t yet have enough data to compare the merits of the compounds but the JP Morgan Healthcare conference did offer insights.

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Will Exelixis Cabozantinib COMET-1 prostate cancer trial be positive?

The share price of Exelixis ($EXEL) is starting a run-up (after months in the doldrums) in advance of anticipated results from the COMET-1 phase 3 trial in metastatic castrate resistant prostate cancer (mCRPC) for cabozantinib (Cometriq, formerly XL184).

Cabozantinib is a small molecule tyrosine kinase inhibitor of c-Met and VEGFR2. It has been shown to significantly improve bone scans and decrease pain, but the $64,000 questions are will patients taking it live longer and feel better?

The answers will come from the COMET-1 trial that has a primary end point of overall survival (OS). It’s a placebo-controlled trial of 960 men with advanced prostate cancer randomly assigned to cabozantinib 60mg (n=640) or prednisone (5mg twice daily) (NCT01605227) who have disease progression after treatment with docetaxel chemotherapy and abiraterone (Zytiga) or enzalutamide (Xtandi).

We previously predicted this trial would be a miss, but did it turn out that way and why?

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Juno Therapeutics takes on Penn in dispute over St Jude Chimeric Antigen Receptor Patent

The Inquirer yesterday reported on Philly.com that start-up Juno Therapeutics (Juno) are now in control of a legal dispute between St Jude Children’s Hospital (St Jude) and the University of Pennsylvania (Penn) over chimeric antigen receptor (CAR) intellectual property that contributed to the development of CTL019, licensed by Penn to Novartis. Thanks to @lomu_j for sharing this news on Twitter.

According to the Inquirer, last month Juno entered an agreement with St Jude to commercialize their CAR T-cell technology, which gave them the right to “control, pursue and defend” the dispute between Penn and St Jude.  On December 18, Juno’s intervention was approved in Federal District Court in Philadelphia.

(Update Jan 10: Zack Seward (@ZackSeward) provides additional commentary on WHYY Philadelphia newsworks on “The high-stakes legal fight over a ‘cancer cure from Penn.’ He reports that St Jude have every confidence in their patent.

 

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ASCO GU 2014 Prostate Cancer Preview #GU14

As 2013 comes to an end, rather than look back as many are doing, I’m looking forward to 2014. January is a busy month for cancer meetings with the ASCO organized gastrointestinal cancers symposium (ASCO GI) and genitourinary cancers symposium (ASCO GU) both taking place in San Francisco a few weeks apart.

In fact, looking at the calendar of forthcomings meetings, 2014 looks to have a West Coast focus, with the annual meeting of the American Association for Cancer Research (AACR) taking place in San Diego in April, and the American Society of Hematology (ASH) annual meeting also heading to San Francisco in December.

Transcontinental airfares are notoriously expensive at the last minute so if flying from the East Coast, do make travel plans early!

The ASCO GU symposium takes place at the San Francisco Marriott Marquis from Jan 20 – February 1, 2014. The abstracts for meeting go online at 5pm Eastern Time on Jan 28.

ASCO in a December 19 press release have already announced what will be highlighted on the January 28 press cast, and what many of the media can be anticipated to write about from the meeting.

Perhaps not surprisingly the Medivation PREVAIL trial data (LBA1) is top of the list; the abstract for this presentation has already been published online as Professor Tombal (@BertrandTOMBAL) kindly highlighted on Twitter.

This preview highlights some of the prostate cancer abstracts and presentations to watch out for at the meeting:

Drugs discussed in this post include: enzalutamide (Xtandi), abiraterone (Zytiga), ODM-201, ARN-509, ipilimumab (Yervoy).

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ASH 2013: New BTK Inhibitor ONO-4059 shows early promise in CLL – is it a future competitor to ibrutinib?

Chronic Lymphocytic Leukemia (CLL) was one of the hot topics at this year’s annual meeting of the American Society of Hematology (ASH), and a new CLL drug that caught my attention was the second-generation Bruton’s Tyrosine Kinase (BTK) inhibitor ONO-4059 from Ono Pharmaceuticals.

Professor Gilles Salles (Lyon, France) presented promising efficacy data from a phase 1 study of ONO-4059 in relapsed/refractory CLL and high risk CLL (#676).

Unfortunately after his presentation, Prof Salles declined my request for a quick interview citing a prior commitment with a large pharma company and subsequently failed to turn up for an agreed interview the next day. Talking about ONO-4059, at least with the media, did not appear to be a priority!

However, as a potential competitor to other BTK inhibitors in development such as ibrutinib (Pharmacyclics/JNJ) and CC-292 (Celgene/Avila) it’s worthy of a mention in the conference coverage and a quick post about the data presented.

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Juno Therapeutics takes on Novartis and seeks to revolutionize the treatment of blood cancers – an interview with Renier Brentjens

One of the benefits of attending the American Society of Hematology (ASH) annual meeting that finished earlier this week in New Orleans is the opportunity to talk to experts who are at the forefront of their field.

Renier Brentjens, MD PhD,  is Director of Cell Therapeutics at Memorial Sloan-Kettering Cancer Center (MSKCC) and one of the scientific founders of Juno Therapeutics (Juno), a start-up company that recently raised $120M in Series A financing.

Luke Timmerman wrote about the company launch on Xconomy and you can read the Dec 4 press release from Juno here.

Like a modern day David versus Goliath, Juno Therapeutics has set itself up to compete with Novartis in the exciting world of chimeric antigen receptor (CAR) modified T cell therapy that has already shown dramatic results in pediatric and adult acute lymphoblastic leukemia (ALL).

A lot of media attention has focused on the Novartis collaboration with the University of Pennsylvania to develop a novel therapy using CAR modified T cells (CART-19/CTL019) that can be directed against tumor cells that express the CD19 antigen.

The potential promise of CAR modified T cell therapies has already led to a flurry of law suits between the St Jude Children’s Hospital (St Jude) and University of Pennyslvania (U Penn).

According to the Daily Pennsylvanian, U Penn are seeking to invalidate a St Jude patent while St Jude have claimed violations of the terms of a material transfer agreement that allowed access by Carl June (U Penn) to work done by Dario Campana (St Jude).

It will be interesting to see what intellectual property Novartis actually owns and whether they did a thorough enough due diligence prior to licensing the rights to CTL019 from U Penn.

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ASH 2013 Novel Treatments for CLL – notes from the road

New Orleans – the hematology diehards were up early yesterday for the 7.30 am oral session on some of the most interesting data at the annual meeting of the American Society of Hematology (ASH) on potential new treatments for Chronic Lymphocytic Leukemia (CLL).

Just to make sure everyone’s Fitbits were well exercised, the organizers put the session in the farthest end of the Convention center! Like many of the CLL sessions, it was a full house with multiple financial analysts sitting in the row behind me taking copious notes and pictures.  Unlike at ASCO, there is no virtual meeting, so you can’t replay any of the oral scientific sessions at a later date. If you didn’t see it, you missed it! There’s no substitute for boots on the ground.

What this post is about is my subjective opinion and top-line impressions of the information presented and some of the key strategic issues and challenges that came across listening to a full presentation of the latest data. I’m not going to rehash the press releases and the abstract data, most readers have already assimilated that.

It is what it says — notes from the road — the kind of things I’d write in a trip report if I were in a company.

The four presentations covered in this post are:

Abstract 871: Dinaciclib (SCH 727965) Is a Novel Cyclin-Dependent Kinase (CDK) Inhibitor That Exhibits Activity In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia (CLL).

Abstract 872: Bcl-2 Inhibitor ABT-199 (GDC-0199) Monotherapy Shows Anti-Tumor Activity Including Complete Remissions In High-Risk Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL).

Abstract 873: Randomized, Phase II Dose Optimization Study Of Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) In Patients With Relapsed, Refractory CLL.

Abstract 874: Phase I Trial Of Autologous CD19-Targeted CAR-Modified T Cells As Consolidation After Purine Analog-Based First-Line Therapy In Patients With Previously Untreated CLL.

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ASH 2013 Novel Agents in Lymphoma – notes from the road

New Orleans – 5pm on Sunday at the annual meeting of the American Society of Hematology (ASH) saw the start of the oral sessions, where the latest research and clinical trial data is presented.

I attended the novel agents in lymphoma session, and this post offers some top-line “notes from the road” on the following presentations:

Abstract 85: Idelalisib Ph2 data in patients with double (Rituximab and Alkylating Agent) refractory indolent Non-Hodgkin Lymphoma (iNHL).

Abstract 86: SAR245409 Monotherapy in relapsed/refractory Follicular Lymphoma from phase 2 ARD12130 study.

Abstract 87: Phase 2 study of BAY 80-6946 (copanlisib) in relapsed/refactory, indolent or aggressive lymphomas.

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