Biotech Strategy Blog

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

Posts from the ‘VC & Financing’ category

Like the Battle of Britain, the cancer immunotherapy landscape is a dynamic one where tactical decisions can make the difference between “winning” and “losing.”

As Bristol Myers recently found out in first-line NSCLC, if you choose the wrong trial design or adopt an overly-aggressive strategy, you can end up losing badly (see post: Detailed thoughts on BMS CheckMate 026 1L trial in NSCLC)

A recent trip to the operations bunker at former RAF Uxbridge, from where the fighters of 11 Group were directed, shows how close we came to losing the Battle of Britain.  Had the German Luftwaffe continued to target RAF airfields instead of diverting their efforts on London, the outcome of the war is likely to have been quite different.

History provides a valuable lesson that strategy and tactics can and do matter; in R&D the targets you choose and how effectively you execute on a plan can make a big difference to outcome.

Battle of Britain Bunker Plot

Pictured: the RAF 11 Group Operations plot as it looked on September 15, 1940.

In Part 2 of the BSB interview with PsiOxus Therapeutics CEO Dr John Beadle, we discuss corporate strategy, and some of the challenges faced by an emerging Biotech company, many of which are likely to be shared by other small companies in the field.

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San Francisco JPM16 Day 3It’s Day 3 of the JP Morgan Healthcare Conference in San Francisco, and we hope that you’re enjoying our commentary and analysis around some of the presentations & news each day. If you’re reading this and aren’t a subscriber already, then why not become one?

We’re not offering a substitute for watching a company presentation yourself, they’re freely available by webcast and several companies have also put up their presentations up on their websites, but in a world awash with information competing for time and attention, we hope we’ve teased out a few of the noteworthy points.

Yesterday, on the Day 2 post we commented on $AMGN, $RHBBY, $BMY, $SGMO, $IMGN and more.

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San Francisco JPM16 Day 2It’s Tuesday at the 2016 JP Morgan Healthcare conference in San Francisco (Twitter #JPM16).

Each day of #JPM16 we’re doing a rolling blog post which we’re updating throughout the day with commentary and insights on the company presentations we’re covering.

While we’re not giving a blow-by-blow account, many companies have the slides readily available, we will be commenting on noteworthy news, and what we learn about corporate strategy going into 2016.

For those of you who like to catch up with the final summary of each day’s highlights, you can read yesterday’s Day 1 synopsis here and our interview with Seattle Genetics CEO, Clay Siegall here.

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San Francisco JPM16 Day 1It’s Day 1 of the annual pilgrimage to San Francisco for the JP Morgan Healthcare conference. In light of the success of the daily rolling blogs we’ve done around the conferences we cover, for the first time we’re doing a rolling blog for each day of #JPM16.

Throughout the day (schedule permitting) we’ll be updating the post with commentary around noteworthy news.

Company presentations mentioned in this post include: $PBYI, $CELG, $GILD, $INCY, $SGEN, $MDVN. There’s also commentary on several of the deals announced by Roche, Juno, Novartis, Sanofi, AstraZeneca & Merck.

If you want to follow along yourself, here’s the link to the JPM16 webcasts & conference agenda.

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At ASCO 2014, one of the posters that attracted a lot of attention was the one from Kite Pharma ($KITE) on their rapid cell expansion (RACE) technology for the production of engineered autologous T cell therapy.

Dr Renier Brentjens at 2012 Chemotherapy Foundation Symposium

As regular blog readers will know, we’ve been following the development of CD19-targeted T cells for the treatment of B cell malignancies such as CLL, ALL and aggressive NHL for some time.

Back in Autumn 2012, at the Chemotherapy Foundation Symposium (CFS) in NYC, more commonly known as the “Greenspan” meeting after the late Dr Ezra Greenspan, we heard presentations on early CAR-T cell data from Dr Renier Brentjens (pictured right) of Memorial-Sloan Kettering Cancer Center (MSKCC) and Dr Michael Kalos from the University of Pennsylvania (Penn).

At ASH 2012, we wrote about the data presented by Dr Carl June in the Ernest Beutler Prize Lecture. Dr Blazar, who jointly received the award, gave this quote from Dr Beutler, which is a reminder of why basic science is worthy of funding, and how important it is to innovation:

“The tendency to merely elaborate on what many others are doing arises, at least in part, from the almost universal misconception that our understanding of nature is profound, that most or all of the basic concepts have already been discovered, and that success in science consists of filling in the blanks with large teams of collaborators.”

What started off as pure academic research, has within a short period of time, become a hot (if not the hottest) area of immunotherapy drug development as inspired by the potential of early data, companies and investors pour money into commercializing CAR-T cell therapy.

Novartis had obtained the exclusive rights to Penn’s CTL019 CAR-T cell therapy in August 2012 at what now seems a bargain price.

Juno Therapeutics was subsequently created with $176M in Series A private equity funding at the end of 2013 to commercialize the CAR-T cell research of Memorial Sloan Kettering in New York and Seattle’s Fred Hutchinson Cancer Research Center.

Last week brought further development with an Initial Public Offering (IPO) from Kite Pharma who have a collaboration with the National Cancer Institute (NCI). Kite said they expected to raise $106M at a share price of $17, which was at the high end of the range. The shares soared 70% in initial trading, and closed at $29 on Friday.

To throw more fuel into the competitive fire, Pfizer have announced the signing of an agreement with French company, Cellectis, to collaborate on the development of their CAR-T cell technology.

In this first of a series of blog posts on gems from the ASCO poster hall, we take a look at the data presented by Kite Pharma and some of the challenges and opportunities the company faces.

Please note this post offers no investment advice and makes no recommendation on whether you should buy or sell shares in $KITE.

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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.

Picture of Dr Renier Brentjens, Director of Cell Therapeutics, Memorial Sloan-Kettering Cancer Center

Picture Credit: MSKCC

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.

juno-therapeuticsLike 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.

Subscribers to premium content can login to read my interview with Renier Brentjens and listen to audio excerpts from what was a fascinating conversation about a new immunotherapy that has the potential to revolutionize hematology.

Last night Luke Timmerman of Xconomy posted a nice article on the formation of a new Seattle startup, Juno Therapeutics, which aims to develop the chimeric antigen receptor therapy (CART) based on autologous T cells developed by Memorial Sloan Kettering (MSK) in New York, Fred Hutchinson Cancer Center (FHCC) and the Seattle Children’s Hospital, both in Seattle.

Juno secured $120M in Series A funding, which is pretty good for a two month old startup and shows how much excitement there is for this exciting technology.

How does this new development impact the CART landscape and in particular, the U Penn and Novartis partnership?

BIO-CEO-2012-New-York-CityThe 2012 BIO CEO & Investor conference starts today in New York.

The meeting from February 13-14 is being held at the landmark Waldorf-Astoria hotel.

I’m looking forward to seeing some of the iconic hotel features such as the 1893 lobby clock originally produced for the Chicago World Fair.

With Wall Street analysts and investors in mind, the main focus of the 14th annual conference is on publicly traded biotechnology companies.

I expect that a number of the corporate presentations will be webcast, but if you are unable to be in NYC, you can follow the #BIOCEO2012 twitter conversation below:

 

As always, part of the attraction of these events is the opportunity for networking.

Rodman & Renshaw are hosting a party at the Rockefeller Center’s sunken plaza restaurant.

I hope to see you there or at one of the BIO CEO 2012 receptions.

 

Update Waldorf-Astoria Hotel 8.13 am February 13, 2012
I was all set-up with my trusty Zi8 flip camera to record a few clips of Moncef Slaoui’s fireside chat to share with blog readers, but was publicly told off by BIO staff that I could not shoot any video, despite a media registration. The head of media relations for BIO was not readily available when I asked to speak with her about this.

I’m sorry BIO but you’ve lost the plot. There’s no unpublished scientific data at this meeting, no information that is not publicly available, being webcast or being tweeted. If I’m not welcome, I do have other things to do with my time than attend your meeting, write blog posts about, do a video report & tweet about it. #fail

Update Waldorf-Astoria Hotel 8.58 am  February 13, 2012

Waldorf-Astoria-Hotel-Lobby-ClockAfter 20 minutes I have given up waiting for a BIO media rep to talk to about the “no video” policy for this meeting.

If organizations have a specific photo/video policy for a conference they should take the trouble to communicate this beforehand, at registration or prior to a session starts. Nobody bothered to do that at BIO CEO 2012 today. That’s inept organization.

What BIO did communicate by email to those who registered for BIO CEO 2012 in advance was that:

“By registering for this meeting, attendees authorize BIO to use any photographs taken during the Conference, which may be included in promotion materials.” 

BIO could at the same time clearly have indicated any photography/video policy for media or attendees.  They didn’t.

In the absence of any specific instruction otherwise and the fact that all attendees had consented to be photographed, I had no reason to believe that video or photography was prohibited.

What’s more, I shot a video report at BIO 2011 that I am sure the folk at BIO were aware of. I received no complaints about it, and if I shot a video report before it would not be a leap of imagination to expect I might shoot another video report.

Nobody likes to be publicly humiliated or told they can’t do something in a public forum after a session has started.  I certainly didn’t enjoy that happening to me today.

As a result of my experiences at BIO CEO 2012, Biotech Strategy Blog will not be providing any publicity, promotion or coverage of any future BIO event.

I am sorry if this inconveniences any blog readers. However, on reflection, I don’t think it’s a great loss given that there’s no breaking science or clinical trial data presented at any BIO meeting and company presentations are usually webcast or otherwise publicly available.

The fourteenth annual BIO CEO & Investor Conference takes place next week (February 13-14, 2012) in New York at the Waldorf-Astoria hotel. I will be commuting from New Jersey so will not be experiencing at first hand the charm of staying at this iconic hotel.

BIO-Investor-CEO-Conference-New-York-2012-Waldof-AstoriaThe focus of the meeting is on publicly-traded biotechnology companies, and provides an opportunity for investors, analysts and industry executives to hear company presentations, undertaken one-on-one partnering discussions and listen to pharmaceutical industry leaders present their vision of the future.

Wifi permitting I will be live tweeting from the sessions I attend (@3NT).  I expect others at the conference such as @adamfeurestein to be sharing news and insights.  You can follow the twitter conversation using the (rather long) hashtag #BIOCEO2012.

My focus at the meeting will be on some of the workshops, rather than the company presentations which typically are shared on investor relations websites of publicly traded companies,.  A few that caught my attention include:

Secrets of Oncology Success – Lessons and Trends in Phase II Clinical Trial Outomes

In my opinion, too many companies rush phase II drug development, particularly in oncology.  I recently saw a company go to phase III on the basis of a 14 patient trial.   I will be interested to see what insights the panel offer on what trial designs they liked and which they didn’t and what lessons others can learn from this for new product development.

Speakers in this session include Mohammad Azab, CMO of Astex Pharmaceuticals and Michael Morrissey, CEO of Exelixis.

Neurology: “Alz” Well that Ends Well – Settling the Beta-Amyloid Debate

I doubt very much that this program will settle the debate over the amyloid hypothesis of Alzheimer’s disease, and whether this presents a “real” drug development target.  The challenge in this area is that by the time amyloid deposits can be imaged in the brain, the damage has already been done.

The amyloid load seen in the brain is also only loosely related to cognitive decline, suggesting that even if a therapeutic were able to remove plaque from the brain, it might not alleviate the symptoms of cognitive decline.

Drugs may need to target earlier stages of the disease such as synaptic decline, before beta-amyloid buildup is suggested.  Synaptic proteins have been suggested as a target.

I look forward to hearing the panels views on the current state of Alzheimer’s drug development and what the emerging targets may be.

The 2012 BIO CEO & Investor conference looks to be an interesting meeting in New York next week. If you are attending do let me know as it would be good to meet up if the opportunity presents.

BioPharm America 2011 Banner

A conference I regretably will not be at, but would have like to have attended is BioPharm America 2011 – 4th International Biotechnology Partnering Conference that is taking place in Boston from today until this Friday, September 9th.

The program overview suggests that it will be an interesting meeting with sessions on personalized medicine, business development and strategy and partnering. On friday there’s a briefing on Regenerative Medicine and Cell Therapy: The Road to Commercialization. If like me, you are unable to attend, you can follow the conversation on twitter using the hashtag #BPA11 (nice and short!).  I noticed there’s already some excellent live tweeting from the event. I’ve added an aggregator below to make it easier to follow or catch up on the news. Just click on the play button to see the tweets:  

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