Friday, May 31, 2019

Ultra Laminar Flow


Happy Science Friday Everyone.
It makes me happy to see someone who loves laminar flow as much as I do.

Thursday, May 30, 2019

Daily Update - May 30th, 2019

Manuscripts -

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval
JAMA
- Conclusion in summary: A dartboard would an equally effective to with which to designate Accelerated Approval status

ADC Business - 

Drug Giant Tries New Tactic to Fight Cancer
Wall Street Journal
- Jose Baselga is directing AZ to focus on early stage cancer indications.  Its a risky move because early stage is harder to detect, but maybe easier to treat.  This shift might necessitate an early phase diagnostic technique in concert with the therapy

IPO boom: Antibody experts at Genmab outline global ambition in pitch for $500M
Endpoints News
- With a potential $500M payday, and two concurrent projects with SeaGen and a smaller partnership with ADC Therapeutics.  Genmab is looking to become a major player in our space

Zymeworks' Lead Asset, ZW25, Granted Fast Track Designation from the FDA
Zymeworks
- Zymeworks is continuing its run of headline grabbing with a Fast Track Designation on its lead asset

Regulatory - 

COTA and FDA Partner on Real-World Evidence Program in Breast Cancer
Biospace
- The FDA is taking a more wholistic view of cancer therapy with the help of COTA and real-world evidence.  It is attempting to move beyond a single-minded view of Progression Free Survival times

In The Clinic - 

Benefit of Antibody Drug Conjugate T-DM1 in HER2+ BC
TargetedOnc
- Sometimes its easy to forget how directly the ADC space impacts patients.  If that weren't enough, this article proposes that preoperative application of T-DM1 can give indications about how to treat the patient after tumor removal via surgery

Sutro Presents Preliminary Results From Ongoing Phase I Study of STRO-001
ADC Review
- Sutro is announcing the top-line results for their STRO-001 asset at the European Hematology Association conference.  Initial reads look very encouraging.

Beyond the ADC World - 

Trump pushed for the federal right-to-try law. One year later, only two people got treatment
Cincinnati Enquirer
- A perfect example of how a simple fix in the world of pharmaceuticals in anything but...



Tuesday, May 28, 2019

Daily Update - May 28th, 2019

It's been a week since my last update.  Not really living up to the ADC Daily moniker, but I have been accumulating all of the links over the past week.  So here we go. Since there are so many, I am organizing them into categories:

CDMO -

Perks and Pitfalls of Antibody Drug Conjugates: Lessons Learned with Charlie Johnson
The Medicine Maker
-Charlie Johnson, CEO ADC Bio, gives an extensive interview about what they are up to in the UK


Conferences - 

ASCO 2019 ADC Presentation Guide
ADC Review
- A summary table to ADC presentations at this years ASCO.  Also, Beacon Targeted Therapies has put together something similar, reach out to Raj Kumar on LinkedIn if you want access to that one

New Data Demonstrates Potential for RemeGen’s RC48 in HER2+ Cancers
ADC Review
- RemeGen in China has announced that they will release Phase II data on their Ad-Cyla Hybrid (HER2 with vcMMAE) molecule

Brad Loncar’s ASCO19 preview: 5 big ideas to watch for at the ultimate cancer show of the year
Endpoints News
- Brad goes through all of the things he's excited about at ASCO this year.  If you scroll way way down, there is ADC news in there.  But the broader trends in oncology are interesting as well


Manuscripts - 

Insights from capillary electrophoresis approaches for characterization of monoclonal antibodies and antibody drug conjugates in the period 2016–2018
Journal of Chromatography
- A nice review article for the analytical types out there.  All you ever wanted to know about the most recent happenings in the world of CE - CGE, cIEF, CZE, CE-MS

Cancer cells are quick-change artists adapting to their environment
Science Daily
- To anyone researching oncology targets, this paper should be terrifying.  The level of plasticity among cancer cells is significantly higher than previously understood leading to significant difficulties in biomarker utility

Study on the Heterogeneity of T-DM1 and the Analysis of the Unconjugated Linker Structure under a Stable Conjugation Process
ACS Omega
- An in-depth look at conjugation site heterogeneity on Kadcyla.  Very interesting read.

Business - 

Seattle Genetics taps pharma oncology veteran as first-ever chief commercial officer
FiercePharma
- SeaGen is going big time.  Adcetris is up to 6 unique indications, and two more candidates are moving up through the pipeline.  So they are bring in some big pharma experience to lead the expansion

Bicycle raises $61M in downsized IPO, joining fellow biotechs on Nasdaq who have hauled in $1.6B collectively
Endpoints News
- Bicycle therapeutics cashed in for $61M in their IPO.  Which puts it at the bottom of the list for capital raises in Biotech for the year

AstraZeneca Offers a Perch to Cancer High Flier Who Stumbled
Bloomberg News
- Jose Baselga is the new head of AZ's cancer research, this is a facinating article about his progression into this role and what direction the AZ oncology unit is headed towards

------------------------------
Thats it for today.  There are always more coming down the pike.  Is there something I missed?  Contact me. Justin@ADCDaily.com





Monday, May 20, 2019

Daily Wrapup - Monday May 20th

Today is the inaugural day of a new format.  Let me know how you like it:

AbbVie Provides Update on Depatuxizumab Mafodotin (Depatux-M), an Investigational Medicine for Newly Diagnosed Glioblastoma, an Aggressive Form of Brain Cancer
AbbVie Press Release
-More bad news from the world of ADC.

Exelixis and Iconic Therapeutics Enter into Exclusive Option and License Agreement for Novel Antibody-Drug Conjugate Program
Business Wire
-Exelixis is announcing that they are licensing the ICON-1 asset from Iconic Therapeutics  targeting Tissue Factor in cancer cells.

SUN-174 Severe Insulin Resistance and Diabetic Ketoacidosis after Brentuximab Vendotin and Cyclosporin Treatment
Journal of the Endocrin Society
-Brentuximab vedotin induces full diabetic ketoacidosis episode in 23 year old patient.  Take a second to realize how potent these molecules that we are dealing with actually are.

As Daiichi Sankyo-partnered breast cancer drug marches toward finish line, AstraZeneca brings in Canadian scientist Sunil Verma to rev up R&D
Endpoints News
- A massive $7 billion licensing agreement was only the start of a shake-up at AZ.  Add in the removal of MedImmune as a separate entity and now a shakeup at the executive level.  This is a pretty big reckoning for the guys and gals over there.

'Cornucopia' of biopharma innovation blurs drug launch forecasts, analyst laments
FiercePharma
- New technologies mean new cures, but the onslaught of completely new therapies also means increased uncertainty, and that results in higher prices.  Pretty interesting stuff.

Friday, May 17, 2019

The strange path of Mylotarg


Pharmacokinetic/ Pharmacodynamic Modeling To Support The Re‐Approval Of Gemtuzumab Ozogamicin

This is a really cool use of in silico testing to facilitate the package for regulatory approval.  They have used the data set that existed, and then plugged it into existing models and were able to tease out the fact that there was a real therapeutic benefit at the correct dose.
Clearly this is not sufficient in itself to reapprove Mylotarg, but it was part of the package.  Pretty interesting stuff.

CRISPR is going to change medicine, but it is already changing academia

Happy Science Friday all.
CRISPR gets a ton of attention as a potential new therapeutic.  But the reality is, in the short term, its strongest effect is seen in how it has completely changed academic research.  Here is one of those people enacting that change.  Pretty cool stuff.

Learning why cancer drugs work (or don’t)


A new method for glycosylation based site-specific conjugation? Look out Synaffix

Here is a novel approach to combine a transglutaminase process to incorporate a conjugation site at the Q295 site in place of the glycosylation site.  Sounds a lot like Synaffix tech to me.

Thiolation of Q295: Site-specific conjugation of hydrophobic payloads without the need for genetic engineering.

What do you think?

Thursday, May 16, 2019

Mechanism on patients who dont respond to Kadcyla


Antibody-drug conjugate T-DM1 treatment for HER2+ breast cancerinduces ROR1 and confers resistance through activation of Hippotranscriptional coactivator YAP1


This is a pretty interesting paper trying to identify why some patients don't respond to T-DM1 based therapy.  After demonstrating an increased expression of ROR1 resulting from T-DM1 administration, they demonstrate that inhibiting ROR1 could be a potential treatment for these patients.

Pretty cool stuff.

Daiichi gets one out of two drugs approved


In case you hadn't already heard about this.  Now you have:

https://endpts.com/daiichi-sankyo-disappointed-as-fda-experts-spurn-aml-drug-but-vote-in-favor-of-rare-tumor-drug/

https://www.reuters.com/article/us-daiichi-sankyo-fda/fda-advisory-panel-votes-against-daiichi-sankyos-cancer-treatment-idUSKCN1SK2JP
https://www.fiercebiotech.com/biotech/daiichi-s-leukemia-drug-falls-amid-fda-adcomm-s-trial-concerns
https://finance.yahoo.com/news/daiichi-sankyo-announces-outcome-fda-220200236.html
https://www.biospace.com/article/daiichi-sankyo-receives-a-yes-and-no-from-fda-advisory-panel/
https://www.evaluate.com/vantage/articles/news/snippets/us-backs-only-one-two-daiichi-oncology-projects-only-beginning

Wow.

Teva was organizing price fixing with other generics

It looks like Teva was the ringleader in a very large and detailed price fixing scheme:
Lawsuit - Every State v. Every Pharma CMO

In case you don't have time to read a 524 page legal document (me neither), here is a nice summary from FiercePharma instead:
Teva starred in price-fixing scheme, but 19 other companies 'willingly' joined, attorneys general claim

41% of newly approved drugs had 1 PhIII trial - FDA says this should be rare?


Earlier this year, the FDA put out this report:
2018 FDA New Drug Therapy Approvals
Hiding out on page 18 is this little gem where they state that 24 out of 59 drugs (41%) were designated as Fast-Track.  That spurned this great article from Zach Brennan at Endpoints News:
Almost half of all new drug approvals in 2018 relied on one clinical trial

Now the question is, if half of the new drug approvals came from only one trial, while at the same time the FDA states that one trial approvals should be a rare exception, what explains this conflict?

Maybe there are just more applications for diseases with no current standard of care?  Or maybe the FDA just has a funny definition of rare.  They also stated this in their report - 73% of applications were given priority review. 73% sounds more like standard review than priority to me.

Wednesday, May 15, 2019

ImmunoGen's Mirvetuximab isn't dead yet

The Phase III trial of Immunogens Mirvetuximab failed to meet its primary endpoints.  However, that does not mean complete and total death.  It looks like they are continuing to discuss with the FDA and another clinical trial is going to be in the works.

ImmunoGen Provides Regulatory Update on Mirvetuximab Soravtansine Monotherapy in Ovarian Cancer

Hopefully the completion of this trial will lead to success for them, and for the market as a whole.

Iconic Therapeutics is using Zymelink Tech for first ADC

Zymeworks Zymelink technology has been showing some good results in preclinical modeling, and pairing that with a suite of bad news around the PBD based payloads, it makes sense to move forward with this type of a collaboration.

Iconic is going after Tissue Factor targets in oncology, and their molecule ICON-2 is their first ADC product expected to head to the clinic.

Zymeworks is starting to make some waves.  Is this a company to keep an eye on?

Zymeworks Enters its First ZymeLink™ Antibody-Drug Conjugate Platform Licensing Agreement with Iconic Therapeutics


Bicycle Therapeutics is going public

Just in case you ever wonder why people look at you with crossed eyes when you talk about your science, just look in the mirror while you are reading this link...

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

This is impressively boring.  The main point is this, Bicycle Therapeutics is filing an IPO for 4.3 million shares at ~$15 per share which puts their estimate of company value at ~$214.5M.

The obvious benefits of IPOs is the infusion of a significant amount of cash.  But there is nothing free, and this is no exception.  Now the team will be beholden to a board of directors, quarterly reports, and public scrutiny of their finances.

Is it a good idea to file your IPO before demonstrating profitability?  It worked for Amazon, and none of the investors in Uber are too upset right now.  But the pharma industry is not the tech industry.  Growth and success come hard, and only after a lot of work.

ABL Bio has a different kind of business model

 Have you heard of ABL Bio?  Don't worry, me neither...

Buying and selling technology vital to ABL Bio business model

But maybe they are worth a look because they are taking a different approach to ADC development.  Instead of spending the time, effort, and money to build in house proprietary technologies, they are in the business of buying and selling IP.  In some cases that looks like the in-licensing deal they have with LegoBio for ADC Linkers, but in others they are out-licensing their own technologies.  In the end, they think focusing on technology blocks is a faster way to market.

Are they on to something?  And have you seen anything like this before?

A delivery paradigm beyond mAbs might be useful

Here is a nice review paper about targeted drug delivery. 
Managing efficacy and toxicity of drugs: Targeted delivery and excretion

However, they are not talking about mAbs as the vehicle.  This article is focused around physical drug delivery systems. I'll let the authors explain:
This review provides an essence of some newly developed simple but prospective strategies on enhancing the efficacy of drugs/bioactive molecules exploiting various drug delivery systems like micelles, cyclodextrins, liposomes etc. to serve the purpose of targeted delivery towards DNA, by endogenous and/or exogenous means. 
I think the coolest part though is the concept of adsorption and how these could potentially scrub the body of unwanted molecules.  Could this be applied to systematic free drug in order to decrease offsite toxicity? 

What do you think?



A new potential cleavable linker?

Here is a new manuscript out of Georgia State University.  They have developed a click and release chemistry which can be applied to multiple payloads and released upon entrance into a particular cellular environment.

Click and Release: A High-Content Bioorthogonal Prodrug with Multiple Outputs

This could be very interested if you wanted to target the tumor microenvironment, and then used a mAb and a payload as your multiple prodrug attachments.  Happy reading.

FDA puts out Biosimilars Recommendations

The FDA has released a new guidance document detailing their expectations in biosimilar development.  For anyone who has tried to read the actual regulations, these guidance documents are a massive help.  And currently, there are no approved biosimilars in the US so I'm sure this will be particularly timely.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market

How does this affect the ADC market?  As we mentioned last week, (Are ADCs just a fancy way to hold onto a patent?) biosimilars are coming for US Biologics, and ADCs could be an interesting path to keep a patent lasting a little longer, or to identify a new standard of care without all of the risk of a new molecule.

What do you think?  Why aren't biosimilars flodding the market as expected?

Tuesday, May 14, 2019

Targeted therapy is expensive - How will the market move forward


All of these next generation targeted therapies are bringing unbelievable technology to patients who have no other options.
But does our healthcare system have the ability to deal with the staggering price of these therapies?
There is no shortage of articles questioning this:
Is Gilead’s new CAR-T overpriced or is payer bureaucracy to blame for slow pickup?

I know that I have strong opinions about this topic, but I would be very interested in other opinions.  What do you think?  Is there a path forward, or are we running down a dead-end?

Cell Therapy is getting HUGE - But that seems complicated

Novartis is continuing a big push in advance of its expected approval for its second gene therapy product, Zolgensma, by the end of the month.

Novartis says it is ready to meet even 'unprecedented' demand for Zolgensma


To meet this demand they are looking at over a million square feet of manufacturing space, including the new acquisition from AZ in Colorado.  They are also building a distributed network of individualized cell therapy centers around the country, and working with the FDA to relax the regulations around the products to increase their potential patient population.

I'm getting tired just typing all of this.  But the reality of this massive effort is that whoever can successfully scale, and get over the hump, will have a massive advantage over the rest of the pharma world.

Monday, May 13, 2019

Are ADCs just a fancy way to hold onto a Patent?


Here is an article about how the upcoming onslaught of trastuzumab biosimilar approval in the US is going to hurt the Roche bottom line.  However, the recent approval of indication expansion for Kadcyla will help to fight against this.  That is giving me an idea that had never occurred to me before...


Roche Gets a Boost from New Kadcyla Indication as US Biosimilars of Herceptin Near

So I have always thought of ADCs as a clever trick to finding a potential use for mAbs which were developed but which didn't show enough therapeutic effect on its own.  Hence why so many mAb companies are in the ADC space.
However, this article made me think that maybe a use case for ADCs is really to just create a marginal improvement over an already successful biologic candidate thereby increasing the patent window of a particular molecule.
This is like the much more complicated version of an extended release tablet in the small-molecule world.

Is this a crazy idea?  Or is it crazy that this hadn't occurred to me before?

AZs big bet looks like its paying off


This week AZ and Daiichi announced that the frontline results from the ongoing Phase II study of trastuzumab deruxtecan (HER2) were a mirror of the "unprecedented" success observed in their smaller Phase I trial.  This is undoubtedly good new, but the cynical side of my brain is tingling...


AstraZeneca’s $7B bet on Daiichi Sankyo’s antibody drug conjugate pays off with pivotal data to back their regulatory pitches

Without a doubt, successful trials is good for patients, and good for the ADC industry.  So good on Daiichi for achieving some success with their lead asset.

But when the deal with AZ was announced, the potentially $7B number was staggeringly large.  Now clinical data are always released to the public at once at the end of the study.  But they are being gathered constantly throughout the duration of the study so I'm guessing AZ new exactly what they were getting into when they bought into this deal.

-It looks like I'm not the only one who thinks that they knew what they were doing when AZ signed this contract.  Here is a different take on the same story:
Astra and Daiichi lay out their plan for a better Herceptin

Regardless, the end result is great news.

Clinical Approvals are a Deathtrap - but getting less Deathly


Here is a nice summary of a report published in Jan of 2019 by CMR International and published in Nature Reviews...  Core finding - Most clinical candidates die in the early phases.  But companies seem to be getting smarter and are increasing their success rate.  The review gives several potential explanations for this.


PhI may still be a killing field of failure but PhIII success rates have surged, signaling tectonic shifts in biopharma R&D

This is a really nice summary about the conclusions in the review.  Also the graphs are interactive and pretty.

Is it surprising that clinical trials are hard?  Not really.  Is it surprising that companies are getting more willing to pull the plug despite heavy up-front investment?  Not really.


Friday, May 10, 2019

Newly published Transglutaminase paper



This article is about a new method for transglutaminase mediated site specific conjugation using targeted peptide sequences engineered into the heavy chain of the antibody.
They demonstrated the effectiveness on trastuzumab and showed efficient conjugation.

Efficient Site‐Specific Antibody‐Drug Conjugation by Engineering of a Nature‐Derived Recognition Tag for Microbial Transglutaminase

This sounds strikingly similar to Catalent's (Formerly Redwood Biosciences) SMARTag technology.  But either way, more conjugation technology is always a good thing.

Immunogen Posts Earnings Report Chalk full of Beta


If you don't love the reporting requirements of public companies, that you aren't living.  Want to know how much the CEO makes - its in there.  Want to know their 3 mo, 6 mo, and 2 year outlook?  Its in there.  Want to know whats happening with Mirvetuximab?  Me too...

ImmunoGen Reports Recent Progress and First Quarter 2019 Financial Results

There is a ton inside of this report worth checking out.  A few highlights are:
  • Top-line results announced from the Phase 3 FORWARD I study of mirvetuximab soravtansine ... suggest a favorable benefit-risk profile in this population. (i.r. mirvetuximab isn't dead as a monotherapy, even in the short term)
  • Meet with the U.S. Food and Drug Administration (FDA) in Q2 to discuss a potential path to registration for mirvetuximab soravtansine as a monotherapy for the treatment of platinum-resistant ovarian cancer patients with high FRĪ± expression.
And because you asked:

I still can't believe they make this stuff public.  Immunogen CEO Mark Enyedy made $2.7 mill in 2017.  Do you work at a public company?  Google it.  Maybe your boss is on there.  Mine was when I worked at a small startup in Mountain View. 



(PS. In case you were wondering.  I am using Beta as a rock-climbing term used to reference route information, not as the financial form of Beta where it references stock price correlation to SP500 movements.  Which to be fair is my second favorite kind of beta)

Adcetris Indications are expanding



Fresh off a big earnings beat that we reported here , SeaGen is continuing to expand its applications for Hodgkins Lymphoma into Canada into other treatment platforms.

Seattle Genetics Announces Progress in Expanding ADCETRIS® (Brentuximab Vedotin) Indications in Canada

This is very similar to what we saw in their financial report, and what is happening in the US.  But with expansion into Canada, this has two major effects:
1) Increased patient population will increase sales
2) Further demonstration of the indication expansion path to broaden the population even further from here.


Next-gen Pharma is expensive, and insurance is complicated

Even though this article is not related to ADCs it is an interesting look at how insurance companies are grappling with the very real issue of treatments which can cost up to $4M per patient.


http://bit.ly/2VfeFYD

This article is particularly interesting in that they talk with insurance companies who are grappling with how to pay for all of this.  There are some ideas about installment plans, but that is complicated by things like:  What happens if the therapy stops working?  Would people continue to pay for an ineffective treatment?  Or what would happen if a person got a new job and therefore a new insurance company?  Would that new insurance company be liable for continuing payment on the old plan?

This author gives us an interesting look at the world behind the science, behind the patients, and down in the nitty gritty of the reality that curing cancer costs money, and the buck has to stop somewhere.

There is another article written by one of my favorite authors - Mark Terry at Biospace - where he interviews the authors of a review paper covering the same topic.
http://bit.ly/2Vbaihq
or the source review article can be found at:
https://go.nature.com/2VeNNZ4

What do you think?  Is there a point where a treatments cost should be factored in as an approval factor?  Is 10X higher cost acceptable for a 5% +/- 4% treatment option?

3D Printed Organs are becoming Real.



Happy Science Friday All!

Wednesday, May 8, 2019

ThermoFisher is coming into the Gene Therapy CDMO space


ThermoFisher is announcing that that they are investing another $125M into their $1.7B acquisition of Brammer Bio to enable them to move into the gene therapy space.  This is interesting for a couple of reasons

WEBINAR: Activated PEGS for ADC Linkers



Here is a webinar that MilliporeSigma is running about using activated PEGs as a linker technology.
Its on May 16th at 11a EST

http://bit.ly/2YcMETx

Targeted Oligonucleotide Delivery



Here is a seemingly nicely written article about the application of targeted oligo delivery conjugation therapies.

With a deal and a debut, targeted oligo delivery gets a boost from ADCs

We have actually reported on both of these before, but its always nice when a real journalist does some journalism.  (This blog has never, and will never claim to be real journalism)

https://www.adcdaily.com/2019/04/lilly-taps-aviditys-antibody.html

Manufacturing Choice Matters


The Cadila plant in India has just completed their response to 14 citations resulting from their recent FDA issued 483 letter.  And in a hilarious example of spin, they present a perfect example of why you need to be careful when choosing a CDMO...

Monday, May 6, 2019

FDA approves ado-trastuzumab emtansine for early breast cancer


On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Friday, May 3, 2019

Regulating mAb analytics

In this nice review, the author covers the current state of mAb analytics, and how the current regulatory state affects their implementation

Organic Synthesis in ADCs

Here is a nice article out of Rice University discussing Organic Synthesis in ADCs.  I'm not going to claim I can understand this type of chemistry.  But if this sort of thing is your flavor...  Enjoy!

https://onlinelibrary.wiley.com/doi/pdf/10.1002/anie.201903498


ADC Bio is hosting a Webinar

ADC Bio is hosting a webinar titled:

Investing for the Future: Unlocking Advanced ADC Manufacturing Innovation on May 15th at 11am EST

Thursday, May 2, 2019

AZ is Back in the Black


AstraZeneca has turned a profit for the first time annually since 2014.  This is driven largely by their oncology portfolio.  Inside of this is the recently announced deal with Daiichi Sankyo for nearly $6 billion if everything works out.
http://bit.ly/2ZNyJoJ

All of this is the say that they are still financially constrained since their rejection of a buyout bid from Pfizer.  Which puts them in a unique spot, and this author seems to take a little bit of the shine off of that Daiichi deal.

Have a read, and what do you think about the 5 year outlook for AZ?  They are pushing hard into ADCs, so what does it say that they are licensing the leading ADC asset from Daiichi for roughly the GDP of a small Caribbean nation?



Zymeworks expanding its leadership team



http://bit.ly/2vyKBNq

Zymeworks has just announced an expansion of their leadership team.  They are bringing in Mark Hollywood from BMS to head the Technical and Manufacturing operations.  Also Neil Josephson is coming over from SeaGen to head the clinical research.  Additionally, Bruce Hart is coming from SeaGen as well to head the Regulatory Affairs group.  And lastly, David Poon in being promoted internally to head up Business Development and Alliance Management.

What do all of these things have in common?  Zymeworks is being proactive about their future development and building out a strong leadership structure to enable successful growth into pipeline commercialization.  Clearly they have confidence that the future it bright.  It will be interesting to see how things materialize over time.

Is this enough to get you excited?  Or does it start to sound like a biotech company is building in layers of bureaucracy which will make advancement more difficult?

SeaGen sales of Adcetris are up 39% this year



http://bit.ly/2vv7H7F 

The earnings season continues with SeaGen reporting strong numbers on the backs of fantastic Adcetris sales.  This was driven largely because Adcetris was approved as a frontline treatment for Hodgkins lymphoma.

Wednesday, May 1, 2019

NHS England is spending $$$ on Hep C



http://bit.ly/NHSEnglandHepC

Take a minute to read this interesting article about NHS Englands attempt to erradicate Hep C.
They also talk about a "Netflix Style" payment arrangement for the state of Washington.

The question is, when President Bernie Sanders initiates Medicare for All, is this what new drug roll-outs are going to look like?  It feels eerily similar to how defense contracts are awarded right now.  And maybe that isn't such a bad thing.
But if you'll notice, there aren't too many smaller companies competing for those bids, so what effect would that have on Biotechs?

The revolving door of Immunomedics is still spinning



https://endpts.com/roiled-by-c-suite-turmoil-and-a-crl-immunomedics-salutes-cmo-rob-iannone-as-he-makes-a-quick-exit/

It wasn't that long ago that CMO Rob Iannone was standing on the stage in San Diego accepting an award for best clinical candidate.

Now he is leaving Immunomedics shortly after the CEO departed and the recent rejection of their candidate sacituzumab govitecan.  Phew, this has been an exhausting turn.  And to be honest, I would be surprised if this was the end of the bad news.

Hopefully they can turn this around sometime soon.

Bicycle Therapeutics is filing for an IPO because...



Bicycle Therapeutics is filing for an IPO because... It turns out that clinical trials are expensive. Either way, Its great to see another novel approach to ADC's (even if not technically an ADC) moving forward and having success. I'm a huge fan of novel approaches to targeted drug delivery, what do you think? https://lnkd.in/eRPVgWR hashtagADC hashtagBicycleTherapeutics hashtagmanufacturing hashtagtrials

Photolabile Payloads? Yes Please!



https://pubs.rsc.org/en/content/articlepdf/2019/cc/c9cc02050k

To be fair, this is tagentially related to ADCs at best.  But it is also exceedingly cool technology.  The basic idea is to create a labile linker to a standard chemotherapy treatment that can be activated through the use of light shined on the tumor. 

The article describes lots of the issues, like the fact that tumors arent transparent.  But one can conceive of a way around that (long wavelengths), and could even see a world where these are targeted and internalized (here is where ADCs come in)

So in summary, it is three steps removed from being real.  But maybe this is something to watch out for in the 5th generation of ADC development?