Tuesday, September 17, 2019

ADCDaily.com - Sep 17th, 2019 - This Week in ADCs

Hello all,

It's been another big couple of weeks in the ADC world.  I'm still astonished at how quickly the news comes flying at us.    But hopefully that is exactly why this series of articles exists.

If you want to receive these updates directly to your inbox, then all you need to do is click on the link below:
Click Here to Subscribe to ADC Daily

Right now, this means that you will receive one link with all of the relevant links that I have found throughout my searching over the past week or two.  And then you will receive a copy of the 5 Things articles as they are published.   And I can tell you as I go through the articles this week.  There are way too many than I can talk about, so if you want a full picture, then you are going to want to subscribe.

We are just getting started, so don't miss out.  I mean, where else are you going to find a custom tailored list of ADC news and manuscripts specifically put together for the scientists and researchers in the world of ADC?

And now, on to the good stuff.

1. Webinar Alert : DoEs in ADCs presented by me

Now clearly this is a nice healthy dose of shameless self-promotion.  So click here, and register now!

Webinar: When to Apply Design of Experiments (DoE) to ADC Development

I have been trying to put together this presentation for the last 4 years, and thanks to the spectacular team in Le Mans, I've got some really good data to demonstrate the power of DoE in ADC development.  I absolutely love nerding out about DoEs, so at the very minimum you can watch me get entirely too excited about this stuff.  And, perhaps, you might learn something at the same time.  So if it sounds interesting, please register and check it out.

2. Have you heard?  ADCs can cure cancer!

Long-term remission by brentuximab vedotin for non-mediastinal gray zone lymphoma refractory to autologous stem cell transplantation
Clinical Lymphoma Myeloma and Leukemia

Here is a nice case study of a woman undergoing multiple rounds of chemotherapy without success until receiving 9 doses of Kadcyla.  This treatment resulted in a complete response that has lasted for 3 years.
Now we all know at an intellectual level that the work that we are doing has real impacts on humanity.  But when I see something like this, I just like to pause for a minute...

And for one brief moment lets forget about all of the other details, revenue targets, profit margins, FDA approvals...  And remember what it is that brings us into work on Monday morning.

3. Light Responsive ADCs

A light-responsive, self-immolative linker for controlled drug delivery via peptide- and protein-drug conjugates†‡
Royal Society of Chemistry

I don't know why, but I have always thought photosensitive prodrugs are an elegant solution to the toxicity issues often associated with ADCs.   This team shows a mechanism to deliver and release doxorubicin intracellularly through antibodies and light.
Most of the time when I see these types of things, I start worrying that you are adding extra complexity to an already complex endeavor, but I guarantee that is exactly what people in the mAb industry were saying during the start up of ADCs.  But wait, there's more...

Near Infrared Photoimmunotherapy: Photo-Activatable Antibody-Drug Conjugates (ADCs)
Bioconjugate Chemistry

If you thought I was excited about one photoactivated ADC. How about two?  This one using a near-infrared photoactivatable dye. 

4. Pay Attention to ADC Therapeutics

Now I can admit, I love economics, and it's possible that I pay too much attention to financials instead of just focusing on the science.  But my question to you all is this...

Currently, PBDs are having a little bit of a rough patch (as I have discussed before).  So based on technology alone, one would think that a company who's primary technology is based on PBDs would be having a little trouble raising money.

Swiss biotech ADC Therapeutics guns for $150M IPO

So then why is ADC T, after coming off of a very impressive funding round of over $275M and reaching a total funding of over $500M still able to look at another $150M in their upcoming IPO?

I've said this before, but it's worth repeating.  Good clinical results are vitally important, but they are a lagging indicator.  If you want to know what is coming up on the horizon.  Follow the money.

All I'm saying is, these guys are legit, and are definitely a company that you should keep your eye on.

5. The FDA wants to modernize

FDA to roll out modernization plan in push for data interoperability
Endpoints News\

FDA to Roll Out Modernization Plan in Push for Data Interoperability
Regulatory Focus

Alright, I have now read these two articles twice each.  And I am still confused.  So here is my summary:

The goal of the FDA is interoperability.  And with more interoperability, they will be more interoperable.  Did I mention that the FDA wants to modernize and increase their interoperability?  All things considered, this is a good thing, the FDA wants to move faster and get drugs to market faster, but if they are going to use the "I" word that many times it would probably be worth defining it.

However, you cannot change something without the inevitable pushback:

Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’
Endpoints News

And with any change, such as the above link, there is going to be pushback.  If the goal is faster, then at some point that means less of something.  And less of something usually means you are not including something which used to be included.  Apparently that has some researchers concerned that valuable information can be expunged.  Only time will tell, but it seems like this type of back and forth is usually the best way to get a good final outcome.

Justin's Thoughts:

Alright, there was one article that I wanted to share, but that I couldn't get myself to put in the 5 Things section

Big Pharma Sinks to the Bottom of U.S. Industry Rankings

Sure, its depressing to be the last in anything.  I mean, I can handle our industry being behind the Airlines, Banking, and Lawyers (to be honest, lawyers hurts a bit).  But to find out that pharma ranks behind Government in favorability is just adding insult to injury.  I guess people don't really care about cures for cancer, blind people regaining sight, or antibiotics and vaccines.  I mean, Polio wasn't really all that bad.

And on that note: One last plug for the Webinar because I can...

Webinar: When to Apply Design of Experiments (DoE) to ADC Development

Have a great week everyone!


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