Wednesday, August 7, 2019

ADCDaily - Aug 7th, 2019 - 5 Things in ADCs this Week


Hello again everyone,

It's time again for another update on the world of ADC. There's been lots of good stuff happening as always in our industry and I'm excited to put some highlights below for you to take a look at.
But before we start with that, I have been working on making it easier to get these updates to you without completely relying on you checking your LinkedIn feed. So if you are interested, I have set up an email newsletter service through my blog site.

So if you want to sign up, click on that box on the left hand column of this page.

And lastly, thank you again for taking the time to read these articles. It seems like I wasn't the only one feeling like an ADC news roundup would be useful. So if you like these and want more, please like, comment, or reshare them because every time you do, it makes it that much easier for me to convince my boss that this is a worthwhile use of my time. And now, on to the good stuff...

1. Video of ADC killing mouse cells

Ok, I know that I already shared this on LinkedIn, but it is just that cool. I have watched this video dozens of times. And when the cells explode like balloons it's just too cool. Maybe this isn't the newsiest thing, but it definitely will add some pep to your step when you get into lab next.

Drug Discovery (Source website)

**Side note: I've also watched the video while only looking at the left side of the screen, and that alone is still amazing.

2. New Frontiers in ADC Development

This article is a bit of a longer read, but this is what happens when you get a bunch of the strongest voices in ADCs together to talk about their industry. Tons of good insight and predictions. A realistic look at the industry today as well as some thoughts on where the industry has failed to meet expectations. The article isn't short, but is worth the time for sure.


The article is great, but some of my favorite insights are:
  • When asked what successes ADCs have had, Chris Martin (ADC Therapeutics CEO replied, "Great drugs are built on the shoulders of good drugs, and the progression over the last five years...is a testament to this."
  • The author asked the panel what are ADCs biggest challenges going forward, and it was fascinating to see how different and varied every answer was depending on their backgrounds and current roles.
  • And when asked what the future holds, the responses ranged from new combination therapies, and payload/linker technologies, to non-oncology applications and expansion of the current marketing authorizations.
3. A pair of articles for my fellow ADC nerds out there

There were two articles that I came across that got my mind running. The first is a comprehensive report of the application of different mass spec technologies to ADC characterization.


To be fair, as a process guy, I don't really understand all of the specifics and nuances that this article covers, but I can tell this is something worth taking a look at for anyone who can properly spell Triple Quad LC-MS/MS

The second article is actually a white paper put out by Innate Pharma trying to sell some aggregation standards.


The short version is that they used their aggregate standard to test a bunch of different conjugates. The cool part is where they were able to use the Temperature of Aggregation (Tagg) as a proxy for aggregation propensity. The paper looks at this on the final product, but it's also potentially a very cool assay that could be helpful in process development. Has anyone played with this to see how process changes can affect ADC stability? I'd be interested to see how this can apply not only across multiple constructs like they look at, but at different times during conjugation. Specifically, around cysteine reduction.

4. Market Reports

Maybe someone out there can help me with this one. As I spend a significant amount of time each week curating all of the interesting stories that I can find about ADCs I invariably come across an incredibly large number of these ADC Market Reports. Here are some examples from the last two weeks alone:


And I have links to at least 6 more of these. All looking the exact same. All telling the same thing. All announcing great and immense growth in the upcoming years. Each one is published by a different company, but they are all asking for ~$3280 for access to the PDF report. Who is buying these things? And how can there possibly be so many? Maybe this is the Pharma market equivalent of the Nigerian prince who wants you to hold onto his money for him.

5. Other Links


This is the first article in this edition of the journal Drugs. It is the science journal version of a montage on the approval of Polivy. So if you want to see the entire package wrapped into a nice little story, look no further.


 I know this isn't about ADCs, but if you're like me, you spend an extraordinary amount of time paying attention to ADCs but only hear tangentially about Gene Therapy and its goings-on. So, for those of us who aren't as informed as we might like, the New England Journal of Medicine put together a fantastic report.

Justin's Thoughts:

Putting together these news summaries has been a lot of fun so far, and there is another idea I have been interested in, but I need your help. Instead of putting together a summary of the latest news, I have been interested in diving a little deeper on a specific topic and trying to put something together that is a little more holistic on one specific area of ADCs.

All of that being said, here is the part where we switch to a choose your own adventure novel. Below are a couple of topic areas I have been thinking about. Vote for your favorite in the comments section below, and I will get working on writing up the winner. And as a second check that this is actually interesting to anyone, I'll say the threshold for a go story will be 20 votes.

Choose Your Own Adventure - Volume 1

A) Epitope Masking as an ADC strategy
B) Non-oncology ADC applications
C) Virtual Companies in the ADC space
D) Other? (Got ideas? Lets hear them!)

Have a great week everyone!
-Justin

Monday, August 5, 2019

ADC Links - Aug 5th, 2019

Videos -

Antibody Drug Conjugate (ADCs) killing mouse breast cancer cells
DRUG DISCOVERY
-The first link is to a video showing cells being killed by an ADC vs its control sample.  In a world of adding clear liquids to clear liquids with very little payout, this concrete video makes me happy.  The second link is the original article, scroll down a ways and the ADC section is in there


Industry -

New Frontiers in ADC Development
The Medicine Maker
- Really interesting article with an interview from some of the major players in the ADC space.  Very long, but also very good with lots of insight into yesterday, today, and tomorrow

Antibody-drug Conjugate Market Top key Players, Size, Share, Demand, Opportunities And Forecasts To 2025
Antibody Drug Conjugate Market Size Is Estimated To Grow at a CAGR of 19% Till 2023 | Industry Trends, Key Players and Global Market Analysis By MRFR
Global Antibody-Drug Conjugate Market Size & Growth by 2019-2024: Companies, Opportunities, Challenges, Growth, Countries, RevenueAntibody Drug Conjugates (ADCs) Market Size: Analysis and In-depth Research on Industry Size, Trends, Emerging Growth Factors and Regional Forecasts to 2025
Antibody Drug Conjugates (ADCs) Market Sales Volume by Global Industrial Growth Rate, Size, Shares, Productions, Demands and Supply Analysis from 2019
Global Antibody-Drug Conjugate Market Size Forecast by 2019-2024: Applications, Geographic Regions, Opportunities, Challenges, Drivers
ANTIBODY-DRUG CONJUGATES MARKET IS SEEING EXPLOSIVE GROWTH BY FUTURE INDUSTRY WINNERS: FORECAST, 2019-2030
GLOBAL CANCER ANTIBODY DRUG CONJUGATES MARKET 2019 ANALYSIS BY TRENDS, SHARE, TOP KEY PLAYERS & FORECAST TO 2025
Antibody Drug Conjugate Market to Experience Significant Growth During the Forecast Period 2018-2025
- Can anybody explain to me why these reports exist?  And how can there possibly be twenty different companies all doing the same research and reaching the same conclusions.  There are at least 5 of these per week, and I just don't understand how there can be that many, and for the low low price of $3280 for an online PDF.  What am I missing?

Weekly Research Analysts’ Ratings Updates for Sutro Biopharma (STRO)
Mayfield Recorder
- In case you wanted to see what happens in the world of cash that flows around the science.  This is a neat little timeline of the Sutro investment ratings.  At some point, I have to wonder if Zachs Investment is just pushing recommendations around to make their customers feel like something is happening.  How can they change their rating on Sutro 5 times in two months

Polatuzumab Vedotin: First Global Approval
Drugs
- Polivy is live and approved.  Here is a nice summary of its journey to get you up to speed

Single‐Use Technology in Biopharmaceutical Manufacture, Second Edition
Wiley and Sons
- Single-use is all the rage in ADC manufacture these days, take a look at Ch 27  Progress in the Development of Single-Use Solutions in Antibody-Drug Conjugate Manufacturing for the good stuff

Regulatory -

Aetna and Anthem will now pay for more kids with a devastating rare disease to get a $2.1 million drug, reversing earlier denials
Business Insider
- People said that $2.1M was too expensive for a drug treatment.  That insurance companies would never cover such a thing.  But here you have Novartis' Zolgensma doing just that.  Curing disease is a powerful thing, and with the pictures of cute kids behind it, the insurance companies will come around eventually.  This is good news for ADCs as well as they aren't cheap by any stretch either

E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES
FDA
- I can't claim to have any great insights into the world of FDA regulation within Clinical Trials, but in case any of you do, they just released a new recommendation document

Manuscripts -

Combination Treatment with an Antibody–Drug Conjugate (A1mcMMAF) Targeting the Oncofetal Glycoprotein 5T4 and Carboplatin Improves Survival in a Xenograft Model of Ovarian Cancer
Targeted Oncology
- This is a pretty unique application of ADCs to prolong progression-free survival.  They are working in combination with platinum-based chemo to target an antigen which becomes expressed as an early sign of disease recurrence

Bioconjugation
Methods in Molecular Biology
- Take a look.  If you are involved in the science of ADC conjugation, then this will be interesting

Investigation of Antibody-Drug Conjugates by Mass Spectrometry
Advancements of Mass Spec in Biomedical Research
- Put your nerd hats on, this is a deep dive into Mass Spec and its application to ADCs

Prediction of Aggregation Propensity and Monitoring of Aggregation of Antibody-Drug Conjugates (ADC) using ProteoStat® Reagents
Drug Target Review
- This is a white paper put out by Innate Pharma.  But it's also potentially a very cool assay that could be helpful in process development.  Has anyone played with this to see how process changes can affect ADC stability?  I'd be interested to see how this can apply not only across multiple constructs like they look at, but at different times during conjugation.  Specifically around cysteine reduction


Reports -

Gene Therapy
New England Journal of Medicine
- I know this isn't about ADCs, but if you're like me.  You spend an extraordinary amount of time paying attention to ADCs but only hear tangentially about Gene Therapy and its goings-on.  So, for thos of us who aren't as informed as we might like, the New England Journal of Medicine put together a fantastic report

Clinical Results -

Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer
Lung Cancer
- Rova-T is not dead yet.  Well, to be fair, I don't know.  But at least this report says that Japanese patients exhibited tolerable toxicity and saw partial response rates of 17%.  They conclude that this is worth further investigation, but that doesn't necessarily mean there will be

Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy
UroToday
- SeaGen keeps rolling with a 44% objective response rate in their pivotal trial.  They are getting closer and closer to bringing their second wholly owned ADC asset


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Thats it for today. There are always more coming down the pike. Is there something I missed? Contact me. Justin@ADCDaily.com
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Monday, July 29, 2019

5 Things to Watch in ADCs this week - July 26th, 2019


This is the second article in my series of updates about the goings on in the world of ADCs over the last two weeks. Thank you all for the likes and comments on the first article. Here is what I have been watching this week.

1.     Seattle Genetics Wins

Clearly the past two weeks were a good stretch for them. So, I've put together the simple SeaGen 3 step plan for ADC success:
Step 1: File a press release where you say that your leading commercial ADC has increased sales by 30%, you have filed a BLA for your second leading candidate, and your third ADC candidate is looking good and expected to be just six months until the release of pivotal Phase II data.

Step 2 : Tell the newly eager investors that you are going to do a round of public financing and that they have the opportunity to give you $500M.

Step 3 : Close said round of funding 3 days later with an extra $575 million in your pocket.

Bravo guys, Bravo.

2. CapEx approval for ADC manufacturing at CDMOs is on the rise

In a very subtle move Lonza is announcing their plan to expand their commercial conjugation facility upon approval of their third commercial ADC (cough...cough...Polivy) with the first two being Kadcyla and my guess is they are the secondary supplier for Adcetris. Now clearly this puts Lonza as the unquestioned leader in ADC conjugation CDMO work, but that doesn't mean they are the only people at the CapEx party.

ADC Bio is just getting their $11M cGMP facility on-line to enable full production of ADCs up to small scale commercial production. This goes along with the WuXi news that we talked about in the last article and Aji Bio who got into the fray at the end of 2018.
Now the question becomes, how much capacity is needed in the ADC Conjugation space, and does their become a point where commercial demand moves beyond the current picture of Lonza having all ADCs not owned by Pfizer, and Pfizer making the other two internally.

3. Antibodies are important, but not the whole story

There were a bunch of stories this week looking at how ADC structure beyond the epitope binding region can affect efficacy. With each one adding a bit to the complex ADC world that we find ourselves in.

If you thought that linker chemistry didn't have an effect on therapeutic index, guess again. By building and testing stereoisomers of linkers with an IGN payload the team at ImmunoGen is showing that linkers are an active participant in ADC therapeutic index.
Now whenever we talk about biologics complexity, there is a legal obligation to give the post-translational modification guys a shout out.


So a team at Oxford developed a native mass spec method to test the structure and function of glycosylation heterogeneity. The answer is always, "Its complex", but a more accurate method is always valuable.
I always find myself wondering what a dinner conversation would look like between groups like this and companies like Sutro or Synaffix who both do away with glycosylation (albeit by very different methods)

4. Targeted Bacteria for Tumor Regression

This is not about ADCs at all but I can't help but share this story because it is just too cool.

Researchers a Columbia have managed to take the "smart bomb" approach of ADCs and apply it to living bacterial cells. The bacterial selectively bind to a CD47 antigen within the tumor which then allows for the body to fight off the "infection" which results in both bacterial cell death along with tumor regression. I'm sure this is a long way from a real treatment, but this is still amazing research

5. A couple links that you shouldn't miss

Sometime last year PBDs stopped being the cool kid at the party. And just like junior high, that may or may not have been fair. But when the FDA feels the need to write up a summary, it is most defintely worth a read.

TL:DR alert. However, if you want a riveting and well-told tale about the history and possible future of CAR-T, then check out this story

A new book has been published covering all aspects of ADC Payloads. Plan on having this sitting on your desk shelf as the definitive guide to ADC payloads for the next 5-10 years.

Justin's Thoughts:

Thanks again for taking the time to read these things. It takes quite a while to mine through all of the different websites, filter through the articles that are actually interesting, and then put something together that summarizes the main points. Hopefully it is useful for you all.
If there is anything that you find interesting in particular or would like to see more of, let me know in the comments and I can tailor these articles to cover those areas.

In the meantime, as I collect these articles, I put them on my blog:
If you want to see all of the articles that were at least tangentially related to the ADC world you can check them out here. It has been noted that the title is more of a dream than a reflection on reality. A more accurate title might be www.adcweekly-ish.com but I have a day job too.
And speaking of the day job. I clearly love to geek out about ADCs all the time, and if you want to chat about what your needs might be and whether or not Novasep might be able to help please don't hesitate to reach out to me directly. My email is Justin.Sweeley@novasep.com, or you can reach out through LinkedIn

In the meantime- check out our ADC offer at the following link:

Have a great weekend everybody.

Justin.


Friday, July 26, 2019

Update - July 26th, 2019

Webinars -

Designing Next-Gen Oncology Clinical Trials
Endpoints News
- Clinical trials in oncology are changing fast.  Don't get left behind

End-to-End Analytical Technology for Process and Quality Improvements in Biologic Drug Production
FiercePharma
- To the analytical folks out there.  Maybe this will be interesting

Regulatory -

Biosimilars Struggle to Gain Market Share in the U.S., Analysis Shows
Biospace News
- A really nice article discussing the reasons that US Biosimilars have not come to market at the same rate as they have around the world.  *Spoiler Alert* It all comes down to money

Seattle Genetics and Astellas Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Seattle Genetics
- SeaGen has just announced that they have filed a BLA for Enfortumab Vedotin based on their successful Pivotal Phase II Trial results.  Is this the potential 6th ADC to come to market?  I think we all hope so

Industry-

How Are Service Companies Responding to the Increased Interest in New Modalities, and What Regulatory and Market Hurdles Still Exist?
Bioprocess International
- Here a video from a panel discussion at CPhI about how CDMOs are handling the increased interest in new biologics technologies

The Promise and Price of Cellular Therapies
The New Yorker
- TL:DR alert.  However, if you want a riveting and well-told tale about the history and possible future of CAR-T, then click this link

Genmab Partners on Cancer Antibodies with BliNK Biomedical, Launches $503M U.S. IPO
GenEngNews
- Genmab is the latest ADC company to file an IPO and was able to increase their bank accounts to the tune of $503M.  They are working two different ADCs, Enapotamab vedotin and tisotumab vedotin which are both in Phase I/II development

Going inside cells, Sung Joo Lee has sketched some big goals for his small — but global — team of drug hunters
Endpoints News
- Orum therapeutics is a tiny team looking at doing some incredible work.  Will they be able to compete in the ADC space with a conjugation specific staff less than that of the Starbucks you went to on your way to work this morning?  Time will tell

CDMOs driving drug conjugate innovation, says ADC Bio
Bioprocess International
- ADC Bio is about to complete their $11M investment into their cGMP Bioconjugation facility.  With 80% of ADC manufacturing being outsourced, there a lot of companies trying to vie for that work, but with WuXi, Aji Bio and Lonza all announcing large CapEx projects in the past couple of weeks, is the market getting saturated with capacity

Seattle Genetics Reports Second Quarter 2019 Financial Results
Seattle Genetics
- Adcetris sales are up 30%, Enfortumab vedotin has BLA filed, Tisotumab vedotin pivotal data expected first half of next year.  Even for a pillar of the ADC industry, this is a very impressive report
Here is The Motley Fool's take on it

Seattle Genetics Announces Pricing of Public Offering of Common Stock
Seattle Genetics
- What do you do with a spectacular quarterly report.  Open your arms and let the money flow in.  Approximately $500M to be exact.  That will help with funding the commercialization of Enfortumab vedotin

Seattle Genetics Announces Completion of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares
BusinessWire
- And boom, that was fast.  Three days later and their wallets are $575M heavier

Roche doomsday is here: Long-feared Herceptin, Avastin biosims bust into U.S. market
FiercePharma
- The biosimilar march is starting slowly, but starting all the same.  Surprisingly, there is only a 15% discount on the biosimilar over the originator drug which is a major departure from the 80-90% reduction in small molecule generic drugs

Lonza Expands Bioconjugation Facility and Announces Approval of Third Commercial ADC
ThomasNet
- In a very subtle move Lonza is announcing their plan to expand their commercial conjugation facility upon approval of their third commercial ADC (cough...cough...Polivy) with the first two being Kadcyla and my guess is they are the secondary supplier for Adcetris

Manuscripts -

Programmable bacteria induce durable tumor regression and systemic antitumor immunity
Nature Medicine
- Ok, this is just plain cool.  Researchers a Columbia have managed to take the "smart bomb" approach of ADCs and apply it to living bacterial cells.  The bacterial selectively bind to a CD47 antigen within the tumor which then allows for the body to fight off the "infection" which results in both bacterial cell death along with tumor regression.  I'm sure this is a long way from a real treatment, but this is still amazing research

Relating glycoprotein structural heterogeneity to function – insights from native mass spectrometry
Current Opinion in Structural Biology
- A very thorough review on glycoprotein heterogeneity out of a team from Oxford.  Including a interesting discussion about function of glycosylation.  Seems particularly interesting considering many ADC companies are looking at doing away with glycosylation entirely.  I'm looking at you Sutro and Synaffix

Cytotoxic Payloads for Antibody–Drug Conjugates
Royal Society of Chemistry
- A new book has been published covering all aspects of ADC Payloads.  Plan on having this sitting on your desk shelf as the definitive guide to ADC payloads for the next 5-10 years

Effect of Linker Stereochemistry on the Activity of Indolinobenzodiazepine Containing Antibody–Drug Conjugates (ADCs)
ACS Medicinal Chemistry Letters
- If you thought that linker chemistry didn't have an effect on therapeutic index, guess again.  By building and testing stereoisomers of linkers with and IGN payload the team at ImmunoGen is showing that linkers are an active participant in ADC TI

An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates
Regulatory Toxicology and Pharmacology
- When the FDA puts out a paper talking about PBD toxicity in ADCs it is probably worth a read.  This one is no exception with trial summaries, recommendations, and target dosings

Toward point-of-care assessment of patient response: a portable tool for rapidly assessing cancer drug efficacy using multifrequency impedance cytometry and supervised machine learning
Microsystems and Nanoengineering
- I'm not going to lie. Statements like, "phase change spectra obtained from multi-frequency impedance cytometry" are making my head spin.  But this looks it could be a very novel way to test ADC efficacy in vivo, but no guarantees because this paper is over my head

Reports -

Indoco caught in maelstrom of FDA concerns as plant hit with warning letter
FiercePharma
- Do you know what is happening with your CDMO?  cGMP is hard, and the FDA is relentless.  This is probably why you see most of the ADC world staying with manufacturing in the US and EU

FDA investigators discover key Strides Pharma quality records in shredding room
FiercePharma
- Don't be surprised if you are getting deja vu.  This article is almost identical to the one above, but worse and with more examples of malfeasance.  Never take your CDMO for granted, and always audit thoroughly

Clinical Results -

New Trastuzumab Combo Therapy Shows Potential in HER2-Expressing Breast Cancers
Specialty Pharmacy Times
- Synthon's herceptin based HER2 ADC is humming along with some good Phase I results showing a 33% ORR

HER2 Heterogeneity Impacts Response Rates in HER2-Positive Breast Cancer
CancerNetwork
- Intratumor heterogeneity of HER2 expression shows differential efficacy in patients.  Meaning that on top of all of the other challenges now we have data that show the system to be even more complicated.  Very interesting read

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Thats it for today. There are always more coming down the pike. Is there something I missed? Contact me. Justin@ADCDaily.com
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Friday, July 12, 2019

Update - July 12th 2019

Regulatory -

Fast-Track Drug Approval, Designed for Emergencies, Is Now Routine
Wall Street Journal
- Don't look now, but as we reported earlier, the Wall Street Journal has noticed that Fast-Track designation doesn't mean all that its cracked up to

The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews
Endpoints News
- When the FDA speaks we should listen.  Janet Woodcock speaks with SVB Leerink about regulatory changes that are coming down the pike.  Well worth a read

The hits keep coming: Apotex loses 31 drug approvals after FDA cites plants for 'inadequate' controls
FiercePharma
- I am reminded of the phrase, "if you think you own your house, try not paying your property taxes and see what happens."  CDMO choice matters, and a thorough, and regular QA review is mandatory for the continued success of your operation.  Need more proof, here is another eerily similar story:
Warning letter faults Akorn management for plant failures
-Metal shavings in your lidocaine?  That can't be good

Industry -

WuXi AppTec raising U.S. profile to counter political attacks
Biocentury
- In the wake of a lot of bad press about Chinese companies, WuXi is trying to fight back

A TRANSGLUTAMINE TAG FOR EFFICIENT SITE - SPECIFIC BIOCONJUGATION
US Patent Application
- Merck has a significant ADC portfolio growing in their European group, and clearly they are also interested in building a suite of patented conjugation technologies for further optimize these constructs

ADC Therapeutics has raised $550M-plus in its quest for their first BLA — and here’s why that’s important
Endpoints News
- Looking at clinical results is an important but lagging indicator.  If you want to know who is going to make waves in the near future, look at who is raising money.  And time and again, that seems to be ADC T

Manuscripts -

Synthesis and evaluation of pyrrolobenzodiazepine dimer antibody-drug conjugates with dual β-glucuronide and dipeptide triggers
European Journal of Medicinal Chemistry
- If the therapeutic window of PBDs is too small, then masking could be a viable option to move forward with

Abstract 4743: Using genome-wide CRISPR screen to understand resistance mechanisms to PCA062, a P-cadherin targeting antibody-drug conjugate
AACR Cancer Research
- This is a pretty cool approach to use CRISPR in order to understand the mechanism behind differential effectiveness of ADC therapies.  They were able to identify a drug resistance pathway contributing to ADC resistance

IMGC936, a first in-class ADAM9-targeting antibody-drug conjugate, demonstrates promising anti-tumor activity
Immunogen
- Here is a new target that Immunogen and Macrogenics are looking at.  The question is, how will this be affected by the shakeup currently going on at Immunogen


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Thats it for today. There are always more coming down the pike. Is there something I missed? Contact me. Justin@ADCDaily.com
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Thursday, July 11, 2019

Update - July 11th, 2019

Webinars -

Dr. Ready on Promising Treatment Approaches in SCLC
OncLive
- Dr. Ready talks about the failure of Rova-T and how it still demonstrates the feasibility of DLL3 as a target antigen for future therapeutics

Regulatory -

Bluebird Bio delays Zynteglo launch as manufacturing trips up another gene therapy
FiercePharma
- The FDA is tightening the screws on their GMP Biologics expectations.  This isn't directly related to ADCs but make no mistake, this is a precendent that we all must follow

Manuscripts -

Antibody-Drug Conjugate-Based Therapeutics: State of the Science
Journal of the National Cancer Institute
- A nice and recent update on the state of ADCs

Clinical Results -

MEN1309/OBT076, a first-in-class Antibody-drug Conjugate (ADC) targeting CD205 in solid tumors.
AACR - Molecular Cancer Therapeutics
- Oxford Bio is showing some good preclinical results about CD205 in TNBC grafts

Industry-

Seducing Pfizer: How Array’s team patiently worked up the ladder to win an $11.4B bid from Albert Bourla
Endpoints News
- Maybe its just me, but seeing behind the curtain about how these big M&A deals goes down is fascinating

BioAtla Appoints Eric Sievers, M.D., As Chief Medical Officer
Yahoo News
- BioAtla is bringing in some SeaGen muscle to help with their clinical trial platform

WUXI BIOLOGICS TO EXPAND INTEGRATED BIOLOGICS CONJUGATION SOLUTION CENTER TO INCLUDE COMMERCIAL MANUFACTURING
WuXi Press Release
- And WuXi continues on its path to world domination with a $10M expansion of their integrated biologics facility to include commercial product production

SpringWorks Therapeutics Announces Global Clinical Collaboration with GlaxoSmithKline to Evaluate Nirogacestat in Combination with Belantamab Mafodotin in Patients with Relapsed or Refractory Multiple Myeloma
Yahoo Finance
- SpringWorks Therapeutics is entering into a clinical colab with GSK for their Belantamab Mafodotin ADC.  GSK has not gone commercial with their ADC yet, but with that fast approaching, expect more of these coming in the future

Who's the next Big Pharma takeout target? Biogen, uniQure, AZ top the list: report
FiercePharma
- With all of the M&A activity, asking the industry insiders who's next isn't a bad plan.  And AZ pops out pretty high on the list.  Could this be the next step in their line of major shakeups

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