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
- 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


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
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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