Update - June 19th, 2019

Webinars -
Regulatory -

An incensed Catalyst Pharma sues the FDA, accusing agency of bowing to political pressure and breaking federal law
Endpoints News
- In a position envied by no-one, the Catalyst team is suing the FDA in order to allow them to continue to charge more than double what a comparable competitor would charge.  Sometimes profits are more important than PR

Merck helps FDA test blockchain for track and trace
FiercePharma

- The FDA is starting an innovative blockchain based program to track pharmaceuticals as the move around the country.  This is an interesting application which can take advantage of the both the anonymity of blockchain as well as its traceability. Results should be reported at the end of the year

Pharma Companies Sue Trump Administration Over Price Disclosure Mandate
Biospace
- Of course companies are worried about disclosing pricing on their commercials.  But I'm sure Carls Jr. didn't want to disclose calories on their burgers either


Partnerships -

ADC Therapeutics raise $76m in Series E expansion
European Biotechnology
- ADC is continuing their growth with another $76M to put into the bank and to help their first BLA application for the PBD based DLBCL targeting ADC

Manuscripts -

Characterization of Positional Isomers of Interchain Cysteine Linked Antibody−Drug Conjugates by High-Resolution Mass Spectrometry
Journal of Analytical Chemistry
- A new mass-spec technique for characterizing interchain cysteine residues resulting from stochastic cysteine conjugation reactions

Marine-Derived Anticancer Agents: Clinical Benefits, Innovative Mechanisms, and New Targets.
Marine Drugs
- With the recent failures of Rova-T and the deprioritation of PBDs by SeaGen there is a renewed interest in widening the therapeutic window of ADCs through warhead selection.  This is an overview of the field of marine prospection for new anticancer molecules

The BCMA bonanza
Nature Reviews
- Aside from the spectacular title. This is a great review of all of the different modalities currently targeting BCMA including the GSK ADC belantomab mafodotin

Quality by Design: A Holistic Approach to Drug Development
Thermo Fisher White Paper
- A nice summary of QdB within drug development and how to apply those principles in the biopharma space

Industry -

Drug to Replace Chemotherapy May Reshape Cancer Care
Bloomberg News
- Nice in depth article about Daiichi/AZs DS-8201 molecule and its broader context in the biologics markets

The top 10 blockbuster drugs in the late-stage pipeline — Evaluate adds 6 new therapies to heavy-hitter list
Endpoints News
[Original Report ]
- There are 2 different ADCs on this list with DS-8201 and sacituzumab govetecan both making the list for highest potential

Sorrento Provides Updates on CD38 Immunotherapies and Implementation of Disruptive GMP Manufacturing for “Off-The-Shelf” Cell Therapy
Sorrento Press Release
- Sorrento is pushing hard to bring their new technologies into the market including in their ADC platform with their first ADC IND to be submitted later this year

Clinical Results -

Sutro Biopharma Announces Encouraging Interim Phase 1 Safety Data on a Potential First-in-Class Antibody-Drug Conjugate STRO-001 for the Treatment of B-cell Malignancies at the European Hematology Association Congress
Sutro Press Release
- Sutro is announcing their first clinical results from their STRO-001 molecule.  This is the first-in-human application of their novel cell-free expression platform and looks encouraging.  More to come as dose limiting toxicities were not reached so dose escalation can continue
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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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Daily Update - Tuesday June 11th, 2019

Regulatory -

FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma
FDA
- FDA grants accelerated approval of Polivy to Genentech.  One more approval is always a good day for ADCs in general

Manuscripts -

A Physical Organic Approach to Tuning Reagents for Selective and Stable Methionine Bioconjugation
ChemRxiv
- Cysteine conjugation is now well established for ADCs but can methionines be used to accomplish site-specific conjugation as well.  Look out THIOmab

Boronic acids as building blocks for the construction of therapeutically useful bioconjugates
Royal Society of Chemistry
- A nice review article about using boronic acids to find new bioconjugate targets

Considerations for the Design of Antibody-Based Therapeutics
Journal of Pharmaceutical Sciences
- Its easy to forget that every ADC is based on the mAb.  This is a nice review about the challenges and intricacies of mAb engineering

Clinical Results -

Positive results from RC48 Clinical Trial in HER2-Positive Metastatic or Unresectable Urothelial Cancer
Biospectrum Asia
- Phase II clincal results showing that HER2 is not limited to breast cancer.  IND to be filed later this year


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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

Science Friday!!

Happy Science Friday all.

HOW OLD ARE YOUR ORGANS? TO SCIENTISTS’ SURPRISE, ORGANS ARE A MIX OF YOUNG AND OLD CELLS
Salk Institute
- Scientists are showing that while we have known for a while that many neurons age is the same as that of the neurons owner.  This new discovery shows that many of our organs are a complex combination of new and old cells.  Many of our organs have cells which are as old as the organism itself.  Very interesting stuff.

Also, as you might be wondering why there is a nuclear test image up above.  This report reminded me of a story I heard about a few years back which detailed how they can actually do this type of testing.  And the answer is Carbon-14 which was created during the above ground nuclear testing done back in the cold war.  It is fascinating stuff.  Here is the original paper, and also a Smithsonian article about it.

Lack of tissue renewal in human adult Achilles tendon is revealed by nuclear bomb 14C
FASEB Journal

Nuclear Bombs Made It Possible to Carbon Date Human Tissue
Smithsonian Magazine

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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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Daily Update - June 5th, 2019

Regulatory -

ImmunoGen shares tank (again) after the FDA nixes a shot at an OK for its armed antibody in wake of a failed PhIII
Endpoints News
- ImmunoGen was trying to use their subset data of patients overexpressing FRa, but the FDA just rejected that attempt and is instead asking for a new Phase III trial.  If stock price is any indication, this is not good news for them

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer
FDA Press Release
- The FDA has been trying to make novel treatments available to more patients outside of the target audience of these trials.  They are pursuing this despite the mixed results seen so far

Clinical Results - (Its an ASCO party!)

Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting
Daiichi Sankyo Press Release
- Daiichi shows positive data for their 3rd ADC candidate, DS-1062, targeting  TROP2.  The data demonstrate that DS-1062 is safe and ready to progress into the dose escalation stage of the study

Ado-trastuzumab emtansine effective, safe in HER2-amplified salivary gland cancers
HemOnc Today
- Kadcyla continues to impress in new indications.  In this study the primary cohort of salivary gland cancer patients showed significant response enabling early meeting of primary endpoint, and immediate expansion into dose escalation phase of study

Mersana Presents Interim Phase 1 Data for XMT-1536 at the 2019 American Society of Clinical Oncology Annual Meeting
Mersana Press Release
- Mersana is releasing their clinical results for XMT-1536 at ASCO.  It looks like the treatment is well tolerated at the 20 mg/m2 dose.  Also the disease control rate was determined to be 61% in NSCLC and 71% in ovarian cancer

Seattle Genetics and Astellas Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer
SeaGen Press Release
- SeaGen shows a 44 percent response rate in patients and is full speed ahead for a BLA by the end of the year.  In related news, John Carroll interviewed SeaGen CEO Clay Siegall about this release and SeaGen more broadly.  Find that interview here

Seattle Genetics Announces Additional Analyses of ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials of ADCETRIS® (Brentuximab Vedotin) at the 2019 ASCO Annual Meeting
SeaGen Press Release
- And the second press release of the day shows that Adcetris continues to expand its indications with two more studies showing efficacy in Hodgkins and non-Hodgkins lymphoma after 3 years


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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

Update - June 3rd, 2019

Webinars -

Recent Advances and the Future of Antibody Engineering
GenEngNews
- June 11th, 11AM EST, Not ADC focused, but clearly related

Regulatory - 

Maryland creates drug affordability review board
BioCentury
- The rising complexity of oncological therapeutics comes with a higher price tag.  Thats starting to raise eyebrows in places.  And its only going to spread more

Partnerships -

ADC Therapeutics Expands to Third Program Using Synaffix’s ADC Platform Under Existing Agreement
Biospace
- ADCT continues to expand their catalog with Synaffix's site specific glycosylation modification platform.  They are up to 3 and counting.  Hopefully they also see success in the clinic

Manuscripts - 

A coiled-coil masking domain for selective activation of therapeutic antibodies
Nature Biotechnology
- SeaGen is at it again with a mAb agnostic masking domain to prevent antigen binding outside of the tumor microenvironmnet

SORLA regulates endosomal trafficking and oncogenic fitness of HER2
Nature Communications
- HER2 is a favorite target for ADCs because of the success of Herceptin as well as Kadcyla.  So any insight into the mechanism of internalization is good information to have


Reports -

Global Oncology Trends 2019 : Therapeutics, Clinical Development and Health System Implications
IQVIA
- A substantial overview of the changes and trends of the year.  Don't miss this one

IQVIA Global Oncology Trends: An Interview with Murray Aitken
Biospace
- And in a follow up to the above article, Murry Aitken gives an interview about the findings

Clinical Results - 

Daiichi Sankyo Presents Preliminary Phase 1 Data for HER3 Targeting ADC U3-1402 in Patients with EGFR Mutated NonSmall Cell Lung Cancer at 2019 ASCO Annual Meeting
Daiichi Sankyo Press Release
- Daiichi continues their stellar run at becoming one of the major players in the ADC space.  On top of the recent success of their DS-8201 asset, their HER3 ADC showed reduction in tumor size in 16 out of 16 patients

First-in-human, dose-escalation, phase (ph) I trial to evaluate safety of anti-Axl antibody-drug conjugate (ADC) enapotamab vedotin (EnaV) in solid tumors.
Journal of Clinical Oncology
- Genmab's anti-Axl ADC is showing progress and moving into the Phase IIa dose expansion with 7 of its original 45 patients




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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