Wednesday, June 19, 2019

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

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