(923.2) The 2021 Marine Pharmacology and Pharmaceuticals Pipeline

Poster Board Number: B200

Alex Wu (College of Pharmacy, Midwestern University), Karolina Jelielek (College of Pharmacy, Midwestern University), Henry Le (College of Pharmacy, Midwestern University), Maryam Butt (Chicago College of Osteopathic Medicine, Midwestern University), David Newman (NIH Special Volunteer, Natural Products Branch, National Cancer Institute), Keith Glaser (AbbVie Inc.), Marsha Pierce (College of Graduate Studies, Midwestern University), Alejandro Mayer (College of Graduate Studies, Midwestern University)

Objective:  Marine organisms continue providing significant chemical biodiversity that contributes to both the global preclinical and clinical pharmaceutical pipelines. A recently (2021) redesigned website www.marinepharmacology.org allows for easier and more frequent updates, thus highlighting the continuous progress in this area of marine pharmacology/pharmaceutical research and drug development.

Hypothesis: There has been progress in the approval and development of marine-derived drugs in 2021.

Methods:  The following four websites were researched to determine new marine-derived drugs approved in 2021: (a) USA:  https://www.accessdata.fda.gov/scripts/cder/daf/ United States Food and Drug Administration (FDA); (b) Europe: https://www.clinicaltrialsregister.eu/ctr-search/search European Clinical Trials register; (c) China:  https://www.chictr.org.cn/enindex.aspx Chinese Clinical Trials register; and (d)   www.clinicaltrials.gov to determine the current status of marine-derived compounds in Phase I, Phase II, and Phase III of drug development.

Results:  Our research supports our hypothesis because in 2021 there has been continued progress in the approval and development of marine-derived drugs. In 2021 the clinical marine pharmaceutical pipeline consisted of 15 marine-derived drugs approved by the FDA, 2 approved in Australia, and 1 approved in China: for cancer, cytarabine (Cytosar-U®, Depocyt®, FDA-approved 1969); for Herpes Simplex Virus, vidarabine (Vira-A®, FDA-approved 1976); for pain, ziconotide (Prialt®, FDA-approved 2004); for hypertriglyceridemia, omega-3-acid ethyl esters (Lovaza®, FDA-approved 2004, Vascepa®, FDA-approved 2012, Epanova®, FDA-approved 2014); for cancer, eribulin mesylate (Halaven®, FDA-approved 2010), brentuximab vedotin (Adcetris®, FDA-approved 2011), trabectedin (Yondelis®, FDA-approved 2015), panobinostat (Farydak®, FDA-approved 2015), plitidepsin (Aplidine®, approved in Australia 2018), polatuzumab vedotin (Polivy™, FDA-approved 2019), enfortumab vedotin-ejfv (PACDEV™, FDA-approved 2019), lurbinectedin (Zepzelca™, FDA-approved 2020, Australia 2021), belantamab mafadotin-blmf (Blenrep™, FDA-approved 2020), disitamab vedotin (Aidixi™, approved in China 2021), and tisotumab vidotin (Tivdak™, FDA-Approved 2021). Furthermore, we determined that there were 33 marine-derived compounds in active clinical trials in 2021: 5 marine-derived compounds were in Phase III, 12 compounds in Phase II, and at least 16 compounds in Phase I. Many of compounds classified as auristatin-containing antibody drug conjugates.

Conclusions:  In 2021, new marine-derived drugs were approved by FDA, as well as in Australia and China. The clinical development of marine-derived drugs remained very robust and active with several advancing to Ph III, Ph II and  entering at Ph I.

Supported by the Chicago College of Pharmacy and the College of Graduate Studies, Midwestern University