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MARINE PHARMACEUTICALS:
THE CLINICAL PIPELINE


As of June 2019, shown below are the marine-derived compounds which have been FDA-approved or are in Phase III, II or I of drug development and are part of the global marine pharmaceutical clinical pipeline since the review published by A.M.S. Mayer, K.B. Glaser, C. Cuevas, R.S. Jacobs, W. Kem, R.D. Little, J. M McIntosh, D.J. Newman, B.C. Potts and D. E. Shuster, Trends in Pharmacological Sciences, 31:255-265, 2010 TIPS (PDF Doc). This paper has been cited 538 times (Google Scholar).

Approved Marine Drugs 

Compound
Name
Trademark

Marine
Organism
Chemical
Class
Molecular
Target
US - Active Clinical
Trials
Europe, Australia- Active Clinical
Trials
Chinese - Active Clinical
Trials
Disease
Area
Company/
Institution
Plitidepsin** Aplidin® Tunicate Depsipeptide eEF1A2 None [7+] None Cancer: Multiple Myeloma, Leukemia, Lymphoma [Pharmamar]
Trabectedin
(ET-743)
Yondelis®
(2015)
*
Tunicate Alkaloid Minor groove of DNA [26+] [29+] None Cancer: Soft Tissue Sarcoma and Ovarian Cancer [Pharmamar]
Brentuximab vedotin
(SGN-35)
Adcetris®
(2011)
*
Mollusk/
cyanobacterium
ADC(MMAE) CD30 & microtubules [56+] [30+] None Cancer: Anaplastic large T-cell systemic maglinant lymphoma, Hodgkin's disease [Seattle Genetics]
Eribulin Mesylate (E7389) Halaven®
(2010)
*
Sponge Macrolide Microtubules [45+] [10+] None Cancer: Metastatic Breast Cancer [Eisai Inc.]
Omega-3-acid ethyl esters Lovaza®
(2004)
*
Fish Omega-3 fatty acids Trygliceride-synthesizing enzymes [18+] [1+] None Hypertriglyceridemia [GlaxoSmithKline]
Ziconotide Prialt®
(2004)
*
Cone snail Peptide N-TypeCa channel [1+] [1+] None Pain: Severe Chronic Pain [Jazz Pharmaceuticals]
Vidarabine
(Ara-A)
Vira-A®
(1976)*
Sponge Nucleoside Viral DNA polymerase [139+]  None None Antiviral: Herpes Simplex Virus [Mochida Pharmaceutical Co.]
Cytarabine
(Ara-C)
Cytosar-U®
(1969)
*
Sponge Nucleoside DNA polymerase [293+] [137+] [11+] Cancer:Leukemia [Pfizer]

* FDA Years Approved     ** Australia Dec 2018 Approved.

Phase III Clinical Status

Compound
Name
Trademark
Marine
Organism
Chemical
Class
Molecular
Target
US - Active Clinical
Trials
Europe - Active Clinical
Trials
Chinese - Active Clinical
Trials
Disease
Area
Company/
Institution
Plinabulin
(NPI-2358)
NA Fungus Diketopiperazine Microtubules [5+] None None Cancer: Non-Small Cell Lung Cancer, Brain Tumor [BeyondSpring Pharmaceuticals]
Tetrodotoxin HalneuronTM Pufferfish Guanidinium alkaloid Sodium Channel [1+] None None Pain: Chronic Pain [Wex Pharmaceutical Inc.]
Lurbinectedin (PM01183) Zepsyre® Tunicate Alkaloid RNA Polymerase II [6+] [5+] None Cancer: Ovarian Cancer, Breast Cancer, SCLC [Pharmamar]
Depatuxizumab mafodotin
(ABT-414)
NA Mollusk/
cyanobacterium
ADC (MMAF) EGFR & microtubules [4+] [+3] None Cancer: Glioblastoma, Pediatric Brain Tumors [AbbVie]
Polatuzumab vedotin 
(DCDS-4501A)
NA Mollusk/ cyanobacterium ADC (MMAE) CD79b & microtubules [3+] [4+] None Cancer: Non-Hodgkin lymphoma, Chronic lymphocytic leukemia, Lymphoma, B-Cell, lymphoma, Follicular [Genentech/Roche]
Marizomib (Salinosporamide A; NPI-0052) NA Bacterium Beta-lactone-gamma lactam 20S proteasome [4+] None None Cancer: Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma, Lymphoma, Multiple Myeloma [Triphase]
Enfortumab Vedotin
ASG-22ME
NA Mollusk/ cyanobacterium ADC (MMAE) Nectin-4 & microtubules [4+] None None Cancer: Tumors; Medical Oncology; Neoplasms; Metastatic Urothelial Cancer [Seattle Genetics]

Phase II Clinical Status

Compound
Name
Trademark
Marine
Organism
Chemical
Class
Molecular
Target
US - Active Clinical
Trials
Europe - Active Clinical
Trials
Chinese - Active Clinical
Trials
Disease
Area
Company/
Institution
GTS-21
(DMXBA)
NA Worm Alkaloid α7 nicotinic acetylcholine receptor [1+] None None Schizophrenia, Alzheimer Disease, Attention Deficit Hyperactivity Disorder, Endotoxemia, Sepsis, Vagal Activity No Link
AGS-16C3F NA Mollusk/
cyanobacterium
ADC (MMAF) ENPP3 & microtubules [1+] None None Cancer: Renal Cell Carcinoma [Agensys & Astellas Pharma]
Plocabulin
(PM184)
NA Sponge Polyketide Minor groove of DNA [2+] None None Cancer: Solid Tumors [Pharmamar]
Tisotumab Vedotin HuMax®-TF-ADC Mollusk/ cyanobacterium ADC (MMAE) Tissue Factor & microtubules [4+] None None Cancer: Ovary Cancer, Cervix Cancer, Endometrium Cancer, Bladder Cancer, Prostate Cancer (CRPC), Cancer of Head and Neck (SCCHN), Esophagus Cancer, Lung Cancer (NSCLC) [GenMab]
GSK2857916 NA Mollusk/ cyanobacterium ADC (MMAF) BCMA [6+] None None Cancer: Multiple Myeloma [GlaxoSmithKline]
Ladiratuzumab vedotin
(SGN-LIV1A)
NA Mollusk/
cyanobacterium
ADC (MMAE) LIV-1 & microtubules [4+] None None Cancer: Breast Cancer [Seattle Genetics]
Bryostatin NA Bryozoan Macrolide
Iactone
Protein kinase C [1+] None None Alzheimer's Disease [Neurotrope BioScience]
Telisotuzumab vedotin
(ABBV-399)
NA Mollusk/ cyanobacterium ADC (MMAE) c-Met [1+] None None Cancer: Solid tumors [Abbvie]
Pinatuzumab vedotin NA Mollusk/ cyanobacterium ADC (MMAE) CD22 [1+] [1+] None Cancer: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma [Genentech]
Enapotamab vedotin (HuMax-AXL) NA Mollusk/ cyanobacterium ADC (MMAE) Axl RTK [3+] None None Cancer: Ovarian Cancer, Cervical Cancer, Endometrial Cancer [Genmab]
RC-48 NA Mollusk/ cyanobacterium ADC (MMAE) HER2 [7+] None None Cancer: Urothelial Carcinoma, Advanced Cancer, Gastric Cancer, HER2 Overexpressing Gastric Carcinoma, Advanced Breast Cancer, Solid Tumors [RemeGen]
CAB-ROR2 (BA-3021) NA Mollusk/ cyanobacterium ADC (MMAE) ROR2 [1+] None None Cancer: Solid Tumor, Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Soft Tissue Sarcoma [BioAtla]
CX-2029 NA Mollusk/ cyanobacterium ADC (MMAE) CD71 [1+] [1+] None Cancer: Solid Tumor, Head and Neck Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer, Diffuse Large B Cell Lymphoma [AbbVie & CytomX Therapeutics]
W0101 NA Mollusk/ cyanobacterium ADC (MMAE) IGF-R1 [1+] [1+] None Cancer: Advanced or Metastatic Solid Tumors [Pierre-Fabre]

Phase I Clinical Status

Compound
Name
Trademark
Marine
Organism
Chemical
Class
Molecular
Target
US - Active Clinical
Trials
Europe - Active Clinical
Trials
Chinese - Active Clinical
Trials
Disease
Area
Company/
Institution
ABBV-085 NA Mollusk/ cyanobacterium ADC (MMAE) LRRC15 [1+] None None Cancer: Solid tumors [Abbvie]
ASG-67E NA Mollusk/ cyanobacterium ADC (MMAE) CD37 & microtubules [1+] None None Cancer: Refractory Lymphoid Malignancy; Relapsed Lymphoid Malignancy [Astellas & Seattle Genetics]
ASG-15ME NA Mollusk/ cyanobacterium ADC (MMAE) SLITRK6 & microtubules [1+] None None Cancer: Metastatic Urothelial Cancer [Astellas & Seattle Genetics]
ARX-788 NA Mollusk/ cyanobacterium ADC (MMAE) HER2 & microtubules [1+]
None None Cancer: Breast Cancer, Gastric Cancer [Ambrex & Zhejiang Medicine]
SGN-CD48A NA Mollusk/ cyanobacterium ADC (MMAE) CD48 & microtubules [1+] None None Cancer: Multiple Myeloma [Seattle Genetics]
XMT-1536 NA Mollusk/ cyanobacterium ADC (Dolaflexin) NaPi2b & microtubules [1+] None None Cancer: Solid tumors [Mersana Therapeutics]
ALT-P7 NA Mollusk/ cyanobacterium ADC (MMAE) HER2 & microtubules [1+] None None Cancer: Breast cancer, Gastric cancer [3SBio & Alteogen]
MORAb-202 NA Sponge ADC (Macrolide) Microtubules [1+] None None Cancer: Solid Tumors [Eisai]
PF-06804103 NA Mollusk/cyanobacterium ADC (Auristatin variant) HER2 [1+] None None Cancer: Breast Neoplasms, Stomach Neoplasms, Esophagogastric Junction Neoplasm, Carcinoma, Non-small-cell Lung [Pfizer & AbbVie]
ZW-49 NA Mollusk/cyanobacterium ADC (Auristatin variant) HER2 [1+] None None Cancer: HER2-expressing Cancers [Zymeworks & BeiGene]

Abbreviations:

ADC: Antibody Drug Conjugate;
Ara-A: 9-β-D-arabinofuranosyladenine
Ara-C: Cytosine Arabinoside
BCMA: B-cell Maturation Antigen
CD: Cluster of Differentiation;
c-Met: Tyrosine-Protein Kinase Met
DMXBA: 3-(2,4-Dimethoxybenzylidene)-Anabaseine
EGFR: Epidermal Growth Factor Receptor;
ENPP3: Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3
FDA: Food and Drug Administration;
GPNMB: Glycoprotein nonmetastatic B;
LIV-1: Zinc transporter SLC39A6;
LRRC15: Leucine rich repeat containing 15
MMAE: Monomethylauristatin E;
MMAF: Monomethylauristatin F;
NaPi2b: Sodium-Dependent Phosphate Transport Protein 2b;
PSMA: Prostate-Specific Membrane Antigen;
TIM-1: T-cell Immunoglobulin domain 1 

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