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Bavituximab

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Bavituximab

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Bavituximab
Monoclonal antibody
Type	Whole antibody
Source	Chimeric (mouse/human)
Target	phosphatidylserine
Clinical data
Routes of administration	infusion
ATC code	none
Pharmacokinetic data
Elimination half-life	30 hrs
Identifiers
CAS Number	648904-28-3^Y
ChemSpider	none
UNII	Q16CT95N25
Chemical and physical data
Formula	C₆₄₄₆H₉₉₄₆N₁₇₀₂O₂₀₄₂S₄₂
Molar mass	145304.87 g·mol⁻¹
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Bavituximab (PGN401) is a human-mouse chimeric monoclonal antibody against phosphatidylserine, which is a component of cell membranes that is exposed when a cell is transformed into solid tumor cancer cell or dies, and when cells are infected with hepatitis C. The process of cell death is highly controlled and so there usually no immune response to phosphatidylserine but when bavituximab binds to it, the conjugate appears to stimulate an immune response in humans.

Biology

Phosphatidylserine is the most abundant anionic phospholipid in the cell's plasma membrane, and is usually positioned internally. However, during apoptosis and several pathological conditions including tumorigenesis or infection by some types of viruses, phosphatidylserine is flipped from an internal to an external position. When external, it can potentially be recognized by antibodies. As such, targeting external phosphatidylserine may be a strategy for novel broad-spectrum anti-viral therapies. Bavituximab is an antibody that binds to complexes of the phosphatidylserine-binding plasma protein β2-glycoprotein 1 and anionic phospholipids. In laboratory experiments, treatment with bavituximab was found to rescue mice from otherwise lethal infections of mouse cytomegalovirus (CMV), and Pichinde virus, a model of Lassa fever virus. Proposed mechanisms for this therapeutic effect included bavituximab directly clearing infectious virus from the bloodstream, and the induction of antibody-dependent cellular cytotoxicity of virus-infected cells.

Bavituximab inhibited replication of influenza in preliminary experiments in chicken eggs.

History

Bavituximab was invented at University of Texas Southwestern Medical Center at Dallas; Peregrine Pharmaceuticals exclusively licensed intellectual property related to bavituximab from the university, including US patent 6,300,308 invented by Alan J. Schroit and US Patents 6,406,693 and 6,312,694 invented in the laboratory Philip E. Thorpe.

As of January 2016, bavituximab had been in a Phase III clinical trial for non-small cell lung cancer (NSCLC), a Phase II/III trial for breast cancer, a Phase II trial for pancreatic cancer, a phase I/II trial for hepatocellular carcinoma, and Phase I clinical trials in malignant melanoma and rectal cancer; its development had been discontinued for influenza and prostate cancer. As of 2011 it had been in a Phase II trial for hepatitis C but no results had been reported as of 2016.

The phase III (SUNRISE) trial for NSCLC was discontinued in early 2016 after analysis of interim results.

Peregrine changed its business focus to contract manufacturing and changed its name to Avid Bioservices at the end of 2017, and in February 2018 it sold bavituximab and its other drug assets to Oncologie Inc.

Monoclonal antibodies for tumors

Tumor

Human	Adecatumumab^§ Amivantamab Ascrinvacumab^§ Atezolizumab Balstilimab^† Botensilimab Cixutumumab^§ Conatumumab^§ Daratumumab Drozitumab^§ Duligotumab^§ Dusigitumab^§ Enfortumab vedotin Enoticumab^§ Figitumumab^§ Flanvotumab^§ Ganitumab^† Glembatumumab vedotin^† Intetumumab^§ Ipilimumab Iratumumab^§ Istiratumab Icrucumab^§ Lexatumumab^§ Lucatumumab^§ Mapatumumab^§ Narnatumab^§ Necitumumab Nesvacumab^§ Nivolumab^# Ofatumumab Olaratumab^† Panitumumab Patritumab^§ Pembrolizumab^# Pritumumab^§ Radretumab^§ Ramucirumab Rilotumumab^† Robatumumab^§ Seribantumab^§ Tarextumab^§ Tisotumab vedotin Teprotumumab^† Tovetumab^§ Vantictumab^§ Votumumab^§ Zalutumumab^†
Mouse	Abagovomab Altumomab pentetate Anatumomab mafenatox Arcitumomab Bectumomab Blinatumomab Capromab pendetide Detumomab Edrecolomab Ibritumomab tiuxetan Igovomab Lilotomab Minretumomab Mitumomab Nacolomab tafenatox Moxetumomab pasudotox Naptumomab estafenatox Oregovomab Pemtumomab^† Racotumomab Satumomab pendetide Solitomab Taplitumomab paptox Nofetumomab merpentan Pintumomab Tenatumomab Tositumomab
Chimeric	Amatuximab^§ Bavituximab^§ Brentuximab vedotin Carotuximab^† Cetuximab Derlotuximab biotin^§ Dinutuximab Ecromeximab^§ Ensituximab^§ Futuximab^§ Girentuximab^† Indatuximab ravtansine^§ Isatuximab Loncastuximab tesirine Margetuximab Mirvetuximab soravtansine Rituximab^# Siltuximab Ublituximab
Humanized	Abituzumab^§ Alemtuzumab Belantamab mafodotin Bevacizumab Bivatuzumab mertansine^§ Brontictuzumab^§ Cantuzumab mertansine^§ Cantuzumab ravtansine^§ Cirmtuzumab Citatuzumab bogatox^§ Clivatuzumab tetraxetan Cofetuzumab pelidotin Dacetuzumab^§ Demcizumab^§ Dalotuzumab^§ Denintuzumab mafodotin^§ Elotuzumab Emactuzumab Emibetuzumab^§ Enoblituzumab^§ Etaracizumab^§ Farletuzumab^§ Ficlatuzumab^§ Flotetuzumab^§ Gemtuzumab ozogamicin Glofitamab Imgatuzumab^§ Inotuzumab ozogamicin Labetuzumab^§ Lifastuzumab vedotin^§ Lintuzumab^§ Lorvotuzumab mertansine^§ Lumretuzumab^§ Matuzumab^§ Milatuzumab^§ Naxitamab Nimotuzumab^† Obinutuzumab Ocaratuzumab^§ Otlertuzumab^§ Onartuzumab^§ Oportuzumab monatox^† Parsatuzumab^§ Pertuzumab Pinatuzumab vedotin^§ Polatuzumab vedotin Rosmantuzumab Rovalpituzumab tesirine^† Sacituzumab govitecan Sibrotuzumab^§ Simtuzumab^§ Sofituzumab vedotin^§ Tacatuzumab tetraxetan^§ Tigatuzumab^§ Trastuzumab^# (+deruxtecan / +emtansine) Tucotuzumab celmoleukin^§ Vandortuzumab vedotin^§ Vanucizumab^§ Veltuzumab^§ Vorsetuzumab mafodotin^§ PankoMab
Rat/mouse hybrid	Catumaxomab Ertumaxomab^§
Chimeric + humanized	Depatuxizumab mafodotin^† Duvortuxizumab Ontuxizumab^§

^#WHO-EM
^‡Withdrawn from market
Clinical trials:
- ^†Phase III
- ^§Never to phase III