Our Technology
Developing First-in-Class drugs (antibodies), that target novel pathways selectively regulating vascular permeability in inflammatory and cardiovascular disease, including acute ischemic stroke
THE DISCOVERY
Regulating vascular (dys)function in acute cardiovascular disease
VST BIO is a biotechnology start-up company, that develops antibodies for the treatment of inflammatory and cardiovascular diseases, including stroke, acute myocardial infarction, but also in oncology.
VST BIO’s First-in-Class drugs target novel pathways selectively regulating vascular permeability. VST BIO technology uses fully human antibodies to target the vasculature to selectively block inflammation- and injury-induced vascular leak, without affecting normal vascular function.
This systemic vascular leak is a co-morbidity seen in a variety of diseases including stroke (CVA, TIA), myocardial infarction, traumatic brain injury, reperfusion injury, ARDS/ COVID-19 infection, oncology, and shock. Originally regarded as a common bystander effect of tissue injury, researchers now understand that vascular permeability (loss of vascular integrity, or ‘vascular leakage’) is detrimental to a cascade of events, including the deposition of local inflammatory cells and free radical formation, that further expand tissue damage (for instance in ischemic stroke; reviewed Sandoval and Witt, Neurobiol. Disc. 2008). Through this infiltration of damaging cells and oxidative stress, together with swelling of the tissue (edema), cerebral damage expands in the first 7 days after the onset of stroke. VST Bio proprietary antibodies aim to restore vascular function and prevent the expansion of cerebral damage in the first days after the onset of symptoms.
Indeed, in cell culture and in stroke models, VST-Bio antibodies completely blocked vascular endothelial growth factor (VEGF)-induced vascular leakage, and reduced significantly stroke-related cerebral damage up to 40%-60%.
The human VTS-201 antibody can safely
Normalize vascular leakage (as seen after VEGF activation)
Prevent inflammatory infiltration
Reduce oxidative stress of reperfusion injury
Reduce swelling of the brain in the acute phase of stroke (i.e. edema formation) and prevents intracerebral pressure build-up
Leading to limitation of overall cerebral damage due to stroke
But more importantly,
conventional (standard-of-care) therapy for ischemic stroke is only effective when given within the first hours after onset of stroke
Since vascular leakage is a phenomenon that continues over the first days after stroke onset, the VTS-201 antibody therapy is effective to reduce ongoing cerebral damage in the first days after onset of stroke.
Reduction of cerebral damage will lead to expedited functional recovery from ischemic stroke and a reduction of long-term neurological symptoms in treated patients
OUR PRODUCT
VST-201
A bolus of VST proprietary humanized antibody to revert vascular dysfunction and prevent ongoing cerebral damage in ischemic stroke patients.
We have developed an IV formulation of a humanized antibody that specifically normalizes vascular dysfunction and prevents ongoing tissue damage (by edema formation, inflammation and oxidative stress) leading to better tissue perfusion and limitation of ongoing cerebral damage in acute cardiovascular disease, like ischemic stroke.
The therapy can be given in the acute phase of the disease up to several days after onset of the ischemic stroke. Improved tissue perfusion and reduction of cerebral damage will lead to expedited recovery and reduction of persisting neurological symptoms
Potential to reverse vascular dysfunction that drives ongoing cerebral damage following acute ischemic stroke.
Leading to accelerated recovery and reduction of persisting neurological symptoms
Simple critical path for development and regulatory approval.
Antibody Therapeutics have been shown to have a favorable safety profile and CMC manufacturing and regulatory path of this non-conjugated antibody therapy is well established and straightforward
Deep market penetration
Our formulation is designed for use in patients with ischemic stroke that present early (within 4-6 hrs. after onset) and late after onset of stroke symptoms (after 6 hrs, and even in first days after onset of stroke symptoms)
Candidate for Breakthrough Designation.
New MOA and the ability to reverse the underlying pathological process even when patients present late at the medical center (more than 6 hrs. after onset), offers a new avenue for stroke patients, who are now not eligible for conventional medical therapy, designate this new therapeutic antibody therapy for Breakthrough Designation
Established proof of safety & efficacy
Demonstrated in both small and large NHP animal models.
INTELLECTUAL PROPERTY
Issued Patents & Highlights if this patent family
Composition of Matter, Pharmaceutical Compositions and Uses of targeting the SDC2- DEP1 pathway to modulate VEGF-R2 (de) phosphorylation and vascular permeability, as seen in acute cardiovascular disease.
WO 2019/232203-A2 - PCT/US2019/034644 - US 62/678.493 “Methods and Compositions to Alleviate Vascular Permeability – Pr. May 31 2018
WO 2021/237159 A1 “Methods of Compositions to treat vascular leak” Nov 25 2021
US 63/338,359 “Selective Regulation of Vascular Permeability” May 4 2022
Clean ISR & WO by International Search Authority
Entered National Phase: US, Canada, Europe, Australia, New Zealand, Japan, Korea, China, India, among others
Will provide COM protection for the API/ VST MAb until at least 2041