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2016 INDUSTRY PARTNERING SUMMIT
UNeMed.com | 402.559.2468
SCHEDULE OF EVENTSMay 10, 2016 | Linder Reading Room, Michael F. Sorrell Center, UNMC | Omaha, Nebraska
9 a.m. Opening Remarks
Overview: UNMC Pharmaceutical Research
Technology & Start-up Presentations
Lunch & Networking
9:10 a.m. Dept. of Pharmacology & Experimental Neuroscience — Howard Gendelman, M.D.
9:25 a.m. Dept. of Cellular & Integrative Physiology — Irving Zucker, Ph.D.
9:40 a.m. Dept. of Pathology & Microbiology — Steven Hinrichs, M.D.
9:55 a.m. Center for Drug Delivery and Nanomedicine — Joe Vetro, Ph.D.
10:10 a.m. Fred & Pamela Buffet Cancer Center — TBA
10:25 a.m. Break
10:35 a.m.Vaccine Strategy for Parkinson’s Disease:
Howard Gendelman, M.D.
10:50 a.m.
Potent small molecule antibacterial
compounds:
Rongshi Li, Ph.D.
11:05 a.m.
Glyoxalase-1 gene therapy for the treatment of
diabetes-related complications:
Keshore Bidasee, Ph.D.
11:20 a.m.
Inhibiting MDSCs for the
treatment of biofilm infections:
Tammy Kielian, Ph.D.
11:35 a.m.CCL21 nanoparticles for cancer immunotherapy:
Joyce Solheim, Ph.D.
1:10 p.m.IKK-beta inhibitors:
Amar Natarajan, Ph.D.
1:25 p.m.
Glucocorticoid prodrug for the improved
treatment of lupus:
Dong Wang, Ph.D.
1:40 p.m.Immune stimulating peptides:
Prommune, Inc.
1:55 p.m. Targeted radiopharmaceuticals:Calidum, Inc.
2:10 p.m.
Nanoformulations for the treatment of acute
spinal cord injury:
ProTransit Nanotherapy, LLC
2:30 p.m. Poster Session & Networking
Welcome toUNeMed’s2016 Industry
PartneringSummit
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Vaccine Strategy forParkinson’s Disease
A group led by Howard Gendelman, M.D., atUNMC has developed a novel vaccine strategycapable o both preventing Parkinson’s Diseaseonset as well as preventing disease progression.
Te vaccine combines the immunogen, N-α-Syn, with a molecular adjuvant that is capableo promoting a regulatory adaptive immune re-sponse (regulatory cell response) such as vaso-active intestinal peptide or GM-CSF.
esting o the Parkinson’s vaccine strategywas carried out in a mouse model o Parkinson’sdisease. reatment using the novel vaccination strategy resulted in a
decrease in activatedmicroglia by 61 percentand a 64 percent decreasein neuronal injury.Furthermore, this vaccinestrategy prevented loss odopaminergic neuronsallowing or an astonishing91 percent survival rate or
dopaminergic neurons.Dr. Gendelman’s group
has recently completeda human study lookingat the effect o a poten-tial adjuvant (GM-CSF)to modulate the immuneprofile in Parkinson’s pa-tients. Administration oGM-CSF successully up-regulated the regulatory cell response providingadditional support or this vaccine strategy.
Prevents
futuredisease,treatsexisting
disease
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2016 INDUSTRY PARTNERING SUMMIT
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27 times morepotent thanvancomycin
against staph
Potent small molecule
antibacterial compounds
Researchers at the University o Nebraska aredeveloping a new class o small molecules or thetreatment o bacterial inections.
Tey have currently developed lead com-pounds with nano-molar MICs against staph and
anthrax. One o these compounds had a potencysimilar to ciprofloxacin against anthrax and was27-old more potent than vancomycin againststaph.
Some o these compounds also displayedbroad spectrum activity demonstrating low mi-cromolar MICs against some gram negative bac-teria such as A. baumannii, Enterobacter, and K.
pneumonia.Work is currently being done to urther eval-uate some o the lead compounds in vivo againststaph and anthrax.
New analogs are also being designed to im-prove activity against gram negative bacteria.
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2016 INDUSTRY PARTNERING SUMMIT
UNeMed.com | 402.559.2468
Reactive carbonyl species areofen over-produced in diseases likediabetes, resulting in increases inoxidative stress, inflammation andDNA damage.
Methylglyoxal, or MGO, isthe most potent o these reactivecarbonyl species. It increases as earlyas three days afer hyperglycemia andcould be responsible or vascular/cardiovascular dysunction.
UNMC research Keshore Bidasee,Ph.D., and his group have developeda gene therapy to strategically
reduce MGO by overexpressesingglyoxalase-1, an enzyme that degradesMGO. Te gene therapy contains akey promoter region that expressesglyoxalase-1 only in damaged cellsthat are producing excess MGO.
When injected intravenously indiabetic animals, the viral constructimproved the unctions o the heartand brain, two key end-organsnegatively impacted in diabetes. Te
therapy also improved cognition andreduced stroke damage (cerebralischemia-reperusion injury), andalso modestly lowered blood glucose.
Glyoxalase-1 overexpression isa novel therapeutic approach orblunting cerebral vascular dysunctionand cognitive impairment in diabetes.Since microvascular dysunction is an
established cause or other diabeticcomplications—blindness, kidneyailure, diabetic cardiomyopathy,erectile dysunction and stroke—lowering MGO levels will alsodiminish these complications.
Gene therapy for the treatment
of diabetes-related complications
Improve
brain & heart
function in
diabetic
patients
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2016 INDUSTRY PARTNERING SUMMIT
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Inhibiting MDSCs for thetreatment of biofilm infections
Prevent,
treat anddestroybiofilms bytargeting
the immunesystem
ammy Kielian, Ph.D., has generated amethod to enhance the ability o a patients’immune system to eliminate bacterial biofilms.Tis method ocuses on the inhibition o speci-ic cell populations knows as myeloid-derived
suppressor cells, or MDSCs.In the presence o MDSCs, inflammation
persists but does not acilitate bacterial clear-ance. In addition, monocyte/macrophage infil-trates are reduced and cell prolieration andcytokine production are inhibited. Depletion oMDSCs enhances the proinflammatory proper-ties o infiltrating monocytes and macrophages
allowing or improved bacterial clearance.Dr. Kielian’s group is currently testing var-ious approaches to inhibit MDSC unction(such as SA3 inhibitors) to identiy potentialtherapeutic strategies or the treatment o bio-film inections.
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2016 INDUSTRY PARTNERING SUMMIT
UNeMed.com | 402.559.2468
CCL21 nanoparticles forcancer immunotherapy
Significant
inhibitionof tumorgrowth inanimal
studies
atiana Bronich, Ph.D., and JoyceSolheim, Ph.D., are developing thechemokine CCL21 as an immuno-therapy. Intratumoral administrationof CCL21 elicits a potent anti-tumorresponse through the recruitment ofimmune cells into the tumor, suchas dendritic cells, cells and naturalkiller cells.
However, one problem with thisapproach is that CCL21 doesn’t lastlong inside the body, and its effectsare short-lived.
o get around this, Drs. Bronichand Solheim created a nanoformula-tion that protects CCL21 from deg-radation and will allow for extendedrelease of CCL21 within the tumorsite, prolonging the chemotactic effect
and increasing the overall therapeuticimpact.
Release kinetics of the nanopar-ticles have been analyzed and op-timized. Te researchers have alsoperformed small scale animal studiesusing subcutaneous Pan02 tumorswhere the nanoformulated CCL21showed significant inhibition of tu-mor growth over nine days.
In addition to use as a standaloneimmunotherapy, the CCL21 nanopar-ticles can also enhance other immu-
notherapies.By enhancing immune infiltration
into tumors, the CCL21 nanoparticlescan greatly enhance the efficacy of tu-mor vaccines, cell therapies, oncolytic
viruses and antibody therapies.
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IKK-beta inhibitors
Researchers at UNMC have identified a set o compounds that act as in-hibitors o the NF-κB pathway and specifically inhibit IKKβ. Initial work hasocused on the lead compound called “13-197.”
“13-197” has been evaluated using a wide variety o in vitro assays anddemonstrated antiprolierative activity against apanel o cancer cell lines. It also inhibited NF-κB
Potentinhibitorof cancer cell
proliferation
mediated gene transcription, enhanced caspase3/7 activity, induced apoptosis, and sensitizedpancreatic cancer cells to gemcitabine.
“13-197” has been tested in two different
in vivo cancer models. In an orthotopic mousemodel o pancreatic cancer, “13-197” signifi-cantly decreased tumor size and tumor metas-tasis. “13-197” also decreased inflammation andmicrovessel density within the pancreatic tum-ors while increasing tumor necrosis.
“13-197”has also been tested in a mouse mod-el o mantle cell lymphoma where it reduced tu-mor burden in the kidney, liver and lungs, andsignificantly increased the overall survival o themice.
Researchers are now working on developingadditional analogs o “13-197,” and hope to ad- vance into the clinic soon.
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Glucocorticoid prodrug for theimproved treatment of lupusA UNMC team led by Dong Wang,
Ph.D., has developed a promisingdrug candidate for the therapy of Lu-pus Nephritis, a kidney disease thataffects 30 percent to 60 percent of Sys-
temic Lupus Erythematosus patients.Te drug candidate is a prodrug of
a commonly prescribed treatment forLupus, a cortiocosteroid called gluco-corticoid. Cortiocosteroids are limit-ed in their ability to effectively treatLupus because they cause severe sys-temic side effects, including adrenalgland suppression, osteoporosis andimpaired liver function.
When modified with polyethyl-ene glycol (PEG), the glucocorticoidprodrug created by Dr. Wang’s teamspecifically targets inflamed kidney
tissue. Te modification essential-ly made it possible to eliminate theharmful side effects, and create a farmore effective long-term treatmentoption for lupus nephritis.
Animal studies showed the newprodrug compound, PEG-glucocor-ticoid, has a long-lasting effect, andthat monthly dosing had a betteroverall effect on established nephritisthan daily traditional treatments. Tetests also showed that the monthlyPEG-glucocorticoid treatment in-creased lifespan and reduced inci-dence of severe kidney disease. Tenew treatment also did not affectbone quality, the peripheral whiteblood cell count or suppress the ad-renal gland.
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Longer-lastingand moreeff ective thantraditional
dailytreatments
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2016 INDUSTRY PARTNERING SUMMIT
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Immune stimulating peptidesPrommune’s lead immune simu-
latory peptide, EP67, selectively en-gages and activates antigen present-ing cells (monocytes, macrophages,dendritic cells) to induce the cellularand molecular elements associatedwith innate immunity—the body’sfirst line o immune deense against
inection.Once activated by EP67, these anti-
gen presenting cells are primed to takeup infective pathogens (bacteria, vi-ruses, fungi) and destroy them via nat-ural cellular mechanisms.
Tus, EP67 can be usedto awaken and direct thebody’s own innate im-mune responses againstinective pathogens—
Host-Directed Immune Terapy(HDI).
Importantly, the EP67-activatedcellular processes for HDI makeno distinction between normal orantibiotic-resistant pathogens. Tus,EP67-mediated HDI can be usedto fight normal as well as antibiot-
ic-resistant infections, and could beused as a complement to traditionalantibiotics to deliver a powerful dualtherapeutic assault on troublesomeinfections.
Prommune Inc.
is a research anddevelopment companythat has created aunique and patentedmeans to safely andeff ectively awaken the
body’s own naturalimmune defenseswithout inflammatoryside-eff ects
UNMC Startup
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2016 INDUSTRY PARTNERING SUMMIT
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Targeted cancer therapyCalidum Inc. is developing compounds that
are tagged with a radioactive isotope that willhelp clinicians better diagnose, track and treat various cancers that include prostate, ovarian,and triple negative breast cancers, neuroblasto-ma and glioblastoma.
Calidum is developing radiopharmaceuticalsthat target the androgen receptor, butyrylcho-
linesterase and a third target.Due to the strong saety and activity data oCalidum’s lead compound, CDM-P123I, the U.S.Food and Drug Administration has approved aPhase-1 clinical trial in prostate cancer patients.
CDM-P123I specifically targets the andro-gen receptor on prostate cancer cells, thus it canboth identiy and effectively destroy those cellswith dramatically reduced side-effects and with higher specificity than current
techniques.Calidum will begin its Phase 1 trial or prostate cancer within the next 12
months, while completing the necessary preclinical studies to initiate humantrials or the additional targets in the next three years.
UNMC Startup
Calidum Inc.
is developingproducts based ona novel concept ofreceptor-targeted& DNA co-targeteddelivery of radiation
directly to the DNAof a cancer cell
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2016 INDUSTRY PARTNERING SUMMIT
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Nanoformulations for
treating acute spinal cord injury
Nearly 1.3 million Americans, most othem young people, are living with pa-ralysis due to spinal cord injury, costing$40.5 billion or their annual care.
Te pathophysiology o traumatic spi-nal cord injury involves the initial physi-cal impact, which leads to secondary in- jury cascades o degenerative cellular andmolecular events. Te secondary injuryspreads along the spinal cord over time,which adds new levels o disability andhas devastating effects.
Proransit Nanotherapy is developingnanoormulated biotherapeutics to pre- vent the degenerative events that ollowsthe injury.
Called Pro-NP,™ the technology provedeffective in regaining locomotive unc-tions when used three hours afer injury.Pro-NP™ could potentially be adminis-tered in the field at the accident site o oren route to a health care acility.
UNMC Startup
ProTransit
Nanotherapy LLC isdeveloping therapiesbased on potentbiomacromoleculartherapueticsusing patented
nanoparticletechnology
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Dept. of Pharmacology andExperimental NeuroscienceChair: Howard Gendelman, M.D.
Dept. Cellular andIntegrative PhysiologyChair: Irving Zucker, Ph.D.
Dept. of Pathology andMicrobiologyChair: Steven Hinrichs, M.D.
Center for Drug Deliveryand NanomedicineJoe Vetro, Ph.D.
Fred & PamelaBuff et Cancer CenterTBA
Department Overviews
CD74-based gene therapy forAlzheimer’s disease (Tomomi Kiyota, Ph.D.)
Development of subtype selectiveNMDA modulators (Dan Monaghan, Ph.D.)
New approaches for the diagnosis & treatment
of pancreatic cancer (Surinder Batra, Ph.D.)
Role of miR-133a in pathophysiology ofdiabetic hearts (Paras Kumar Mishra, Ph.D.)
Screen to identify genes that are essential
and selective for tumor cells (Rob Lewis, Ph.D.)
Antimicrobial peptides and UNMC’santimicrobial peptide database (Gus Wang, Ph.D.)
Pancreatic Diff erentiation Factor 2 a target for
the treatment of cancer (Surinder Batra, Ph.D.)
siRNA Delivery System (Joe Vetro, Ph.D.)
The role of the thromboxane receptor inobesity and diabetes(Saraswathi Viswanathan, Ph.D.)
Efficient insertion of sequences using longersingle stranded repair DNAswith CRISPR/Cas9 genome editing
(Channabasavaiah Gurumurthy, Ph.D.)
Cyclophilin D: A target for thetreatment of renal diseases and obesity(Babu Padanilam, Ph.D.)
Poster Titles
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Transferring technology for UNMC since 1991
25TH ANNIVERSARY
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