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Targeted Therapy for Non Small Cell Lung Carcinoma: Human Phase 1 safety and dose escalation studies

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA162629-02A1
Agency Tracking Number: R44CA162629
Amount: $1,988,100.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-15
Award End Date (Contract End Date): 2019-08-31
Small Business Information
9130 RED BRANCH RD STE U
Columbia, MD 21045-2006
United States
DUNS: 963442723
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 GINETTE SERRERO
 (410) 203-0562
 gserrero@agrx.net
Business Contact
 GINETTE SERRERO
Phone: (410) 884-4100
Email: gserrero@agpharma.com
Research Institution
N/A
Abstract

SignificanceInnew cases of LC andrelated deaths are expected in the USOf new
LC casesare non small cell lung cancerNSCLCandof these are diagnosed with metastaticlocally
advancedinoperable LC with ayr survival of less thanA new approach is required to reduce the overall
death rates in this devastating diseaseEfficacious therapies targeting EGFRALK and ROS translocations and
vEGF are used in standard of careSoCHoweverthey are only effective in ltof the overall NSCLC
populationFDA approved companion diagnostics are used to identify patients that may receive benefit from
these drugsIn spite of these advancesno therapy is curative in advanced disease and median life expectancy
for metastatic NSCLC remains atmthsHypothesisWe have identified GPankDa glycoprotein
autocrine intimately involved in cellular deregulated growth leading to tumor formationThe PIdemonstrated
GPs critical role in the biological process of cancer tumorigenesis and survivalits overexpression in LC
tumors while it is not expressed in normal lung tissueits secretion into biological fluids at increased levels in LC
patients compared to healthy individualsThus using a tissue test to identify tumors that express GPand then
treating these patients with an antibody that neutralizes GPand therefore blocks its autocrine effect on cancer
cells will ainhibit tumor growth and bincrease the efficacy of current LC drugsSupporting EvidencePathological studies established GPtumor expression as a predictive marker for recurrenceClinical studies
showed LC patients with progressive disease have elevated GPserum levels compared to healthy individualsIn Vivo studies demonstrated that AGa recombinant anti GPcan reduce the growth of human LC xenografts
in mice and potentiate the effect of SoC drugsStrategy and ApproachWe will carry out a phase I clinical trial
using AGto determine safety and recommended phasedoseIn additionwe will require tissue collection
and serial blood sampling on all patients to evaluate for GPexpressiontissueand concentrationbloodin
enrolled patients and expansion cohorts of NSCLC and mesotheliomadiseases demonstrated to express GPcorrelated with outcomeThe IHC test measures GPexpression in tumor tissue to identify patients with tumors
expressing GPThe serum GPEIA test can provide real time monitoring of disease status in the SoCSpecific aimManufacturegms of GMP AGfor the Phase I clinical studies Specific AimPerform a
Phase I clinical study inapatients with solid tumors to determine maximum tolerated doseoptimum biological
dose andbexpansion cohorts with LC and mesothelioma patientsOverall ImpactBlocking the action of
GPin aggressive cancer such as LC using a neutralizing antibody willinhibit tumor growthpotentiate
standard of care drugsThere is compelling biological and clinical evidence to suggest that GPis therapeutic
target with companion diagnostics for NSCLC that could impact LC treatment and improve survival of patients
with NSCLCLay outline
Innew cases of LC andrelated deaths are expected in the USThe majority of these
are non small cell lung cancerNSCLCthat are diagnosed with metastatic cancer and onlyof these will
be alive atyrs post diagnosisDrugs that are effective in this disease are only useful in less thanof the
NSCLC population and no curative therapies existA new approach that will benefit a larger population and
provides increased life expectancy needs to be developedWe have identified GPa glycoprotein that is
produced by cancer cells and stimulates growth and survival of the same cancer cells leading to tumor formationGPis found in LC but not normal lung tissueThere is compelling biological and clinical evidence to suggest
that GPis therapeutic target with companion diagnostics for NSCLC that could impact treatment and improve
survival of patients with NSCLCWe have developed a tissue test to identify which tumors express GPand
an anti GPAGto block the action of GPon tumor tissues to ainhibit tumor growth and bincrease the
efficacy of current LC drugsAdditionallya blood test has been developed to monitor patients while on treatmentUsing AGas the therapy with two companion diagnostic tests we will carry out a phase I clinical trial to determine
safety of AGin humans and will collect tumor tissue and blood on all patients to evaluate for GPexpressiontissueand concentrationblood

* Information listed above is at the time of submission. *

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