Immuno-Oncology for Pancreatic Cancer: A Combination Clinical Trial with Chemotherapy and Radiation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44CA203336-02
Agency Tracking Number: R44CA203336
Amount: $775,916.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA14-071
Solicitation Year: 2014
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-01
Award End Date (Contract End Date): 2022-01-31
Small Business Information
440 LEXINGTON ST, Auburndale, MA, 02466-1923
DUNS: 192959851
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (617) 916-5445
Business Contact
Phone: (617) 916-5445
Research Institution
DESCRIPTIONprovided by applicantPancreatic adenocarcinoma has a dismalyear survival of andltThe only potential curative treatment is resectionbut this is achieved in andltof patients and most still die due to micrometastases or residual diseasePatients with unresectable disease receive palliative chemotherapy with a median survival of less thanmonthsThis application proposes a multi pronged approach with an aggressive chemoradiation regimen combined with a viral immuno oncology product to attack residual and metastatic diseaseThe goal is to increase the resection rate andyear survival without further compromising quality of lifeThe project builds on a completed Phasea trial with Gene Mediated Cytotoxic ImmunotherapyGMCIcombined with chemoradiation and surgery that established a safe dose level and demonstrated immune stimulation in pancreatic cancerGMCI generates a polyvalent anti tumor immune response through local delivery of aglatimagene besadenovecAdV tkplus prodrug and has demonstrated synergy with standard of careSOCin multiple tumor typesIn preclinical studiesthe CDT cell dependent systemic effect is potentiated by radiationchemotherapy and surgerywhich debulk and decrease immune inhibitory factors elicited by tumorsGMCI significantly improved survival in a recent Phasestudy in combination with chemoradiation in malignant glioma patients that had received total resectionA neoadjuvant regimen using modified FOLFIRINOXmFXfollowed by gemcitabine radiationGRwas piloted by the investigators at OSU in borderline resectableBRPCand locally advanced pancreatic cancerLAPCThe regimen showed equivalent efficacy with less toxicity than standard FOLFIRINOX and led to more patients becoming resectableComponents of the regimen have been shown to suppress immune inhibitory factors elicited by tumors including myeloid derived suppressor cellsMDSCregulatory T cellsTregand inhibitory cytokinesThese data support the rationale for combining GMCI with mFXGRsurgical resectionThis Fast Track application proposes a Phbclinical trial in BRPC and LAPCThe clinical protocol has received all the necessary regulatory approvals and is ready to launchThe protocol includes a single arm Phase Ib stage to establish the feasibility of the treatment planPhase I segment of the Fast track grantfollowed by a randomized Phasestage of the trialPhase II grant segmentImmune biomarkers including effector T cellsTregsMDSCs and cytokines will be measured before and after each treatment phase and compared between the control and test arm to better understand the mFXGR and GMCI immune effects in this patient populationThis will be the first study of an immunotherapy combined with mFX GR and the first randomized clinical study of GMCI for PanCaThe goal is to obtain the necessary data to support a decision for or against a definitive efficacy study that may improve the outcomes for patients with this devastating diseaseThe transition from Phase Ib to Phase II is preplanned in the protocol as a measurable milestone and will benefit from continuitythus the Fast Track submission

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

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