Delving into the Latest Updates on P10s-PADRE vaccine(University of Arkansas) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine(University of Arkansas), P10s-PADRE/ MONTANIDE ISA 51 VG(University of Arkansas)

Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Triple Negative Breast Cancer

Inactive Indication

Advanced Lung AdenocarcinomaNeoplasm Metastasis

Originator Organization

The University of Arkansas

Active Organization-

Inactive Organization

The University of Arkansas

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.

Start Date25 Jan 2019

Sponsor / Collaborator-

NCT02264236 / WithdrawnPhase 1/2IIT

"Vaccination of Advanced-Stage Lung Cancer Patients" A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial.
This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

Start Date01 Oct 2015

Sponsor / Collaborator

The University of Arkansas

100 Clinical Results associated with P10s-PADRE vaccine(University of Arkansas)

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100 Translational Medicine associated with P10s-PADRE vaccine(University of Arkansas)

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100 Patents (Medical) associated with P10s-PADRE vaccine(University of Arkansas)

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4

Literatures (Medical) associated with P10s-PADRE vaccine(University of Arkansas)

26 Oct 2021·Oncotarget

P10s-PADRE vaccine combined with neoadjuvant chemotherapy in ER-positive breast cancer patients induces humoral and cellular immune responses

Article

Author: Jousheghany, Fariba ; Beck, J. Thaddeus ; Siegel, Eric R. ; Rogers, Lora J. ; Post, Ginell R. ; Makhoul, Issam ; Kieber-Emmons, Thomas ; Ibrahim, Saddam Mohammed ; Pina-Oviedo, Sergio ; Abu-Rmaileh, Muhammad ; Lee, John J. ; Monzavi-Karbassi, Behjatolah

Breast cancer patients diagnosed with HR+/HER2- tumors face a persistent risk of distant recurrence long after completion of their treatment. Strategies to induce anti-tumor immune responses could complement standard-of-care therapies for these patients. The current study was performed to examine the feasibility, safety and immunogenicity of adding P10s-PADRE to standard-of-care chemotherapy in HR+/HER2- early-stage breast cancer patients. Twenty-five subjects were treated in a single-arm Phase Ib clinical trial. Five different immunization schedules were considered to evaluate the feasibility of eliciting an immune response. The primary immunogenicity endpoint was antibody titer. The expression of several activation markers on natural killer (NK) cells and serum concentrations of Th1/Th2 cytokines were also examined. The percentage of tumor-infiltrating lymphocytes (TILs) was determined. Antibody response was superior in schedule C where 3 weekly immunizations preceded the first dose of chemotherapy. A significant change in CD16, NKp46 and CD94 expression levels on NK cells and a rise in serum content of IFN-γ was observed after treatment. Schedule C showed an increase in TILs in residual lesions. The combination therapy is safe and immunogenic with treatment schedule C being immunologically promising. Randomized trials focused on long-term survival outcomes are needed to evaluate clinical benefits.

17 Nov 2017·Oncotarget

Targeting tumor-associated carbohydrate antigens: a phase I study of a carbohydrate mimetic-peptide vaccine in stage IV breast cancer subjects

Article

Author: Kieber-Emmons, Thomas ; Monzavi-Karbassi, Behjatolah ; Jousheghany, Fariba ; Makhoul, Issam ; Siegel, Eric R. ; Hutchins, Laura F. ; Pennisi, Angela ; Emanuel, Peter D. ; Pashov, Anastas D. ; Guo, Xueyan

Tumor-associated carbohydrate antigens (TACAs) support cell survival that could be interrupted by anti-TACA antibodies. Among TACAs that mediate cell survival signals are the neolactoseries antigen Lewis Y (LeY) and the ganglioside GD2. To induce sustained immunity against both LeY and GD2, we developed a carbohydrate mimicking peptide (CMP) as a surrogate pan-immunogen that mimics both. This CMP, referred to as P10s, is the N-terminal half of a peptide vaccine named P10s-PADRE, the C-terminal half of which (PADRE) is a Pan-T-cell epitope. A Phase I dose-escalation trial of P10s-PADRE plus adjuvant MONTANIDE™ ISA 51 VG was conducted in subjects with metastatic breast cancer to test 300 and 500 μg/injection in two cohorts of 3 subjects each. Doses of the P10s-PADRE vaccine were administered to research participants subcutaneously on weeks 1, 2, 3, 7 and 19. Antibody responses to P10s, GD2, and LeY were measured by ELISA. The P10s-PADRE vaccine induced antibodies specifically reactive with P10s, LeY and GD2 in all 6 subjects. Serum antibodies displayed Caspase-3-dependent apoptotic functionality against LeY or GD2 expressing breast cancer cell lines. Immunization with the P10s-PADRE vaccine was well-tolerated and induced functional antibodies, and the data suggest potential clinical benefit.

01 Jan 2015·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Moving a Carbohydrate Mimetic Peptide into the clinic

Q3 · MEDICINE

Article

Author: Peter D Emanuel ; Fariba Jousheghany ; Laura Hutchins ; Angela Pennisi ; Eric Siegel ; Thomas Kieber-Emmons ; Behjatolah Monzavi-Karbassi ; Issam Makhoul

Tumor-Associated Carbohydrate Antigens (TACAs) are broad-spectrum targets for immunotherapy. Immunization with Carbohydrate Mimetic Peptides (CMPs) is a strategy to induce broad-spectrum TACA-reactive antibodies hypothesized to interfere with cellular pathways involved in tumor cell survival. A Phase I study was conducted with a first-in-man CMP referred to as P10s, conjugated to the Pan T cell carrier PADRE, along with MONTANIDE(™) ISA 51 VG as adjuvant over a course of 5 immunizations. While designed as a safety and tolerability study, the potential for therapeutic impact was observed in a subject with metastatic lesions as evaluated before and after vaccine treatment. The subject received Vinorelbine and Trastuzumab (VT) for two months prior to study eligibility. PET scans showed partial response in the lungs and complete resolution of a previously enlarged subpectoral lymph node. Immunization with P10s vaccine resulted in responses to P10s, with serum and plasma antibodies reactive with and cytotoxic to human breast cancer cells in vitro, including the Trastuzumab-resistant HCC1954 cell line. However, the patient developed cystic masses in the brain parenchyma with no apparent evidence of metastases. The subject was switched to Docetaxel, Pertuzumab and Trastuzumab a year later, and her last PET scan showed a complete response in the lungs and lymph nodes. Incubation of cancer cells with a combination of vaccine-induced serum and docetaxel suggests that the induced antibodies sensitize tumor cells for more efficient killing upon administration of docetaxel. The data suggest that P10s-PADRE induces anti-tumor antibody response that in combination with chemotherapy can affect metastatic lesions in breast cancer patients.

100 Deals associated with P10s-PADRE vaccine(University of Arkansas)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasm Metastasis	Phase 2	-	The University of Arkansas	01 Mar 2021
Solid tumor	Phase 2	-	The University of Arkansas	01 Mar 2021
Triple Negative Breast Cancer	Phase 2	US	-	25 Jan 2019
Advanced Lung Adenocarcinoma	Phase 2	US	The University of Arkansas	01 Oct 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01390064 (CTgov)	Phase 1	Metastatic breast cancer	6	Mimotope P10s-PADRE/MONTANIDE ISA 51 VG (Initial Cohort)	proszkfgye(sgdmcrohjs) = gfrxbxpttz cfctifogjn (mkhdzfkgux, bcdantfkxg - zrtjsxwazm) View more	-	03 Jun 2019
				Mimotope P10s-PADRE/MONTANIDE ISA 51 VG (Escalation Cohort)	proszkfgye(sgdmcrohjs) = mriqplefra cfctifogjn (mkhdzfkgux, nhtiswpmay - towhmnhfja) View more