Delving into the Latest Updates on ASP-0113 with Synapse

Overview

Basic Info

Drug Type

DNA vaccine, Prophylactic vaccine

Synonyms

ASP0113 CMV Therapeutic Vaccine, Cytomegalovirus DNA vaccine bivalent, TransVax

+ [2]

Target

CMV pp65

Action

modulators

Mechanism

CMV pp65 modulators(Cytomegalovirus pp65 Antigen modulators)

Therapeutic Areas

Infectious DiseasesOther DiseasesNeoplasms+ [2]

Active Indication-

Inactive Indication

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myelogenous Leukemia+ [6]

Originator Organization

Vical, Inc.

Active Organization-

Inactive Organization

Vical, Inc.Astellas Pharma Global Development, Inc.

Astellas Pharma, Inc.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by the vaccine after repeated ASP0113 IM injection.

Start Date30 Dec 2013

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

[+1]

NCT01974206

/ CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of ASP0113 in this patient population.

Start Date20 Nov 2013

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

[+1]

100 Clinical Results associated with ASP-0113

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100 Translational Medicine associated with ASP-0113

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100 Patents (Medical) associated with ASP-0113

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13

Literatures (Medical) associated with ASP-0113

01 Mar 2021·EClinicalMedicine

A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients

Article

Author: Cywin, Beth ; Chevallier, Patrice ; Ljungman, Per ; Solano, Carlos ; Selleslag, Dominik ; Kakihana, Kazuhiko ; Bermudez, Arancha ; Wang, Xuegong ; Wulf, Gerald ; Young, James ; Kharfan-Dabaja, Mohamed A ; Fredericks, Christine ; Logan, Aaron C ; Langston, Amelia ; Maertens, Johan ; Martino, Rodrigo ; Wingard, John R ; Lee, Dong-Gun ; Lademacher, Christopher ; Smith, Larry R ; Okamoto, Shinichiro ; Boeckh, Michael

BACKGROUNDCytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients.METHODSIn this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who received ≥1 dose of ASP0113/placebo. The primary efficacy endpoint was the proportion of allo-HCT recipients with composite all-cause mortality and adjudicated CMV end-organ disease (EOD) by 1 year post-transplant. ClinicalTrials.gov: NCT01877655 (not recruiting).FINDINGSPatients were recruited between Sept 11, 2013 and Sept 21, 2016. Overall, 501 patients received ≥1 dose of ASP0113 (n = 246) or placebo (n = 255). The proportion of patients with composite all-cause mortality and adjudicated CMV EOD by 1 year post-transplant was 35.4% (n = 87) with ASP0113 and 30•2% (n = 77) with placebo (odds ratio 1.27; 95% confidence interval: 0.87 to 1.85; p = 0.205). Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo. Overall incidence and severity of other TEAEs was similar between groups. T-cell response to pp65 increased over time and was greater with placebo than ASP0113 (p = 0.027).INTERPRETATIONASP0113 did not reduce overall mortality or CMV EOD by 1 year post-transplant. Safety findings were similar between groups.FUNDINGAstellas Pharma Global Development, Inc .

01 May 2020·Clinical Pharmacology in Drug Development

Pharmacokinetics and Immunogenicity of ASP0113 in CMV‐Seronegative Dialysis Patients and CMV‐Seronegative and ‐Seropositive Healthy Subjects

Article

Author: Bonate, Peter L. ; Smith, Larry R. ; Rammelsberg, Diane ; Koester, Anne ; Van Sant, Charles ; Marbury, Thomas C. ; Goldwater, Ronald ; Cho, Kathy ; Boutsaboualoy, Sou ; Zook, Erin C. ; Wang, Xuegong ; Ye, Ming ; Wu, Ruishan

AbstractCytomegalovirus (CMV) infection causes significant morbidity and mortality in immunocompromised transplant patients. ASP0113, a first‐in‐class DNA vaccine containing plasmids encoding CMV phosphoprotein 65 and glycoprotein B (gB), was evaluated in a phase 1b, subject‐blinded study in CMV‐seropositive (n = 13) and CMV‐seronegative (n = 12) healthy and CMV‐seronegative dialysis subjects (n = 12) randomized to ASP0113 or placebo. End points included pharmacokinetics, anti‐gB antibody levels, phosphoprotein 65–specific T‐cell responses measured by ex vivo enzyme‐linked immune absorbent spot (ELISpot) assay and 10‐day cultured ELISpot and Stat T‐cell activation assays, and safety. ASP0113 concentrations peaked at 2‐10 and 24‐48 hours; the pharmacokinetics were similar across groups. No group demonstrated significant anti‐gB antibody responses. T‐cell responder rates in the cultured ELISpot assay were 8/12 (66.7%, 95%CI 35% to 90%) and 4/12 (33.3%, 95%CI 10% to 65%) in CMV‐seronegative healthy subjects and dialysis patients, respectively, whereas ex vivo ELISpot assay response rates were 4/11 (36.4%, 95%CI 11% to 69%) and 0/12, respectively. Responses peaked at week 27, with lower magnitude observed in CMV‐seronegative dialysis patients versus CMV‐seronegative healthy subjects. No serious adverse events occurred; the most common adverse event in ASP0113‐vaccinated patients was injection‐site pain (64.9%). Some CMV‐seronegative healthy subjects and dialysis patients had T‐cell responses; no humoral responses were detected.

01 Dec 2018·American Journal of TransplantationQ1 · MEDICINE

A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor

Q1 · MEDICINE

Article

Author: Shah, Malay ; Weidemann, Alexander ; Vincenti, Flavio ; Ram Peddi, V ; Wang, Xuegong ; Shihab, Fuad ; Merville, Pierre ; Budde, Klemens ; Lee, Misun ; Cassuto-Viguier, Elisabeth ; Wyburn, Kate ; Lademacher, Christopher ; Flegel, Teresa ; Erdman, Jay

Cytomegalovirus (CMV) is a latent infection in most infected individuals, but can be pathogenic in immunocompromised kidney transplant recipients. ASP0113 is a DNA-based vaccine for the prevention of CMV-related mortality and end-organ disease in transplant recipients. The efficacy, safety, and immunogenicity of ASP0113 was assessed in a phase 2, double-blind, placebo-controlled study in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Transplant recipients were randomized (1:1) to receive 5 doses of ASP0113 (5 mg; n = 75) or placebo (n = 74) on Days 30/60/90/120/180 posttransplant, and they received prophylactic valganciclovir/ganciclovir 10-100 days posttransplant. The primary endpoint was the proportion of transplant recipients with CMV viremia ≥1000 IU/mL from Day 100 through to 1 year after the first study vaccine injection. There was no statistically significant difference in the primary endpoint between the ASP0113 and placebo groups (odds ratio 0.79, 95% confidence interval 0.43-1.47; P = .307). There were similar numbers of transplant recipients with treatment-emergent adverse events between groups; however, more transplant recipients reported injection site pain in the ASP0113 group compared with placebo. ASP0113 did not demonstrate efficacy in the prevention of CMV viremia in this CMV-seronegative kidney transplant population, but demonstrated a safety profile similar to placebo. ClinicalTrials.gov registration number: NCT01974206.

100 Deals associated with ASP-0113

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hematopoietic stem cell transplantation	Phase 3	United States	Astellas Pharma Global Development, Inc.	11 Sep 2013
Hematopoietic stem cell transplantation	Phase 3	Spain	Astellas Pharma Global Development, Inc.	11 Sep 2013
Hematopoietic stem cell transplantation	Phase 3	Japan	Astellas Pharma Global Development, Inc.	11 Sep 2013
Hematopoietic stem cell transplantation	Phase 3	Belgium	Astellas Pharma Global Development, Inc.	11 Sep 2013
Hematopoietic stem cell transplantation	Phase 3	Germany	Astellas Pharma Global Development, Inc.	11 Sep 2013
Hematopoietic stem cell transplantation	Phase 3	Australia	Astellas Pharma Global Development, Inc.	11 Sep 2013
Hematopoietic stem cell transplantation	Phase 3	South Korea	Astellas Pharma Global Development, Inc.	11 Sep 2013
Hematopoietic stem cell transplantation	Phase 3	Canada	Astellas Pharma Global Development, Inc.	11 Sep 2013
Cytomegalovirus Infections	Phase 3	-	Vical, Inc.	-
Cytomegalovirus Infections	Phase 3	-	Vical, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01974206 (CTgov)	Phase 2	Cytomegalovirus Infections	150	Placebo (Placebo)	ojocklbsbc(dqdncljcty) = ymmnfwgyzt aycnrmuphz (amwpmzqukd, qiwjpnhnju - gmqgkiolnx) View more	-	04 Jan 2022
				ASP0113 (ASP0113)	veanegchub(dtnmybuugy) = lsitulwqpq aejqokwraj (dzdprpewud, juxxaglkdg - wnxjtwgygb) View more
NCT01877655 (Pubmed) Manual	Phase 3	Cytomegalovirus Infections	501	ASP0113	(afwcmeqvtm) = uggshvixfr qevkgkxamb (axvalzqhhz )	Negative	19 Mar 2021
				Placebo	(afwcmeqvtm) = qbrkmlvlmn qevkgkxamb (axvalzqhhz )
NCT01974206 (Pubmed \| MMWR Morb Mortal Wkly Rep \| Am J Transplant) Manual	Phase 2	Cytomegalovirus Infections	149	ASP0113	(oiqgtixrqk): OR = 0.79 (95% CI, 0.43 - 1.47), P-Value = 0.307 View more	Negative	01 Dec 2018
				Placebo
NCT01877655 (HELIOS, CTgov)	Phase 3	Cytomegalovirus Infections \| Hematopoietic stem cell transplantation	514	Placebo (Placebo)	hdybyztfmi(qffhozdigm) = lgbzlcsrus gfnvrmlpzv (cviibtrruz, ginjcojvvp - spdecwyltb) View more	-	28 Nov 2018
				ASP0113 (ASP0113)	hdybyztfmi(qffhozdigm) = uwzuzfawbl gfnvrmlpzv (cviibtrruz, pbrvhbjjsj - kdnuifqstq) View more