Delving into the Latest Updates on NEO-PV-01 with Synapse

Overview

Basic Info

Drug Type

Personalized antigen vaccine, Synthetic peptide vaccine, Therapeutic vaccine

Synonyms

Neo Vax, NeoAntigen-peptides, Neoantigen vaccine

+ [7]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsNervous System DiseasesEndocrinology and Metabolic Disease+ [2]

Active Indication

Ovarian CancerRenal Cell CarcinomaGlioblastoma

Inactive Indication

Bladder CancerChronic Lymphocytic LeukemiaMelanoma+ [5]

Originator Organization

Dana-Farber Cancer Institute, Inc.

Active Organization

BioNTech US, Inc.

Dana-Farber Cancer Institute, Inc.

The Broad Institute, Inc.

+ [1]

Inactive Organization

BioNTech SE

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This research study is studying the drugs called NeoVax (a new type of personalized neoantigen vaccine) in combination with CDX-301 and Nivolumab or Pembrolizumab as a possible treatment for melanoma.
The names of the study drugs involved in this study are:
Personalized Neoantigen peptides (which combined with poly-ICLC make the vaccine NeoVax)
Poly-ICLC (Hiltonol)
CDX-301
Nivolumab (Opdivo)
Pembrolizumab (Keytruda)

Start Date03 Jan 2022

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT03219450 / RecruitingPhase 1IIT

A Pilot Study of a Personalized Neoantigen Cancer Vaccine With and Without Low-Dose Cyclophosphamide or Pembrolizumab in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated Chronic Lymphocytic Leukemia.

This research study is studying a novel type of CLL vaccine as a possible treatment for chronic lymphocytic leukemia (CLL)
The names of the study interventions involved in this study are:
Personalized NeoAntigen Vaccine
Poly-ICLC
Cyclophosphamide
Pembrolizumab

Start Date18 Aug 2021

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+3]

100 Clinical Results associated with NEO-PV-01

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100 Translational Medicine associated with NEO-PV-01

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100 Patents (Medical) associated with NEO-PV-01

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181

Literatures (Medical) associated with NEO-PV-01

01 Dec 2024·Vaccine

Association of SARS-CoV-2 immunoserology and vaccination status with myocardial infarction severity and outcome

Article

Author: Sánchez-Galarraga, Icíar ; Anel, Jorge ; Royuela, Ana ; González, Elisa ; Gómez-Lozano, Natalia ; Sánchez-Arjona, Alberto ; Blasco, Ana ; García-Gómez, Sergio ; de la Fuente, Jorge ; Silva, Lorenzo ; Pérez-Redondo, Marina

BACKGROUNDThe COVID-19 pandemic adversely affected the severity and prognosis of patients with acute myocardial infarction (MI) caused by atherothrombosis (type 1 MI). The effect, if any, of COVID-19 vaccination and natural SARS-CoV2 serologic immunity in these patients is unclear. Our aim was to analyze the association between the severity and outcome of patients with type 1 MI and their previous SARS-CoV2 vaccination and serostatus.METHODSA single-center retrospective cohort study conducted between March 1, 2020 and March 1, 2023. Clinical and follow-up information was collected from medical records and patients. Total antibodies (IgM, IgA, IgG) to nucleocapsid (N) antigens were measured by ECLIA (electrochemiluminescence-based immunoassay) to test the immune response to natural infection. If positive, IgM and IgG antibodies to spike (S) surface antigens were measured by CLIA to test the immune response to vaccine or natural infection. Multivariable logistic regression analysis was performed, adjusting for age, sex, hypertension, diabetes, and dyslipidemia.RESULTSTotal sample of 949 patients, 656 with ST-segment elevation MI (STEMI) and 293 with non-ST-segment elevation MI (NSTEMI). Mean age was 64 (SD 13) years, 80 % men. Pre-admission vaccination status was: ≥ 1 dose, 53 % of patients; complete vaccination, 49 %; first booster dose, 25 %. The majority (84 %) of vaccines administered were mRNA-based. Six months after MI, 92 (9.7 %) patients had a major adverse cardiac event (MACE) and 50 died; 11 % of patients had severe heart failure or cardiogenic shock (Killip III-IV) after STEMI. Vaccinated patients with STEMI and positive serology (Pos/Vax group) had a higher risk of Killip III-IV on admission: OR 2.63 (1.27-5.44), p = 0.010. SARS-CoV-2 S-specific IgG titers were highest in this group (median > 2080 AU/mL, [IQR 1560- >2080] vs 91 [32-198] in the unvaccinated group). In the overall sample, a higher incidence of 6-month MACE was not demonstrated (OR 1.89 [0.98-3.61], p = 0.055).CONCLUSIONSThe combination of vaccination and natural SARS-CoV2 infection was associated with the development of severe heart failure and cardiogenic shock in patients with STEMI, possibly related to an increased serological response.

01 Sep 2024·Progress in Community Health Partnerships: Research, Education, and Action

The Voices on Vax Campaign: Lessons Learned from Engaging Youth to Promote COVID Vaccination

Article

Author: Mendelson, Tamar ; Gaither, James ; Salmon, Daniel A. ; Forr, Amanda ; Powell, Terrinieka W. ; Dudley, Matthew Z. ; Brewer, Janesse ; Powell, Terrinieka W ; Dudley, Matthew Z ; Clinton, Taylor ; Wilson, Paige ; Johnson, Sydney ; Holifield, Joni ; Salmon, Daniel A ; Harr, Lindsey ; Benson, Lori Rose

Abstract: Background: The Voices on Vax campaign was a collaborative effort that engaged youth to create an interactive website and social media presence to increase COVID vaccine confidence and uptake among African American families in Baltimore, Maryland. Objectives: To describe lessons learned and offer recommendations for future health communication campaigns involving youth ambassadors and virtual platforms. Methods: We collected website analytics and limited data from pop-up surveys on the Voices on Vax website, as well as reflections from the youth ambassadors about their experiences. Lessons Learned: Challenges included difficulties engaging the priority population and methodological limitations of our campaign’s impact evaluation. Successes included our focus on youth and adaptive engagement strategies. Conclusions: We recommend using techniques to maximize engagement by the priority population, conducting in-person outreach, incorporating mixed methods data collection, and providing a mix of structured training and creative freedom to youth ambassadors.

01 Aug 2024·MedComm

Circular RNA‐based neoantigen vaccine for hepatocellular carcinoma immunotherapy

Article

Author: Cai, Guang ; Cai, Zhixiong ; Li, Yingying ; Zhang, Cuilin ; Gao, Shaodong ; Zhao, Bixing ; Liu, Xiaolong ; Li, Fang ; Zhuang, Qiuyu ; Wang, Yingchao ; Wang, Fei

AbstractmRNA vaccines are regarded as a highly promising avenue for next‐generation cancer therapy. Nevertheless, the intricacy of production, inherent instability, and low expression persistence of linear mRNA significantly restrict their extensive utilization. Circular RNAs (circRNAs) offer a novel solution to these limitations due to their efficient protein expression ability, which can be rapidly generated in vitro without the need for extra modifications. Here, we present a novel neoantigen vaccine based on circRNA that induces a potent anti‐tumor immune response by expressing hepatocellular carcinoma‐specific tumor neoantigens. By cyclizing linearRNA molecules, we were able to enhance the stability of RNA vaccines and form highly stable circRNA molecules with the capacity for sustained protein expression. We confirmed that neoantigen‐encoded circRNA can promote dendritic cell (DC) activation and enhance DC‐induced T‐cell activation in vitro, thereby enhancing T‐cell killing of tumor cells. Encapsulating neoantigen‐encoded circRNA within lipid nanoparticles for in vivo expression has enabled the creation of a novel circRNA vaccine platform. This platform demonstrates superior tumor treatment and prevention in various murine tumor models, eliciting a robust T‐cell immune response. Our circRNA neoantigen vaccine offers new options and application prospects for neoantigen immunotherapy in solid tumors.

100 Deals associated with NEO-PV-01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 1	US	BioNTech US, Inc.	04 May 2018
Glioblastoma	Phase 1	-	BioNTech US, Inc.	-
Glioblastoma	Phase 1	-	Bristol Myers Squibb Co.	-
Glioblastoma	Phase 1	-	The Broad Institute, Inc.	-
Glioblastoma	Phase 1	-	Dana-Farber Cancer Institute, Inc.	-
Melanoma	Preclinical	US	Bristol Myers Squibb Co.	01 Oct 2016
Transitional Cell Carcinoma	Preclinical	US	BioNTech SE	01 Oct 2016
Urothelial Carcinoma of the Urinary Bladder	Preclinical	US	Bristol Myers Squibb Co.	01 Oct 2016
Bladder Cancer	Discovery	US	Bristol Myers Squibb Co.	01 Oct 2016
Non-Small Cell Lung Cancer	Discovery	US	Bristol Myers Squibb Co.	01 Oct 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03380871 (Pubmed) Manual	Phase 1	Non-squamous non-small cell lung cancer First line	38	pemetrexed+carboplatin+NEO-PV-01+pembrolizumab	(xqldfpftbq) = xdzajhovwc uzmhfiaeoe (tseldsdbdt )	Positive	17 Aug 2022
NCT03380871 (NT-002, AACR2021) Manual	Phase 1	Squamous non-small cell lung cancer First line	38	NEO PV 01+pemetrexed+carboplatin+pembrolizumab (ITT)	(utfitmwhmj) = qgszlyeufv oakjptfgun (skansvqvsn, 5.6 - 16.8) View more	Positive	01 Jul 2021
				NEO PV 01+pemetrexed+carboplatin+pembrolizumab (VAX)	(utfitmwhmj) = pbwvrclwyq oakjptfgun (skansvqvsn, 5.6 - 16.8) View more
NCT03380871 (NT-002, SITC2020)	Phase 1	Squamous non-small cell lung cancer First line	38	NEO-PV-01	gkjsipjjqh(ogiptaifzi) = jmbocwcwhh znjsrxoapz (yatouwcpxy ) View more	Positive	10 Dec 2020
				Pembrolizumab	gkjsipjjqh(ogiptaifzi) = ldqnnmxrce znjsrxoapz (yatouwcpxy ) View more
NCT02897765 (NT-001, SITC2019)	Phase 1	Neoplasms RECON tumor neoantigen abundance \| peripheral TCR repertoires	-	NEO-PV-01 + adjuvant	qrzivlqfbn(cvwwdbliqn) = igpoyejlje saitmuedyq (capueceelk ) View more	Positive	01 Nov 2019
				Nivolumab	qrzivlqfbn(cvwwdbliqn) = pirowwywey saitmuedyq (capueceelk ) View more