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-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [4]

Active Indication

Follicular LymphomaChronic Lymphocytic LeukemiaOvarian Cancer+ [2]

Inactive Indication

Bladder CancerMelanomaMetastatic melanoma+ [4]

Originator Organization

Dana-Farber Cancer Institute, Inc.

Active Organization

BioNTech US, Inc.

Bristol Myers Squibb Co.

Dana-Farber Cancer 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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82

Literatures (Medical) associated with NEO-PV-01

13 Mar 2025·Nature

A neoantigen vaccine generates antitumour immunity in renal cell carcinoma

Article

Author: Li, Shuqiang ; Afeyan, Alexander B ; Olsen, Lars R ; Iorgulescu, J Bryan ; Greenslade, Haley ; Hacohen, Nir ; Tu, Chloe R ; Braun, David A ; Signoretti, Sabina ; Getz, Gad ; Southard, Jackson ; Shetty, Keerthi ; Mehndiratta, Ambica ; Aster, Jon C ; McGregor, Bradley A ; Shim, Bohoon ; Choueiri, Toni K ; Moranzoni, Giorgia ; Gabriel, Stacey ; LeBoeuf, Nicole R ; Chea, Vipheaviny ; Keskin, Derin B ; Pedersen, Christina B ; Shukla, Sachet A ; Leshchiner, Ignaty ; Mossanen, Matthew ; Carulli, Isabel ; Ott, Patrick A ; Elagina, Liudmila ; Carr, Steven A ; Forman, Juliet ; Tarren, Anna ; Livak, Kenneth J ; Hirsch, Michelle S ; Fritsch, Edward F ; Vanasse, Allison P ; Forman, Cleo ; Chang, Steven L ; Simon, Jeremy M ; Blass, Eryn ; Howard, Alexis A ; Olive, Oriol ; Schindler, Nicholas R ; Liu, Yiwen ; Duke-Cohan, Joseph ; Neuberg, Donna S ; Wu, Catherine J ; Klaeger, Susan ; Sarkizova, Siranush ; Oliveira, Giacomo

Personalized cancer vaccines (PCVs) can generate circulating immune responses against predicted neoantigens^1-6. However, whether such responses can target cancer driver mutations, lead to immune recognition of a patient's tumour and result in clinical activity are largely unknown. These questions are of particular interest for patients who have tumours with a low mutational burden. Here we conducted a phase I trial (ClinicalTrials.gov identifier NCT02950766) to test a neoantigen-targeting PCV in patients with high-risk, fully resected clear cell renal cell carcinoma (RCC; stage III or IV) with or without ipilimumab administered adjacent to the vaccine. At a median follow-up of 40.2 months after surgery, none of the 9 participants enrolled in the study had a recurrence of RCC. No dose-limiting toxicities were observed. All patients generated T cell immune responses against the PCV antigens, including to RCC driver mutations in VHL, PBRM1, BAP1, KDM5C and PIK3CA. Following vaccination, there was a durable expansion of peripheral T cell clones. Moreover, T cell reactivity against autologous tumours was detected in seven out of nine patients. Our results demonstrate that neoantigen-targeting PCVs in high-risk RCC are highly immunogenic, capable of targeting key driver mutations and can induce antitumour immunity. These observations, in conjunction with the absence of recurrence in all nine vaccinated patients, highlights the promise of PCVs as effective adjuvant therapy in RCC.

01 Jan 2025·Neoplasia

Depletion of regulatory T cells enhances the T cell response induced by the neoantigen vaccine with weak immunogenicity

Article

Author: Zhou, Qiao ; Liu, Jiajun ; Zhao, Bi ; Cheng, Lan ; Zhou, Haosu ; Liu, Yanfang ; Sun, Qinying ; Huang, Ruichen ; Dong, Yuchao ; Zhang, Wei ; Qin, Hao ; Wang, Jun ; Jiao, Yang ; Xia, Yang ; Ning, Yunye ; Feng, Tangtao ; Su, Xiaoping ; Song, Xiuyan

BACKGROUNDThe neoantigen vaccine has remarkable potential in treating advanced cancer due to its tumor specificity and ability to bypass central tolerance mechanisms. However, numerous neoantigens show poor immunogenicity, and the immune inhibitory factors of present in both tumors and tumor-draining lymph nodes impair the efficacy of cancer neoantigen vaccine. Eliminating immunosuppressive cells will improve the priming and expansion of anti-tumor immune cells induced by the vaccine.METHODSIn this study, a Treg-depleting regimen (consisting of CD25mAb and low-dose cyclophosphamide (LD-CTX)) was used in conjunction with a neoantigen vaccine for treating mice with solid tumors. We constructed two types of tumor models and investigated differences in therapy efficacy in the four groups (PBS, vaccine, CD25mAb+CTX and combination) at the genetic and protein levels. ELISPOT and TCR sequencing were applied to detect the expansion of neoantigen reactive T cells (NRT) and tumor antigen spreading.RESULTSIn the combinational group, the ELISPOT results showed an obvious expansion of NRT cells induced by weak immunogenic peptides. The combinational group exhibited significant improvement in inhibiting the tumor growth extended the survival time of tumor-bearing mice, and promoted T cells infiltration into tumors. Besides, compared to the Vac group, more neoantigen-targeted and TAA-targeted T cells were detected in the combinational group by TCR sequencing. The results of transcriptomic sequencing and flow cytometry showed that the number of Tregs in the combinational group was lower, while the proportions of memory effector T cells and effector T cells were higher than those in the vaccine group. An increase in mature DCs was also observed in vaccinated mice after receiving this Treg-depleting strategy.CONCLUSIONOur research first revealed that inhibiting the normal function of Tregs transformed "weaker" neoantigens into "stronger" ones, while also contributing to the proliferation of NRT cells. This Treg-depleting strategy allowed neoantigens with poor immunogenicity to elicit a robust immune response, thereby augmenting the efficacy of the neoantigen vaccine in delaying tumor growth and prolonging the survival of the hosts.

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 ; Zhuang, Qiuyu ; Li, Fang ; Liu, Xiaolong ; 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 melanoma	Phase 1	United States	BioNTech US, Inc.	08 Oct 2018
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 1	United States	BioNTech US, Inc.	04 May 2018
Bladder Cancer	Phase 1	United States	Bristol Myers Squibb Co.	01 Oct 2016
Melanoma	Phase 1	United States	Bristol Myers Squibb Co.	01 Oct 2016
Non-Small Cell Lung Cancer	Phase 1	United States	Bristol Myers Squibb Co.	01 Oct 2016
Transitional Cell Carcinoma	Phase 1	United States	BioNTech SE	01 Oct 2016
Urothelial Carcinoma of the Urinary Bladder	Phase 1	United States	Bristol Myers Squibb Co.	01 Oct 2016
Glioblastoma	Phase 1	-	Dana-Farber Cancer Institute, Inc.	-
Glioblastoma	Phase 1	-	BioNTech US, Inc.	-
Glioblastoma	Phase 1	-	The Broad Institute, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02950766 (Pubmed) Manual	Phase 1	Renal Cell Carcinoma Adjuvant	9	NeoVax ± ipilimumab	(sjmblyoyda) = rfjksgewkw udqqwvvpba (xlqgetwjjf ) View more	Positive	05 Feb 2025
NCT03380871 (Pubmed) Manual	Phase 1	Non-squamous non-small cell lung cancer First line	38	pemetrexed+carboplatin+NEO-PV-01+pembrolizumab	(askrawkonc) = kmwxcogajj gxfcpdezil (ndllqgokbi )	Positive	17 Aug 2022
NCT03380871 (NT-002, AACR 12021 \| AACR 22021) Manual	Phase 1	Squamous non-small cell lung cancer First line	38	NEO PV 01+pemetrexed+carboplatin+pembrolizumab (ITT)	(uidifgehao) = powxhigseb folmxbvscx (omorclmkhb, 5.6 - 16.8) View more	Positive	01 Jul 2021
				NEO PV 01+pemetrexed+carboplatin+pembrolizumab (VAX)	(uidifgehao) = llvzaljusm folmxbvscx (omorclmkhb, 5.6 - 16.8) View more
NCT03380871 (NT-002, SITC2020)	Phase 1	Squamous non-small cell lung cancer First line	38	NEO-PV-01	zijsskrzqv(uzkgmxzeqw) = espfouidjw rcupammerm (ieinhmnngj ) View more	Positive	10 Dec 2020
				Pembrolizumab	zijsskrzqv(uzkgmxzeqw) = xtbajsjkax rcupammerm (ieinhmnngj ) View more
NCT02897765 (NT-001, SITC2019)	Phase 1	Neoplasms RECON tumor neoantigen abundance \| peripheral TCR repertoires	-	NEO-PV-01 + adjuvant	(zttymyvsxp) = benkvwbaks yxsdhgqioa (futmykmpsm ) View more	Positive	01 Nov 2019
				Nivolumab	(zttymyvsxp) = ipwdplxiff yxsdhgqioa (futmykmpsm ) View more