This research study is studying a novel type of FL vaccine as a possible treatment for follicular lymphoma (FL).
The agents involved in this study are:
Rituximab
Personalized NeoAntigen vaccine
Poly-ICLC
Pembrolizumab

Start Date14 Mar 2022

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

NCT04930783 / RecruitingPhase 1IIT

A Phase Ib Study of NeoVax in Combination With CDX-301 and Nivolumab or Pembrolizumab and in Patients With Melanoma

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

100 Translational Medicine associated with NEO-PV-01

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

172

Literatures (Medical) associated with NEO-PV-01

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.

01 Jul 2024·Clinical Cancer Research

Integrating Multisector Molecular Characterization into Personalized Peptide Vaccine Design for Patients with Newly Diagnosed Glioblastoma

Article

Author: Rao Venkata, Lakshmi P ; Chicoine, Michael R ; Livingstone, Alexandra J ; Garfinkle, Elizabeth A R ; Kim, Albert H ; Miller, Katherine E ; Zipfel, Gregory J ; Johanns, Tanner M ; Dunn, Gavin P ; Roberts, Kaleigh F ; Dowling, Joshua L ; Mardis, Elaine R ; Dacey, Ralph G

AbstractPurpose:Outcomes for patients with glioblastoma (GBM) remain poor despite multimodality treatment with surgery, radiation, and chemotherapy. There are few immunotherapy options due to the lack of tumor immunogenicity. Several clinical trials have reported promising results with cancer vaccines. To date, studies have used data from a single tumor site to identify targetable antigens, but this approach limits the antigen pool and is antithetical to the heterogeneity of GBM. We have implemented multisector sequencing to increase the pool of neoantigens across the GBM genomic landscape that can be incorporated into personalized peptide vaccines called NeoVax.Patients and Methods:In this study, we report the findings of four patients enrolled onto the NeoVax clinical trial (NCT0342209).Results:Immune reactivity to NeoVax neoantigens was assessed in peripheral blood mononuclear cells pre- and post-NeoVax for patients 1 to 3 using IFNγ-ELISPOT assay. A statistically significant increase in IFNγ producing T cells at the post-NeoVax time point for several neoantigens was observed. Furthermore, a post-NeoVax tumor biopsy was obtained from patient 3 and, upon evaluation, revealed evidence of infiltrating, clonally expanded T cells.Conclusions:Collectively, our findings suggest that NeoVax stimulated the expansion of neoantigen-specific effector T cells and provide encouraging results to aid in the development of future neoantigen vaccine–based clinical trials in patients with GBM. Herein, we demonstrate the feasibility of incorporating multisector sampling in cancer vaccine design and provide information on the clinical applicability of clonality, distribution, and immunogenicity of the neoantigen landscape in patients with GBM.

01 Jun 2024·American Society of Clinical Oncology Educational Book

State-Of-The-Art Advancements on Cancer Vaccines and Biomarkers

Review

Author: Svane, Inge Marie ; Strum, Scott ; Andersen, Mads Hald ; Weber, Jeffrey S ; Siu, Lillian L

The origins of cancer vaccines date back to the 1800s. Since then, there have been significant efforts to generate vaccines against solid and hematologic malignancies using a variety of platforms. To date, these efforts have generally been met with minimal success. However, in the era of improved methods and technological advancements, supported by compelling preclinical and clinical data, a wave of renewed interest in the field offers the promise of discovering field-changing paradigms in the management of established and resected disease using cancer vaccines. These include novel approaches to personalized neoantigen vaccine development, as well as innovative immune-modulatory vaccines (IMVs) that facilitate activation of antiregulatory T cells to limit immunosuppression caused by regulatory immune cells. This article will introduce some of the limitations that have affected cancer vaccine development over the past several decades, followed by an introduction to the latest advancements in neoantigen vaccine and IMV therapy, and then conclude with a discussion of some of the newest technologies and progress that are occurring across the cancer vaccine space. Cancer vaccines are among the most promising frontiers for breakthrough innovations and strategies poised to make a measurable impact in the ongoing fight against cancer.

News (Medical) associated with NEO-PV-01

20 Aug 2024

·www.pharmamanufacturing.com

Emergent donates 50,000 doses of mpox vaccine to Africa

Emergent BioSolutions, working with the World Health Organization and the U.S. government to help address the current mpox outbreak across Central Africa, has pledged to donate 50,000 doses of its ACAM2000 vaccine. The vaccines will be donated through the humanitarian organization Direct Relief, that has a history of providing medicines to the Democratic Republic of the Congo, as well as the other impacted countries of Burundi, Kenya, Rwanda and Uganda. Emergent's ACAM2000 was approved in 2007 for immunization against smallpox disease for persons determined to be at high risk for infection. The second-generation smallpox vaccine doesn't yet have the FDA nod for mpox, but Emergent filed an sBLA with the agency last October seeking the expanded indication. The shot, however, comes with risks . The live virus vaccine is administered via a two-pronged stainless steel needle that pricks the skin several times in the upper arm with a droplet of the vaccine. If successful, a red, itchy sore spot at the site of the vaccination will appear within a few days. Those who receive the vaccine can spread the virus used, a pox virus known as vaccinia, to themselves or others through contact with the vaccine site. Additionally, the vax shouldn't be administered to those who weakened immune systems, such as those with HIV, and can cause myocarditis and pericarditis. Bavarian Nordic also has a live, non-replicating smallpox and monkeypox vaccine, branded Jynneos in the U.S. and Imvamune/Imvanex internationally, approved by the FDA in 2019. Following the WHO declaring the mpox outbreak a public health emergency of international concern, the Danish drugmaker ramped up manufacturing capacity, promising it could manufacture 10 million doses by the end of 2025, in addition to current orders.

Drug ApprovalVaccine

24 Jun 2024

·pipelinereview.com

AstriVax enters clinical phase with its novel vaccine platform technology

LEUVEN, Belgium I June 24, 2024 I The first participants have been dosed in a Phase I clinical study to test the safety and efficacy of AstriVax’s prophylactic vaccines for yellow fever (AVX70120) and rabies (AVX70481) in healthy adults. The first-in-human safety and immunogenicity data generated by this study will be a stepping stone in advancing AstriVax immunotherapies to clear chronic infections such as Hepatitis B and human papillomavirus (HPV) infections. The company’s first-in-human clinical study, called SAFYR, will be conducted in two Belgium-based, world-class vaccine clinical trial sites: the Centre for Vaccinology in Ghent and Vaccinopolis in Antwerp. The study will evaluate the safety and characterize the immune response of the company’s prophylactic vaccines for yellow fever and rabies in close to 100 healthy adults aged 18 to 40. The results are also expected to provide clinical proof of concept for the AstriVax vaccine platform. Mathieu Peeters, MD, Chief Development Officer at AstriVax : “This clinical trial evaluates our cutting-edge technology in a clinical proof-of-concept study. We use plasmids that deliver live-attenuated virus vectors along with the target viral antigen. This self-amplifying mechanism is designed to elicit strong and long-lasting immune responses with only microdoses.” The novel AstriVax vaccines are potential game-changers in the fight against viral pathogens. Developed with the company’s innovative vaccine platform, they are easy to produce, have limited cold chain requirements, and are expected to trigger a strong and lasting immune response. Paving the way for immunotherapies Today, AstriVax is a clinical-stage company with a rich pipeline targeting viral infections, including treatment of infectious diseases with critical unmet medical needs like chronic Hepatitis B, which affects over 250 million people, and HPV infections, a leading cause of cervical cancer. Hanne Callewaert, Ph.D., CEO and co-founder of AstriVax : “Less than two years ago, our journey began with solid, academically developed technology and a €30 million seed round. In May 2023, we were awarded a grant from Flanders Innovation & Entrepreneurship (VLAIO) to further advance our technology. I’m deeply grateful to my exceptional team for shaping the company into what it is today, and I look forward to continuing our journey towards better global health together. We anticipate our chronic hepatitis B immunotherapeutic will enter the clinical phase in 2025, marking yet another significant milestone for AstriVax. ” Media contact Hanne Callewaert, Ph.D, CEO of Astrivax, corporate@astrivax.com . About AstriVax Founded in 2022, AstriVax NV aims to address global challenges in vaccinology with its innovative plug-and-play vaccine platform. The company develops novel prophylactic and therapeutic vaccines that are easy to produce, have reduced cold chain requirements, and offer broad and long-lasting protection against various infectious diseases. AstriVax is supported by well-known investors V-Bio Ventures, Fund+, Flanders Future TechFund managed by PMV, Thuja Capital, Ackermans & van Haaren, OMX Europe Venture Fund (Mérieux Equity Partners and Korys), BNP Paribas Fortis Private Equity, and the KU Leuven Gemma Frisius Fund. AstriVax is located in the BioHub in Leuven. For more information, please visit astrivax.com . SOURCE: AstriVax

VaccinePhase 1Immunotherapy

100 Deals associated with NEO-PV-01

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma	Phase 1	-	Bristol Myers Squibb Co.	-
Glioblastoma	Phase 1	-	BioNTech US, Inc.	-
Glioblastoma	Phase 1	-	Dana-Farber Cancer Institute, Inc.	-
Glioblastoma	Phase 1	-	The Broad Institute, Inc.	-
Metastatic melanoma	Preclinical	US	BioNTech US, Inc.	08 Oct 2018
Melanoma	Preclinical	US	BioNTech US, Inc.	01 Oct 2016
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Discovery	US	BioNTech US, Inc.	04 May 2018
Bladder Cancer	Discovery	US	BioNTech US, Inc.	01 Oct 2016
Non-Small Cell Lung Cancer	Discovery	US	BioNTech US, Inc.	01 Oct 2016
Transitional Cell Carcinoma	Discovery	US	BioNTech SE	01 Oct 2016

Clinical Result

Indication

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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	(jyxmsanrwi) = qjvwktmfgu gkmqjrhzjf (iuxzhlozgy )	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)	(xpzdcfzcvp) = ixyaujbggu dqabysxprk (ifswdlfjek, 5.6 - 16.8) View more	Positive	01 Jul 2021
				NEO PV 01+pemetrexed+carboplatin+pembrolizumab (VAX)	(xpzdcfzcvp) = zekpuqybur dqabysxprk (ifswdlfjek, 5.6 - 16.8) View more
NCT03380871 (NT-002, SITC2020)	Phase 1	Squamous non-small cell lung cancer First line	38	NEO-PV-01	iwfywkrmcd(zwhjbdvsrh) = hljrjdpajh zkcfykxbjd (mmblmaxjqn ) View more	Positive	10 Dec 2020
				Pembrolizumab	iwfywkrmcd(zwhjbdvsrh) = aslhrjmvmt zkcfykxbjd (mmblmaxjqn ) View more
NCT02897765 (NT-001, SITC2019)	Phase 1	Neoplasms RECON tumor neoantigen abundance \| peripheral TCR repertoires	-	NEO-PV-01 + adjuvant	hqdwgymtud(dtoxjwtozu) = krbygdzkfa tuyoutvskm (ngqbmfyevj ) View more	Positive	01 Nov 2019
				Nivolumab	hqdwgymtud(dtoxjwtozu) = vvrlhxcwfw tuyoutvskm (ngqbmfyevj ) View more

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