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

163

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

BACKGROUND:

The 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.

METHODS:

A 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.

RESULTS:

Total 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).

CONCLUSIONS:

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

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

Abstract:

mRNA 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.

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
Chronic Lymphocytic Leukemia	Phase 1	US	-	17 Aug 2021
Ovarian Cancer	Phase 1	US	Dana-Farber Cancer Institute, Inc.	20 Nov 2020
Renal Cell Carcinoma	Phase 1	US	Bristol Myers Squibb Co.	03 Mar 2019
Glioblastoma	Phase 1	US	-	11 Oct 2018
Metastatic melanoma	Phase 1	US	BioNTech US, Inc.	08 Oct 2018
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 1	US	BioNTech US, Inc.	04 May 2018
Bladder Cancer	Phase 1	US	Bristol Myers Squibb Co.	01 Oct 2016
Melanoma	Phase 1	US	Bristol Myers Squibb Co.	01 Oct 2016
Non-Small Cell Lung Cancer	Phase 1	US	Bristol Myers Squibb Co.	01 Oct 2016
Transitional Cell Carcinoma	Phase 1	US	BioNTech SE	01 Oct 2016

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	pyrngxdzdr(wwnphvqgzs) = wjasbqixxw bkqlqfboep (wlcsstspzg )	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)	kkzgjzmwrg(lxzbctgyul) = wvbvlbrkbl trmkpjvgnd (itgnmxcnoh, 5.6 - 16.8) View more	Positive	01 Jul 2021
				NEO PV 01+pemetrexed+carboplatin+pembrolizumab (VAX)	kkzgjzmwrg(lxzbctgyul) = olnqertjgo trmkpjvgnd (itgnmxcnoh, 5.6 - 16.8) View more
NCT03380871 (NT-002, SITC2020)	Phase 1	Squamous non-small cell lung cancer First line	38	NEO-PV-01	savwxzbyss(ohgjskrydk) = zkfoholnen sqgwtrohbb (ztrkzutwsk ) View more	Positive	10 Dec 2020
				Pembrolizumab	savwxzbyss(ohgjskrydk) = twakmgxyvn sqgwtrohbb (ztrkzutwsk ) View more
NCT02897765 (NT-001, SITC2019)	Phase 1	Neoplasms RECON tumor neoantigen abundance \| peripheral TCR repertoires	-	NEO-PV-01 + adjuvant	snhsatzqsv(ksjmnsldre) = msovojwpjh efomojzjgo (fgspcacoej ) View more	Positive	01 Nov 2019
				Nivolumab	snhsatzqsv(ksjmnsldre) = gjsflslrpz efomojzjgo (fgspcacoej ) View more

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