Delving into the Latest Updates on CV-9202 with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, mRNA vaccine

Synonyms

+ [1]

Target

5T4 x MAGEC1 x MAGEC2 x MUC1 x NY-ESO-1 x survivin

Action

inhibitors, antagonists

Mechanism

5T4 inhibitors(Trophoblast glycoprotein inhibitors), MAGEC1 antagonists(MAGE family member C1 antagonists), MAGEC2 antagonists(MAGE family member C2 antagonists)

+ [3]

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Non-Small Cell Lung Cancer

Inactive Indication

metastatic non-small cell lung cancer

Originator Organization

Cancer Research Institute

Active Organization

Ludwig Institute for Cancer Research Ltd.C.H. Boehringer Sohn AG & Co. KG

Cancer Research Institute

Inactive Organization

CureVac NV

PharmaJet, Inc.

CureVac SE

+ [2]

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 1038074778

Sequence Code 1038074779

Sequence Code 1038074782

Sequence Code 1038074781

Sequence Code 1038074783

Sequence Code 1038074780

This is an open-label, multicenter, 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC.
Arm A: messenger ribonucleic acid (mRNA) Vaccine [BI 1361849 (formerly CV9202)] + anti-programmed death ligand 1 (PD-L1) antibody [durvalumab]
Arm B: messenger ribonucleic acid (mRNA) Vaccine [BI 1361849] + anti-programmed death ligand 1 (PD-L1) [durvalumab] + anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody [tremelimumab]
The run-in evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (inclusive of subjects from the run-in).

Start Date20 Dec 2017

Sponsor / Collaborator

Ludwig Institute for Cancer Research Ltd.

[+5]

EUCTR2014-004959-30-BE

/ Not yet recruitingPhase 2

A randomised, double-blind phase II trial to determine efficacy, safety and immunogenicity of BI 1361849 (CV9202) maintenance vaccination therapy versus placebo given intradermally in patients with inoperable locally advanced NSCLC after definitive concurrent chemoradiation (CRT) therapy - Phase II study of BI 1361849 (CV9202) vs. placebo after definitive CRT

Start Date11 May 2016

Sponsor / Collaborator

SCS Boehringer Ingelheim Comm.V

NCT01915524

/ TerminatedPhase 1

An Exploratory, Open-label Phase Ib Study of RNActive®-Derived Cancer Vaccine and Local Radiation as Consolidation and Maintenance Treatment in Patients With Stage IV NSCLC and a Response or Stable Disease After First-line Chemotherapy or Therapy With an EGFR Tyrosine Kinase Inhibitor

The purpose of this study is to determine whether the new RNActive derived lung cancer vaccine CV9202 in combination with local radiation therapy is safe, tolerable and immunogenic for the consolidation and maintenance treatment of stage IV non small cell lung cancer (NSCLC) after first-line chemotherapy or therapy with an EGFR tyrosine kinase inhibitor.

Start Date01 Apr 2013

Sponsor / Collaborator

CureVac NV

100 Clinical Results associated with CV-9202

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100 Translational Medicine associated with CV-9202

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100 Patents (Medical) associated with CV-9202

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Literatures (Medical) associated with CV-9202

31 Dec 2025·Human Vaccines & Immunotherapeutics

Efficiency enhancement in main path extraction in mRNA vaccine field: A novel approach leveraging intermediate patents, with shielding origin and terminus patent edges

Article

Author: Lu, Yan ; Yang, Xiaoyi ; Jian, Zhongquan ; Yan, Shu ; Xu, Dongzi ; Ouyang, Zhaolian ; Zhang, Ting ; Chen, Juan ; Pan, Lizi ; Wu, Qingqiang

mRNA vaccines offer groundbreaking technological advantages and broad application potential. Their rapid advancement, particularly during the COVID-19 pandemic, is the result of decades of research and numerous technological breakthroughs. These discoveries build upon each other, forming dense, interconnected networks of progress. Studying the technological development paths of mRNA vaccines is therefore essential. Main path analysis (MPA) is particularly effective for mapping out development trajectories within complex and interconnected networks, which serves as a powerful tool for identifying key nodes and innovations. This study introduces a novel approach to extracting main paths from a patent citation network in the mRNA vaccine field. Initially, we shielded edges connecting the origin and terminus patents. Subsequently, we extracted the main paths from intermediate patents, and then, we reintegrated the edges connecting the origin and terminus patents based on the citation relationships, resulting in a comprehensive extraction of the main paths. The research findings indicate a consistency among the global main paths, global key-route main paths, local forward main paths, and local key-route main paths within the mRNA vaccine field. The patents on the main paths predominantly focus on nucleic acid modifications and delivery systems. The local backward main paths identify a greater number of patents, especially those related to litigation, offering a richer and more diverse set of technological insights. This study significantly advances the methodology of MPA, with the innovative shielding technique offering a fresh perspective for navigating complex networks and providing a deeper understanding of technological development in the mRNA vaccine domain.

01 Apr 2025·Journal of Controlled Release

Role of PEGylated lipid in lipid nanoparticle formulation for in vitro and in vivo delivery of mRNA vaccines

Article

Author: Ba, Ki Hyun ; Seow, Brandon Yi Loong ; Liao, Kuo-Chieh ; Zhang, Yue ; Yang, Yi Yan ; Zhang, Li ; Wan, Yue

mRNA-loaded lipid nanoparticles (mRNA-LNPs) hold great potential for disease treatment and prevention. LNPs are normally made from four lipids including ionizable lipid, helper lipid, cholesterol, and PEGylated lipid (PEG-lipid). Although PEG-lipid has the lowest content, it plays a crucial role in the effective delivery of mRNA-LNPs. However, previous studies have yet to elucidate the key factors of PEG-lipid that influence the properties of LNPs. This study reported how PEG-lipid content, lipid tail length, and chemical linkage between PEG and lipid affected in vitro and in vivo properties of mRNA-LNPs. Forty-eight LNP formulations were prepared and characterized. The results revealed that a PEG-lipid molar content exceeding 3 % significantly reduced the encapsulation efficiency of mRNA in LNPs via manual mixing. An increased PEG-lipid content also significantly decreased mRNA translation efficiency. Although the chemical linkage had minimal impact, the lipid tail length of PEG-lipid significantly affected the properties of mRNA-LNPs, irrespective of whether the LNPs were prepared using manual or microfluidic mixing. mRNA-LNPs made from ALC-0159 with C14 lipid tails, which is used in Pfizer/BioNTech COVID-19 mRNA vaccines, or C16-Ceramide-PEG preferably accumulated in the liver, while mRNA-LNPs prepared from C8-Ceramide-PEG were largely found in the lymph nodes. In a mouse SARS-CoV-2 Delta variant spike protein-encoded mRNA vaccine model, mRNA-LNPs made from either C8-Ceramide-PEG or C16-Ceramide-PEG yielded comparable vaccination efficacy to mRNA-LNPs made from ALC-0159, while mRNA-LNPs formulated with DSPE-PEG with C18 lipid tails mediated lower vaccination efficacy. C16-Ceramide-PEG LNPs and DSPE-PEG LNPs induced higher anti-PEG antibody response than C8-Ceramide-PEG and ALC-0159 LNPs. All the LNPs tested did not cause significant toxicity in mice. These results offer valuable insights into the use of PEG-lipid in LNP formulations and suggest that C8-Ceramide-PEG holds potential for use in the formulation of mRNA vaccine-loaded LNPs.

01 Apr 2025·Vaccine

sa-mRNA influenza vaccine raises a higher and more durable immune response than mRNA vaccine in preclinical models

Article

Author: Xu, Howard ; Chang, Cheng ; Palladino, Giuseppe ; Scalzo, Tina ; Wen, Yingxia ; Petkov, Daniel ; Ferrari, Annette ; Rossignol, Evan ; Patel, Harsh

mRNA-based vaccines can be rapidly manufactured and have been demonstrated clinically to raise robust immune responses to COVID-19 and protect against severe COVID-19 disease. The clinical immunogenicity and efficacy of self-amplifying mRNA (sa-mRNA) vaccines have also been demonstrated, along with a longer duration of action than mRNA vaccines. However, a detailed understanding of differences between sa-mRNA and conventional mRNA vaccines with modified bases is lacking. Compared with a N¹ψ-modified mRNA platform, when using an sa-mRNA approach, we observed a > 100-fold greater transfection efficiency for multiple antigens by sa-mRNA, all of which also showed high durability for gene-of-interest (GOI) production. The enhanced magnitude and durability of GOI expression by sa-mRNA compared with modified mRNA was also analysed in vivo using a luciferase reporter construct. In this experiment, sa-mRNA produced >100-fold cumulative bioluminescence compared with an mRNA construct. The elevation in GOI production translated into greater in vivo immunogenicity, where a 10-fold lower dose of sa-mRNA generated similar binding and neutralizing titers for the avian pandemic influenza H5N1 strain in both mouse and rat models. The sa-mRNA construct also generated comparable or higher antigen-specific CD8 T cell responses at 10-fold lower doses than mRNA. The lower doses of sa-mRNA generated a reduced elevation of reactogenic biomarkers while still generating similar or higher immunogenicity in rats and mice compared with modified mRNA. The current study suggests the potential of leveraging dose sparing, improved durability, enhanced immunogenicity, and possibly reduced reactogenicity of the sa-mRNA platform for vaccine applications.

1

News (Medical) associated with CV-9202

17 Aug 2021

·www.biospace.com

Boehringer, CureVac Terminate Lung Cancer Project on Poor Performance

Andreas Arnold/picture alliance via Getty Images Tübingen-based biopharmaceutical firm CureVac has revealed in its latest financial report that its lung cancer program with German biotechnology company Boehringer Ingelheim has been terminated. The move ends a €500m exclusive treatment exploration and development partnership which both parties signed seven years ago (2014). The collaboration focused on the viability of using CureVac's CV9202 therapeutic mRNA vaccine with afatinib in patients who have been diagnosed with advanced or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). It was also being tested in combination with chemo-radiation therapy in patients who have unresectable stage III NSCLC. However, in a brief statement hidden among its financials, CureVac said that it had terminated the agreement in June, with the process expected to be finalized by November 2021. The company said that despite the decision to discontinue their partnership on the project, the two firms will still continue to find ways to collaborate on other ways to use CureVac's RNA technology for other potential treatment purposes. While it did not explicitly state a reason, CureVac added that they were working with a "legacy program" that used an older protamine formulation, which was being developed seven years ago. It also stated that it is continuing its Phase I of II clinical trial for the potential of BI1361849 for NSCLC. CureVac did not provide any further details about the termination or any other plans moving forward. However, what is noticeable is that it comes just two months after it reported weak efficacy results of only 47% for an mRNA vaccine against COVID-19. Other rival medications had an efficacy of more than 90%. Industry observers had been setting their sights on the vaccine as it was thought to last longer and cost less. "While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging," said CureVac's Chief Executive Officer, Dr. Franz-Werner Haas, in a statement. "In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge." The CureVac-Boehringer trial involved 40,000 participants, with 75% based in Latin America and 25% in Europe. The 47% who showed efficacy represented around 46 cases from the vaccinated group and 88 cases in the placebo group. As part of that deal, CureVac received €35 million and was set to achieve milestone payments of as much as €430 million plus royalties from future sales. Boehringer has yet to issue an official statement about this revelation.

VaccineRadiation TherapyFinancial StatementCollaboratemRNA

100 Deals associated with CV-9202

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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-small cell lung cancer	Phase 3	United States	Boehringer Ingelheim GmbH	20 Dec 2017
metastatic non-small cell lung cancer	Phase 3	United States	MedImmune LLC	20 Dec 2017
metastatic non-small cell lung cancer	Phase 3	United States	PharmaJet, Inc.	20 Dec 2017
Non-Small Cell Lung Cancer	Phase 2	-	Cancer Research Institute	-
Non-Small Cell Lung Cancer	Phase 2	-	C.H. Boehringer Sohn AG & Co. KG	-
Non-Small Cell Lung Cancer	Phase 2	-	Ludwig Institute for Cancer Research Ltd.	-
metastatic non-small cell lung cancer	Discovery	United States	MedImmune LLC	20 Dec 2017
metastatic non-small cell lung cancer	Discovery	United States	Boehringer Ingelheim GmbH	20 Dec 2017
metastatic non-small cell lung cancer	Discovery	United States	PharmaJet, Inc.	20 Dec 2017
Non-Small Cell Lung Cancer	Discovery	Germany	CureVac SE	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2024 Manual	Phase 1	Non-Small Cell Lung Cancer	57	BI1361849 + durvalumab	(dzuikwcuuf) = jgtlvjympv yzlelzkhno (bwdvvifsmw ) View more	Positive	05 Apr 2024
				BI1361849 + durvalumab + tremelimumab	(dzuikwcuuf) = fvtrqkffvc yzlelzkhno (bwdvvifsmw ) View more
NCT03164772 (CTgov)	Phase 1/2	metastatic non-small cell lung cancer	61	PharmaJet Tropis® device+Durvalumab+BI 1361849 (Arm A: BI 1361849 mRNA Vaccine + Durvalumab)	(xztlecpuel) = ifajbqnwmb ctpywcuhew (deioxhlxdp, nqlnuxuuoe - gibfeuktmv) View more	-	27 Sep 2022
				PharmaJet Tropis® device+Tremelimumab+Durvalumab+BI 1361849 (Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab)	(xztlecpuel) = qwoodrjfud ctpywcuhew (deioxhlxdp, oyraqupazk - dlwkjqjvda) View more
NCT01915524 (Pubmed \| J Immunother Cancer) Manual	Phase 1	metastatic non-small cell lung cancer	26	local radiation+BI1361849	(pthyhnwufw) = Three patients had grade 3 BI1361849-related adverse events (fatigue, pyrexia); there was one grade 3 radiation-related event (dysphagia) sbgsnnqkrq (ptsycpkuhd ) View more	Positive	08 Feb 2019