AbstractThe difficulties with antibody-based therapies stem from their steep costs, complex procedures, and contamination risks. We investigate the use of in vitro transcription (IVT) for mRNA production, presenting a novel approach to traditional antibody treatments by promoting internal protein or antibody synthesis. We aim to create innovative mRNA-based anti-PD-L1 antibodies with strong immunotherapeutic effectiveness. The study begins with mouse immunization and hybridoma generation. Immunizing mice with the glycosylated extracellular domain of PD-L1 produces mouse antibodies against human PD-L1. Hybridomas, derived from post-immunization splenocytes, yield monoclonal antibodies screened for PD-L1 binding affinity via flow cytometry. A neutralizing assay identifies 22 antibodies with similar IC50 values and shared binding epitopes. M1, chosen for glycospecificity, affinity, and neutralizing activity, undergoes additional evaluation for the expression and anti-tumor efficacy of mRNA-encoded antibodies. The expression of M1 and atezolizumab antibodies is facilitated through an mRNA-lipid nanoparticles (LNPs) delivery system. Following intravenous administration in mice, sustained serum levels of M1 (ranging from 100 to 700 μg/mL at 24 hours post-injection) are observed. Serum concentrations of M1 and atezolizumab antibody peak at the first timepoint (24 or 48 h) after mRNA-LNP injection, respectively, and then significantly decrease within the next 4 days, with a gradual decline over the next 2 weeks. Conversely, the serum concentrations of M1 or atezolizumab protein decline significantly 24 hours post-injection and consistently stay at a baseline level (t1/2 of 94 and 4 h for M1 mRNA-LNP and protein, respectively). This indicates that the injection of encoded mRNA in mice can stably and continuously express antibodies.Administering Atezolizumab mRNA-LNP through two intravenous injections leads to a significant decrease in MC38 tumor growth, exhibiting a dose-dependent effect (TGI% = 8.1, 43.1, and 62.8 for doses of 0.2, 0.6, and 1 mg/kg, respectively). A complete tumor regression was observed up to day 19 following injection with a 2 mg/kg dose of mRNA-LNP (TGI% = 90.8%). Remarkably, a 3 mg/kg dose of atezolizumab antibody demonstrates a similar reduction in tumor growth as 0.6 mg/kg of the mRNA-LNP formulation in this model. In conclusion, this research underscores the potential of LNP-formulated mRNA as a transformative approach, converting the human body into a site for the continuous, stable expression of antibodies, offering a promising alternative to traditional protein-based therapies for combating cancer. This innovative approach shows promise in overcoming the limitations associated with traditional antibody production and clinical utilization.Citation Format: Ezra Chung, Yong Sik Bong, Renxiang Chen, Michael Zhang, Steven Long, Dong Shen. Novel mRNA encoding anti-PD-L1 monoclonal antibodies for cancer immunotherapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1368.

04 Apr 2023·Cancer Research

Abstract 5738: A pan-ras mRNA vaccine elicits specific immune responses and inhibits tumor growth in the mouse model of colon cancer

Author: He, Jiaxi ; Wang, Cun Yu ; Liu, Wei ; Chen, Renxiang ; Brown, David M. ; Bong, Yong-Sik ; Shen, Dong

AbstractKRAS mutations are present in about 25% of tumors, making them one of the most common mutated oncogenes among human cancers. Specifically, KRAS G12 mutation (89%) is the most common in tumors, followed by G13 (9%) and Q61 (1%). These mutations were once considered “undruggable” for many years until appearance of sotorasib. However, it was developed only for G12C mutation.We designed a Pan-Ras neoantigen mRNA vaccine (mRNA-1521), which covers all prevalent RAS mutations to achieve broad-spectrum cancer therapy. We synthesized a multiepitope neoantigen KRAS mRNA vaccine (mRNA-1521) and examined its immune response and anti-tumor efficacy in the colon cancer of Balb/c mice. Two groups (A, B) of mice were immunized with mRNA-1521 on days 0, 21, and 49, while PBS was given to two other groups (C, D) as the control on the same days. All mice were inoculated with CT26 cells (colon carcinoma cell line harboring G12D mutation) on day 56. Afterward, anti-PD1 antibodies were administered to groups A and C every two days. Tumor sizes were measured every 3 days after inoculation until anyone exceeded 1500mm3 in the control group. The serum IgG titer and T cell response of mice were explored using ELISA and splenocyte ELISpot assay after euthanasia. Tumor tissues were harvested and embedded in paraffin for the immunohistochemistry (IHC) test. Next-generation sequencing (NGS) was also applied to investigate the whole transcriptome analysis.Tumor growth rates in all treatment groups were slower than in the control group. Among them, the mean tumor size and weight in the combination group of mRNA-1521 and anti-PD1 (372mm3, 0.48g) were only 25% of the PBS group (1488mm3, 2g). On average, the anti-PD1 and vaccine groups had moderate tumor size and weight (1100mm3/1.5g and 886mm3/1.26g, respectively). The splenocytes from the mice in each group were collected. The IFN-γ secreting splenocytes in the combination group were 50% higher than the mRNA-1521 group. Furthermore, the total IgG titer of vaccine-immunized mice (OD450nm>2) was 3 and 4 times higher than the anti-PD1 and control groups. The IHC showed that the tumor tissues in the vaccine groups had more CD8+ and granzyme B+ CD8+ T cell infiltrations than in the control group. Whole transcriptome analysis showed that RAS downstream gene expressions were significantly lower in the vaccine group, indicating that the RAS vaccine was effective in inhibiting signaling pathways accounting for tumor proliferation, progression, and migration.In conclusion, prophylactic immunization of mRNA-1521 inhibited tumor growth in the mouse model of colon cancer. Its inhibitory effects on tumor growth were more remarkable in the combination of anti-PD1 antibodies. Moreover, the vaccine could elicit specific T and B cell responses, which are crucial in anti-cancer immunotherapy.Citation Format: Renxiang Chen, Wei Liu, David M. Brown, Yong-Sik Bong, Jiaxi He, Dong Shen, Cun Yu Wang. A pan-ras mRNA vaccine elicits specific immune responses and inhibits tumor growth in the mouse model of colon cancer. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5738.

News (Medical) associated with Rnaimmune, Inc.

18 Dec 2023

·www.prnewswire.com

RNAimmune Receives Investigational New Drug Application Clearance from U.S. FDA for mRNA-Based Respiratory Syncytial Virus Vaccine RV-1770

GERMANTOWN, Md and GUANGZHOU, China, Dec. 18, 2023 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced that, its subsidiary RNAimmune, Inc. ("RNAimmune"), a leading biotech company specializing in mRNA-based vaccines and therapeutics, has obtained a green light from the U.S. Food and Drug Administration (FDA) to proceed with its Investigational New Drug application for Phase I clinical trials of RV-1770, an mRNA vaccine targeting the human Respiratory Syncytial Virus (RSV). RNAimmune will begin a Phase I clinical study to assess the safety and tolerance of RV-1770, a combination of an mRNA-based vaccine with a proprietary lipid nanoparticle formulation, aimed at preventing RSV infection in adults. Healthy volunteers between the ages of 18–49 and an older adult group aged 60–79 will receive a single dose of RV-1770 intramuscularly, using one of three dosage levels: 50 μg, 100 μg, or 200 μg. The study plans to recruit a total of 162 participants divided into two cohorts of younger and older adults with 81 each. All participants will undergo a 12-month post-vaccination monitoring for evaluation of RV-1770's safety and immunogenicity. RV-1770 is an innovative mRNA-based vaccine formulation with a unique AI-enhanced design using the sequence of the recent RSV clinical isolate. It demonstrated immunogenic responses and neutralization against both type A and B strains of RSV in preclinical cotton rat studies. "The IND clearance from the FDA represents a significant leap forward in our mission to provide a safe and effective solution against RSV infection and its profound impact on human health," stated Dr. Dong Shen, President and Chief Executive Officer of RNAimmune. "As we embark on clinical trials aimed at assessing the safety and efficacy of RV-1770, this achievement underscores the potential of RNAimmune's mRNA technology platform in the battle against RSV and the prevention of associated respiratory diseases. Dr. Patrick Lu, Chairman of the board of directors of RNAimmune, commented: "RV-1770 has a unique mRNA sequence design with a proprietary nanoparticle formulation that has already shown superb preclinical safety and efficacy. These results clearly demonstrate the strength of RNAimmune's scientific team in quickly executing on its second vaccine program to move into clinical stage, working effectively with the company's regulatory team and the FDA." Dr. Dewan Zeng, Chief Executive Officer of Zhejiang Innoforce Pharmaceuticals Co., Ltd., the CDMO partner of the RV-1770 project, added: "We sincerely congratulate our partner, RNAimmune, on the FDA clearance of this IND application, and we are honored to be a partner in this innovative journey. We aim to leverage our cutting-edge technologies in ATMP manufacturing to help our partners to bring more effective ATMP to patients worldwide." About Respiratory Syncytial Virus RSV is a major cause of hospitalizations due to pneumonia and bronchiolitis. Substantial morbidity and socioeconomic burden are associated with RSV infection worldwide. Populations with higher susceptibility to developing severe RSV include premature infants, children with chronic lung disease of prematurity or congenital heart disease, elderly individuals aged > 65 years, and immunocompromised individuals. In the pediatric population, RSV can lead to long-term sequelae such as wheezing and asthma, which are associated with increased health care costs and reduced quality of life. Treatment for RSV is mainly supportive, and general preventive measures such as good hygiene and isolation are highly recommended. Despite being a significant public health concern, the U.S. has only two approved RSV vaccines, and there is no approved RSV vaccine in China. RNAimmune's RSV mRNA vaccine aims to address this unmet medical need by leveraging messenger RNA technology. About RNAimmune, Inc. RNAimmune is a pioneering biotech company dedicated to developing mRNA-based therapeutics and vaccines. With its global headquarters in Germantown, Maryland, USA, and a China headquarters in International BioIsland, Guangzhou, RNAimmune aims to address unmet medical needs by harnessing messenger RNA technology to create innovative solutions for infectious diseases, cancer, and other health challenges. RNAimmune holds a global exclusive right to the proprietary Polypeptide Lipid Nanoparticle (PLNP) technology for mRNA delivery from Sirnaomics. Additionally, RNAimmune possesses various independent proprietary R&D platforms, including artificial intelligence and directed neoantigen prediction, ALEPVA algorithm for nucleic acid sequence design, next-gen lipid nanoparticle (LNP) carrier systems, circular RNA, and self-amplify mRNA platforms. RNAimmune's diverse pipeline includes vaccines for infectious diseases (RSV, COVID-19, influenza, HSV, etc.) and cancer vaccines (RAS, NY-ESO-1), along with mRNA-encoded antibodies. RNAimmune has achieved significant potential and is a leader in the field of mRNA vaccines and therapeutics. For more information about RNAimmune and its RSV mRNA vaccine development, please visit . About Sirnaomics (stock code: 2257) Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Company's GalAhead™ technology, is currently in Phase I development. The Company has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the establishment of the Group's manufacturing facility in China, Sirnaomics is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: . SOURCE Sirnaomics

VaccinePhase 1mRNAINDImmunotherapy

18 Dec 2023

·www.prnewswire.com

Innoforce's Partner RNAimmune Granted IND Clearance for RSV mRNA Vaccine from FDA

HANGZHOU, China, Dec. 18, 2023 /PRNewswire/ -- RNAimmune, Inc., a partner of Innoforce, announced the U.S. Food and Drug Administration (FDA) granted IND clearance for its RV-1770 Respiratory Syncytial Virus (RSV) mRNA vaccine. Innoforce congratulates RNAimmune on this significant milestone achievement, which is also significantly advancing in the fight against RSV. As the CDMO partner for RNAimmune, Innoforce provided end-to-end services from plasmid, mRNA IVT, to LNP encapsulation, including process development and optimization, clinical batch GMP manufacturing, and CTD document preparation for the IND submission to the FDA. RSV is a highly contagious virus causing severe respiratory illness, particularly in infants, the elderly, and individuals with weakened immune systems. Despite being a significant public health concern, the US has only two approved RSV vaccines. RNAimmune's RSV mRNA vaccine aims to address this unmet medical need by leveraging mRNA technology. With the FDA's IND clearance, RNAimmune can now commence clinical trials to evaluate the safety and effectiveness of its RSV mRNA vaccine in human subjects. This is also a remarkable example of how a Chinese CDMO can support an IND application to the US FDA, demonstrating the advantages of Innoforce's mature mRNA platform and high-quality CDMO services in accelerating the development and commercialization of mRNA therapeutics and other advanced therapy medicinal products (ATMPs). Dr. Dong Shen, President and Chief Executive Officer of RNAimmune, expressed his excitement about the IND approval, stating, "We are thrilled to receive IND approval for our RSV mRNA vaccine, a groundbreaking advancement in infectious disease prevention. This marks a significant step forward in our mission to provide a safe and effective solution to combat RSV and its devastating impact on human health." Dr. Dewan Zeng, Chief Executive Officer of Innoforce, was delighted with the milestone RNAimmune achieved, stating, "We sincerely congratulate our partner, RNAimmune, on the FDA clearance of this IND application, and we are honored to be a partner in this innovative journey. We aim to leverage our cutting-edge technologies in ATMP manufacturing to help our partners bring more effective ATMP to patients worldwide. About RNAimmune RNAimmune is a pioneering biotech company dedicated to developing mRNA-based therapeutics and vaccines. With its global headquarters in Germantown, Maryland, USA, and a China headquarters in International BioIsland, Guangzhou, RNAimmune aims to address unmet medical needs by harnessing messenger RNA technology to create innovative solutions for infectious diseases, cancer, and other health challenges. RNAimmune holds a global exclusive right to the proprietary Polypeptide Lipid Nanoparticle (PLNP) technology for mRNA delivery from Sirnaomics. Additionally, RNAimmune possesses various independent proprietary R&D platforms, including artificial intelligence and directed neoantigen prediction, ALEPVA algorithm for nucleic acid sequence design, next-gen lipid nanoparticle (LNP) carrier systems, circular RNA, and self-amplify mRNA platforms. RNAimmune's diverse pipeline includes vaccines for infectious diseases (RSV, COVID-19, influenza, HSV, etc.), cancer vaccines (RAS, NY-ESO-1), and mRNA-encoded antibodies. RNAimmune has achieved significant potential and is a leader in mRNA vaccines and therapeutics. For more information about RNAimmune and its RSV mRNA vaccine development, please visit . About Innoforce Innoforce enables the innovation and global supply of plasmid DNA, RNA, and cell and gene therapeutics powered by a world-class manufacturing and development hub. With extensive expertise in process development and manufacturing of ATMPs, Innoforce can be a trusted partner for your innovative ATMP projects from R&D through commercialization. SOURCE Innoforce Pharmaceuticals

VaccinemRNAINDImmunotherapyClinical Study

23 May 2023

·www.globenewswire.com

Telesis Bio to Present at SynBioBeta 2023

Highlighting application of the Molecular Biology Workstation to accelerating vaccine and biologics discoverySAN DIEGO, May 23, 2023 (GLOBE NEWSWIRE) -- Telesis Bio Inc. (NASDAQ: TBIO), a leader in automated multi-omic and synthetic biology solutions, today announced they will be showcasing their benchtop automation solutions for synthetic biology at SynBioBeta 2023 which is being held May 23-25 in Oakland, California. Telesis Bio will present in two speaker sessions: Todd R. Nelson, Ph.D., CEO and Founder of Telesis Bio and David Brown, Ph.D., Director R&D, RNAimmune will present “Beyond COVID: Leveraging synthetic biology to advance the potential of mRNA-based vaccines” on Tuesday May 23rd. RNAimmune will showcase the application of the BioXp platform for accelerating their vaccine discovery workflows. Daniel Gibson, Ph.D., CTO and Co-founder will present “Streamlining molecular biology workflows throughout biologics discovery” on Wednesday, May 24th. His presentation will focus on the BioXp platform technology and updates on expanding capabilities in synthetic biology, library preparation for NGS and application of on-demand automated synthesis with SOLA EDS technology. The award winning BioXp® system and associated BioXp® De novo and Select synthesis kits as well as NGS library prep kits provide a complete automated solution for accelerating many synthetic biology and genomics workflows throughout discovery. The system assists researchers in optimizing their discovery process by enabling sequence to screening in days, rather than weeks or months with alternative methods. Telesis Bio will also present in two poster sessions at the conference: Qi Zhang, Ph.D. Scientist, R&D will present “Automated solutions for addressing mRNA synthesis bottlenecks in therapeutics discovery” and David Weiss, Director of Product Management will present “Construction & Sequence Verification of Custom Genomes: Using the BioXp to streamline design to test workflow” to showcase application of the NGS library preparation kits for plasmid sequencing on the BioXp platform. For more information on Telesis Bio at SynBiobeta visit: https://telesisbio.com/synbiobeta-2023/ About Telesis BioTelesis Bio is empowering scientists with the ability to create novel, synthetic biology-enabled solutions for many of humanity’s greatest challenges. As inventors of the industry-standard Gibson Assembly® method and the first commercial automated benchtop DNA and mRNA synthesis system, Telesis Bio is enabling rapid, accurate and reproducible writing of DNA and mRNA for numerous downstream markets. The award-winning BioXp® system consolidates, automates, and optimizes the entire synthesis, cloning and amplification workflow. As a result, it delivers virtually error-free synthesis of DNA and RNA at scale within days and hours instead of weeks or months. Scientists around the world are using the technology in their own laboratories to accelerate the design-build-test paradigm for novel, high-value products for precision medicine, biologics drug discovery, vaccine and therapeutic development, genome editing, and cell and gene therapy. Telesis Bio is a public company based in San Diego. For more information, visit www.telesisbio.com. Telesis Bio, the Telesis Bio logo, Gibson Assembly, and BioXp are trademarks of Telesis Bio Inc. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include statements and guidance regarding Telesis Bio’s future financial performance as well as statements regarding the future release and success of new and existing products and services. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled Risk Factors and elsewhere in our Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission on May 12, 2023, as amended on May 1, 2023. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Telesis Bio disclaims any obligation to update these forward-looking statements. Contact:Jen CarrollVice President of Investor Relationsjen.carroll@telesisbio.com

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Pipeline Snapshot as of 24 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

RV-1730 ( SARS-CoV-2 antigen )	COVID-19 More	IND Approval
M1 mRNA-LNP(Rnaimmune) ( PDL1 )	Neoplasms More	Preclinical
NY-ESO-1 Cancer Vaccines (RNAimmune) ( NY-ESO-1 )	Neoplasms More	Discovery
Pan-RAS tumor vaccine (RNAimmune) ( RAS )	Neoplasms More	Discovery

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