Aimé Bio's mRNA COVID-19 Vaccine (LVRNA009) Receives Strong Endorsement Following Successful Phase I Trial Results and IPO Filing

Amid the ongoing COVID-19 pandemic, vaccines have undoubtedly taken center stage. mRNA vaccines, with their significant speed advantages in research and development as well as production, have propelled numerous companies to “star” status. The most typical examples are international mRNA giants such as Moderna and BioNTech, which successfully broke into the mainstream spotlight and gained widespread public recognition through their mRNA vaccines, generating billions of dollars in global revenue in just a single quarter.

Many capable domestic enterprises have demonstrated equally impressive performance in mRNA vaccine R&D, drawing keen attention from the market. Recently, AIM Vaccine, China’s largest private vaccine group with a full industry chain, held a data analysis report meeting for the Phase I clinical trial of its core product, the mRNA COVID-19 vaccine (LVRNA009), at Shulan (Hangzhou) Hospital.

At the conference, Chen Guiling, Director of the Phase I Clinical Trial Research Office at Shulan (Hangzhou) Hospital, presented the safety data from the Phase I clinical trial of LVRNA009, with results showingLVRNA009 demonstrated a favorable safety and tolerability profile.Director Chen Guiling stated, “LVRNA009 has completed the 28-day safety observation period following full immunization across the low-, medium-, and high-dose groups in adults. Among the 24 subjects in each dose group, compliance has been observed to be 100%.”

Regarding the safety results of the Phase I clinical trial of LVRNA009, Director Chen Guiling stated that particular attention should be paid to the incidence of fever in patients during the Phase I clinical trial of LVRNA009—All adverse events associated with LVRNA009 were Grade 1 or 2 in severity; no adverse events of Grade 3 or higher occurred. No serious adverse events (SAEs) or adverse events of special interest (AESIs) were reported. Throughout the trial, no cases of fever of Grade 3 or higher were observed.

Director Chen Guiling stated,“Fever thresholds differ between China and other countries; China adopts stricter criteria with a lower temperature cutoff, resulting in a higher number of reported fever-related adverse events.”However, LVRNA009 has undoubtedly delivered encouraging results from its Phase I clinical trial.

In addition, Dr. Shan Chao from the Wuhan Institute of Virology, Chinese Academy of Sciences, presented the results of live-virus neutralizing antibody tests at the conference, stating that “the GMT on day 56 was over 570 in the adult low-dose group, over 1,500 in the adult medium-dose group, and over 840 in the adult high-dose group.”

Compared with the Phase I clinical trial results of similar products, LVRNA009 demonstrated excellent safety and immunogenicity.Currently, the Phase I clinical trials of three domestic mRNA vaccines are being conducted at the Phase I Clinical Trial Research Center of Shulan (Hangzhou) Hospital. Among them, the first mRNA vaccine to initiate trials has already entered Phase III clinical trials abroad.

Qin Xiaofeng, a professor at the Suzhou Institute of Systems Medicine under the Center for Systems Research, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union Medical College, was greatly encouraged after reviewing the data from the Phase I clinical trial of AIM Vaccine’s mRNA vaccine. He stated:“LVRNA009 has few adverse reactions and a high neutralizing antibody titer, showing great promise.”Other top experts present at the meeting also praised the Phase I results of AIM Vaccine’s mRNA COVID-19 vaccine (LVRNA009).

In light of the current epidemic prevention and control situation, experts stated thatDrugs cannot end the epidemic; vaccines are the effective means for COVID-19 prevention and control.Vaccines will continue to be used on a large scale in the future, and the country needs to make long-term strategic investments in innovative vaccine research and development. The current implementation of sequential vaccination in China is of great significance.

“Since its establishment, AIM Vaccine has consistently invested in the R&D of blockbuster products, deployed large-scale production capacity, and built comprehensive commercialization capabilities. Meanwhile, by adhering to a development path combining independent innovation with external collaborations, we have achieved coverage across multiple technological platforms for vaccine R&D on an all-encompassing basis, thereby ensuring a well-structured product pipeline and continuous iteration,” stated Mr. Zhou Yan, Founder, Chairman of the Board, and CEO of AIM Vaccine.In recent years, AIM Vaccine has strategically launched a series of blockbuster innovative vaccines, including the mRNA COVID-19 vaccine, the 13-valent pneumococcal polysaccharide conjugate vaccine, the quadrivalent meningococcal polysaccharide conjugate vaccine, the bivalent hand, foot and mouth disease vaccine (EV71-CA16), and upgraded iterations of the rabies vaccine.

At the conference, Professor Zeng Guang, a renowned expert in public health and epidemiology, delivered a keynote report titled “Outlook on the Prevention and Control of COVID-19.” Professor Zeng believed thatWhile the novel coronavirus may gradually attenuate, it cannot be eradicated; given that SARS-CoV-2 is likely to coexist with humans over the long term, China must implement sequential immunization.This is to establish a robust and optimal herd immunity barrier. He articulated the importance of vaccine prevention in plain language: “With vaccines, we no longer fear it!”

Professor Wang Yu, Distinguished Visiting Professor at the Vanke School of Public Health and Tsinghua University and former Director of the Chinese Center for Disease Control and Prevention (China CDC), illustrated his viewpoint by citing the historical responses to H7N9 avian influenza and poliomyelitis: “Antiviral drugs cannot halt viral transmission and infection; COVID-19 vaccines will continue to be deployed on a large scale.” Furthermore, Professor Wang provided an accessible overview of how mRNA technology is applied in vaccine products, stating,Given the short time since the emergence of the novel coronavirus, our understanding of its biological behavior remains limited. Therefore, concerted efforts from pharmaceutical companies and scientists are urgently needed, as the development of new vaccine technologies is an endless endeavor.

Xu Jianqing, a Distinguished Professor at Fudan University and researcher at the Institute of Biomedical Sciences, outlined the challenges in controlling the COVID-19 pandemic and progress in vaccine development. “Currently, the proportion of asymptomatic infections is very high, making it highly challenging to achieve herd immunity through natural infection or reliance on a single vaccine,” Xu stated.mRNA vaccines demonstrate significant advantages as booster doses in sustaining antibody persistence and addressing variant strains.

At the report session, Dr. Peng Yucai, Chief Scientist of AIM Vaccine, focused on elaborating the features of AIM’s mRNA COVID-19 vaccine, starting from the product’sGene Sequence Design, mRNA Delivery Methods, Vaccine Stability, and Product Quality Controlamong other aspects, providing a comprehensive overview of the advantages of the mRNA COVID-19 vaccine (LVRNA009).

Dr. Peng introduced that the mRNA COVID-19 vaccine (LVRNA009) originates from Lifanda’s R&D and production base.Lifanda has been researching mRNA vaccines since 2017, pioneering this field in China.To date, Lifanda’s R&D and production base has established a comprehensive team. In addition to mRNA R&D capabilities, it operates its own pilot-scale production workshop capable of manufacturing clinical trial materials for Phase I and Phase II studies, thereby ensuring quality control of mRNA products.

“We have devoted considerable time to implementing comprehensive quality control for our mRNA products, which is a rare achievement,” said Dr. Peng.

Furthermore, it is worth noting that LVRNA009, an mRNA-based COVID-19 vaccine, employs the most advanced and widely adopted lipid nanoparticle (LNP) delivery technology. This advantage is reflected in its higher mRNA encapsulation efficiency and delivery efficacy compared to previous technologies, as well as its good uniformity and controllability of particle size. Additionally, the manufacturing process is relatively simple and easily scalable.

In response to the bottleneck in domestically constrained equipment and instruments, AIM Vaccine proactively chose to tackle these hard challenges by “gnawing on the tough bones.” By adopting a model of “in-house R&D plus collaboration,” it has successfully developed certain upstream equipment and instruments, branding them under the name “Lituo.”“Current factors across the board have bolstered our confidence in developing this type of product,” said Dr. Peng.

It is also understood that AIM Vaccine’s mRNA COVID-19 vaccine has entered Phase II clinical trials, with trial data expected to be obtained in June or July this year, and an application for sequential vaccination is set to be submitted shortly.

In addition to clinical studies, the industrialization of mRNA COVID-19 vaccines was also a hot topic at the conference. Dr. Xiong Changyun, Vice President of AIM Vaccine and head of mRNA industrialization, introduced AIM Vaccine’s future roadmap for the industrial development of its mRNA vaccines.

“AIM Vaccine is currently establishing modular production facilities for mRNA vaccines in multiple regions. It plans to complete Installation Qualification (IQ) and Operational Qualification (OQ) by March–April 2022, Performance Qualification (PQ) by May–June 2022, and commence engineering batch production of mRNA COVID-19 vaccines in June.”The factory is expected to be completed by the end of this year and commence production next year, with an estimated annual capacity of 400 million doses. We are fully confident in our ability to achieve sufficient capacity to meet market demand.“Dr. Xiong Changyun said.”