Research, Translation, editing : Gan Yung Chyan, KUCINTA SETIA
News (1)
UBI Vaccine UB-612 Phase 2 clinical results have no adverse reactions
Image : The results of the Phase 2 trial of UB-612 are released. (The picture is taken from the online press conference)
The covi vaccine UB-612 developed by the domestic vaccine manufactuter United Biomedical Inc. Asia (UBI) announced on 27 June 2021 the Phase II clinical analysis report. UBI emphasized that the Phase 2 clinical data is in line with expectations and has good safety, tolerability and immune response.
The full text of the press release of UBI is translated as follows:
UB-612 is the world’s first Multitope Protein/Peptide-based Vaccine (MPV) for COVID-19, using its unique patented platform technology to target the SARS-CoV-2 virus.
In addition to the precisely designed S1-RBD virus antigens, UB-612 has also added original CTL and Th epitope peptides. These peptides are selected from the group that can bind to human MHC I and II and are derived from viruses that have immunity. Advantageously, the conservative sequence regions of M, S2 and N proteins are not prone to mutation.
The precisely designed Th/CTL modulated peptide can activate T cells and trigger the memory response and utility function of T cells. It is expected that the multi-component UB-612 vaccine in the human body will cause balanced B cell activation and expand T cell immunity. Reaction to achieve good protection effect. In addition, the UB-612 vaccine does not need to be transported and stored in an ultra-low temperature cold chain, which has a competitive advantage over mRNA vaccines developed by companies such as Pfizer/BioNTech.
In the first phase of the unblinded clinical trial, a total of 60 subjects participated in the analysis of low, medium and high dose trials. The phase one clinical trial was completed at the end of May 2021. The analysis results showed that: safety and It was well tolerated, and no serious adverse reactions occurred in all subjects.
In terms of immunogenicity, the seroconversion rate of the neutralizing antibody in the high-dose group was 100% 14 and 28 days after the second dose, and the geometric mean titer of neutralizing antibody (Geometric Mean Titer, GMT) increased by more than 40 times.
The second phase of the clinical trial adopts a multi-center, placebo-controlled, randomized, observer-blind design to further explore the immunogenicity, safety and tolerability of the UB-612 vaccine. The total number of cases admitted is 3,850, including young people aged 12 to 18, adults aged 19 to 64, and older ethnic groups over 65 years old.
Among them, the ratio of the vaccine group to the control group is 6:1. Vaccination for the first subject began on February 26 this year, and the second dose of vaccination for all core group subjects was completed on May 18. There are 12 clinical trial centers and 4,000 in total. Multiple subjects participated.
According to the technical requirements and trial design of the competent authority, the second phase of clinical trials reached at least 3,000 subjects in the vaccine group at least one month after the second dose of vaccine on 10 June, and reached all core populations on June 16. After the subjects received the second dose of vaccine, the median tracked the interim analysis conditions for at least two months, and in late June, all relevant raw data for the interim analysis was entrusted to a third-party clinical trial trust agency (Contract Research Organization; CRO). For data collection and analysis, the Independent Data Monitoring Committee (IDMC) was held on 27 June to conduct interim report analysis, and it is planned to conduct trials to unblind in mid-to-late November this year.
The mid-term analysis data of the second phase trial showed:
The safety and tolerability of the UB-612 vaccine were good, and all subjects had no serious adverse reactions related to the vaccine.
Safety data: the rate of local adverse reactions and pain at the injection site of UB-612 vaccination was 64.59% in the vaccine group and 23.33% in the placebo group; the rate of redness and swelling at the injection site was 34.06% in the vaccine group and 5.61% in the placebo group. The rate of systemic adverse reactions and fever of UB-612 vaccination was 1.93% in the vaccine group and 1.81% in the placebo group; the rate of fatigue was 37.47% in the vaccine group and 38.34% in the placebo group; the rate of headache was 17.01% in the vaccine group; the placebo group was 18.63%; the rate of diarrhea was 10.23% in the vaccine group and 9.95% in the placebo group; the rate of muscle pain was 35.69% in the vaccine group and 17.72% in the placebo group.
In the immunogenic response part: the seroconversion rate of the antibody titer 28 days after the second dose was 95.65% in the adult (19 to 64 years old) vaccine group, and in the elderly (65 years old) Above) the vaccine group was 88.57%; the neutralizing antibody titer was 102.3, which was similar to the results of the first phase clinical trial and was in line with expectations, and the results between vaccine batches also met the EUA standards. In clinical trials, the main components and adjuvants of the drugs used in the clinical trials of Phase I and Phase II must use the same ingredients and doses. Under the enlargement of the number of samples of clinical subjects, the effect of the test drugs should show similar results. If the difference within the range of 2 times is reasonable, the result difference exceeds the range of 2 times, we must go deep into the cause of such a big difference.
In addition, we also conducted exploratory research in the second phase of clinical trials, showing that the UB-612 vaccine can produce a good Th1 type T cell immune response and induce CD8+ killer T cells (Killer T Cell) to kill virus-infected cells. It helps prevent the occurrence of severe illness, and provides the second layer of protection besides neutralizing antibodies.
The results of the analysis in the second phase of clinical trials are in line with expectations, and the results of the first phase of clinical trials can be repeated with approximately 20 times the number of subjects. In addition, in terms of the effective protection of the mutant strain, analysis of the first-phase subject samples showed that the neutralizing antibody induced by UB-612 had the same level of titer against the Indian delta strain. Because the amino acid sequence of the synthetic peptide of the designed new coronavirus that causes the T cell immune response is not easily mutated, the immune response generated by the UB-612 vaccine can cope with the existing widely spread Indian Delta mutant strain.
In addition, the US Vaxxinity team has held a pre-IND meeting with the US FDA in February this year, and will cooperate with the University of Nebraska Medical Center; UNMC to use UB-612 as the accepted Pfizer, Moderna and The booster vaccine for Johnson & Johnson vaccines whose neutralizing antibody titers are gradually declining will be undergoing the second phase of clinical trials of "mixed and strengthened administration".
In addition to being committed to biological drug R&D, clinical trials, formulation and process analysis method technology development and production technology, UBI also focuses on the export of CDMO for US injection products. Currently, it has obtained several self-owned injection products and CDMO for international customers in the United States. The injection of ANDA has begun to enter commercial mass production, which is expected to contribute to the revenue of UBI.
The parent company of UBI is responsible for the development, clinical trials and sales of the new crown vaccine. UBI mainly undertakes the formulation and process technology and production business of the latter part of the vaccine. The mid-term data analysis of UB-612 is in line with expectations and is helpful Enhancing the possibility of UBI to accept orders in the future can increase the company's revenue and source of profit to a certain extent.
UBI has signed a contract for the manufacture of UB-612 vaccine with its parent company. Currently, the planned foreign phase III test vaccine is produced by the parent company UBI entrusted by the company. After UB-612 obtains the EUA at home and abroad, UBI will entrust UBI Asia to be responsible for the formulation and other manufacturing processes and production of the orders received by UBI. Up to now, UBI Asia has received orders for the production of 5 million doses of vaccines from Uniasia Biotech from the Ministry of Health and Welfare, and will successively arrange shipments in accordance with the production schedule.
UBI is responsible for the preparation and production of the formula of the vaccine. The protein stock solution, adjuvant, synthetic peptide, etc. are required to be formulated before filling. United Biopharmaceuticals is responsible for the production of protein undiluted solution, which requires a long production cycle. After obtaining EUA approval, the annual supply will be set at 100 million to 120 million doses. Due to the long validity period of the vaccine, when all the stability data is completed, a small pre-purchase order such as 1 million doses signed by Vaxxinity and Paraguay will be included in the set annual supply. UBI is the priority and main formulation preparation and production base of UB-612 vaccine, and UBI and the parent company United Biotech have signed a vaccine commission manufacturing contract. As long as UBI’s production capacity is sufficient, Vaxxinity and UBI vaccine order will be arranged in advance with the production schedule, delivery date and quantity, and will be quickly delivered to the designated location in accordance with the production plan.
Ref: https://ec.ltn.com.tw/article/breakingnews/3584179?utm_source=business&utm_medium=OFFICIAL&utm_campaign=WEBPUSH&utm_content=20210627, https://staygate.blogspot.com/2021/06/refrain-from-flying-singapore-airlines.html
News (2)
Vaccine conversion protection power is about 80 to 90%, resistant to Delta variant
The covi vaccine UB-612 developed by UBI announced today the interim analysis report of the second phase clinical trial. UBI said that if it is compared with the serum internal antibodies of patients who have recovered from Wuhan pneumonia, the protection is about 80-90%, because the data is made by the Academia Sinica, the credibility is high, but because the Phase III clinical trial has not been implemented, this data is still for reference only.
In addition, UBI also stated that for the effective protection of the mutant strain, analysis of the first-phase subject samples showed that the neutralizing antibody induced by UB-612 had the same level of titer against the Delta strain (Covi72). Because the amino acid sequence of the synthetic peptide of the designed new coronavirus that causes the T cell immune response is not easily mutated, the immune response generated by the UB-612 vaccine can cope with the existing widely spread Covi72.
News (3)
Expert: Compared with others, the antibody titer of UB-612 is lower
UBI announced on 27 June 2021 the interim report of the Phase II clinical trial of its covi vaccine UB-612 but virus experts frankly said that compared with other vaccines, the titer of the neutralizing antibody of UB-612 is low. The Food and Drug Administration will wait for the manufacturer to send the package, and then review the emergency use authorization (EUA) according to the schedule.
UBI held a press conference in the evening to announce the interim analysis report of the second phase of the UB-612 clinical trial. In terms of immunogenicity, adults between 18 and 65 years old were seropositive after receiving 2 doses of UB-612. The rate was 95.65%, and the neutralizing antibody titer was 102.3.
Another domestic manufacturer MVC Vaccines recently also announced the data of the second phase of the interim report. After 2 doses of complete vaccination, the seroconversion rate reached 99.8%, and the neutralizing antibody titer was 662.
Shi Xinru, director of the Center for Research on Emerging Viruses of Chang Gung University, said in a joint interview with the media in the evening that if the vaccine-related data comes from the same laboratory of the Academia Sinica, and to ensure that the standard curves before and after a large number of analyses are consistent, they are slightly comparable.
Shi Xinru said frankly that compared with other vaccines, the neutralizing antibody titer of UB-612 is indeed low, and she feels sad, regretful, and pity for this.
Shi Xinru said that the Chang Gung University team also analyzed the neutralizing antibody titer for the Moderna vaccine, which is about 600 to 700.
The different experimental designs may affect the level of neutralizing antibody. It is estimated that if the neutralizing antibody is made by the Academia Sinica the neutralizing antibody titer of the Moderna vaccine may reach more than 2000.
Although UBI claims that UB-612 can induce Killer T Cells to kill virus-infected cells, it is expected to provide a second level of protection in addition to neutralizing antibodies.
Shi Xinru believes that it is necessary to enter the third phase of clinical trials to verify the protection of the vaccine.
News (4)
Taiwan's FDA to compare the titers of neutralizing antibodies produced by AstraZeneca with Taiwan's covi vaccines
The Food and Drug Administration of the Ministry of Health and Welfare will adopt an immune bridging method to compare the titers of neutralizing antibodies produced by AZ vaccines with domestic vaccines.
Shi Xinru said that the titers of neutralizing antibodies for AZ vaccines studied abroad are about 600, which is close to the high-end. However, she believes that if the country only collects data on AZ vaccination of 200 medical staff, it may be insufficiently representative and not scientifically objective.
However, Shi Xinru still affirms the future international market layout of UB-612 and the annual output of 100 million to 120 million doses.
The Director of Food and Drug Administration Wu Xiumei said that the data of UB-612 has not been seen so far, and the manufacturer has not sent the package. The review plan will not be carried out until the package is sent.
News (5)
Neutralizing antibody titer study of AZ vaccine in progress
The neutralizing antibody titer study of the AZ vaccine is also in progress according to the procedure. After that, the emergency use authorization (EUA) of domestic vaccines will be reviewed according to the schedule. In addition, today's epidemic reporter will ask the media whether the EUA's review of the neutralizing antibody titer of the AZ vaccine will cause patent infringement disputes. Chen Shizhong, the commander of the Central Epidemic Command Center, responded that regarding disputes related to drug patents, he will consult the law and the pharmaceutical industry to properly handle related issues. (Central News Agency)
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