United Biomedical Inc (聯亞生技) yesterday announced that the interim analysis of phase 2 trials for its COVID-19 vaccine, UB-612, showed that the jab’s safety and immunogenicity met the drugmaker’s expectations.
United Biomedical would submit a final report to the Food and Drug Administration (FDA) by the end of this month and apply for emergency use authorization, UBI Pharma Inc (聯亞藥業) spokesperson Vivien Fan (范瀛云) told an online news conference on behalf of the firm’s parent company.
The announcement came after Medigen Vaccine Biologics Corp (高端疫苗) on June 10 said it was seeking FDA’s emergency use authorization for its COVID-19 vaccine after reporting positive phase 2 trial results.
United Biomedical is planning to complete phase 2 trial data unblinding in late November and is considering conducting phase 3 trials in India, aiming to recruit 11,000 participants, Fan said.
UB-612 is a multitope protein/peptide-based vaccine. United Biomedical on Feb. 26 started enrolling participants for the phase 2 trials and completed the enrollment phase on May 18.
The drug was administered to 3,850 participants in the multi-regional, randomized, double-blinded and placebo-controlled study, the company said.
They were divided into three age groups: twelve to 18 years, 19 to 64 years, and 65 and older, it said, adding that one in every seven participants was administered a placebo.
Fan said that phase 2 trial results indicated that UB-612 was safe, as no adverse reactions were recorded throughout trials.
The vaccine showed no significant side effects, as 1.93 percent of participants who received UB-612 had a fever, compared with 1.81 percent in the placebo group, she said.
Among those who received the vaccine, 37.47 percent reported feeling tired, compared with 38.34 percent in the placebo group, Fan said.
Among those who received UB-612, 17.01 percent reported having a headache, 35.69 percent reported sore muscles and 10.23 percent said they had diarrhea, compared with 18.63 percent, 17.72 percent and 9.95 percent respectively for those who were given a placebo, she added.
Immunogenicity results were promising, as 95.65 percent of trial participants in the 19-to-64 age bracket showed a COVID-19 specific immune memory 28 days after receiving the second dose of the vaccine, she said, adding that the figure was 88.57 percent for older participants.
The geometric mean titer (GMT), which indicates the level of neutralizing antibody response, was 102.3, United Biomedical said, adding that the result met its expectations based on phase 1 trials.
The GMT figure also showed lot-to-lot consistency, meeting the FDA’s standards for emergency use authorization, it said.
The phase 2 trials also indicated a similar degree of GMT figure when tested for the Delta variant of COVID-19, the company added.
GROWING OWINGS: While Luxembourg and China swapped the top three spots, the US continued to be the largest exposure for Taiwan for the 41st consecutive quarter The US remained the largest debtor nation to Taiwan’s banking sector for the 41st consecutive quarter at the end of September, after local banks’ exposure to the US market rose more than 2 percent from three months earlier, the central bank said. Exposure to the US increased to US$198.896 billion, up US$4.026 billion, or 2.07 percent, from US$194.87 billion in the previous quarter, data released by the central bank showed on Friday. Of the increase, about US$1.4 billion came from banks’ investments in securitized products and interbank loans in the US, while another US$2.6 billion stemmed from trust assets, including mutual funds,
AI TALENT: No financial details were released about the deal, in which top Groq executives, including its CEO, would join Nvidia to help advance the technology Nvidia Corp has agreed to a licensing deal with artificial intelligence (AI) start-up Groq, furthering its investments in companies connected to the AI boom and gaining the right to add a new type of technology to its products. The world’s largest publicly traded company has paid for the right to use Groq’s technology and is to integrate its chip design into future products. Some of the start-up’s executives are leaving to join Nvidia to help with that effort, the companies said. Groq would continue as an independent company with a new chief executive, it said on Wednesday in a post on its Web
JOINT EFFORTS: MediaTek would partner with Denso to develop custom chips to support the car-part specialist company’s driver-assist systems in an expanding market MediaTek Inc (聯發科), the world’s largest mobile phone chip designer, yesterday said it is working closely with Japan’s Denso Corp to build a custom automotive system-on-chip (SoC) solution tailored for advanced driver-assistance systems and cockpit systems, adding another customer to its new application-specific IC (ASIC) business. This effort merges Denso’s automotive-grade safety expertise and deep vehicle integration with MediaTek’s technologies cultivated through the development of Media- Tek’s Dimensity AX, leveraging efficient, high-performance SoCs and artificial intelligence (AI) capabilities to offer a scalable, production-ready platform for next-generation driver assistance, the company said in a statement yesterday. “Through this collaboration, we are bringing two
Even as the US is embarked on a bitter rivalry with China over the deployment of artificial intelligence (AI), Chinese technology is quietly making inroads into the US market. Despite considerable geopolitical tensions, Chinese open-source AI models are winning over a growing number of programmers and companies in the US. These are different from the closed generative AI models that have become household names — ChatGPT-maker OpenAI or Google’s Gemini — whose inner workings are fiercely protected. In contrast, “open” models offered by many Chinese rivals, from Alibaba (阿里巴巴) to DeepSeek (深度求索), allow programmers to customize parts of the software to suit their
RSS