OBI Pharma Inc (台灣浩鼎) yesterday released the results of its second and third-phase clinical trials of a new breast cancer drug, OBI-822, saying the outcome of the study shows “no statistical significance.”
While the study did not meet the primary efficacy endpoint of progression-free survival (PFS), the results still contain “meaningful scientific and clinical information,” which have provided “clear direction for future product development,” the company said in a statement.
OBI Pharma chairman Michael Chang (張念慈) said the company has received valuable information from the clinical trials, such as a substantial improvement in the PFS rate of the treatment group who demonstrated an immune response to the vaccine, as well as a clear, positive trend in the secondary endpoint of overall survival for patients.
Photo: CNA
“This information is very important for designing the global third-phase study of the new drug,” Chang said in the statement.
OBI-822 is designed to target Globo H, an oligosaccharide tumor antigen, to trigger the immune system to generate antibodies that activate cytotoxic T cells to destroy cancer cells.
Industry observers have viewed the drug as a promising aid to active immunotherapy for metastatic breast cancer, with curative effects far better than Herceptin of Swiss pharmaceuticals maker Roche Holding AG and Ibrance of US pharmaceuticals firm Pfizer Inc.
Chinese-language monthly Wealth Magazine executive director Hsieh Chin-ho (謝金河) yesterday raised some questions about OBI Pharma.
“The market was waiting for the results of OBI Pharma’s phase two and three trials for OBI-822 today, but the outcome is worse than expected, as it did not pass clinical trials,” Hsieh wrote in a post on his Facebook page. “How seriously will the news affect the company’s shares? I am afraid it cannot be taken in so easily,” he wrote.
OBI Pharma, the most expensive stock in the biotech sector, closed at NT$681 on the Taipei Exchange in Friday trading, down 3.81 percent from the previous session. The stock rose 3.97 percent this year and surged by 119.7 percent from its listing price of NT$310 in March last year.
The fate of the shares of another drug company in 2014 might be a lesson for OBI Pharma shares, Hsieh said, referring to Medigen Biotechnology Corp (基亞).
In July 2014, Medigen Biotechnology Corp announced an interim study of its new liver cancer drug, PI-88, saying it did not yield positive results, which drove its shares down for 20 straight sessions by the maximum daily limit until it fell to NT$112.5 from NT$459.
The sell-off in Medigen spread to other biotech stocks, causing great losses to investors at the time, Hsieh said.
‘BIG LOSS’: This year might see the last generation of Huawei’s Kirin chips, as their production would stop next month because they are made using US technology Chinese tech giant Huawei Technologies Co (華為) is running out of processor chips to make smartphones due to US sanctions and would be forced to stop production of its own most advanced chips, a company executive has said, in a sign of growing damage to Huawei’s business from US pressure. Huawei, one of the biggest producers of smartphones and network equipment, is at the center of US-Chinese tension over technology and security. Washington last year cut off Huawei’s access to US components and technology, and those penalties were tightened in May, when the White House barred vendors worldwide from using US
’WHITE BOX’: The open platform would give local firms access to Cisco’s cloud-based mobile network to develop 5G telecom equipment and tap into the global market The Ministry of Economic Affairs (MOEA) yesterday introduced a new 5G “open lab” in collaboration with US-based information technology and networking giant Cisco Systems Inc to address the rapidly growing “white box” 5G networking equipment market. The open lab will be a platform where Taiwanese manufacturers can access Cisco’s cloud-based mobile network to develop their own 5G telecom equipment, such as small-cell base stations, network switches, modems and Internet of things (IoT) devices, a ministry statement said. The open platform would allow Taiwanese manufacturers to tap into the lucrative 5G telecom equipment market, which was previously monopolized by Nokia Oyj, Ericsson AB
CORPORATE SCANDAL: Cathay Life has invested NT$13.3 billion in Bank Mayapada since 2015, but the latest loss of NT$8.8 billion has completely written off its investment Cathay Life Insurance Co (國泰人壽) yesterday said it would recognize an investment loss of NT$8.8 billion (US$298.1 million) in Indonesia’s Bank Mayapada Internasional Tbk PT due to concerns about the lender’s operations amid a corporate scandal. The company said it would revise its earnings result for June, from a net profit of NT$6.52 billion to a net loss of NT$520 million, its first monthly loss over the past 17 months. After booking an investment loss of NT$5.2 billion in Bank Mayapada earlier this year, Cathay Life has so far recognized total investment losses of NT$14 billion in the lender, executive vice president
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) yesterday reported that revenue last month expanded 25 percent annually, but fell 12.8 percent month-on-month to NT$105.96 billion (US$3.59 billion). In the first seven months of this year, the chipmaker’s revenue surged 33.6 percent to NT$727.26 billion, compared with NT$544.46 billion a year earlier. TSMC has said it aims to grow its revenue by more than 20 percent this year. The company has since May 15 stopped taking new orders from Huawei Technologies Co (華為), its second-biggest customer after Apple Inc, due to the US’ restrictions on exports containing US technologies. TSMC has no plans to
RSS