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.
CHIP CRUNCH: Apple’s woes show that even the king of the technology world is not immune from global shortages made worse by the COVID-19 pandemic Apple Inc is likely to slash its projected iPhone 13 production targets for this year by as many as 10 million units as prolonged chip shortages hit its flagship product, people with knowledge of the matter said. The company had expected to produce 90 million new iPhone models in the final three months of this year, but it is now telling manufacturing partners that the total would be lower because Broadcom Inc and Texas Instruments Inc are struggling to deliver enough components, the people said. Apple gets display parts from Texas Instruments, while Broadcom is its longtime supplier of wireless components. One Texas
Units of Intel Corp and Samsung Electronics Co are targeting to resume full operations of their Ho Chi Minh City plants by the end of next month, a move that could provide relief to global supply chains. Saigon Hi-Tech Park is helping its tenants, many of which are running at about 70 percent capacity, to operate fully next month, park deputy manager Le Bich Loan said in a phone interview. She did not elaborate on the steps the park is taking, particularly efforts at bringing back workers who fled to home provinces. The Ho Chi Minh City unit of Nidec Sankyo Corp,
EVA Airways Corp (長榮航空) and China Airlines Ltd (中華航空), the nation’s two major airlines, reported accelerated revenue growth in the third quarter compared with the previous two quarters, thanks to robust air cargo business. EVA Airways yesterday said sales for last quarter rose 40 percent year-on-year to NT$25.81 billion (US$917 million), compared with an increase of 25 percent in the second quarter and a fall of 35 percent in the first quarter. China Airlines said sales grew 39 percent to NT$34.6 billion in the third quarter, after gaining 10 percent in the second quarter and falling 14 percent in the first quarter. EVA
Hon Hai Precision Industry Co (鴻海精密) is embarking on a recruitment drive to hire 200,000 workers in Shenzhen, China, as it ramps up production of the new iPhone 13 series, Chinese business news outlet Eastmoney.com reported. Hon Hai is seeking to recruit those heading back to the city after China’s seven-day National Day holiday, which began on Oct. 1, to help churn out the estimated 100,000 iPhone 13s produced on the site each day, the report said. Following last month’s global release of the iPhone 13, Hon Hai entered its traditional peak season, and workers at its Chinese production sites are said
RSS