By Sneha S K and Siddhi Mahatole (Reuters) -IO Biotech said on Monday its experimental combination vaccine for a type of skin cancer helped slow the disease’s progression in a late-stage study, but narrowly missed the main goal as the results did not show statistical significance. Shares of the drug developer, which had surged as […]
Health
IO Biotech’s cancer vaccine shows improvement, but narrowly misses study goal
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By Sneha S K and Siddhi Mahatole
(Reuters) -IO Biotech said on Monday its experimental combination vaccine for a type of skin cancer helped slow the disease’s progression in a late-stage study, but narrowly missed the main goal as the results did not show statistical significance.
Shares of the drug developer, which had surged as much as 50% before the bell, were down 22.4% in morning trading.
IO Biotech was testing the vaccine, in combination with Merck’s Keytruda, in 407 patients having advanced melanoma.
The company said patients who received the combination vaccine Cylembio lived without their disease getting worse for a median of 19.4 months, compared to 11 months for those who received Keytruda alone.
The result, however, did not meet the margin of statistical significance of 0.045, the company said.
“This was a very narrow miss, just by a hair,” CEO Mai-Britt Zocca said on a conference call.
The company said the combination vaccine was well tolerated with no new safety signals. It also observed a trend toward an improvement in overall survival.
IO Biotech plans to meet with the U.S. Food and Drug Administration this fall to discuss the data and next steps for a potential regulatory submission.
“There is likely still potential for FDA approval as the FDA may accept filing for a subgroup of patients, or may request for more mature overall survival data due next year,” H.C. Wainwright analyst Emily Bodnar said.
IO Biotech plans to conduct additional tests over the next two weeks, Chief Medical Officer Qasim Ahmad told Reuters.
In 2022, there were an estimated 1.5 million people living with melanoma of the skin in the U.S., according to government data. Currently, the FDA-approved treatments for the condition include Keytruda and Bristol Myers’ Opdivo. Moderna is also testing its skin cancer vaccine in combination with Keytruda.
(Reporting by Sneha S K and Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)