The biopharma’s data manipulation controversy continues with a recently leaked City University of New York report, which found signs of “egregious” and “deliberate” misconduct by a company advisor.
Pictured: MRI scans of the brain/iStock, Nomadsoul1
Cassava Sciences on Friday reiterated its confidence in the underlying science of its lead late-stage Alzheimer’s asset simufilam, which the biopharma company will continue to advance through a Phase III clinical development program.
The statement by the Texas-based company follows the “purported” final report of an internal investigation conducted by the City University of New York (CUNY) in relation to alleged scientific misconduct by Hoau-Yan Wang, a scientific advisor to Cassava and an academic researcher at the school. According to Cassava’s announcement, the CUNY report was leaked to the press and was published Thursday by Science, along with an article outlining its findings.
The 50-page report said that the investigation committee, which consisted of research-active faculty at CUNY, found evidence that “highly” suggested “deliberate misconduct” by Wang.
The investigation also identified “long-standing and egregious misconduct in data management and record keeping” by Wang, who was unable to provide “even a single datum or notebook in response to any allegation.” This frustrated the investigation committee, which in turn was unable to objectively arrive at a conclusion for the accusations.
“But to be clear, the committee concludes that Dr. Wang’s inability or unwillingness to provide primary research materials to this investigation represents egregious misconduct,” the report concluded.
Science obtained the report from a source who asked to remain anonymous because “they are not authorized to share it,” according to the article.
Nonetheless, in response to the CUNY investigation, Cassava contends that the report fails to provide evidence of data manipulation. Instead, the company maintains that it focuses on “internal record-keeping failures at CUNY.”
Cassava also cast doubt on the integrity of the report, particularly questioning its timing and conduct. According to the company, the CUNY report was leaked to the press shortly after it detected a “40% increase in short selling activity” in its stocks. Cassava also claims that Science’s source is a “person paid by a lawyer for certain short-sellers.”
The company also takes issue with the investigation being conducted entirely by CUNY, which it said denied all of Cassava’s requests for information and offers of participation. The investigation committee “did not interview any employee of Cassava Sciences,” which leaves the university with no “legitimate basis on which to make accusations against the Company or its employees,” according to the company.
Cassava CEO Remi Barbier said that the company remains “confident in the underlying science” for its lead candidate simufilam, which is currently in Phase III development for Alzheimer’s disease.
The controversy started in August 2021 when a whistleblower—through legal representatives—launched a citizen’s petition to ask federal regulators to step in and stop the company’s clinical trials for simufilam, citing signs of data manipulation in some of Cassava’s results. Soon after, the SEC launched its own investigation into the claims.
In February 2022, the FDA denied the citizen’s petition and a few months later the Journal of Prevention of Alzheimer’s Disease took Cassava’s side, concluding that there was not enough evidence to support the claim of data manipulation.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
