[Editor’s note: A three-and-a-half-year MIT inquiry that concluded in early 2023 cleared Ram Sasisekharan and his lab of allegations of research misconduct.] Last year, Japanese drugmaker Otsuka Pharmaceutical paid $430 million to acquire Waltham, Massachusetts-based Visterra, a firm that combines computational and experimental technologies to develop monoclonal antibodies for kidney disease, viral infections and other indications. Now, a group of executives at another firm allege that a Visterra antibody and an additional antibody that originated in the same academic lab were copied from prior research.
In a paper published Monday in the journal mAbs, executives from Lebanon, New Hampshire-based Adimab – led by CEO Tillman Gerngross – presented what they called evidence that Visterra’s monoclonal antibody for influenza, VIS410, is essentially the same drug as another antibody, Ab044. The paper, titled “Connecting the sequence dots: shedding light on the genesis of antibodies reported to be designed in silico,” took aim at the work of Massachusetts Institute of Technology researcher Ram Sasisekharan and his team, including publications in two journals in 2015 and 2018.
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In an email, sent through a spokesperson, Sasisekharan denied the allegations and wrote that he has consulted a legal team and a number of industry experts and was evaluating next steps, including potential legal action.
“Searching the patent database with the VIS410 sequences produces exact matches to an earlier US patent publication from 2013 describing Ab044 with a similar inventorship group,” the Adimab executives wrote. They pointed to a comparison of tables of the antibodies’ amino acid sequences from the two sources that they assert “confirms that VIS410 and AB044 are in fact the same antibody.”
The paper went on to point out what it called a “remarkable similarity” between an antibody for Zika virus from Sasisekharan’s lab, ZAb FLEP, and another antibody against the same virus, EDE1 C8.
Shares of Otsuka fell 1.6 percent, from 3,953 to 3,890 yen, on the Tokyo Stock Exchange Monday. They opened Thursday morning at 3,804 yen, but subsequently began to rise again. Otsuka acquired Visterra last July.
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Sasisekharan dismissed the paper as an “opinion piece” that was “founded on a baseless conjecture and filled with entirely false claims.” He further wrote that it was accepted within two days of submission and was not peer-reviewed, and that he only learned about it from another journalist, having not been contacted either by the authors of the journal’s editors. “In short, the accusations are false, intentionally damaging, and commercially driven,” he wrote. “Authors did not make appropriate attempts to utilize accepted channels to investigate the facts prior to public publication and distribution.”
Sasisekharan disputed two key claims in the paper. In particular, he wrote that while he was an author on a study of VIS410 and its activity against the flu strain H7N9, he was not an inventor, and neither he nor MIT has claimed ownership. In addition, he wrote there are “fundamental differences” between ZAb FLEP and EDE1 C8, “which are the result of how the antibody was designed to bind to a ‘Zika-specific’ mutationally constrained epitope.”
In a phone interview, Gerngross said he and his team were not making an accusation. “We put out a paper that documented facts, and we interpreted those facts in a particular way,” he said, adding that if there was anything wrong in the paper, it would be immediately corrected and that he was willing to debate what was presented in the paper. “If [Sasisekharan] wants to take legal action in court, we’re happy to do it in court.”
Gerngross also stated that Adimab had no commercial interest in making its assertions, noting that the allegedly copied research was performed by groups in Europe.
A request for comment from Otsuka was not immediately returned by the time of publication. In an email, an MIT spokesperson wrote, “While federal regulations and MIT policy do not allow us to comment on any particular matter, research integrity at MIT is paramount. MIT has policies and confidential processes in place to assess concerns that might be raised.”
Photo: ClaudioVentrella, Getty Images
CORRECTION: An earlier version of this story incorrectly stated that Ab044 was Adimab’s product. The story has been corrected.