Johnson & Johnson CAR-T partner GenScript yo-yos on fake data allegations

Hong Kong, S.A.R., China biotech GenScript has had a turbulent 48 hours, with its shares plummeting yesterday on allegations of data falsification in a CAR-T program, only to rebound after it strongly denied the claims.

The root of the controversy is a report from Flaming Research, a little-known outfit which describes itself as "a team of seasoned equity investors who [are]  intent on uncovering and exposing fraudulent companies globally to protect the public interest." It also admits, however, that it "may have a direct or indirect short position in the stock and stand to benefit in the event the stock declines."

Flaming’s report claims that GenScript unit Legend Biotech manipulated data and concealed safety problems with CAR-T therapy JNJ-68284528 (also known as LCAR-B38M), which started a phase 1b/2 trial in multiple myeloma earlier this year and is in with a chance of being the first anti-BCMA to get regulatory approval.

JNJ-68284528 hit the headlines at last year’s ASCO meeting after Legend reported a 100% objective response rate with the therapy in treatment-resistant, relapsed myeloma patients. Impressed with the data, J&J took a license to the CAR-T last December, paying a hefty $350 million upfront for rights outside China. The deal was hailed as a coming-of-age moment for Chinese biotech.

Now, Flaming claims to have contacted doctors involved in the study who suggest the response rate was much lower at 60%-70%. It also points to nonadherence to the trial protocol at some investigator sites, and one case of a fatal reaction to the CAR-T—known as a cytokine storm—that it alleges was concealed by the biotech.

GenScript insists that is nonsense, saying in a statement (PDF) that all the clinical data it has disclosed are "true and traceable" and have been submitted in totality to the FDA and its counterpart in China, where JNJ-682845 has been submitted for approval.

The biotech also accuses Flaming of "blatant slander" with regard to some inaccurate claims it makes in the report about Legend’s CAR-T design process, refutes the suggestion that its intellectual property on JNJ-68284528 is weak, and says after the patient death it "immediately notified all researchers in the form of a researcher’s letter and disclosed the incident to the public."

It goes on to say that it "believes that Flaming’s ultimate aims are to drive down the price of the shares and undermine the company’s reputation," adding that it is "consulting its legal advisers and will consider taking legal actions against Flaming."

BCMA has become a hot target in immuno-oncology, and J&J/GenScript are competing with Celgene and Bluebird Bio and Kite Pharma/Gilead Sciences to bring an BCMA-targeted CAR-T through development and onto the market.

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