HDT Bio has a COVID-19 vaccine candidate and some National Institutes of Health funding to develop it. But its chosen manufacturing partner stole trade secrets and co-opted the shot—or so the company claims in a lawsuit filed Monday in a Washington state federal court.
The lawsuit says HDT Bio tapped Gennova Biopharmaceuticals, an Emcure Pharmaceuticals subsidiary, to manufacture portions of its COVID vaccine. Gennova didn't hold up its end of the deal, the lawsuit claims. Instead, Gennova and Emcure took HDT's technology and claimed the vaccine as their own.
HDT's lawsuit names Emcure, but not Gennova. In a statement, Emcure said it has been wrongly added to the lawsuit and plans to request a dismissal.
HDT Bio launched in 2019 and began working on a COVID vaccine shortly after the pandemic began in early 2020. By the first quarter, the company said it had a functional shot that used self-amplifying RNA and that it had proven effective in animal trials. A few months later, in September, the company locked up an $8.2 million grant from the National Institute of Allergy and Infectious Diseases to cover development and manufacturing costs for the shot.
That vaccine was the basis of the deal that allegedly went awry, the lawsuit says. HDT locked up an agreement with Gennova and its CEO Sanjay Singh in April 2020, followed by a more formal licensing deal in August 2021. The agreement made Gennova responsible for manufacturing components of HDT’s vaccine in exchange for exclusive commercial rights in India.
From there, the relationship soured.
“When HDT agreed to work with Gennova, it mistakenly viewed Dr. Singh as a trusted friend and missionary with a common cause,” the complaint said.
In the nearly two years since April 2020, Emcure forced Gennova to hold back key data and regulatory documents, stymieing progress on the vaccine, the lawsuit claims.
The issue boiled over in summer 2021 after Emcure and Gennova filed patent applications on vaccine tech HDT says was its own.
“To be clear: the License Agreement does not give Emcure any rights at all,” according to the suit. “Thus, Gennova was no more entitled to disclose HDT's trade secrets to Emcure for Emcure’s use than to any other non-party to the License Agreement.”
Around this time, in May 2021, HDT announced that the first patients had been dosed in a phase 1/2 trial of its vaccine in India.
“This trial is a major milestone for Gennova and us,” HDT Bio CEO Steve Reed said in a release at the time. “An important part of HDT’s mission is establishing value-sharing partnerships with drug companies in historically underserved countries.”
Six months later, the lawsuit says, Singh told Reed that the vaccine produced by Gennova and Emcure did not fall within the parameters of the licensing agreement.
In its statement, Emcure said it's not a party to the disagreement.
“Emcure Pharma has no connection whatsoever with the matter,” said a company spokesperson. “Emcure has been legally advised that no suit lies against it; and it has been wrongly joined as a party.”
A spokesperson for HDT Bio said in an email, "our complaint against Emcure speaks for itself."