New monoclonal antibody to prevent rabies is cheaper, more potent and easier to manufacture than current immune globulin therapy; will be used in conjunction with rabies vaccine.

The Serum Institute of India has announced the global launch of Rabishield, a rabies monoclonal antibody developed in partnership with UMass Medical School. Rabies, a fatal disease caused by the bite or scratch of an infected animal, kills an estimated 20,000 people every year—two people every hour—in India. Rabishield, a U.S.-patented product, will help close the gaps in rabies prevention and is expected to significantly reduce the rabies mortality rate in India.

“The launch of Rabishield represents a watershed moment in the history of treating this disease. While rabies is rare in the United States, worldwide it kills more than 50,000 people a year who often don’t have access to the treatment they need,” said Chancellor Michael F. Collins. “Rabishield will go a long way toward dramatically reducing rabies deaths. We are proud to have partnered with the Serum Institute of India to make treatment available and gratified by the global public health impact of the commonwealth’s only public medical school.”

“Scientists at MassBiologics and the Serum Institute of India are focused on improving the health of people around the world,” said Mark S. Klempner, MD, executive vice chancellor for MassBiologics of UMass Medical School and professor of medicine at UMMS. “We identified the very real need for an alternative to the existing rabies immune globulin treatment so that more people in dire need will have access to this life-saving therapy designed to prevent rabies infection. This new monoclonal antibody for rabies is more potent and easier to manufacture than existing treatment, which is expensive and in short supply.”

The current treatment for someone bitten by a potentially rabid animal is to be vaccinated against rabies, but the vaccine alone is not enough as, in some cases, the disease develops before the vaccine can take effect. The only way to adequately protect the victim is to provide passive immunization via rabies immune globulin, which provides immediate protection with neutralizing antibodies before the immune system begins making its own antibodies.

However, rabies immune globulins are in short supply. Equine rabies immune globulins, while inexpensive, are obtained from horses and can cause allergic reactions and serum sickness. Human rabies immune globulins, derived from human blood, are safer but very expensive. It is estimated that only about two percent of patients who require the rabies immune globulin receive appropriate post-exposure treatment.

To address this global public health issue, scientists at MassBiologics developed a rabies monoclonal antibody that might be used in place of human and equine immune globulins. MassBiologics then partnered with the Serum Institute to develop and manufacture the monoclonal antibody in India.

Rabishield is manufactured by recombinant DNA technology. It offers passive immunization against rabies and is active against all rabies serotypes found in India. It is more potent and therefore requires a lower dose than current rabies immune globulins and it is much more cost effective.

“Our new drug—Rabishield—is a first-of-its-kind rabies human monoclonal antibody in the world. We have completed the scale-up of the manufacturing process as well as the clinical development of Rabishield. The drug is being distributed nationwide in India,” said Adar Poonawalla, chief executive officer of Serum Institute of India.