U.S. signs $450 million contract with Regeneron for COVID-19 therapy

By Manojna Maddipatla

(Reuters) – The U.S. government signed a $450 million contract with Regeneron Pharmaceuticals Inc for its potential COVID-19 antibody cocktail, the drug maker said on Tuesday.

The agreement, the first by the Trump administration to support a therapy, comes under the government’s “Operation Warp Speed” program that is aimed at faster distribution of vaccines and treatments to fight the new coronavirus when trials are successful.

The United States is also funding manufacturing and several trials for potential vaccines and has rushed to secure billions of doses of the vaccines being tested by companies around the world.

Earlier in the day, Novavax Inc received a $1.6 billion grant, the biggest award yet from Operation Warp Speed, to cover testing, manufacturing and sale of a potential coronavirus vaccine.

Under the contract with Regeneron, signed with the HHS’ Biomedical Advanced Research and Development Authority and the Department of Defense, the doses manufactured under the project will be owned by the federal government.

Regeneron’s cocktail, REGN-COV2, contains an antibody made by the company and another isolated from recovered COVID-19 patients. Rivals Eli Lilly and AbbVie are also pursuing antibody therapies for the respiratory illness.

REGN-COV2 is being tested separately for both preventing and treating COVID-19, with a late-stage prevention trial being run jointly with the National Institutes of Health.

The agreement covers a fixed number of bulk lots intended to be completed in the fall of 2020, Regeneron said.

A range of 70,000 to 300,000 potential treatment doses or 420,000 to 1,300,000 prevention doses are expected to be available from these lots, with initial doses to be ready as early as end of summer.

The U.S. government would make the doses available to Americans at no cost, if EUA or product approval is granted, Regeneron said.

Shares of Regeneron were up 1.4% at $636.11. They have risen 67% so far this year.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

Military veterans suffering PTSD get back on course with golf

FILE PHOTO - The pin on the 6th hole casts a shadow across the green in Augusta, Georgia, U.S. April 4, 2017. REUTERS/Jonathan Ernst

(Reuters) – Sylvan Olivieri, who suffers from post traumatic stress disorder (PTSD) after serving in the Vietnam War as a U.S. Marine, is among dozens of veterans who have sought therapy on the golf course.

Olivieri, who is completely new to the game, told Reuters he learned of the Professional Golfers’ Association’s (PGA) Helping Our Patriots Everywhere (HOPE) program through his PTSD group.

“The first time was rough because I was making some minor mistakes but the instructors got me straight,” Olivieri said at the West Point Golf Course, just steps from New York’s prestigious U.S. Military Academy.

“I’m motivated. It’s all for fun, relaxation,” he said.

The U.S. Department of Veterans Affairs, which is a partner in the program with the PGA, said its goal is to help veterans assimilate back into their communities through the social interaction, mental stimulation and physical exercise that golf provides.

PTSD is caused by an overactive fear memory and includes a broad range of psychological symptoms that can develop after someone goes through a traumatic event.

A study published in JAMA Psychiatry, decades after the end of the U.S. war in Vietnam, said more than one in 10 of all American veterans continues to experience at least some symptoms of post traumatic stress disorder.

“PGA HOPE is an opportunity to bring veterans out onto the golf course and give them something to look forward to,” said Andy Crane, the head PGA professional at West Point Golf Course.

The program started in 2014 and the six-week course is now offered at more than 80 locations across the country. It is free to military veterans and fully funded by the PGA’s charitable foundation.

Bobby Colletti also turned to golf in hopes of happiness. He served in the U.S. Army in Iraq and as a contractor in Afghanistan and started abusing drugs after returning home.

“I thought at first (drugs) helped,” he said. “But then it turned into a problem and kind of just made everything worse to the point where you almost want to commit suicide because of it.”

Colletti heard about PGA HOPE while in treatment for addiction and said it “has definitely helped me along the way in my process of recovery.”

Colletti encouraged his stepfather John Edd, a Vietnam War veteran, to try golf. Edd completed the program two years ago and the two have since become regulars on the golf course.

Like Colletti, Olivieri said the course helped him heal and he now describes himself as “a pretty happy guy.”

“It puts you in a different place,” he said of golf. It makes you concentrate. You are not thinking about anything else but that ball. That period of time is PTSD-free.”

(Editing by Melissa Fares and Bill Trott)

New diabetes treatment could be ‘game-changer’

A new form of treatment for Type 1 Diabetes that uses a patient’s own cells to fight the disease is being hailed as a potential “game-changer” after an early trial suggests that it’s safe for patients.

A research team headed by University of California San Francisco scientists recently put the treatment through its first U.S. safety trial and said patients reported no serious side effects.

That’s cleared the way for more tests, but there’s a way to go before the method is mainstream. Researchers still need to determine how effective the new form of treatment is against Type 1 Diabetes, an immune disease in which human bodies attack the cells that produce insulin.

While many traditional treatment methods go after the immune system, the researchers wrote in a news release that may increase the odds of a person developing an infection or even cancer.

The method being studied involves removing less than two cups of blood from a patient’s body to find certain kinds of cells called regulatory T cells, or Tregs. Scientists sort the Tregs and place them in a growth medium to boost their numbers, then inject them back into the patient’s body.

The goal is for those enriched Tregs to help bodies battle the attacks on insulin-producing cells while still keeping their immune systems fit enough to hold off other diseases and infections.’

The researchers said in the news release that all the signs to date have been encouraging, and that all of the 14 patients tolerated the Treg treatment well. The next step is a Phase 2 trial, another step toward confirming the treatment is actually beneficial for patients with the disease.

“This could be a game-changer,” UC San Francisco researcher Jeffrey A. Bluestone said in the news release. “For type 1 diabetes, we’ve traditionally given immunosuppressive drugs, but this trial gives us a new way forward. By using Tregs to ‘re-educate’ the immune system, we may be able to really change the course of this disease.”

About 1.25 million Americans have Type 1 Diabetes, the American Diabetes Association says.