Sunday, September 20, 2020

August . 3, 2020   GENEVA - As the world awaits a COVID-19 vaccine, the next big advance in battling the pandemic could come from a class of biotech therapies widely used against cancer and other disorders - antibodies designed specifically to attack this new virus. Development of monoclonal antibodies to target the virus has been endorsed by leading scientists. Anthony Fauci, the top U.S. infectious diseases expert, called them “almost a sure bet” against COVID-19.

When a virus gets past the body’s initial defenses, a more specific response kicks in, triggering production of cells that target the invader. These include antibodies that recognize and lock onto a virus, preventing the infection from spreading.

Monoclonal antibodies - grown in bioreactor vats - are copies of these naturally-occurring proteins.

Scientists are still working out the exact role of neutralizing antibodies in recovery from COVID-19, but drugmakers are confident that the right antibodies or a combination can alter the course of the disease that has claimed more than 675,000 lives globally.

“Antibodies can block infectivity. That is a fact,” Regeneron Pharmaceuticals executive Christos Kyratsous said.

Regeneron is testing a two-antibody cocktail, which it believes limits the ability of the virus’ to escape better than one, with data on its efficacy expected by late summer or early fall. “Protection will wane over time. Dosing is something we don’t know yet,” said Kyratsous.

The U.S. government in June awarded Regeneron a $450 million supply contract. The company said it can immediately begin production at its U.S. plant if regulators approve the treatment.

Eli Lilly and Co, AstraZeneca, Amgen, and GlaxoSmithKline were cleared by the U.S. government to pool manufacturing resources in order to scale up supplies if any of these drugs prove successful.

Even with that unusual cooperation among rivals, manufacturing these medicines is complex and capacity is limited. There is also a debate over whether a single antibody will be powerful enough to stop COVID-19.

AstraZeneca said it plans to start human trials of its dual-antibody combination within weeks.

Lilly, which began human testing in June of two antibody candidates in separate trials, is focusing on a one-drug approach.

“If you need a higher dosage or more antibodies, fewer people can be treated,” Lilly Chief Scientific Officer Dan Skovronsky said.

‘INSTANT IMMUNITY’

Unlike vaccines, which activate the body’s own immune system, the impact of infused antibodies eventually dissipates.

Still, drugmakers say monoclonal antibodies could temporarily prevent infection in at-risk people such as medical workers and the elderly. They could also be used as a therapeutic bridge until vaccines become widely available.

“In a prophylactic setting we think we may achieve coverage for up to six months,” said Phil Pang, chief medical officer of Vir Biotechnology, which aims to start testing an antibody in non-hospitalized patients next month with partner GSK.

“The advantage of an antibody is that it is basically instant immunity,” said Mark Brunswick, senior vice president at Sorrento Therapeutics, which aims to begin human trials next month of a single antibody candidate.

Safety risks for monoclonal antibodies are considered low, but their cost can be quite high. These type of drugs for cancer can cost over $100,000 a year.

There is also concern that the coronavirus could become resistant to specific antibodies. Researchers are already at work on second-generation compounds with targets other than the crown-like spikes the virus uses to invade cells.

“We are trying to develop something that is complementary,” Amgen research chief David Reese said. Amgen is working with Adaptive Biotechnologies Corp.

Researchers in a recent paper published in the journal Nature said they had discovered several new, very potent, antibodies directed to an area where the virus attaches to human cells and to a region of the spike that has not attracted attention.

“To avoid development of resistance you want to target different sites,” study author and Columbia University professor David said.

There are also questions about when in the course of the illness it might be best to employ these new weapons.

“Giving an antibody later on after infection might not be that helpful, said Florian Krammer, microbiology professor at New York’s Icahn School of Medicine. “Given early, they probably work well.”

ATLANTA (AP) — Rapper and actor T.I. has settled civil charges with the U.S. Securities and Exchange Commission that he helped promote a fraudulent cryptocurrency. T.I., whose real name is Clifford Harris, agreed to a civil settlement with the SEC that was announced Friday. He is paying a $75,000 fine and agreeing not to sell or market similar securities for at least five years. Harris got into trouble, the SEC said, because he used his social media accounts to promote FLiK, falsely claiming to be a co-owner, and asked an unnamed actor and comedian to also promote FLiK, providing language calling it T.I.’s “new venture.” The SEC says both of those moves broke federal laws against selling securities without registering with the SEC. The charges against Harris were part of a larger enforcement action against others including film producer Ryan Felton, who faces wire fraud and other charges in a 28-count indictment unsealed Wednesday.

PHILADELPHIA (AP) — Legal advocates are lining up on both sides of actor Bill Cosby’s appeal as the Pennsylvania Supreme Court prepares to review his 2018 sex assault conviction. Cosby was the first celebrity to go on trial in the #MeToo era, and his appeal could resolve lingering questions about how the cases should be tried. For starters, the high court will try to clarify when other accusers can testify against a defendant — and when the additional testimony amounts to character assassination. Public defenders in Philadelphia, in a friend-of-the-court brief filed in Cosby’s appeal, noted that courts have given conflicting guidance on the issue.

NEW YORK (AP) — The Council of Fashion Designers of America gave its top fashion awards on Monday to Gabriela Hearst for womenswear and Kerby Jean-Raymond for menswear. The two designers led a group of winners that the CFDA said was the most diverse in the 39-year history of the awards. It was the second honor in two days for Jean-Raymond, the prominent Black founder of the Pyer Moss label, who was also named Designer of the Year by Harlem’s Fashion Row in a virtual ceremony on Sunday. The CFDA winners also included Telfar Clemens, who won the accessories award, and Christopher John Rogers, who won for American emerging designer. All four were first-time winners.

NEW YORK (AP) — There’s a scene in a new documentary about Paris Hilton, where the so-called socialite is speaking with former classmates from a Utah boarding school. They joke about how on her reality series “The Simple Life,” Hilton pretended to be clueless over many things— including how to perform any sort of manual labor. One bluntly described it as “some straight-up (expletive),” as they all laughed. “I don’t think you had like a high-pitch voice back then,” was another observation. None of this is a surprise to Hilton. What’s revealed in “This is Paris,” which debuted for free Monday on Hilton’s YouTube channel, is that the ultra-glam, baby-talking young woman whose standard line was “that’s hot,” was a manufactured caricature not just for fame but self-protection, too.