News Scan for Sep 22, 2022

News brief

Spero, GSK to partner on oral carbapenem for complicated UTIs

Biopharmaceutical company Spero Therapeutics announced today that it has entered into a licensing agreement with GSK for the antibiotic tebipenem pivoxil hydrobromide (HBr).

Under the agreement, GSK will receive an exclusive license to develop and commercialize the novel oral carbapenem, which is being developed for treatment of complicated urinary tract infections, in all territories except Japan and certain other Asian countries.

"There is a high unmet medical need for a novel oral antibiotic as an alternative to intravenous hospital therapy for drug-resistant complicated urinary tract infections," Luke Miels, MBA, Chief Commercial Officer for GSK, said in a press release.

In April, the Food and Drug Administration (FDA) told Spero that its review of the New Drug Application for tebipenem HBr had identified issues in the phase 3 trial results for the drug and that the data may not support approval. Following that meeting, the company announced that it was stopping all commercialization activities for tebipenem HBr and would reduce its workforce.

The FDA recently told Spero, however, that positive results from an additional phase 3 trial supported by confirmatory nonclinical evidence of efficacy could be sufficient to support approval. The company says it expects to start the trial in 2023.

"Spero's agreement with GSK provides a critical step towards fully realizing the value tebipenem HBr can potentially provide to physicians, payors, and patients," said Spero Chief Executive Officer Ankit Mahadevia, MD.
Sep 22 Spero Therapeutics press release
May 4 CIDRAP News scan

NSABB proposes tighter oversight of certain pathogen research

A federal group that advises the National Institutes of Health (NIH) on biosecurity issues met yesterday to review draft recommendations on experiments with potentially dangerous viruses and other pathogens, which call for tighter scrutiny, according to the Washington Post.

In January, the National Science Advisory Board for Biosecurity (NSABB) met for the first time since 2020, during which the NIH asked the group to review government policies for work on potentially dangerous pathogens. The NIH asked the panel to look at both gain-of-function (GOF) studies and dual-use research of concern—or studies that could be used for both good or ill. In taking on the task, the NSABB formed two working groups and held listening sessions.

According to the Post, advisers in their draft report urge the government to broaden its definition of the kinds of experiments that require special review and safety measures to include pathogens that are a public health or national security threat. Current policies more narrowly focus on deadlier pathogens. Though the report doesn't single out SARS-CoV-2, the broader focus would include disruptive but less deadly threats.

Finalized recommendations aren't expected for the next several months. In 2012, the NSABB was instrumental in making recommendations about publishing controversial H5N1 avian flu transmission GOF studies. Then in 2016, the White House asked the group to recommend guidance on assessing and funding GOF studies.
Sep 21 Washington Post story
NSABB draft recommendations

COVID-19 Scan for Sep 22, 2022

News brief

Study shows previous Omicron infection most protective against BA.2

A study in The Lancet Infectious Diseases demonstrates that previous Omicron BA.1 infection was the most protective factor against BA.2 infection (associated with a risk reduction of 72%) and gave greater protection than primary infection with pre-Omicron SARS-CoV-2 (38%) or three doses of an mRNA vaccine in people with no previous infection (46%).

The test-negative case-control study involved Quebec healthcare workers to compare those who had a positive SARS-CoV-2 test during the period of Omicron BA.2 dominance, from Mar 27 to Jun 4, 2022, with healthcare workers who had a negative test during the same period.

The primary COVID-19 infection had to take place at least 30 days before the study period, with pre-Omicron infections occurring between Feb 20, 2020, and Nov 27, 2021. Omicron BA.1 attribution was given for all cases between Dec 26, 2021, and Mar 26, 2022. In total, 37,732 presumed Omicron BA.2 cases were compared with 73,507 randomly selected controls.

The authors said that among cases, 1,159 (3.1%) had a primary infection combined with two mRNA vaccine doses, and 1,436 (3.8%) had a primary infection and three vaccine doses. Among controls, 687 (10.9%) had a primary infection combined with two vaccine doses, and 821 (13.4%) had a primary infection and three vaccine doses.

Hybrid immunity from BA.1 infection plus two or three mRNA vaccine doses increased effectiveness to 96% for longer than 5 months. Notably, a third vaccine dose conferred no improvement to that hybrid protection.

"These data provide immunological context for the importance of hybrid immunity in managing the current surges caused by the BA.2.12.1, BA.4, and BA.5 subvariants in populations with high frequencies of vaccination and BA.1 or BA.2 infection," writes David Hui, MD, of the Chinese University of Hong Kong, in a commentary on the study. "Another important factor in reducing infection risk is heterologous booster vaccination with different platforms to maximise the breadth of vaccine-induced immunity, especially in countries primarily using inactivated vaccine."
Sep 21 Lancet Infect Dis study and commentary

Agreement paves way for greater global Paxlovid access

Pfizer today announced that it has signed an agreement with the Global Fund to supply up to 6 million Paxlovid courses for 132 low- and middle-income countries to help treat COVID-19.

The countries will be able to access the drug through the Global Fund's existing pandemic response mechanism, which has been used to provide grant support for tests, treatments, personal protective equipment, and other elements for strengthening heathcare systems.

In a statement, Pfizer said it expects the supply to begin this year, based on regulatory approval and country demand. Countries can buy supplies through tiered pricing at Pfizer's nonprofit rate. Albert Bourla, Pfizer's chief executive officer, said the contact with the Global Fund boosts equitable access to treatments for high-risk groups in low- and middle-income countries. The company also said the agreement builds on earlier efforts to ease access.

In US developments, an official with the Food and Drug Administration said this week that updated COVID boosters for children ages 5 to 11 years old will be authorized in the coming weeks, according to ABC News. Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research, was speaking at an event with the COVID-19 Vaccine Education and Equity Project. Earlier this month, the new booster was cleared for emergency use in people as young as 12.
Sep 22 Pfizer statement
Sep 21 ABC News story