ASCO News: BioNTech and Pfizer's bispecifics, and Pazdur — Day 2

• Former CDC director Tom Frieden has warned that upcoming changes to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) will significantly reduce the CDC's presence in foreign countries. • Frieden argues that slashing this international infrastructure leaves the U.S. more vulnerable to global health threats, citing current hantavirus and Ebola outbreaks as critical examples.

• Several U.S. jurisdictions have reduced the legal authority of public health officials following backlash over COVID-19 mandates, including lockdowns, school closures, and vaccine requirements. • These legislative changes limit the ability of state and local health departments to implement restrictive measures during future health crises.

• The Centers for Disease Control and Prevention (CDC) is seeking public comment and recommendations on a continuing information collection request. • The agency is requesting approval from the Office of Management and Budget (OMB) for an estimated 583 annual burden hours.

• The CDC has identified containing the spread of Ebola as its top priority amidst ongoing health concerns. • The Trump administration is reportedly disregarding established infectious disease playbooks, raising concerns about the federal response to outbreaks.

• In the phase III INDIGO trial, the investigational monoclonal antibody obexelimab substantially outperformed a placebo in treating immunoglobulin (Ig)G4-related disease. • This development positions obexelimab to compete with the only drug currently approved for the condition, potentially offering patients a new therapeutic option.

• In May 2026, pharmaceutical advancements focused on KRAS, a protein previously deemed "undruggable," with new research exploring the efficacy of the drug daraxonrasib. • A first-line study is currently underway to determine if daraxonrasib can be used earlier in treatment, either as a monotherapy or in combination with chemotherapy.

• The FDA has fast-tracked bepirovirsen, a first-of-its-kind drug for hepatitis B, following trial results showing it may allow some patients to stop treatment entirely. • In a study of 1,838 patients receiving weekly shots for six months, approximately 20% of bepirovirsen recipients achieved a "functional cure," meaning the virus remained undetectable for six months after all medication ceased.

• The U.S. FDA has approved ensitrelvir (Xocova), an oral antiviral developed by Shionogi, for the post-exposure prevention of COVID-19. • The medication is authorized for use in individuals aged 12 years and older who have been exposed to the SARS-CoV-2 virus.

• Missouri State Rep. Dave Griffith is advocating for psychedelic-assisted therapy to treat veterans suffering from depression and post-traumatic stress disorder. • The initiative follows an April executive order signed by Donald Trump titled “Accelerating Medical Treatments for Serious Mental Illness,” which aims to speed up drug approvals and clinical trial participation.

• The FDA has approved Shionogi’s Xocova (ensitrelvir) as the first oral therapy designed to prevent Covid-19 after a person has been exposed to the virus. • The approval follows the Scorpio-Pep trial involving 2,387 participants aged 12 and older who were asymptomatic but had been exposed to a symptomatic household member.

• Merck (known as MSD outside the U.S. and Canada) announced the publication of new clinical trial work on May 7, 2026. • The announcement was distributed via Business Wire from Rahway, N.J., targeting both healthcare professionals and consumers.