Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
RFK Jr. fires all CDC vaccine panel members and replaces them with several vaccine skeptics
On Monday, HHS Secretary Robert F. Kennedy Jr. (RFK Jr.) removed all 17 members of the CDC committee known as the Advisory Committee on Immunization Practices (ACIP). ACIP consists of vaccine experts who make recommendations on new and existing FDA-approved vaccines for the public. Noel Brewer, a public health researcher at the University of North Carolina who had been on the panel, told USA Today, “None of us had any idea that this was coming, so it came out of the blue and it was not something that’s ever been done before with ACIP.” USA Today also reported that Louisiana Republican senator Bill Cassidy said that the firings go against a promise that RFK Jr. made to maintain the current members of ACIP during his confirmation hearings.
On Wednesday, RFK Jr. announced eight new committee members in a post on X. STAT reported that several of the new members are well-known critics of vaccines, and many do not have expertise in vaccines. Speaking to NPR, vaccine policy researcher Dorit Reiss said, “It tells me that Kennedy is setting up a committee that would be skeptical of vaccines, and possibly willing to implement an anti-vaccine agenda.” The new committee is scheduled to meet on June 25th. – Allison Whitten
NIH scientists dissent to the agency’s research cuts and politicization
On Monday, NIH scientists and staff signed the “Bethesda Declaration,” a statement in dissent of the Trump Administration’s cuts to NIH-funded research. The scientists addressed their letter to NIH director Jay Bhattacharya and sent a copy to RFK Jr. They outlined their concerns in a document modeled after Bhattacharya’s 2020 “Great Barrington Declaration” in which he and two coauthors enumerated their concerns about COVID-19 lockdowns. In the NIH researchers’ dissent, they write of the 2,100 NIH grants that the new administration has cancelled so far, and they explain how these cuts not only waste taxpayer dollars but also prevent people from taking what could be lifesaving drugs in clinical trials or from no longer monitoring implanted experimental medical devices. “Ending a $5 million research study when it is 80% complete does not save $1 million, it wastes $4 million,” they wrote. – Stephanie DeMarco
Merck inches closer to approval for first oral PCSK9 inhibitor for high cholesterol
Merck announced positive results from its Phase 3 CORALreef trials testing enlicitide, a novel macrocyclic peptide drug that could become the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) to treat high cholesterol. The compound works by blocking the PCSK9 protein to prevent it from binding to low-density lipoprotein (LDL) receptors. In a press release, the company wrote that enlicitide significantly reduced LDL cholesterol compared to the placebo group, as well as compared to a group taking two other oral medications to lower LDL cholesterol: ezetimibe and bempedoic acid. DDN previously covered the development and Phase 2b results of enlicitide, in which Merck Clinical Director Douglas Johns said, “I believe that an oral treatment should help doctors introduce this really, really powerful mechanism earlier in a person’s, what we call their patient journey. So [instead of] having to wait until you've gone a huge distance with a bunch of different drugs, this might be something that they could take earlier on and with easier access.” – Allison Whitten
FDA approves Merck’s RSV antibody for infants
In another success for Merck this week, the FDA approved the company’s monoclonal antibody that prevents disease due to respiratory syncytial virus (RSV) infections for newborns and infants. RSV can cause severe disease in older adults and very young children. While multiple RSV vaccines are available for older adults, none are approved in children. Pfizer does, however, have Abrysvo, a maternal RSV vaccine where RSV antibodies pass from the pregnant person to the developing fetus, protecting the infant from the virus until they are about six months old. Merck’s drug, called Enflonsia, is now the second preventative antibody drug available for RSV; it joins AstraZeneca and Sanofi’s drug Beyfortus, which the FDA approved in 2023. Unlike Beyfortus, the same dose of Enflonsia can be given to infants of any weight. The team at Merck plans to have Enflonsia available before the 2025-2026 RSV season begins. – Stephanie DeMarco
Metsera announces weight loss results with non-GLP-1 treatment
Metsera announced that their first-in-class, once-monthly subcutaneous synthetic version of the amylin hormone led patients to lose up to 8.4 percent of their body weight when adjusted for placebo. In a press release, Metsera Chief Medical Officer Steve Marso said, “We observed five-week body weight loss comparable to that of leading GLP-1-based medicines, and we identified efficacious starting doses with placebo-like tolerability. These data position MET-233i as a potential best-in-class amylin.” The company said that they plan to continue testing the treatment as a monotherapy and in combination with their long-acting GLP-1 drug, MET-097i. – Allison Whitten
Bristol Myers Squibb’s RayzeBio makes a radiochemistry deal in prostate cancer
In a $350 million deal with a potential value of up to $1.35 billion, RayzeBio — Bristol Myers Squibb (BMS)’s radiopharma company — is partnering with Philochem, an Italian-Swiss biotechnology company, on developing a small molecule radiotracer for diagnosing and treating prostate cancer. In this new partnership, the companies will work together to advance OncoACP3, which is a small molecule radiotracer that binds to the protein Acid Phosphatase 3 (ACP3), which is expressed at high levels in prostate cancers. ACP3 would represent a new biomarker in the prostate cancer space; most therapies target prostate-specific membrane antigen (PSMA). In the press release, the Philochem researchers said that OncoACP3 has shown promising results so far as a diagnostic due to its tumor selectivity and long tumor residence time in a Phase 1 study. The RayzeBio and Philochem team are working on IND-enabling studies to test the therapeutic qualities of OncoACP3 carrying actinium-225, the alpha particle emitting radioisotope that RazyeBio uses in their radiotherapies for cancer. – Stephanie DeMarco
