A trio of European cancer vaccine specialists have filed progress reports, with advances in technology and targeting, fresh infusions of cash, and off-the-shelf products moving into the clinic. Six years on from its formation, Ervimmune closed a series A at €17 million (US$19.9 million) to drive forward clinical development of lead program Ervac-01. Accession Therapeutics Ltd. raised a further £30.5 million (US$40.4 million) from its existing investors, following dosing of four patients with Trocept-01. And Infinitopes Ltd. added $15.4 million to its seed round, as it finalizes preparations for a phase I/IIa trial of the lead product ITOP-1.
The New York attorney general’s office has filed suit against the former CEO of Emergent Biosolutions Inc., alleging insider trading, while at the same time announcing a settlement with the company, which agreed to pay $900,000 in penalties for approving the illegal trading plan. The lawsuit stems from reports of vaccine contamination at the company’s manufacturing plant during the height of the COVID pandemic.
In recent years, messenger RNA (mRNA) vaccines have shown significant success in preventing viral and bacterial infections, as well as in cancer immunotherapy and other disease applications. In particular, the development of lipid nanoparticle (LNP)-encapsulated mRNA has revolutionized vaccine development thanks to several advantages, including elevated immunogenicity, rapid manufacturing and a generally favorable safety profile compared to viral vectors and traditional adjuvant-based vaccines.
U.S. Health and Human Services Secretary Robert Kennedy has once again expanded the CDC’s Advisory Committee on Immunization Practices (ACIP), this time adding two more ob-gyns to the membership list. As a result, the ACIP, which can have up to 19 members, now numbers 13, three of whom are ob-gyns.
The chaos Health and Human Services Secretary Robert Kennedy has injected into the U.S. vaccine market could have long-term consequences as vaccine makers reevaluate business decisions and pipelines.
Cansino Biologics Inc. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for the company’s 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (PCV24).
With the stroke of a pen and no input from the CDC’s Advisory Committee for Immunization Practices, acting CDC Director Jim O’Neill cut the number of vaccines the agency routinely recommends for children to 11 on Jan. 5, down from 17 in 2024.
Excessive production of pro-inflammatory cytokines or aging-related chronic inflammation disrupts immunity and diminishes the efficacy of vaccines, although the underlying mechanisms remain unknown. Moreover, these pro-inflammatory cytokines are linked to adverse vaccine reactions. These two issues can lead to vaccine hesitancy, resulting in lower vaccination rates.
If the 2025 U.S. life sciences regulatory scene were to be summed up in one word, it would have to be uncertainty. Two words might be more definitive – chaotic uncertainty.
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