Vaxcyte’s 24-Valent Pneumococcal Vaccine Shows Best-In-Class Potential

Small Biotech Hopes To Compete In Big Pharma-Dominated Market

The biotech’s share price jumps more than two-thirds as analysts hail top-line Phase I/II data as better than expected. Vaxcyte hopes to hold Phase III planning discussions with the FDA in 2023.

Vaccine syringe
Vaxcyte's proof-of-concept data for its PCV candidate has company, investors excited • Source: Shutterstock

Vaxcyte, Inc. unveiled top-line Phase I/II data for its 24-valent pneumococcal conjugate vaccine (PCV) on 24 October, showing safety comparable to Pfizer Inc.’s Prevnar 20 and demonstrating non-inferiority on opsonophagocytic activity (OPA) across all 20 serotypes covered by Prevnar 20, with higher immune responses seen on 16 serotypes. VAX-24 also addresses four serotypes of invasive pneumococcal disease not covered by Prevnar 20 or any competing product and met standard superiority criteria for each in the data readout, the company said.

[Sidebar#SC145396]

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from Clinical Trials

Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

 
• By 

Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

 
• By 

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

Sponsored By:

Nancy Tests SPARC-931-part

The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D

Scrip-R&D-Premium: ‘Article’ article that includes different Composer content

 
• By 

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.