Affinivax is a biopharmaceutical company that specializes in creating vaccines designed to enhance protection against infectious diseases. Their innovative vaccine conjugation technology, known as MAPS, has the potential to produce novel vaccines that provide broader coverage against diseases than currently available vaccines, as well as protect against infections for which there are no effective immunization strategies. The company is currently focused on advancing a lead program targeting Streptococcus pneumoniae, a pathogen responsible for significant morbidity and mortality in children and adults globally. Affinivax was founded by world-renowned experts in infectious diseases and vaccines and is supported by the Bill & Melinda Gates Foundation and an exclusive license from Boston Children's Hospital for the MAPS technology platform intellectual property.

Tags

Infectious Diseases

Respiratory Diseases

Prophylactic vaccine

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	2

Top 5 Drug Type	Count

Prophylactic vaccine	2

Top 5 Target	Count

SARS-CoV-2 S protein	1

Drugs associated with Affinivax, Inc.

ASP-1004

Target-

Mechanism

Immunostimulants

Active Org.

Affinivax, Inc.

Originator Org.

Affinivax, Inc.

Active Indication

Klebsiella Infections [+1]

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

SARS-CoV-2 MAPS vaccine(Affinivax)

Target

SARS-CoV-2 S protein

Mechanism

SARS-CoV-2 S protein inhibitors [+1]

Active Org.

Affinivax, Inc.

Originator Org.

Affinivax, Inc.

Active Indication

COVID-19

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Affinivax, Inc.

NCT04525599

/ CompletedPhase 1

A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

The purpose of this study is to evaluate the safety and tolerability of three dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have previously been administered the routine three-dose series of PCV13.
This study will also evaluate the immunogenicity (production of an immune response) of three different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who have previously been administered the routine three-dose series of PCV13.

Start Date22 Sep 2020

Sponsor / Collaborator

Affinivax, Inc.

NCT04265911

/ CompletedPhase 1

ASP3772 Phase 1 Study: Single Ascending Dose Study in Japanese Healthy Male and Female Adults, and PPSV23-controlled, Randomized, Single Ascending Dose Study in Japanese Elderly Male and Female Subjects

The purpose of this study is to evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults 20 to 49 years of age.
This study will also evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly, in comparison to the active comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly subjects 65 to 85 years of age.

Start Date19 Feb 2020

Sponsor / Collaborator

Affinivax, Inc.

NCT03803202

/ CompletedPhase 1/2

A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, a Pneumococcal Vaccine

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.

Start Date24 Jan 2019

Sponsor / Collaborator

GSK Plc

[+1]

100 Clinical Results associated with Affinivax, Inc.

0 Patents (Medical) associated with Affinivax, Inc.

Literatures (Medical) associated with Affinivax, Inc.

13 Aug 2025·mBio

Novel Klebsiella pneumoniae and Pseudomonas aeruginosa MAPS vaccine combining O polysaccharides and pathogen-specific proteins

Article

Author: Pasetti, Marcela ; Cross, Alan ; Malley, Richard ; Kolasny, Jacqueline ; Simon, Raphael ; Nkeze, Joseph ; Fox, Heather ; Michon, Francis ; Leney, Mark ; Permala Booth, Jasnehta ; Sycheva, Lada ; Ambrosino, Donna ; Shridhar, Surekha ; Hegerle, Nicolas ; Molrine, Deborah ; Apolinario, Ethel ; Hyun, Sang ; Saia, Greg ; Siber, George R. ; Choi, Myeong-Jin ; Tennant, Sharon M. ; Amin, Mohammed N. ; Sinclair, James E. ; Curtis, Brittany ; Broering, Teresa ; Sen, Shaichi

ABSTRACT:

Klebsiella pneumoniae (KP) and Pseudomonas aeruginosa (PA) are leading causes of healthcare-associated and community-acquired infections. Despite decades of efforts, there are no licensed vaccines for either pathogen. The surface O polysaccharides (OPS) of Klebsiella pneumoniae and Pseudomonas aeruginosa are essential virulence factors for these bacteria and are targets of protective antibacterial antibodies. The multiple antigen presenting system (MAPS) vaccine platform was used to create a multivalent Klebsiella / Pseudomonas vaccine in which the surface OPS of four Klebsiella and eight Pseudomonas strains were linked to a high MW biotinylated Klebsiella oxytoca (KO) K19 capsular polysaccharide backbone and subsequently linked to pathogen-specific fusion proteins, consisting of Klebsiella MrkA, the Pseudomonas flagellin B D2 subunit, and PcrV. We show here that these MAPS complexes incorporating KP and PA OPS, as well as pathogen-specific proteins, were highly immunogenic in rabbits and mice and induced functionally active antibodies in vitro and in murine animal models.

IMPORTANCE:

Infections caused by Klebsiella pneumoniae (KP) and Pseudomonas aeruginosa (PA) are widely recognized to be of “urgent” and “serious” concern, in part because of their widespread antimicrobial resistance. To date, there is no licensed vaccine for either pathogen. We developed a novel multiple antigen presenting system (MAPS) vaccine platform that contains eight O polysaccharides (OPS) of PA and four OPS of KP, which will cover over 80% of clinical infections with these pathogens. In addition, this vaccine includes three pathogen-relevant proteins acting both as carrier proteins to provide T cell help for these polysaccharides as well as to elicit functionally active antibodies that may also protect against KP and PA infection. The use of pathogen-relevant proteins that may contribute to vaccine efficacy in place of the more traditional carrier proteins is a novel concept. The MAPS vaccine platform also generates Th17 and Th1 responses. This KP/PA MAPS vaccine may prevent infection with these pathogens and reduce their transmissibility.

01 Jan 2025·VACCINE

Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naïve Japanese adults: A phase 1 randomized dose-escalation trial

Article

Author: Haranaka, Miwa ; Hashimoto, Atsuki ; Malley, Richard ; Ebara, Masaki ; Chichili, Gurunadh R ; Oizumi, Yuki ; Nanra, Jasdeep ; Nakano, Takashi ; Sebastian, Shite ; Borys, Dorota ; Smulders, Ronald ; Iwahana, Mioko

BACKGROUND:

The burden of pneumococcal diseases remains high in Japan. Pn-MAPS24v is a novel MAPS-based vaccine containing complexes of 24 serotype-specific polysaccharides (PS), non-covalently coupled with fusion protein 1 (CP1). This study evaluated the safety and immunogenicity of different dose levels of Pn-MAPS24v, administered in Japanese adults either subcutaneously (SC) or intramuscularly (IM).

METHODS:

In this phase 1, dose-escalation, observer-blind trial conducted in Japan, 54 pneumococcal vaccine-naïve adults aged 20-49 years (stage 1), and 72 adults aged 65-85 years (stage 2) were sequentially enrolled. In stage 1, participants were randomized 1:1 (SC:IM) to receive a single Pn-MAPS24v dose at one of the dose levels (1 μg, 2 μg, or 5 μg per PS). In stage 2, participants were randomized 3:1 (Pn-MAPS24v:23-valent pneumococcal polysaccharide vaccine [PPSV23]) and 1:1 (SC:IM) to receive a single dose of either Pn-MAPS24v (one of three dose levels), or PPSV23. Solicited adverse events (AEs) were collected through 7 days post-vaccination, and treatment-emergent AEs (TEAEs) up to 1 month post-vaccination. Serotype-specific opsonophagocytic activity titers and immunoglobulin G (IgG) concentrations, as well as anti-CP1 IgG concentrations were measured before and 1 month post-vaccination.

RESULTS:

No safety or reactogenicity concerns were identified in any age category across groups. No grade 3-4 TEAEs, serious AEs, or deaths were reported. Regardless of the age category, dose level, administration route, or study vaccine, the frequency of reported TEAEs was low and all vaccine-related TEAEs were mild. Pain, tenderness, and fatigue were the most frequently reported solicited AEs. One month post-vaccination, Pn-MAPS24v induced serotype-specific immune responses that were comparable or higher than those elicited by PPSV23. The immune responses were similar after SC and IM administration.

CONCLUSION:

Pn-MAPS24v showed an acceptable safety profile and was immunogenic after SC and IM administration, therefore supporting the further development of Pn-MAPS24v in Japan.

CLINICALTRIALS:

gov: NCT04265911.

01 Apr 2024·Vaccine

Safety, tolerability and immunogenicity of a novel 24-valent pneumococcal vaccine in toddlers: A phase 1 randomized controlled trial

Article

Author: Malley, Richard ; Malinoski, Frank ; Rupp, Richard ; Siber, George ; Smulders, Ronald ; Chichili, Gurunadh R ; Borys, Dorota ; Sebastian, Shite ; Santos, Vicki ; Kovanda, Laura L

BACKGROUND:

Pneumococcal conjugate vaccines (PCVs) significantly reduced pneumococcal disease burden. Nevertheless, alternative approaches for controlling more serotypes are needed. Here, the safety, tolerability, and immunogenicity of a 24-valent (1/2/3/4/5/6A/6B/7F/8/9N/9V/10A/11A/12F/14/15B/17F/18C/19A/19F/20B/22F/23F/33F) pneumococcal vaccine based on Multiple Antigen-Presenting System (MAPS) technology (Pn-MAPS24v) was assessed in toddlers.

METHODS:

In this phase 1, blinded, dose-escalation, active-controlled multicenter study conducted in the United States (September/2020-April/2022), 12-15-month-old toddlers primed with three doses of 13-valent PCV (PCV13) were randomized 3:2 to receive a single dose of one of three Pn-MAPS24v dose levels (1 μg/2 μg/5 μg per polysaccharide) or PCV13 intramuscularly. Reactogenicity (within 7 days), treatment-emergent adverse events (TEAEs, within 180 days), serious/medically attended adverse events (SAEs/MAAEs, within 180 days), and immunogenicity (serotype-specific anti-capsular polysaccharide immunoglobulin G [IgG] and opsonophagocytic activity [OPA] responses at 30 days post-vaccination) were assessed.

RESULTS:

Of 75 toddlers enrolled, 74 completed the study (Pn-MAPS24v 1 μg/2 μg/5 μg: 15/14/16, PCV13: 29). Frequencies of local (60 %/67 %/31 %) and systemic events (67 %/67 %/75 %) in the Pn-MAPS24v 1 μg/2 μg/5 μg and the PCV13 (55 %, 79 %) groups were in similar ranges. TEAEs were reported by 47 %/40 %/63 % of Pn-MAPS24v 1 μg/2 μg/5 μg recipients and 52 % of PCV13 recipients. No vaccine-related SAE was reported. At 30 days post-vaccination, for each of the 13 common serotypes, ≥93 % of participants in each group had IgG concentrations ≥0.35 μg/mL; >92 % had OPA titers ≥lower limit of quantitation (LLOQ), except for serotype 1 (79 %). For 7/11 unique serotypes (2/8/9N/11A/17F/22F/33F), at all dose levels, ≥78 % of Pn-MAPS24v recipients in each group had IgG concentrations ≥0.35 μg/mL and 80 %-100 % had OPA titers ≥LLOQ.

CONCLUSIONS:

In 12-15-month-old toddlers, a single dose of Pn-MAPS24v showed an acceptable safety profile, regardless of dose level; AEs were reported at similar frequencies by Pn-MAPS24v and PCV13 recipients. Pn-MAPS24v elicited IgG and OPA responses to all common and most unique serotypes. These results support further clinical evaluation in infants.

News (Medical) associated with Affinivax, Inc.

27 Jan 2026

·www.businesswire.com

Clarametyx Biosciences Strengthens Scientific Advisory Board With Expert Appointments to Advance Pipeline Programs

COLUMBUS, Ohio--(BUSINESS WIRE)--Clarametyx Biosciences, Inc. (“Clarametyx”), a clinical-stage biotechnology company developing immune-enabling medicines to address biofilm-driven chronic respiratory disease, today announced the appointment of four new expert advisors to its Scientific Advisory Board (SAB) – Bruce Forrest, MD, George Siber, MD, Obadiah Plante, PhD, and C. David Zarley, PhD – as the Company accelerates development for its anti-biofilm technologies in chronic respiratory disease following the recent announcement of positive top line data for its lead asset, CMTX-101. “On the heels of our positive topline trial data, we continue to build momentum with our anti-biofilm therapeutic pipeline and have bold aspirations to enrich this pipeline with complementary programs that can address persistent unmet medical needs. The evolution of our Scientific Advisory Board is a critical step to enable us to fully explore the clinical potential reach of these approaches,” said David V. Richards, Chief Executive Officer. “Drs. Forrest, Siber, Plante and Zarley, each of whom have world-class biologic therapeutic and vaccine expertise and a deep appreciation for the need for innovation in addressing biofilm-driven disease, will offer critical external validation and insights to help enhance our ongoing development efforts.” Clarametyx welcomes these new colleagues to our SAB: Dr. Bruce Forrest brings over 35 years of global leadership in pharmaceutical development with specialty expertise in biopharmaceuticals and vaccines development. Dr. Forrest previously served as Board Member, Corporate Officer and Executive Director (Head) of R&D for Wyeth K.K. in Japan and as Senior Vice President at Wyeth Pharmaceuticals (now Pfizer). Dr. George Siber is an infectious disease-trained physician with 50 years of experience in developing vaccines and antibody products. Dr. Siber was most recently a Co-founder and Board Member of Affinivax. He was previously Executive Vice President and Chief Scientific Officer of Wyeth Vaccines (now Pfizer). Dr. Obadiah Plante is an internationally recognized leader in biotech, vaccines and infectious disease research. He is President at P5 Innovations and recently served as SVP and Head of Research at Kinvard Bio. Previously, he led vaccine and immunotherapy research in infectious disease at Moderna. Dr. David Zarley has over 30 years of experience in the research, development and manufacturing of viral, bacterial and therapeutic vaccines. He was previously Vice President for Program Management at Pfizer Vaccine Research and Development. About Clarametyx Biosciences Clarametyx Biosciences is combating the formidable challenge of chronic respiratory diseases through an innovative technology platform targeting the biofilm—a protective layer around bacteria that drives inflammation and disease exacerbation. The Columbus, Ohio-based company is building a pipeline of immune-enabling medicines, including CMTX-101, which has completed a successful Phase 2a study for cystic fibrosis-related, biofilm-driven infections, and CMTX-301, which is in preclinical development. For more information, visit us on the web or on LinkedIn.

Phase 2Executive ChangeVaccine

13 Feb 2025

·www.businesswire.com

$87.46 Bn Pediatric Vaccine Market Opportunities and Strategies to 2033: Advancements in Conjugate Vaccines for Pneumococcal Disease, Inactivated Poliovirus Vaccine Aids Polio Eradication Programs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Pediatric Vaccine Market Opportunities and Strategies to 2033" report has been added to ResearchAndMarkets.com's offering. This report describes and explains the pediatric vaccine market and covers 2018-2023, termed the historic period, and 2023-2028, 2033F termed the forecast period. The report evaluates the market across each region and for the major economies within each region. The global pediatric vaccine market reached a value of nearly $41.16 billion in 2023, having grown at a compound annual growth rate (CAGR) of 6.71% since 2018. The market is expected to grow from $41.16 billion in 2023 to $59.31 billion in 2028 at a rate of 7.58%. The market is then expected to grow at a CAGR of 8.08% from 2028 and reach $87.46 billion in 2033. The global pediatric vaccine market is highly concentrated, with large players in the market. The top ten competitors in the market made up to 60.85% of the total market in 2023. The market concentration can be attributed to the presence of large players in different geographies. Merck & Co. Inc. was the largest competitor with a 30.82% share of the market, followed by SANOFI S.A. with 7.67%, Pfizer, Inc. with 6.95%, Seqirus (CSL Limited) with 3.62%, GlaxoSmithKline plc with 3.58%, Johnson & Johnson with 2.79%, Daiichi Sankyo Co. Ltd. with 1.96%, Novavax, Inc. with 1.24%, AstraZeneca Plc. with 1.11% and Novartis AG with 1.10%. Market-trend-based strategies for the pediatric vaccine market include focusing on developing new vaccines, focus on the development of conjugate vaccines to improve the immune response in children and focusing on new vaccines. Player-adopted strategies in the pediatric vaccine market include focus on expand operations by new vaccine approvals and strengthening its market position through strategic partnerships. Growth in the historic period resulted from increasing birth rates in developing regions, increasing incidence of pediatric diseases, government and NGO funding, increasing mandatory vaccination policies. Factors that negatively affected growth in the historic period was high healthcare costs. Going forward, increasing healthcare expenditure, rising incidence of chronic diseases among children, new vaccination awareness campaigns will drive the growth. Factor that could hinder the growth of the pediatric vaccine market in the future include shortage of healthcare professionals and supply chain disruptions. North America was the largest region in the pediatric vaccine market, accounting for 41.42% or $17.05 billion of the total in 2023. It was followed by Asia Pacific, Western Europe and then the other regions. Going forward, the fastest-growing regions in the pediatric vaccine market will be Asia Pacific and Africa where growth will be at CAGRs of 9.05% and 8.25% respectively. These will be followed by Middle East and South America where the markets are expected to grow at CAGRs of 7.94% and 7.90% respectively. The pediatric vaccine market is segmented by vaccine type into monovalent vaccines and multivalent vaccines. The monovalent market was the largest segment of the pediatric vaccine market segmented by vaccine type, accounting for 70.69% or $29.09 billion of the total in 2023. Going forward, the multivalent segment is expected to be the fastest growing segment in the pediatric vaccine market segmented by vaccine type, at a CAGR of 8.31% during 2023-2028. The pediatric vaccine market is segmented by technology into live attenuated, inactivated, toxoid, conjugate and other technologies. The conjugate market was the largest segment of the pediatric vaccine market segmented by technology, accounting for 37.08% or $15.26 billion of the total in 2023. Going forward, the other technologies segment is expected to be the fastest growing segment in the pediatric vaccine market segmented by technology, at a CAGR of 7.75% during 2023-2028. The pediatric vaccine market is segmented by application into infectious disease, allergy, cancer, pneumococcal disease, influenza, measles, mumps and rubella and other applications. The infectious disease market was the largest segment of the pediatric vaccine market segmented by application, accounting for 35.69% or $14.69 billion of the total in 2023. Going forward, the measles, mumps and rubella segment is expected to be the fastest growing segment in the pediatric vaccine market segmented by application, at a CAGR of 9.19% during 2023-2028. To take advantage of the opportunities, the analyst recommends the pediatric vaccine companies to focus on developing targeted pediatric vaccines, focus on expanding conjugate vaccine development, focus on expanding pediatric vaccine portfolios, focus on multivalent pediatric vaccines, focus on live attenuated pediatric vaccines, expand in emerging markets, focus on expanding distribution channels to reach broader demographics, focus on pricing strategies for pediatric vaccine companies, leverage digital channels, strengthen healthcare provider outreach and focus on infectious disease market and pediatric vaccine development. Opportunity Insights The top opportunities in the pediatric vaccine market segmented by vaccine type will arise in the monovalent segment, which will gain $12.22 billion of global annual sales by 2028. The top opportunities in the pediatric vaccine market segmented by technology will arise in the conjugate segment, which will gain $6.83 billion of global annual sales by 2028. The top opportunities in the pediatric vaccine market segmented by application will arise in the infectious disease segment, which will gain $5.5 billion of global annual sales by 2028. The pediatric vaccine market size will gain the most in the USA at $6.37 billion. Major Market Trends Developing New Pediatric Vaccines For Better Public Health Outcomes Advancements in Conjugate Vaccines For Protecting Children Against Pneumococcal Disease Innovative Inactivated Poliovirus Vaccine Aids Polio Eradication Programs Key Mergers and Acquisitions SK bioscience Acquired IDT Biologika GlaxoSmithKline Public Limited Company Acquired Affinivax Inc Key Attributes: Report Attribute Details No. of Pages 286 Forecast Period 2023 - 2033 Estimated Market Value (USD) in 2023 $41.16 Billion Forecasted Market Value (USD) by 2033 $87.46 Billion Compound Annual Growth Rate 7.8% Regions Covered Global Key Topics Covered: 1. Executive Summary 1.1 Pediatric Vaccine - Market Attractiveness and Macro economic Landscape 2. Table of Contents 3. List of Tables 4. List of Figures 5. Report Structure 6. Market Characteristics 6.1 General Market Definition 6.2 Summary 6.3 Pediatric Vaccine Market Definition and Segmentations 6.4 Market Segmentation by Vaccine Type 6.4.1 Monovalent Vaccines 6.4.2 Multivalent Vaccines 6.5 Market Segmentation by Technology 6.5.1 Live Attenuated Vaccines 6.5.2 Inactivated Vaccines 6.5.3 Toxoid Vaccines 6.5.4 Conjugate Vaccines 6.5.5 Other Technologies 6.6 Market Segmentation by Application 6.6.1 Infectious Disease 6.6.2 Allergy 6.6.3 Cancer 6.6.4 Pneumococcal Disease 6.6.5 Influenza 6.6.6 Measles, Mumps and Rubella (MMR) 6.6.7 Other Applications Companies Featured Merck & Co.Inc. SANOFI S.A. Pfizer, Inc. Seqirus (CSL Limited) GlaxoSmithKline plc. Johnson & Johnson Daiichi Sankyo Co. Ltd. Novavax, Inc. AstraZeneca Plc. Novartis AG Maruho Co., Ltd. Indian Immunologicals Limited (IIL) Sinovac Biotech Ltd. Sinopharm Group Chongqing Zhifei Biological Products Co., Ltd. Walvax Biotechnology Co., Ltd. Hualan Biological Engineering Inc. Beijing Tiantan Biological Products Corp. Shenzhen Kangtai Biological Products Co., Ltd. GSK Sanofi Pasteur Moderna Eli Lilly's Taltz Baxter Corporation Laboratorios Silanes Instituto Pasteur Mexico Emergent BioSolutions Dynavax Technologies Corporation International Finance Corporation (IFC) Vaxart, Inc. Takeda Instituto Butantan Biofarma Laboratorio Pfeiffer Laboratorio Sao Paulo DP World Shifavaccine BioMedical Ltd. Lifera Arabio ediWound Ltd. Kocak Farma Abdi Ibrahim Julphar Gulf Pharmaceutical Industries Aspen Pharmacare Vacsera May & Baker Nigeria Plc. Evans Medical Plc. For more information about this report visit https://www.researchandmarkets.com/r/vkuk0c About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

VaccineAcquisition

23 Dec 2024

·www.fiercebiotech.com

Sanofi pays SK bioscience €50M as children\'s pneumococcal vaccine enters phase 3

The partnership between Sanofi and SK bioscience dates back to 2014, when the French pharma paid $23 million upfront to get the ball rolling on vaccine development.\n Sanofi is handing SK bioscience 50 million euros ($52 million) as the longtime partners take their next-gen pneumococcal conjugate vaccine program into phase 3.The move follows a phase 2 win last year for the candidate, a 21-valent pneumococcal conjugate vaccine previously called GBP410 and now renamed PCV21, which demonstrated comparable immunogenicity to a control vaccine.By including 21 serotypes, the partners aim to offer broader coverage than the current approved pneumococcal conjugate vaccines for children. Sanofi announced Monday morning that it has now launched the shot into a phase 3 study, making it the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter a late-stage study in infants and toddlers.Sanofi and SK will co-fund the research and development costs, with Sanofi also paying SK the 50 million euro upfront fee. An undisclosed amount of development and commercial milestone payments could follow. Should PCV21 make it to market, Sanofi will commercialize the vaccine worldwide, except for in SK’s home turf of South Korea.“Given the vast unmet public health needs in [invasive pneumococcal disease], we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV,” Thomas Triomphe, Sanofi\'s head of vaccines, said in the Dec. 23 release.“Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease,” Triomphe added. The partnership between Sanofi and SK dates back to 2014, when the French pharma paid $23 million upfront to get the ball rolling on vaccine development.There are currently two FDA-approved pneumococcal vaccines for children—Merck & Co.’s 15-valent Vaxneuvance and Pfizer’s 20-valent Prevnar 20.Sanofi isn’t the only Big Pharma hoping to expand the range of serotypes available in pneumococcal vaccines. GSK had been working on a 24-valent candidate acquired via its $2.1 billion acquisition of Affinivax but revealed in October that it had axed the asset. In June, Merck’s 21-valent Capvaxive became the first pneumococcal vaccine specifically designed for adults to receive FDA approval.Then, in September, Vaxcyte unveiled what analysts called “stunning” phase 1/2 data in adults for its 31-valent candidate that, if replicated in a large pivotal study, could pose a serious threat to Prevnar 20. A separate phase 2 trial of Vaxcyte’s shot in infants has recently launched.

$Sanofi pays SK bioscience €50M as children\'s pneumococcal vaccine enters phase 3$

Phase 2Phase 3VaccineAcquisitionClinical Result

100 Deals associated with Affinivax, Inc.

100 Translational Medicine associated with Affinivax, Inc.

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Drug(Targets)	Indications	Global Highest Phase

ASP-1004	Klebsiella Infections More	Preclinical
SARS-CoV-2 MAPS vaccine(Affinivax) ( SARS-CoV-2 S protein )	COVID-19 More	Preclinical
Streptococcus pneumoniae vaccine (Affinivax)	Streptococcal Infections More	Pending

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