A Phase 2, open-label, single-center, extension study to evaluate the booster response induced by Vi-CRM197 after priming with either Vi-CRM197 or Typherix administered in adult subjects in H01_04TP study

Start Date12 Sep 2011

Sponsor / Collaborator-

JPRN-jRCT2080221374 / Unknown statusPhase 2

A Phase IIa, Multicenter, Treatment Assigned, Open-Label, Long-Term Extension Study To Determine Safety, Tolerability And Immunogenicity Of ACC-001 With QS-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease(B2571001)

Start Date02 Feb 2011

Sponsor / Collaborator

Pfizer Japan, Inc.

NCT01227564 / CompletedPhase 2

A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.

This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Start Date01 Feb 2011

Sponsor / Collaborator

Pfizer Inc.

[+1]

100 Clinical Results associated with Vanutide cridificar

100 Translational Medicine associated with Vanutide cridificar

100 Patents (Medical) associated with Vanutide cridificar

440

Literatures (Medical) associated with Vanutide cridificar

02 Dec 2024·ANGEWANDTE CHEMIE-INTERNATIONAL EDITION

Non‐Natural MUC1 Glycopeptide Homogeneous Cancer Vaccine with Enhanced Immunogenicity and Therapeutic Activity

Article

Author: Bernardes, Gonçalo J. L. ; Lazaris, Foivos S. ; Guerreiro, Ana ; Labão‐Almeida, Carlos ; Ghirardello, Mattia ; Oroz, Paula ; Compañón, Ismael ; Corzana, Francisco ; Marques, Marta C.

Abstract:

Glycopeptides derived from the glycoprotein mucin‐1 (MUC1) have shown potential as tumor‐associated antigens for cancer vaccine development. However, their low immunogenicity and non‐selective conjugation to carriers present significant challenges for the clinical efficacy of MUC1‐based vaccines. Here, we introduce a novel vaccine candidate based on a structure‐guided design of an artificial antigen derived from MUC1 glycopeptide. This engineered antigen contains two non‐natural amino acids and has an α‐S‐glycosidic bond, where sulfur replaces the conventional oxygen atom linking the peptide backbone to the sugar N‐acetylgalactosamine. The glycopeptide is then specifically conjugated to the immunogenic protein carrier CRM197 (Cross‐Reactive Material 197), a protein approved for human use. Conjugation involves selective reduction and re‐bridging of a disulfide in CRM197, allowing the attachment of a single copy of MUC1. This strategy results in a chemically defined vaccine while maintaining both the structural integrity and immunogenicity of the protein carrier. The vaccine elicits a robust Th1‐like immune response in mice and generates antibodies capable of recognizing human cancer cells expressing tumor‐associated MUC1. When tested in mouse models of colon adenocarcinoma and pancreatic cancer, the vaccine is effective both as a prophylactic and therapeutic use, significantly delaying tumor growth. In therapeutic applications, improved outcomes were observed when the vaccine was combined with an anti‐programmed cell death protein 1 (anti‐PD‐1) checkpoint inhibitor. Our strategy reduces batch‐to‐batch variability and enhances both immunogenicity and therapeutic potential. This site‐specific approach disputes a prevailing dogma where glycoconjugate vaccines require multivalent display of antigens.

01 Dec 2024·APPLIED MICROBIOLOGY AND BIOTECHNOLOGY

Structure-guided design and evaluation of CRM197-scaffolded vaccine targeting GnRH for animal immunocastration

Article

Author: Li, Mengge ; Tang, Shiyu ; Weng, Jiachen ; Yao, Wenrong ; Duan, Yurong ; Zhao, Junjie ; Li, Wenjie ; Wei, Zhun ; tang, Shiyu ; Liu, Sha ; Tang, Xiaowen ; Cui, Weiwei

Immunocastration is a humane alternative to surgical castration for controlling population and estrous behaviors in animals. Gonadotropin-releasing hormone (GnRH), the pivotal initiating hormone of the hormonal cascade in mammals, is the optimal target for immunocastration vaccine development. Cognate antigen-mediated cross-linking of B cell receptors (BCRs) is a strong activation signal for B cells and is facilitated by repetitive surface organizations of antigens. In this study, we describe the structure-guided design of highly immunogenic chimeric proteins with variant numbers of GnRH peptide insertion by epitope grafting. Linear B-cell epitopes of cross-reacting material 197 (CRM197) were replaced with multiple copies of GnRH peptide, and the inserts were displayed on the surface of the designs while maintaining the overall folding of CRM197. Among the seven designs, TCG13, which carries 13 copies of GnRH peptide, was the most immunogenic, and its immunocastration efficacy was evaluated in male mice. Vaccination with the BFA03-adjuvanted TCG13 induced potent humoral immunity and reduced the serum testosterone concentration in mice. It could significantly decrease sperm quality and severely impair gonadal function and fertility. These results demonstrate that CRM197 holds great value as a scaffold for epitope presentation in peptide-based vaccine development and supports TCG13 as a promising vaccine candidate for animal immunocastration. KEY POINTS: • Provide a feasible way to design chimeric immunogen targeting GnRH by epitope grafting. • CRM197 can accommodate the insertion of multiple copies of heterologous epitope peptides. • Administration with the most immunogenic design led to effective immunocastration in male mice.

01 Nov 2024·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

CRM197-scaffolded vaccines designed by epitope grafting ameliorate cognitive decline in an Alzheimer's disease model

Article

Author: Wang, Ying ; Liu, Sha ; Bao, Jinli ; Cui, Weiwei ; Li, Wenjie ; Wei, Zhun ; Duan, Yurong ; Gu, Tiantian ; Tang, Xiaowen ; Mao, Junyuan

Alzheimer's disease (AD) is the leading cause of dementia in the elderly. Amyloid-beta (Aβ) plaque accumulation and tau neurofibrillary tangles (NFTs) formation in the brain are major neuropathological hallmarks of AD. Immunotherapies targeting Aβ and/or tau are deemed the most promising approaches for AD. Administrations with monoclonal antibodies against Aβ have yielded substantial breakthroughs clinically. Most vaccines tested clinically so far failed to prove efficacious in large part due to inappropriate design of vaccine antigens. In this study, a structure-guided approach was employed to design novel antigens targeting Aβ and/or tau by grafting multiple copies of Aβ and/or tau B-cell epitope peptide onto CRM₁₉₇, which is the most widely used carrier protein in polysaccharide conjugate vaccines. The immunogenicity of the vaccines was evaluated in BALB/c mice and the efficacy was tested in a transgenic mouse model of human amyloidopathy. The antigens were highly immunogenic early vaccination substantially ameliorated cognitive decline in APP/PS1 mice and significantly reduced insoluble Aβ_42/40 in the brains. These results demonstrate that the engineered antigens have protective effects on AD mice, offering a promising translatable strategy for the prevention and/or treatment of AD.

News (Medical) associated with Vanutide cridificar

08 Oct 2024

·www.prnewswire.com

Korea's SK bioscience Acquires Stake in U.S. Biotech Fina Biosolutions

SK bioscience invested USD 3 million in FinaBio, a U.S. company specializing in next-generation conjugate vaccine technology. With the agreement, SK bioscience expects to improve the immunogenicity and productivity of conjugate vaccines, including those for pneumoniae and typhoid. The company will accelerate its future growth strategies by exploring and investing in promising global companies. SEONGNAM, South Korea and ROCKVILLE, Md., Oct. 8, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the company has signed an agreement to acquire a stake in Fina Biosolutions (FinaBio), a promising R&D biotechnology company based in Rockville, Maryland, United States, by investing USD 3 million. With this acquisition, SK bioscience will become FinaBio's first and sole strategic investor. Continue Reading Korea’s SK bioscience Acquires Stake in U.S. Biotech Fina Biosolutions Founded in 2006, FinaBio specializes in the research and development of conjugate vaccines for pneumoniae, meningococcal, typhoid, and other diseases. Among other assets, FinaBio has developed FinaXpress, a proprietary E. coli expression system which they use for producing proteins not previously made in these bacteria, including many carrier proteins like CRM197. Marketed as EcoCRM®, FinaBio has expanded access to this critical protein. FinaBio is also developing a next-generation conjugation technology that is site-specific and targets the desired location for antigen binding, hence boosting immunogenicity and productivity. FinaBio collaborates with a number of global biotech companies and institutions, including The Serum Institute of India, The Chengdu Institute of Biology in China, and Inventprise in the U.S. to supply conjugation technology and carrier proteins, including CRM197. Leveraging its expertise in conjugation, the company will continue to grow its business units, including conjugate vaccine development services, reagents and technologies. SK bioscience, which already manufactures conjugate vaccines such as pneumococcal and typhoid vaccines, will actively utilize FinaBio's CRM197 technology. It aims to secure the high effectiveness of diverse conjugate vaccines while increasing profitability through high-yield processes. Dr. Andrew Lees, Founder and CEO of FinaBio, said, "We appreciate SK's confidence in Fina Biosolutions. The investment will accelerate the global commercialization of EcoCRM®(CRM197). Combined with our efficient conjugation technology, this will enable the development of the next generation conjugate vaccines. It will also allow us to continue our mission of promoting affordable vaccines." Jaeyong Ahn, CEO and President of SK bioscience, said, "We are delighted to continue developing partnerships with global firms that have next-generation vaccine technology. Through our mid- to long-term collaboration with FinaBio, we will advance the vaccines we are developing to the next level and strengthen our competitiveness for global market expansion." Recently, SK bioscience has been actively investing in global companies to create synergies in business. In June 2024, the company signed an agreement to acquire the controlling stake in a German company, IDT Biologika, one of the top 10 global vaccine contract manufacturers and completed the acquisition earlier this month. In July 2024, SK bioscience inked a Simple Agreement for Future Equity (SAFE) with Sunflower Therapeutics, a U.S. biotech company known for its own yeast-based protein manufacturing technology, which facilitates the development and production of diverse antigens and antibodies. SK bioscience continues to secure its competitiveness through strategic investments in promising companies with exceptional technology and M&As to lay the foundation for a great leap forward into a leading global company. About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin ([email protected]) Jeannie S. Pak ([email protected]) Fina Biosolutions Andrew Lees ([email protected]) SOURCE SK bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccineAcquisitionmRNA

17 Jun 2024

·www.prnewswire.com

Primrose Bio Announces Investment from 1315 Capital to Advance Manufacturing Solutions for Next-Generation Therapeutics

SAN DIEGO, June 17, 2024 /PRNewswire/ -- Primrose Bio, Inc. ("Primrose," the "Company"), a company focused on developing and licensing its manufacturing technologies for nucleic acids and proteins used in therapeutics and vaccines, announced a significant equity investment from 1315 Capital, a Philadelphia-based, healthcare-focused growth equity firm. These funds will enable the continued development and commercial expansion of its three major offerings: Prima RNApols™: proprietary RNA polymerase enzymes that significantly improve mRNA manufacturing by improving yields up to 5x, eliminating double-stranded RNA, and enhancing cap incorporation compared to the currently used T7 RNA polymerase standard. Pfenex Expression Technology®: a validated microbial expression system used in five approved drugs which consistently shows 10-20x higher yields over E.coli, CHO, and yeast-based systems as well as an unparalleled success rate in complex proteins. PeliCRM®: the only commercially available CRM197 conjugate vaccine carrier protein used in approved products. "We are thrilled to have the support of such a high-quality organization and team at 1315 Capital who share our vision of expanding opportunities in biomanufacturing technologies for the pharmaceutical industry," said Dr. Helge Zieler, CEO of Primrose. "With this investment, we are well-positioned to advance our therapeutic protein and nucleic acid manufacturing solutions with our existing large-pharma collaborators and future partners." "There has been a tremendous amount of innovation in therapeutics over the last decades, and relatively little in their production systems. Primrose's validated technology platforms address an increasingly important challenge facing the industry as drugs get more complex, and pricing pressure continues to mount," said Matt Reber, Partner at 1315 Capital. "We are excited to partner with Primrose as they continue to expand their commercial reach with their suite of proprietary technologies." About Primrose Bio, Inc. Primrose Bio was formed in 2023 through the merger of Primordial Genetics, Inc. and Pfenex to create an integrated end-to-end technology platform for solving complex drug manufacturing and design challenges. Primrose major offerings include Prima RNApols: improved enzymes for mRNA manufacturing, Pfenex Expression Technology: a validated production system with up to 20x higher yields over other systems and an unparalleled success rate in making complex proteins, and PeliCRM197: the only commercially available CRM197 conjugate vaccine carrier protein used in approved products. Several of the world's leading pharmaceutical companies use Primrose Bio's technology, including Merck, Jazz Pharmaceuticals, Alvogen, Serum Institute of India, Arcellx, Arcturus and others. For more information, please visit . About 1315 Capital 1315 Capital is a private investment firm with over $1 billion of assets under management that provides growth capital to commercial-stage healthcare services, pharmaceutical & medical technology outsourcing, medical technology, and health & wellness companies. 1315 Capital targets both minority and majority investments in companies where high-quality management teams can rapidly scale platform companies into large and important businesses that positively impact patients, physicians, and the broader healthcare system. For more information, please visit . SOURCE Primrose Bio

VaccinemRNAsiRNA

03 Apr 2024

·www.sciencedaily.com

Developing a vaccine for the 'zombie drug' xylazine

Chemical biologists design an early 'proof-of-concept' vaccine that could lead to the first effective treatment of xylazine overdose in people. Xylazine is an FDA-approved sedative and pain reliever for use in animals, but it has severe adverse effects when used in humans. It is now illicitly being added to opioids, like fentanyl and heroin, as well as cocaine -- leading to a sharp rise in overdose deaths. Now, Scripps Research chemical biologists have developed a vaccine to block the effects of xylazine's toxicity. The vaccine works by training the immune system to attack the drug, which is described in a new paper published in Chemical Communications on April 1, 2024. "We demonstrated that a vaccine can reverse the symptoms of a xylazine overdose in rodents," says study senior author Kim D. Janda, PhD, the Ely R. Callaway, Jr. Professor of Chemistry at Scripps Research. "There is currently no remedy for xylazine poisoning other than supportive care, thus, we believe our research efforts and the data we have provided will pave the way for an effective treatment in humans." The rapid increase in lethal drug overdoses attributed to xylazine combined with fentanyl prompted the White House Office of National Drug Control Policy to declare this combination an emerging threat to the United States. Xylazine intoxication presents similarly to opioid overdose, causing respiratory and central nervous system depression, and it can heighten the effects of opioids. However, naloxone -- typically administered to reverse the effects of opioids -- does not tackle the impact of xylazine, highlighting the need for effective measures to treat acute toxicity caused by xylazine. Researchers suspect xylazine works by reducing blood flow to the brain, among other areas of the body. The drug also causes non-healing skin lesions and wounds, often located on the forearms and lower legs, that can require amputation in some cases -- giving it the nickname "zombie drug." Although no treatment currently exists, targeted vaccines may offer a solution. Vaccines nudge the immune system to create antibodies to fend off invaders. Antibodies can target viruses, bacteria and toxins. However, sometimes molecules are too small to initiate an immune response, as is the case with xylazine. So, to circumvent this problem, the researchers created a vaccine using a design principle that Janda pioneered, which relies on pairing the drug molecule (called a hapten) with a larger carrier molecule (a protein) and an adjuvant. In this study, the scientists combined a xylazine hapten with multiple different protein types, to see which combination would create a robust immune response against xylazine. The team tested three vaccine formulations (termed TT, KLH and CRM197, based on the protein involved) to see which vaccine cocktail could help rodents after being challenged with xylazine. One of the three vaccines (TT) significantly increased movement in mice given xylazine after 10 minutes, while two of the three vaccines (TT and KLH) led to an improvement in breathing. The scientists also examined how these vaccines would limit xylazine blood brain barrier, (BBB) permeation, a filtering mechanism that scrutinizes drug penetration. When xylazine was injected, it immediately crossed into the brain to bind with receptors. Antibodies typically cannot navigate the BBB; however, two of the three vaccines (TT and KLH) showed a strong ability to stop xylazine from reaching its receptors in the brain, limiting its detrimental effects. A provisional patent has been filed on the research. In the future, his team will build off this work to create a bifunctional antibody that will reverse both fentanyl and xylazine's toxicity simultaneously, something that naloxone cannot do. "A monoclonal antibody treatment could be given in tandem with the vaccine to provide both immediate and long-term protection from both opioid substance use disorders as well as opioid-xylazine overdoses," says Janda. "This strategy could make a significant impact on the opioid epidemic." "Evaluation of a Hapten Conjugate Vaccine Against the 'Zombie Drug' Xylazine" was co-authored by Mingliang Lin, Lisa M. Eubanks, Bin Zhou, and Kim D. Janda, all of Scripps Research. Funding for the study was provided by the Shadek family and Pearson Foundation.

Vaccine

100 Deals associated with Vanutide cridificar

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 2	FR	Pfizer Inc.	01 May 2007
Alzheimer Disease	Phase 2	FR	Janssen Alzheimer Immunotherapy Research & Development LLC	01 May 2007
Alzheimer Disease	Phase 2	DE	Janssen Alzheimer Immunotherapy Research & Development LLC	01 May 2007
Alzheimer Disease	Phase 2	DE	Pfizer Inc.	01 May 2007
Alzheimer Disease	Phase 2	ES	Pfizer Inc.	01 May 2007
Alzheimer Disease	Phase 2	ES	Janssen Alzheimer Immunotherapy Research & Development LLC	01 May 2007

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00959192 (CTgov)	Phase 2	Alzheimer Disease	32	QS-21	efefpnheob(yvhfhxgzqw) = canlfrdpfu jebfujkayk (swgcroinls, cdhinpofxm - bzsdgwzvhn) View more	-	01 Jan 2016

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