A Phase 1a Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study Assessing Safety and Immunogenicity of Px563L and RPA563 Administered by Intramuscular Injection in Healthy Adult Volunteers

The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.

Start Date01 Dec 2015

Sponsor / Collaborator

Pelican Inc

[+1]

100 Clinical Results associated with Recombinant protective antigen vaccines(Pfenex, Inc.)

100 Translational Medicine associated with Recombinant protective antigen vaccines(Pfenex, Inc.)

100 Patents (Medical) associated with Recombinant protective antigen vaccines(Pfenex, Inc.)

124

Literatures (Medical) associated with Recombinant protective antigen vaccines(Pfenex, Inc.)

01 Jun 2024·Advanced Healthcare Materials

Self‐Generating Gold Nanocatalysts in Autologous Tumor Cells for Targeted Catalytic Immunotherapy

Article

Author: Liu, Zhiyong ; Luan, Xiaowei ; Yang, Jingjing ; Qin, Shurong ; Zeng, Fei ; Liu, Yuta ; Lu, Qianglan ; Song, Yujun ; He, Bangshun ; Pan, Yongchun

AbstractEmploying tumor whole cells for tumor immunotherapy is a promising tumor therapy proposed in the early stage, but its therapeutic efficacy is weakened by the methods of eliminating pathogenicity and the mass ratio of the effective antigen carried by itself. Here, by adding gold ion to live cancer cells in the microfluidic droplets, this work obtains dead tumor whole cells with NIR‐controlled catalytic ability whose pathogenicity is removed while plenary tumor antigens, major structure, and homing ability are reserved. The engineered tumor cell (Cell‐Au) with the addition of prodrug provides 1O2 in an O2‐free Russell mechanism, which serves better in a hypoxic tumor microenvironment. This tumor whole‐cell catalytic vaccine (TWCV) promotes the activation of dendritic cells and the transformation of macrophages into tumor suppressor phenotype. In 4T1 tumor‐bearing mice, the Cell‐Au‐based vaccine supports the polarization of cytotoxicity T cells, resulting in tumor eradication and long‐term animal survival. Compared with antigen vaccines or adoptive cell therapy which takes months to obtain, this TWCV can be prepared in just a few days with satisfactory immune activation and tumor therapeutic efficacy, which provides an alternative way for the preparation of personalized tumor vaccines across tumor types and gives immunotherapy a new path.

01 May 2024·Carbohydrate Polymers

The immunogenicity of p24 protein from HIV-1 virus is strongly supported and modulated by coupling with liposomes and mannan

Article

Author: Turánek Knötigová, P ; Raška, M ; Ledvina, M ; Zachová, K ; Sloupenská, K ; Paulovičová, E ; Effenberg, R ; Odehnalová, N ; Vaškovicová, N ; Bartheldyová, E ; Hromádka, R ; Křupka, M ; Turánek, J ; Hubatka, F

Anti-viral and anti-tumor vaccines aim to induce cytotoxic CD8+ T cells (CTL) and antibodies. Conserved protein antigens, such as p24 from human immunodeficiency virus, represent promising component for elicitation CTLs, nevertheless with suboptimal immunogenicity, if formulated as recombinant protein. To enhance immunogenicity and CTL response, recombinant proteins may be targeted to dendritic cells (DC) for cross presentation on MHCI, where mannose receptor and/or other lectin receptors could play an important role. Here, we constructed liposomal carrier-based vaccine composed of recombinant p24 antigen bound by metallochelating linkage onto surface of nanoliposomes with surface mannans coupled by aminooxy ligation. Generated mannosylated proteonanoliposomes were analyzed by dynamic light scattering, isothermal titration, and electron microscopy. Using murine DC line MutuDC and murine bone marrow derived DC (BMDC) we evaluated their immunogenicity and immunomodulatory activity. We show that p24 mannosylated proteonanoliposomes activate DC for enhanced MHCI, MHCII and CD40, CD80, and CD86 surface expression both on MutuDC and BMDC. p24 mannosylated liposomes were internalized by MutuDC with p24 intracellular localization within 1 to 3 h. The combination of metallochelating and aminooxy ligation could be used simultaneously to generate nanoliposomal adjuvanted recombinant protein-based vaccines versatile for combination of recombinant antigens relevant for antibody and CTL elicitation.

01 Feb 2024·International Journal of Biological Macromolecules

Biophysical and biochemical characterization of a recombinant Lyme disease vaccine antigen, CspZ-YA

Article

Author: Lee, Jungsoon ; Chen, Yi-Lin ; Strych, Ulrich ; Lin, Yi-Pin ; Bottazzi, Maria Elena ; Chen, Wen-Hsiang ; Liu, Zhuyun

Lyme disease, caused by Lyme Borrelia spirochetes, is the most common vector-borne illness in the United States. Despite its global significance, with an estimated 14.5 % seroprevalence, there is currently no licensed vaccine. Previously, we demonstrated that CspZ-YA protein conferred protection against Lyme Borrelia infection, making it a promising vaccine candidate. However, such a protein was tagged with hexahistidine, and thus not preferred for vaccine development; furthermore, the formulation to stabilize the protein was understudied. In this work, we developed a two-step purification process for tag-free E. coli-expressed recombinant CspZ-YA. We further utilized various bioassays to analyze the protein and determine the suitable buffer system for long-term storage and formulation as a vaccine immunogen. The results indicated that a buffer with a pH between 6.5 and 8.5 stabilized CspZ-YA by reducing its surface hydrophobicity and colloidal interactions. Additionally, low pH values induced a change in local spatial conformation and resulted in a decrease in α-helix content. Lastly, an optimal salinity of 22-400 mM at pH 7.5 was found to be important for its stability. Collectively, this study provides a fundamental biochemical and biophysical understanding and insights into the ideal stabilizing conditions to produce CspZ-YA recombinant protein for use in vaccine formulation and development.

News (Medical) associated with Recombinant protective antigen vaccines(Pfenex, Inc.)

22 Jun 2023

·www.prnewswire.com

Global Cancer Diagnostics Partnering Deal Terms and and Agreement Analysis Report 2023: Access to Over 900 - Access to Company A-Z, Headline, Upfront, Milestone, Upfront and Royalty Data

DUBLIN, June 22, 2023 /PRNewswire/ -- The "Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023" report has been added to ResearchAndMarkets.com's offering. The Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023 report provides an understanding and access to over 900 cancer diagnostics partnering deals and agreements entered into by the worlds leading healthcare companies. This report provides details of the latest cancer diagnostics agreements announced in the life sciences since 2016. The report takes the reader through a comprehensive review cancer diagnostics deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering cancer diagnostics partnering deals. The report presents financial deal term values for cancer diagnostics deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals. The middle section of the report explores the leading dealmakers in the cancer diagnostics partnering field; both the leading deal values and most active cancer diagnostics dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market. One of the key highlights of the report is that over 900 online deal records of actual cancer diagnostics deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. The initial chapters of this report provide an orientation of cancer diagnostics dealmaking. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in cancer diagnostics dealmaking since 2016, including details of headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading cancer diagnostics deals since 2016. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in cancer diagnostics dealmaking with a brief summary followed by a comprehensive listing of cancer diagnostics deals announced by that company, as well as contract documents, where available. Chapter 5 provides a comprehensive and detailed review of cancer diagnostics partnering deals signed and announced since Jan 2016, where a contract document is available in the public domain. Each deal title links via Weblink to an online version of the deal record and contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of cancer diagnostics partnering deals signed and announced since Jan 2016. The chapter is organized by specific cancer diagnostics technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. A comprehensive series of appendices is provided organized by cancer diagnostics partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of cancer diagnostics technologies and products. Key benefits Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023 provides the reader with the following key benefits: In-depth understanding of cancer diagnostics deal trends since 2016 Access to headline, upfront, milestone and royalty data Detailed access to actual cancer diagnostics contracts entered into by leading biopharma companies Identify most active cancer diagnostics dealmakers since 2016 Insight into terms included in a cancer diagnostics partnering agreement, with real world examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies In Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023, the available deals are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Technology type Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Partial list of companies featured Aetna Amgen Angle Axela Bayer BL&H Ceres COTA CSIRO Cypre D-Eye Dako Dell Eigen Falco Fscan GIMDx Glide Grail IBM iCAD IPMD Item KEW Lab21 Mavig Medx MIODx NASA Ochin Orot+ RAW Roche Sebia Seer TaiRx Take2 Telik UPMC ZoBio For more information about this report visit 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. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

16 Feb 2023

·www.biospace.com

Lumendi Receives 510(k) Clearance for Two New Devices

Company Achieves New Milestone with Over 4,000 Therapeutic Procedures Completed Across the U.S., Europe and Asia, Using DiLumen™ Endoluminal Interventional Platform WESTPORT, Conn.--(BUSINESS WIRE)-- Connecticut-based medical device innovator Lumendi, LLC today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new, more cost-effective design, based on the long-standing success of the DiLumen EZ-Glide platform, has been modified and streamlined. This press release features multimedia. View the full release here: Lumendi, LLC., All Rights Reserved. ©2023 “The DiLumen EZ¹ device will meaningfully enhance our product portfolio by meeting more procedure specific needs for complex polyp resections which are conducted through EMR. Globally, EMR procedures represent the majority share of the over one million polyp resections conducted, annually,” said Dr. Peter Johann, Chief Executive Officer of Lumendi, Ltd. The company also announced that it simultaneously received FDA 510(k) clearance of a second device, the DiLumen C¹, which is designed to facilitate complex polyp resection in the colon and rectum via endoscopic submucosal dissection (ESD). C¹’s design offers a single working channel that accommodates an atraumatic grasper, providing more direct tissue manipulation and traction. Use of the C¹ and grasper helps improve curative removal of precancerous and non-invasive cancerous polyps during ESD. Following several years of feedback from leading clinicians, Lumendi believes that inadequate stability, tissue manipulation and traction, combined with ineffective cutting, dissecting and cauterizing, continues to be a major challenge for many therapeutic procedures in the digestive tract. With DiLumen, DiLumen EZ1 and DiLumen C1, Lumendi now offers a complete set of devices to perform any kind of complex polypectomy and potential other interventions in the entire colon. ”Since 2017, clinicians in the U.S., EU, the UK and Asia, have completed over 4,000 procedures with the commercially available DiLumen EZ Glide. These newest devices, when combined with the increasing market adoption of DiLumen EZ Glide, will accelerate Lumendi’s continued vision to shift procedures away from invasive gastrointestinal surgeries, towards endoluminal procedures with lower complication rates, little to no hospital stays and very minimal recovery times,” added Dr. Johann. “In addition, based on our success impacting therapeutic procedures in the colon and using our current technology, we will look to expand our development program into upper GI interventions, which we expect will lead to better patient outcomes.” The DiLumen EZ¹ and C¹ are part of a growing platform of accessories that work in conjunction with endoscopes and gastroscopes used in the large intestine, which assist with navigational access, optical visualization, diagnosis and endotherapeutic treatment. About Lumendi, LLC (Lumendi) Headquartered in Westport, Connecticut, Lumendi, LLC, is a wholly owned subsidiary of Lumendi Ltd., a privately held, innovative medical device company based in Maidenhead, UK. Lumendi focuses on developing, marketing and distributing surgical tools and devices that provide safe, cost-effective solutions for minimally invasive gastrointestinal interventions. Follow us on YouTube Lumendi YouTube Twitter Lumendi USA

Drug Approval

17 Jan 2023

·www.businesswire.com

Swiss American CDMO Sliding into a “Frictionless Future” with LiquiGlide Agreement

DALLAS--( BUSINESS WIRE )-- Swiss American CDMO (Contract Development and Manufacturing Organization), a Dallas-based medical device and drug product manufacturer specializing in topical skin care products, announces its new agreement with LiquiGlide, the inventors of the EveryDrop™ dispensing platform, a breakthrough non-toxic slippery surface technology that eliminates the friction between solids and liquids, resulting in zero product waste for consumer packaged goods. With this agreement, Swiss-American is the first CDMO offering LiquiGlide’s technology to the global skin care market. The technology is made from materials classified as safe by the FDA, meets rigorous safety and regulatory standards, and has been commercially launched in Europe, North America and Asia in other packaged goods categories. “Swiss-American brings continuous innovation to our clients, resulting in breakthrough skin and sun care formulations and new pathways in production and packaging. We are excited to bring this technology to the skin care market and are ready to leverage our quality and product safety standards to ensure successful and compliant product launches,” said Komel Grover, president and CEO of Swiss American CDMO. “If a consumer spends $20 for a lotion, they should get $20 worth from the bottle. Another great benefit is the remaining packaging is better prepared for recycling in a more sustainable manner.” “We are thrilled to work with a leading manufacturing firm like Swiss-American CDMO that is as rigorous about quality, safety and compliance as we are,” said Daniel Rippy, CEO of LiquiGlide. “In addition, beyond the significant sustainability advantages of the technology, the EveryDrop dispensing platform is a tool for product developers to reimagine products and packaging to create new user experiences and differentiate from competitors. We are excited to partner with Swiss American CDMO to offer products that are better for brands, consumers and the planet.” LiquiGlide’s research indicates that, world-wide, more than 50 billion packages sold every year will be discarded with enough product remaining inside to fill 110,000 semi-trucks. But with LiquiGlide, because all product is evacuated, the package is more acceptable to recycling centers. Swiss-American will leverage global skin care expertise, in close partnership with LiquiGlide, to introduce this win-win solution. “This agreement with LiquiGlide is a testament to our focus on bringing groundbreaking technology and innovation to our clients and their consumers,” Grover said. “We look forward to 2023 and what this new technology will enable our team of scientists to achieve, when coupled with our flexible, lean manufacturing and strong partnerships.” About Swiss American CDMO Swiss American CDMO (Contract Development and Manufacturing Organization) delivers breakthrough innovation and superior manufacturing of topical solutions to global skin companies and personal care products including cosmetic, OTC drug and medical device regulatory pathways. For over 30 years, Dallas-based Swiss-American has helped build popular brands using a unique blend of marketplace insight, scientific formulation and quality-driven, lean manufacturing expertise. www.sacdmo.com About LiquiGlide LiquiGlide’s revolutionary technology eliminates the friction between liquids and solids to allow liquids to flow with ease. Invented at MIT by Dave Smith and Professor Kripa Varanasi, LiquiGlide’s technology eliminates a fundamental design constraint and enables real, powerful breakthroughs across industries, transforming the way we manufacture package, and consume viscous products. LiquiGlide also improves quality of life and patient care by enabling medical devices that can reduce the risk of occlusion and infection as well as improve the delivery of highly viscous drugs and biologics. To learn more, visit https://liquiglide.com/ .

100 Deals associated with Recombinant protective antigen vaccines(Pfenex, Inc.)

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