News – Page 10 – Sanaria

Attenuated PfSPZ Vaccine induces strain-transcending T cells and durable protection against heterologous controlled human malaria infection

January 19, 2017 By Alexander Hoffman In Publications No Comments

Abstract

A live-attenuated malaria vaccine, Plasmodium falciparum sporozoite vaccine (PfSPZ Vaccine), confers sterile protection against controlled human malaria infection (CHMI) with Plasmodium falciparum (Pf) parasites homologous to the vaccine strain up to 14 mo after final vaccination. No injectable malaria vaccine has demonstrated long-term protection against CHMI using Pf parasites heterologous to the vaccine strain. Here, we conducted an open-label trial with PfSPZ Vaccine at a dose of 9.0 × 105 PfSPZ administered i.v. three times at 8-wk intervals to 15 malaria-naive adults. After CHMI with homologous Pf parasites 19 wk after final immunization, nine (64%) of 14 (95%CI, 35–87%) |

Sanaria’s PfSPZ Vaccine Provides High-Level Defense Against Malaria In U.S. Navy and Army Clinical Investigation

January 12, 2017 By Matt Feldman In Press Releases No Comments

Sanaria Inc. continues to achieve success in its coordinated efforts to develop a safe, effective and affordable vaccine that delivers mass malaria protection in humans and promotes elimination of the disease worldwide. Research published today in JCI Insight by a team of clinical investigators at the Naval Medical Research Center and Walter Reed Army Institute of Research reports that Sanaria® PfSPZ Vaccine protected against Plasmodium falciparum malaria when clinical trial participants were exposed to two strains of parasites.

Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation

September 22, 2016 By Matt Feldman In Press Releases No Comments

Sanaria Inc. today announced it has received U.S. Food and Drug Administration (FDA) Fast Track designation for its preventative vaccine for malaria, Sanaria® PfSPZ Vaccine. Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction.

African Trials Moving Ahead with Great Success

September 20, 2016 By Matt Feldman In News No Comments

Our vaccine is currently being tested for safety, tolerability and efficacy in Mali (West Africa) and Tanzania (East Africa).

Sanaria’s Dr. Stephen L. Hoffman won the Daily Record’s Innovator of the Year Award

August 26, 2016 By Matt Feldman In Awards No Comments

Check out more from the Innovator of the Year awards.|

Rationale and plans for developing a non-replicating, metabolically active, radiation-attenuated Plasmodium falciparum sporozoite vaccine.

August 26, 2016 By Matt Feldman In Publications No Comments

Annually, malaria causes >300 million clinical cases and 1 million deaths, is responsible for the loss of >1% of gross domestic product (GDP) in Africa and is a serious concern for travelers. An effective vaccine could have a dramatic impact on the disease. For 20 years, scientists have tried to develop modern, recombinant 'subunit' malaria vaccines. This has been difficult. In fact, there is only one recombinant protein vaccine on the market for any disease, and no vaccines based on synthetic peptides, recombinant viruses, recombinant bacteria or DNA plasmids.

In memoriam: Donald ‘DA’ Henderson

August 22, 2016 By Matt Feldman In News No Comments

Sanaria joins the international public health community in remembering Donald 'DA' Henderson after his death on August 19, 2016. Sanaria was honored to receive a visit from DA in June 2011, where after describing his relentless dedication to the eradication of Smallpox, he offered insights, advice and encouragement to Sanaria at what was a critical time in our PfSPZ Vaccine clinical development program.

Weill Cornell Alumni Association Honors Dr. Stephen Hoffman

May 26, 2016 By Matt Feldman In News No Comments

This year, Dr. Stephen Hoffman, M.D. ’75 was awarded the Weill Cornell Medicine Alumni Association Award of Distinction for his significant accomplishments as a physician, scientist and entrepreneur. Watch:

Protection against malaria at 1 year and immune correlates following PfSPZ vaccination

May 18, 2016 By Matt Feldman In Publications No Comments

In its latest issue, Nature Medicine published Sanaria's paper about the findings at 1 year post-PfSPZ vaccination. An attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) vaccine, PfSPZ Vaccine, is highly protective against controlled human malaria infection (CHMI) 3 weeks after immunization, but the durability of protection is unknown. We assessed how vaccine dosage, regimen, and route of administration affected durable protection in malaria-naive adults.

Could This Be the First Malaria Vaccine?

May 9, 2016 By Matt Feldman In In The Media, Publications No Comments

US News & World Report features a story on Sanaria's new finding that our experimental vaccine against malaria has provided protection for some against the illness for more than a year.

Sanaria’s Malaria Vaccine Yields Unprecedented Protection In Clinical Trial

May 6, 2016 By Matt Feldman In Press Releases No Comments

Results of a clinical trial of Sanaria® PfSPZ (Plasmodium falciparum sporozoite) Vaccine to prevent malaria infections, published today in the online issue of Nature Medicine magazine, show that the vaccine provided protection against infection with malaria parasites for at least 14 months in subjects who were exposed to Plasmodium falciparum parasites. The findings put the Sanaria vaccine on track to be the first malaria vaccine providing durable protection against infection with malaria parasites. Plasmodium falciparum is the malaria parasite that causes about 438,000 deaths and 214 million cases annually.

Sanaria Earns ‘Bioscience Company Of The Year’ Award

July 1, 2015 By Matt Feldman In Awards, News No Comments

The Montgomery County Small Business Awards were announced June 24 and the winner of the "Bioscience Company of the Year" is Sanaria, Inc.

Government Of Equatorial Guinea And Oil Companies Agree To $48.5 Million Funding Of Malaria Vaccine Development Program With Sanaria Inc.

June 29, 2015 By Matt Feldman In Press Releases No Comments

The Government of the Republic of Equatorial Guinea announced an agreement with industry partners, Marathon Oil Corporation, Noble Energy Inc. and AMPCO, to sponsor the clinical development of Sanaria® PfSPZ Vaccine against malaria, including a series of clinical trials from 2015 until 2018.

Dr. Stephen L. Hoffman wins 2015 CEO of the year at the World Vaccine Congress, Vaccine Industry Excellence Awards

May 19, 2015 By Matt Feldman In Awards, News No Comments

Announced at the award ceremony during the 15th World Vaccine Congress, the 8th Vaccine Industry Excellence (ViE) Awards recognise those who have done outstanding work in the field, honour those who have made significant contributions to the development of the sector, and celebrate the great achievements made in the world of vaccines in the last year.

Sanaria’s Executive VP of Manufacturing and Process Development, Dr. B. Kim Lee Sim, featured in Malaymail

April 12, 2015 By Matt Feldman In In The Media No Comments

At a recent photoshoot by legendary photographer Annie Leibovitz of prominent scientists honoured by the Bill & Melinda Gates Foundation, one woman stood out from the rest. Dr Betty Sim Kim Lee is the president and leading researcher of an organisation working on the development of vaccines for infectious diseases. She is also a Malaysian, a proud Nyonya born and bred in Kota Bharu. So, how did this small town girl become one of the most important malaria fighters in the world today?

Direct venous inoculation of Plasmodium falciparum sporozoites for controlled human malaria infection: a dose-finding trial in two centres

March 18, 2015 By Matt Feldman In Publications No Comments

In the latest edition of Malaria Journal, Mordmüller et al. report on their findings. Their conclusions: IV inoculation of PfSPZ is safe, well tolerated and highly reproducible. It shall further accelerate development of anti-malarial interventions through standardization and facilitation of CHMI. Beyond this, rational dose selection for whole PfSPZ-based immunization and complex study designs are now possible.

Cryoport and Sanaria Expand Logistics Partnership Supporting Malaria Vaccines distributed in Liquid Nitrogen Vapor Phase;

February 23, 2015 By Matt Feldman In Press Releases No Comments

Cryoport, Inc., the leading provider of advanced cryogenic logistics solutions for the life sciences industry, serving markets including immunotherapies, stem cells, cell lines, clinical research organizations, vaccine manufacturers and reproductive medicine, today announced that the Company is enhancing its cryogenic logistics support of its Sanaria partnership, which includes Sanaria’s production of malaria vaccine as well as its research and development efforts.

Sanaria recognized as a NIH SBIR/STTR Notable Success

November 12, 2014 By Matt Feldman In News No Comments

“NIH SBIR funding provided Sanaria with critical early-stage dollars to get our lead vaccine off the ground. Without this funding, Sanaria would have never gotten started and our malaria vaccine would not exist. No other investor would have provided money for this type of high-risk research.”

– Dr. Steve Hoffman, CEO of Sanaria

Read the full NIH SBIR story!|

First controlled human malaria infection in Africa shows that PfSPZ Challenge can be used for drug and vaccine development in the field

July 28, 2014 By Matt Feldman In News No Comments

The innovative PfSPZ Challenge is key to success for speedier testing of new malaria vaccine and drugs.

Explainer: GSK submits to EMA; Sanaria takes different approach

July 24, 2014 By Matt Feldman In In The Media No Comments

GSK submitted a regulatory application to the European Medicines Agency for its malaria vaccine candidate, RTS,S. Sanaria and GSK's different approaches are explained in this Wall Street Journal article.

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