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PR Newswire

Rosa & Co. to Present at the 7th Annual Shanghai Symposium on Clinical and Pharmaceutical Solutions Through Analysis (CPSA Shanghai 2016): Innovative Approaches to Reduce Attrition and Predict Clinical Outcomes

SAN CARLOS, Calif., April 14, 2016 /PRNewswire/ — Rosa & Co. LLC, the leading commercial drug development advisory firm in Quantitative Systems Pharmacology (QSP)/PhysioPD™, today announced that Ms. Sharan A. Pagano, Senior Vice President of Scientific Alliances will present at the 7th Annual Shanghai Symposium on Clinical & Pharmaceutical Solutions through Analysis on Friday, April 22nd, 2016. The conference focuses on the current industrial landscape and the global need to bring products to market faster. The program promotes discussion and exchange of experiences, ideas, and visions and will highlight speakers and sessions that provide real-world experiences with new technologies and critical insights into current challenges and future needs.

Ms. Pagano’s talk, entitled “Mechanistic Physiological PhysioPD™ Models in Drug Development:  A Proven Quantitative Systems Pharmacology (QSP) approach” will focus on the process of creating and conducting research using PhysioPD Platforms to drive scientific innovation in the pharmaceutical industry. PhysioPD Platforms are QSP models designed with multidisciplinary client team input. The PhysioPD research approach is planned to impact client decisions and has been successful across many therapeutic indications.

In recent years, QSP has emerged as a powerful research approach that enables scientific insight and informs early discovery to clinical development decisions. The most innovative R&D organizations in the industry are increasingly adopting PhysioPD Models as an essential research component for more informed decision-making. Rosa’s participation in this international conference further demonstrates its commitment to expanding the adoption of QSP into a standard research method used within the pharmaceutical industry.

“Rosa & Co. is honored to share our perspective, gained from over 13 years of experience growing our practice, on modeling processes, the groundbreaking Model Qualification Methodology, designed by Rosa, and the impact of PhysioPD-based biological research to support decision-making in the pharmaceutical industry.”

– Dr. Mike Reed, Chief Scientist, PhysioPD, Rosa & Co. LLC

About Rosa
Rosa supports clients with their critical decisions – from preclinical through clinical development – by creating and using customized PhysioPD™ Research Platforms that connect mechanisms to outcomes.  PhysioPD Platforms are used to simulate normal and disease physiology, drug action, patient variability, and trial outcomes. Rosa’s clients are involved in Platform creation, testing, and biological simulation research. Clients retain the Platform as a program asset to support decisions and future research. Rosa’s staff has unparalleled professional experience applying biological modeling and simulation research to accelerate drug development and has over 13 years of client engagements in virtually all therapeutic areas. Rosa is unique in its breadth and depth of disease area experience, including metabolic diseases, immuno-oncology, oncology, cardiovascular, inflammation, immune dysfunction, central nervous system disorders, dermatology, rare disease, and antibacterial/antiviral biology. For more information, visit
http://www.rosaandco.com/news.html

Rosa and the Rosa logo are registered trademarks of Rosa & Co. LLC.

Media Contact:
Stephanie Sherman
Email
425-591-5738

SOURCE Rosa & Co.

[…]

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PR Newswire

Rosa & Co. to Present at the 7th Annual Shanghai Symposium on Clinical and Pharmaceutical Solutions Through Analysis (CPSA Shanghai 2016): Innovative Approaches to Reduce Attrition and Predict Clinical Outcomes

SAN CARLOS, Calif., April 14, 2016 /PRNewswire/ — Rosa & Co. LLC, the leading commercial drug development advisory firm in Quantitative Systems Pharmacology (QSP)/PhysioPD™, today announced that Ms. Sharan A. Pagano, Senior Vice President of Scientific Alliances will present at the 7th Annual Shanghai Symposium on Clinical & Pharmaceutical Solutions through Analysis on Friday, April 22nd, 2016. The conference focuses on the current industrial landscape and the global need to bring products to market faster. The program promotes discussion and exchange of experiences, ideas, and visions and will highlight speakers and sessions that provide real-world experiences with new technologies and critical insights into current challenges and future needs.

Ms. Pagano’s talk, entitled “Mechanistic Physiological PhysioPD™ Models in Drug Development:  A Proven Quantitative Systems Pharmacology (QSP) approach” will focus on the process of creating and conducting research using PhysioPD Platforms to drive scientific innovation in the pharmaceutical industry. PhysioPD Platforms are QSP models designed with multidisciplinary client team input. The PhysioPD research approach is planned to impact client decisions and has been successful across many therapeutic indications.

In recent years, QSP has emerged as a powerful research approach that enables scientific insight and informs early discovery to clinical development decisions. The most innovative R&D organizations in the industry are increasingly adopting PhysioPD Models as an essential research component for more informed decision-making. Rosa’s participation in this international conference further demonstrates its commitment to expanding the adoption of QSP into a standard research method used within the pharmaceutical industry.

“Rosa & Co. is honored to share our perspective, gained from over 13 years of experience growing our practice, on modeling processes, the groundbreaking Model Qualification Methodology, designed by Rosa, and the impact of PhysioPD-based biological research to support decision-making in the pharmaceutical industry.”

– Dr. Mike Reed, Chief Scientist, PhysioPD, Rosa & Co. LLC

About Rosa
Rosa supports clients with their critical decisions – from preclinical through clinical development – by creating and using customized PhysioPD™ Research Platforms that connect mechanisms to outcomes.  PhysioPD Platforms are used to simulate normal and disease physiology, drug action, patient variability, and trial outcomes. Rosa’s clients are involved in Platform creation, testing, and biological simulation research. Clients retain the Platform as a program asset to support decisions and future research. Rosa’s staff has unparalleled professional experience applying biological modeling and simulation research to accelerate drug development and has over 13 years of client engagements in virtually all therapeutic areas. Rosa is unique in its breadth and depth of disease area experience, including metabolic diseases, immuno-oncology, oncology, cardiovascular, inflammation, immune dysfunction, central nervous system disorders, dermatology, rare disease, and antibacterial/antiviral biology. For more information, visit
http://www.rosaandco.com/news.html

Rosa and the Rosa logo are registered trademarks of Rosa & Co. LLC.

Media Contact:
Stephanie Sherman
Email
425-591-5738

SOURCE Rosa & Co.

[…]

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PR Newswire

Tunitas Therapeutics Expands Board of Directors with Appointment of Dr. Mervyn Turner

SOUTH SAN FRANCISCO, Calif., April 14, 2016 /PRNewswire/ — Tunitas Therapeutics, Inc. today announced the appointment of Mervyn Turner, Ph.D. to the Tunitas Board of Directors.

“Merv has had an illustrious career of over 30 years in pharmaceutical drug discovery, research and development, business development and corporate strategy,” said Nolan Sigal, M.D., Ph.D., President and Chief Executive officer of Tunitas. “We expect that his deep experience in taking therapeutics from discovery through the entire development cycle, his important industry perspective, and his global connections within the pharmaceutical industry will provide enormous value to Tunitas.”

Before retiring from Merck & Co., Dr. Turner was the company’s first Chief Strategy Officer, and drove strategy planning and resource planning discussions. Prior to that, he served as head of World Wide Licensing and External Research, where he was personally involved in more than 200 strategic transactions.  As Site Head for both Merck & Co. Inc.’s largest R&D facility (Rahway, NJ) and its most productive lab (Merck Frosst, Canada), he oversaw the introduction of multiple development candidates.

Dr. Turner is currently an Advisor to Bay City Capital in San Francisco. In addition to serving on the Board of Tunitas, he is also on the Board of the private biotechnology companies Pharmakea and EnGeneIC. Merv serves on the Steering Committee of the Wellcome Trust’s “Seeding Drug Discovery” program.

About Tunitas Therapeutics

Tunitas Therapeutics, Inc. (South San Francisco) is dedicated to the discovery and development of novel therapeutics designed to transform the treatment of patients with serious allergic diseases. Its proprietary platform facilitates the generation of fusion proteins that target novel inhibitory pathways on allergic cells, leading to inhibition of the key mediators of allergic hypersensitivity and the production of IgE, the antibody class that triggers the allergic response. Epsi-gam, the company’s lead drug candidate, is designed as a long-term treatment for any IgE-mediated disease, including asthma and severe food allergy. The molecule has recently entered phase 1 clinical trials. Specific treatments for cat allergy and peanut allergy will follow epsi-gam into the clinic. For more information on Tunitas Therapeutics, please visit the company’s website at http://www.tunitastherapeutics.com.

Contact:

Nolan H. Sigal, M.D., Ph.D.
President & CEO
Tunitas Therapeutics, Inc.
(650) 887-4747
info@tunitastherapeutics.com

Joan Kureczka
Kureczka/Martin Associates
(415) 821 2413
Joan@kureczka-martin.com

Logo – http://photos.prnewswire.com/prnh/20160226/337975LOGO

 

SOURCE Tunitas Therapeutics, Inc.

[…]

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PR Newswire

Tunitas Therapeutics Expands Board of Directors with Appointment of Dr. Mervyn Turner

SOUTH SAN FRANCISCO, Calif., April 14, 2016 /PRNewswire/ — Tunitas Therapeutics, Inc. today announced the appointment of Mervyn Turner, Ph.D. to the Tunitas Board of Directors.

“Merv has had an illustrious career of over 30 years in pharmaceutical drug discovery, research and development, business development and corporate strategy,” said Nolan Sigal, M.D., Ph.D., President and Chief Executive officer of Tunitas. “We expect that his deep experience in taking therapeutics from discovery through the entire development cycle, his important industry perspective, and his global connections within the pharmaceutical industry will provide enormous value to Tunitas.”

Before retiring from Merck & Co., Dr. Turner was the company’s first Chief Strategy Officer, and drove strategy planning and resource planning discussions. Prior to that, he served as head of World Wide Licensing and External Research, where he was personally involved in more than 200 strategic transactions.  As Site Head for both Merck & Co. Inc.’s largest R&D facility (Rahway, NJ) and its most productive lab (Merck Frosst, Canada), he oversaw the introduction of multiple development candidates.

Dr. Turner is currently an Advisor to Bay City Capital in San Francisco. In addition to serving on the Board of Tunitas, he is also on the Board of the private biotechnology companies Pharmakea and EnGeneIC. Merv serves on the Steering Committee of the Wellcome Trust’s “Seeding Drug Discovery” program.

About Tunitas Therapeutics

Tunitas Therapeutics, Inc. (South San Francisco) is dedicated to the discovery and development of novel therapeutics designed to transform the treatment of patients with serious allergic diseases. Its proprietary platform facilitates the generation of fusion proteins that target novel inhibitory pathways on allergic cells, leading to inhibition of the key mediators of allergic hypersensitivity and the production of IgE, the antibody class that triggers the allergic response. Epsi-gam, the company’s lead drug candidate, is designed as a long-term treatment for any IgE-mediated disease, including asthma and severe food allergy. The molecule has recently entered phase 1 clinical trials. Specific treatments for cat allergy and peanut allergy will follow epsi-gam into the clinic. For more information on Tunitas Therapeutics, please visit the company’s website at http://www.tunitastherapeutics.com.

Contact:

Nolan H. Sigal, M.D., Ph.D.
President & CEO
Tunitas Therapeutics, Inc.
(650) 887-4747
info@tunitastherapeutics.com

Joan Kureczka
Kureczka/Martin Associates
(415) 821 2413
Joan@kureczka-martin.com

Logo – http://photos.prnewswire.com/prnh/20160226/337975LOGO

 

SOURCE Tunitas Therapeutics, Inc.

[…]

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PR Newswire

Novogene Establishes First U.S. Genomic Sequencing Center Located at UC Davis; Acquires Second Illumina Hi-Seq X Ten System

SAN DIEGO, April 14, 2016 /PRNewswire/ — Novogene, a leading provider of genomic services and solutions with cutting edge NGS and bioinformatics expertise, announced today that it has established its first genomics sequencing center in the United States, located on the Sacramento campus of the University of California, Davis. The company also announced that it has purchased its second Illumina Hi-Seq X Ten system — the first system to enable whole human genome sequencing for less than $1,000 — and that it is installing five of these sequencers in the newly established facility at UC Davis.

The purchase of a second Hi-Seq X Ten system adds further to Novogene’s NGS sequencing capacity, among the largest in the world at 36,000 human genomes per year. Novogene was the first company in China to acquire Illumina’s Hi-Seq X Ten system when introduced in early 2014, and has extensive experience using the system to provide­­ whole genome sequencing service. 

Novogene’s genome sequencing center at UC Davis, scheduled to open in early May, will provide to U.S. and global customers high-quality whole genome sequencing and analysis of human, plant and animal samples for biomedical and agricultural research. Novogene’s goal is to establish a CLIA-certified laboratory in the UC Davis facility to enable human genome sequencing for clinical applications as well, including the diagnosis, prevention and treatment of disease. In addition to the ultra-high-throughput Illumina Hi-Seq X instruments, the facility will incorporate other state-of-the-art NGS technologies coupled with Novogene’s cutting-edge bioinformatics and analytical capabilities. In addition to serving the needs of researchers globally, Novogene anticipates that the facility will also benefit UC Davis scientists focused on cancer, regenerative and precision medicine, animal and agricultural research, as well as its broader academic community.

“We are proud to announce the establishment of our first genomic center in the U.S. as well as the acquisition of our second Illumina Hi-Seq X Ten system,” stated Dr. Ruiqiang Li, Founder and Chief Executive Officer of Novogene.  “We look forward to providing U.S.-based NGS services and bioinformatics analyses in support of diverse global genomics research needs. As one of the first and largest users of Illumina’s HiSeq X Ten systems, we are uniquely positioned to rapidly provide customers with the highest quality whole genome sequencing data.”

About Novogene
Novogene Bioinformatics Technology Company, Ltd., headquartered in Beijing with branches in the U.S. and United Kingdom, is a leading genomics solution provider with cutting edge bioinformatics expertise and one of the largest sequencing capacities in the world. Committed to quality service and scientific excellence, Novogene has achieved rapid growth and industry recognition by working in partnership with diverse healthcare, educational and research institutions around the globe to realize the unlimited potential of the rapidly evolving world of genomics. The company has completed nearly 10,000 projects and sequenced 140,000-plus samples for more than 6,000 global customers, with research findings published by top-ranked journals such as Science and Nature. Novogene is the first company in China to purchase Illumina’s HiSeq X Ten system and is the only Illumina Genome Network partner in China. Novogene Corporation is Novogene’s U.S. subsidiary, based in San Diego, CA. Please see http://en.novogene.com for more information.

Media Contact: 
Joyce Peng, Ph.D.
Global Marketing Director and General Manager
Novogene Corporation
+1-626-222-5584
joyce.peng@novogene.com

 

SOURCE Novogene Corporation

[…]

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PR Newswire

Novogene Establishes First U.S. Genomic Sequencing Center Located at UC Davis; Acquires Second Illumina Hi-Seq X Ten System

SAN DIEGO, April 14, 2016 /PRNewswire/ — Novogene, a leading provider of genomic services and solutions with cutting edge NGS and bioinformatics expertise, announced today that it has established its first genomics sequencing center in the United States, located on the Sacramento campus of the University of California, Davis. The company also announced that it has purchased its second Illumina Hi-Seq X Ten system — the first system to enable whole human genome sequencing for less than $1,000 — and that it is installing five of these sequencers in the newly established facility at UC Davis.

The purchase of a second Hi-Seq X Ten system adds further to Novogene’s NGS sequencing capacity, among the largest in the world at 36,000 human genomes per year. Novogene was the first company in China to acquire Illumina’s Hi-Seq X Ten system when introduced in early 2014, and has extensive experience using the system to provide­­ whole genome sequencing service. 

Novogene’s genome sequencing center at UC Davis, scheduled to open in early May, will provide to U.S. and global customers high-quality whole genome sequencing and analysis of human, plant and animal samples for biomedical and agricultural research. Novogene’s goal is to establish a CLIA-certified laboratory in the UC Davis facility to enable human genome sequencing for clinical applications as well, including the diagnosis, prevention and treatment of disease. In addition to the ultra-high-throughput Illumina Hi-Seq X instruments, the facility will incorporate other state-of-the-art NGS technologies coupled with Novogene’s cutting-edge bioinformatics and analytical capabilities. In addition to serving the needs of researchers globally, Novogene anticipates that the facility will also benefit UC Davis scientists focused on cancer, regenerative and precision medicine, animal and agricultural research, as well as its broader academic community.

“We are proud to announce the establishment of our first genomic center in the U.S. as well as the acquisition of our second Illumina Hi-Seq X Ten system,” stated Dr. Ruiqiang Li, Founder and Chief Executive Officer of Novogene.  “We look forward to providing U.S.-based NGS services and bioinformatics analyses in support of diverse global genomics research needs. As one of the first and largest users of Illumina’s HiSeq X Ten systems, we are uniquely positioned to rapidly provide customers with the highest quality whole genome sequencing data.”

About Novogene
Novogene Bioinformatics Technology Company, Ltd., headquartered in Beijing with branches in the U.S. and United Kingdom, is a leading genomics solution provider with cutting edge bioinformatics expertise and one of the largest sequencing capacities in the world. Committed to quality service and scientific excellence, Novogene has achieved rapid growth and industry recognition by working in partnership with diverse healthcare, educational and research institutions around the globe to realize the unlimited potential of the rapidly evolving world of genomics. The company has completed nearly 10,000 projects and sequenced 140,000-plus samples for more than 6,000 global customers, with research findings published by top-ranked journals such as Science and Nature. Novogene is the first company in China to purchase Illumina’s HiSeq X Ten system and is the only Illumina Genome Network partner in China. Novogene Corporation is Novogene’s U.S. subsidiary, based in San Diego, CA. Please see http://en.novogene.com for more information.

Media Contact: 
Joyce Peng, Ph.D.
Global Marketing Director and General Manager
Novogene Corporation
+1-626-222-5584
joyce.peng@novogene.com

 

SOURCE Novogene Corporation

[…]

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PR Newswire

Zavante Initiates The ZEUS Study For ZTI-01 For The Treatment Of Complicated Urinary Tract Infections

The pivotal registration study is designed to demonstrate efficacy and safety of ZTI-01 (fosfomycin for injection) in combating serious infections including those related to multidrug-resistant pathogens

SAN DIEGO, April 14, 2016 /PRNewswire/ — Zavante Therapeutics, Inc., a privately held, late clinical-stage biopharmaceutical company, today announced that it has initiated the ZEUS (ZTI-01 Efficacy and Safety) study. ZEUS is a pivotal clinical study for ZTI-01 (fosfomycin for injection), an antibiotic designed to treat hospitalized patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).  ZTI-01, the Company’s lead product candidate, is a first-in-class, broad spectrum I.V. antibiotic under development to treat serious infections, including those caused by multidrug-resistant (MDR) pathogens. The Company expects to complete the ZEUS study in the second half 2017.

“Initiation of our pivotal study for ZTI-01 is an important milestone for Zavante and demonstrates the implementation expertise of our management team,” said Ted Schroeder, founder, president and CEO of Zavante. “The closing of our Series A financing has provided us with financial resources that we believe will be sufficient to initiate and complete the ZEUS study, with a goal of filing a New Drug Application, or NDA, for ZTI-01 with the U.S. Food and Drug Administration (FDA) late in the second half of 2017. We are excited to introduce ZTI-01 as a new class of injectable antibiotics that we hope will be a valuable tool for physicians in the U.S. fighting serious infections including those caused by multidrug-resistant pathogens in the hospital setting.”  

ZEUS is a multi-national, randomized, active-controlled, double-blind study that is expected to provide substantive data to support the use of ZTI-01 to address the unmet medical need of treating cUTI, including patients with MDR infections. It is anticipated that approximately 110 clinical sites will participate in the study to enroll 460 hospitalized patients with cUTI, including AP. ZEUS is the single pivotal study intended to support an NDA for ZTI-01 in the U.S. The study is titled “Multi-center, randomized, double-blind, comparative study to evaluate the safety and efficacy of ZTI-01 vs. piperacillin/tazobactam in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults.”

“The lack of available and effective antibiotics for these life threatening multidrug-resistant pathogens has created an important unmet medical need that is widely acknowledged by national medical agencies and societies,” said George Drusano, M.D., professor of medicine and director of the Institute for Therapeutic Innovation, Department of Medicine in the College of Medicine at the University of Florida.  “An antibiotic with a unique mechanism of action like ZTI-01 would be an important addition to our antibacterial armamentarium when treating seriously ill patients in the hospital.   For the most seriously ill patients, the potential for ZTI-01 to interact positively in combination with antibiotics of other classes is a real plus.”

ZTI-01 is a first-in-class injectable epoxide antibiotic that has demonstrated a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR bacterial strains, for which current antibiotic therapeutic choices are severely limited. In September 2014, the FDA initially granted Qualified Infectious Disease Product (QIDP) designation for ZTI-01 for the indication of cUTI. In December 2015, the FDA expanded the QIDP designations for ZTI-01 to include complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), and acute bacterial skin and skin structure infections (ABSSSI). Additionally, the FDA granted fast-track designations for all four QIDP designations. These QIDP designations make ZTI-01 eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five-years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act.

About Zavante Therapeutics, Inc.

Zavante is a privately-held, late clinical-stage biopharmaceutical company focused on licensing, developing and commercializing novel products that address serious unmet medical needs in the hospital.

Additional information is available at www.zavante.com.

ZAVANTE and ZAVANTE THERAPEUTICS are registered trademarks of Zavante Therapeutics, Inc.

Logo – http://photos.prnewswire.com/prnh/20151215/296383LOGO

 

SOURCE Zavante Therapeutics, Inc.

[…]

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PR Newswire

Zavante Initiates The ZEUS Study For ZTI-01 For The Treatment Of Complicated Urinary Tract Infections

The pivotal registration study is designed to demonstrate efficacy and safety of ZTI-01 (fosfomycin for injection) in combating serious infections including those related to multidrug-resistant pathogens

SAN DIEGO, April 14, 2016 /PRNewswire/ — Zavante Therapeutics, Inc., a privately held, late clinical-stage biopharmaceutical company, today announced that it has initiated the ZEUS (ZTI-01 Efficacy and Safety) study. ZEUS is a pivotal clinical study for ZTI-01 (fosfomycin for injection), an antibiotic designed to treat hospitalized patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).  ZTI-01, the Company’s lead product candidate, is a first-in-class, broad spectrum I.V. antibiotic under development to treat serious infections, including those caused by multidrug-resistant (MDR) pathogens. The Company expects to complete the ZEUS study in the second half 2017.

“Initiation of our pivotal study for ZTI-01 is an important milestone for Zavante and demonstrates the implementation expertise of our management team,” said Ted Schroeder, founder, president and CEO of Zavante. “The closing of our Series A financing has provided us with financial resources that we believe will be sufficient to initiate and complete the ZEUS study, with a goal of filing a New Drug Application, or NDA, for ZTI-01 with the U.S. Food and Drug Administration (FDA) late in the second half of 2017. We are excited to introduce ZTI-01 as a new class of injectable antibiotics that we hope will be a valuable tool for physicians in the U.S. fighting serious infections including those caused by multidrug-resistant pathogens in the hospital setting.”  

ZEUS is a multi-national, randomized, active-controlled, double-blind study that is expected to provide substantive data to support the use of ZTI-01 to address the unmet medical need of treating cUTI, including patients with MDR infections. It is anticipated that approximately 110 clinical sites will participate in the study to enroll 460 hospitalized patients with cUTI, including AP. ZEUS is the single pivotal study intended to support an NDA for ZTI-01 in the U.S. The study is titled “Multi-center, randomized, double-blind, comparative study to evaluate the safety and efficacy of ZTI-01 vs. piperacillin/tazobactam in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults.”

“The lack of available and effective antibiotics for these life threatening multidrug-resistant pathogens has created an important unmet medical need that is widely acknowledged by national medical agencies and societies,” said George Drusano, M.D., professor of medicine and director of the Institute for Therapeutic Innovation, Department of Medicine in the College of Medicine at the University of Florida.  “An antibiotic with a unique mechanism of action like ZTI-01 would be an important addition to our antibacterial armamentarium when treating seriously ill patients in the hospital.   For the most seriously ill patients, the potential for ZTI-01 to interact positively in combination with antibiotics of other classes is a real plus.”

ZTI-01 is a first-in-class injectable epoxide antibiotic that has demonstrated a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR bacterial strains, for which current antibiotic therapeutic choices are severely limited. In September 2014, the FDA initially granted Qualified Infectious Disease Product (QIDP) designation for ZTI-01 for the indication of cUTI. In December 2015, the FDA expanded the QIDP designations for ZTI-01 to include complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), and acute bacterial skin and skin structure infections (ABSSSI). Additionally, the FDA granted fast-track designations for all four QIDP designations. These QIDP designations make ZTI-01 eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five-years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act.

About Zavante Therapeutics, Inc.

Zavante is a privately-held, late clinical-stage biopharmaceutical company focused on licensing, developing and commercializing novel products that address serious unmet medical needs in the hospital.

Additional information is available at www.zavante.com.

ZAVANTE and ZAVANTE THERAPEUTICS are registered trademarks of Zavante Therapeutics, Inc.

Logo – http://photos.prnewswire.com/prnh/20151215/296383LOGO

 

SOURCE Zavante Therapeutics, Inc.

[…]

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PR Newswire

Sorrento to Present at the Upcoming American Association for Cancer Research (AACR) Annual Meeting

SAN DIEGO, April 14, 2016 /PRNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (Sorrento), a clinical-stage oncology company developing new treatments for cancer and associated pain, announced today 3 poster presentations at the upcoming AACR Annual Meeting 2016 at the Ernest N. Morial Convention Center in New Orleans, Louisiana, USA, April 16 – 20, 2016.

Data to be presented include in vitro studies of an anti-5T4 antibody drug conjugate (ADC), mechanistic studies of a co-stimulatory anti-TIM3 antibody, and preclinical studies of an anti-c-Met ADC in non-small cell lung cancer models.

Abstract Number: 1214
Presentation Title: Development of anti-5T4 antibody-drug conjugates, ZV05-ADCs for targeted cancer therapy in different type of cancers
Session Category: Experimental and Molecular Therapeutics
Session Date and Time: Monday Apr 18, 2016 8:00 AM – 12:00 PM
Location: Convention Center, Halls G-J, Poster Section 15
Author Block: Zhaohui Li*, Hong Zhang#, Dylan Deng#, Tong Zhu#, Gang Chen#, Sheldon Cao*, David Miao#, *Zova Biotherapeutics, Inc., Hangzhou, Zhejiang, PR China, #Sorrento Therapeutics, Inc., San Diego, CA

Abstract Number: 3214  
Presentation Title: A Fully Human Anti-TIM3 Antibody with Co-Stimulatory Activity
Session Category: Immune Checkpoints 2
Session Date and Time: Tuesday Apr 19, 2016 8:00 AM12:00 PM
Location: Convention Center, Halls G-J, Poster Section 25
Author Block: J Dixon Gray, Irina Krapf, Heyue Zhou, Gunnar F. Kaufmann. Sorrento Therapeutics, Inc., San Diego, CA

Abstract Number: 3897  
Presentation Title: A novel c-Met targeting antibody drug conjugate for NSCLC
Session Category: Cancer Chemistry
Session Date and Time: Tuesday Apr 19, 2016 1:00 PM – 5:00 PM
Location: Convention Center, Halls G-J, Poster Section 21
Author Block: Lingna Li, Katherine Fells, Julia Guo, Pia Muyot, Edwige Gros, Yanliang Zhang, Yingqing Sun, Hong Zhang, Yanwen Fu, Tong Zhu, Jian Cao, Gunnar F. Kaufmann,
Gang Chen, Zhenwei Miao. Sorrento Therapeutics, Inc., San Diego, CA

About Sorrento Therapeutics, Inc. 

Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for cancer, inflammation and autoimmune diseases. Sorrento’s lead products are multiple late-stage biosimilar and biobetter antibodies, as well as clinical CAR-T therapies targeting solid tumors.

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Sorrento’s and its subsidiaries’ prospects; Sorrento’s expectations for its technologies and collaborations; Sorrento’s and its subsidiaries’ advances made in developing antibody drug conjugates (ADCs), human monoclonal antibodies using its proprietary G-MAB fully human antibody technology and any of their other respective technologies, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

All other trademarks and trade names are the property of their respective owners.

© 2016 Sorrento Therapeutics, Inc.  All Rights Reserved.

Logo – http://photos.prnewswire.com/prnh/20150105/167173LOGO

 

SOURCE Sorrento Therapeutics, Inc.

[…]