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QPEX BIOPHARMA is developing a pipeline of agents addressing critical needs for the treatment of infectious diseases in the inpatient and outpatient settings.

Qpex management has a record of deep expertise in the discovery, development, and regulatory approval of anti-infective medicines, including an extensive record of working with public/private partnerships focused on new antibiotics to combat antimicrobial resistance.

 

Untreatable infections due to antimicrobial drug resistance negates many advances in medical technology

 

The year 2019 marks the 50th anniversary of the publication of the landmark science fiction novel The Andromeda Strain (Michael Crichton).  The story describes the fictitious account of a highly mutable micro-organism that infects and kills humans, escapes containment, and threatens mankind. 

The story behind the Andromeda Strain makes for great novels and films on the horrors of a battle between man and unseen micro-organisms. In our “real world”, we are now challenged by antimicrobial drug resistance (also known as AMR), common bacterial pathogens no longer are treatable by antibiotic drugs.  Infections that were once considered mild  and easily treated can become life threatening in the absence of active antibiotics.  

 

AMR results in a world where the advances in modern medicine are lost...

 

DEFINE

drug resistance mechanisms

 

IMPROVE

existing proven classes of drugs

FIND

new chemical classes of drugs that overcome drug resistance

Making antibiotics work better

We have important partnerships and we communicate the optimal use of our products

COLLABORATE

DISCOVERY

ENZYME INHIBITION

COMBINE

Reversing antibiotic resistance

 
 

​​Dan Burgess

Executive Chairman of the Board

Carol Gallagher, PharmD

New Enterprise Associates,

Board Member

​​​

​​Kevin Li, PhD

LYZZ Capital, Board Member

​​​

Michael N. Dudley, PharmD

President, CEO, Board Member

Terry Gould

Adams Street Partners, Board Member

Douglas Reed, MD

Hatteras Venture Partners, Board Member

 
 

Qpex Biopharma and Brii Biosciences Enter Into a Strategic Collaboration to Develop and Commercialize Antibiotics for Drug-Resistant Infections in China

  • Multi-product collaboration will address pathogens for which the World Health Organization (WHO) has declared there is a “critical need” for new drugs due to carbapenem-resistance in Acinetobacter, Pseudomonas aeruginosa, and Enterobacteriaceae (CRE)

  • Qpex grants license to its current product portfolio in greater China territories to Brii Biosciences while Qpex retains all other rights globally, including the U.S. and Europe

 

SAN DIEGO, Calif., October 22, 2019 – Qpex Biopharma, Inc., a biopharmaceutical company dedicated to the discovery and development of innovative anti-infective therapies, today announced that it has entered into a multi-product collaboration with Brii Biosciences to develop and commercialize Qpex’s portfolio in China of potentially best-in-class therapies to treat a range of multi-drug resistant gram-negative infections.

“We are thrilled to be working together with a team that shares our vision and dedication to address the global antimicrobial resistance problem,” said Michael Dudley, Pharm.D., President and CEO of Qpex Biopharma. "Brii Bio’s depth of understanding in this field and their unique, cross-regional operating model make them the ideal collaborator in bringing our treatments to this important region where endemic drug-resistance problems can be well addressed by our portfolio.”

The portfolio includes the following investigational products:

  • OMNIvance: an intravenous-administered, beta-lactamase inhibitor (BLI) based product that may provide best-in-class coverage of Acinetobacter species, Enterobacteriaceae, and Pseudomonas aeruginosa, including carbapenem-resistant strains

  • ORAvance: an orally-administered BLI combination for the treatment of multi-drug resistant gram-negative infections in outpatient settings, or to allow hospitalized patients to switch from IV to oral therapy

  • Next-generation polymyxin: an IV-administered, targeted spectrum synthetic polymyxin with an enhanced therapeutic profile designed to address highly resistant infections caused by Pseudomonas and Acinetobacter

OMNIvance and ORAvance use Qpex’s novel ultra-broad-spectrum beta-lactamase inhibitor QPX7728 that inhibits both serine and metallo beta-lactamases, and restores the activity of multiple IV and oral beta-lactam antibiotics against drug-resistant gram- negative pathogens.

 

“The higher level of antibiotic resistance is a very serious problem in China and the spread of super bugs crossing borders is a recognized global threat,” said Zhi Hong, Ph.D., co-founder and CEO of Brii Bio. “We are delighted to join forces with Qpex to advance its portfolio of medicines that will help address this public health threat and complements our overall infectious disease strategy in China.”

Under the terms of the agreement, Brii Biosciences will obtain a license to develop, manufacture, and commercialize the portfolio in greater China, which includes Taiwan, Hong Kong, Macau and the People’s Republic of China. Brii Biosciences will make an upfront payment, as well as success-based development, regulatory and commercial milestone payments, and share in the costs of a global development program. Qpex Biopharma will also receive tiered royalties on sales in the Brii Bio territory.

About Qpex Biopharma

Qpex Biopharma (www.qpexbio.com) is a San Diego-based biopharmaceutical company with a pipeline of best-in-class agents addressing critical needs for treatment of infectious diseases in the inpatient and outpatient settings. Qpex was launched in 2018 with investments from New Enterprise Associates, Adams Street Partners, LYZZ Capital, Hatteras Venture Partners and Stanford University Draper Fund. The company’s scientists and clinicians have a record of deep expertise in the discovery and development of anti-infective agents, and an extensive record of working with public- private partnerships, including partnerships with the Biomedical Advanced Research and Development Authority (BARDA) that led to the first approved antimicrobial drug product under that program in 2017.

About Brii Biosciences

Brii Biosciences (Brii Bio) is committed to serving patients’ needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight. With operations in the People’s Republic of China and the United States, the company is poised to serve as a bridge to deliver transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the health and wellbeing of patients around the world. The company is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and other illnesses. For more information, visit www.briibio.com.

Contact
Katherine Smith for Qpex Biopharma (619) 849-5378 katherine@canalecomm.com

Qpex Biopharma to Present its Anti-infective Portfolio at IDWeek 2019

 

SAN DIEGO, September 25, 2019 – Qpex Biopharma today announced scientific presentations on its investigational anti-infectives at the IDWeek 2019 Conference to be held October 2-6 in Washington, DC.

Qpex scientists and external collaborators will be making the first public presentations on QPX9003, a next generation polymyxin antibiotic for multi-drug resistant Acinetobacter and Pseudomonas aeruginosa. In addition, they will present new data on the ultra-broad-spectrum beta-lactamase inhibitor QPX7728, focusing on its first-in- class properties as an inhibitor with potent activity with multiple beta-lactam antibiotics in Acinetobacter and Pseudomonas, as well as in Enterobacteriaceae that produce serine and metallo beta-lactamases.

“We are pleased to report new data at IDWeek on our clinical candidates that demonstrate compelling preclinical properties as best-in-class agents for Acinetobacter, Pseudomonas, and Enterobacteriaceae,” said Michael Dudley, PharmD, FIDSA, President and CEO of Qpex Biopharma. “We welcome the opportunity to engage with the infectious disease community on the excellent progress of these programs as part of our ongoing portfolio collaboration with BARDA,” he added. 

 

Three poster presentations on the microbiological properties of QPX7728, and two posters on the microbiological properties and preclinical pharmacology of the clinical candidate QPX9003 will be presented by Qpex scientists and external collaborators.  Data show that QPX7728 has potent inhibition of clinically important beta-lactamases from Classes A, B, C, and D that are often present in multi-drug resistant (MDR) Acinetobacter, Pseudomonas, and Enterobacteriaceae. Notably, QPX7728 is active in strains of carbapenem-resistant Enterobacteriaceae (CRE) with resistance to ceftazidime-avibactam. The two posters on QPX9003 will show its improved potency and therapeutic index for Acinetobacter and Pseudomonas aeruginosa in animal models over polymyxin B. 

 

ID Week is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). 

 

The Qpex Biopharma presentations are listed below; additional information may be found at the IDWeek 2019 website at IDweek.org.  All times listed below are in Eastern Daylight Time.

 

Date: Thursday, October 3, 2019

Poster Session: 068 - Novel Antimicrobials and Approaches Against Resistant Bugs

Time: 12:15pm-1:30pm

Place: Poster Area

 

Presentation Titles (abstract numbers), authors, and summary: 

 

QPX7728 (Ultra-Broad-Spectrum β-Lactamase Inhibitor) Presentations

 

Activity of Novel β-Lactamase Inhibitor QPX7728 Combined with β-Lactam Agents When Tested against Carbapenem-Resistant Enterobacteriaceae (CRE) Isolates (#677)

Mariana Castanheira, Jill Lindley, Holly Juynh, Rodrigo Mendes, and Olga Lomovskaya

QPX7728 restored the activity of several BLs when tested against 508 CRE isolates that produce serine and metallo carbapenemases.  

 

In Vitro Activity of the β-lactamase Inhibitor QPX7728 in Combination with Several β-lactams against Acinetobacter baumannii and Pseudomonas aeruginosa (#681)

Olga Lomovskaya, Jill Lindley, Debora Rubio-Aparicio, Kirk Nelson, and Mariana Castanheira

QPX7728 restored the activity of meropenem against carbapenem-resistant Acinetobacter baumannii, with  >95% of isolates inhibited by ≤8 µg/ml of meropenem. In a representative panel of Pseudomonas aeruginosa, multiple beta-lactam antibiotics tested in combination with QPX7728 resulted in >90% susceptibility. For a challenge panel of highly drug-resistant Pseudomonas aeruginosa, QPX7728 in combination with ceftolozane or piperacillin were the most potent combinations.  

 

Potency of the Beta-Lactamase Inhibitor QPX7728 Is Minimally Affected by KPC Mutations that Reduce Potency of Ceftazidime-Avibactam (#727)

Kirk Nelson, Debora Rubio-Aparicio, and Olga Lomovskaya

Mutations in the KPC enzyme that result in microbiological and clinical resistance to ceftazidime-avibactam do not affect the potency of QPX7728 in combination with various beta-lactam antibiotics, including ceftazidime. 

 

QPX9003 (Next Generation Polymyxin) Presentations

 

Activity of a Novel Polymyxin Analog, QPX9003, Tested against Resistant Gram-Negative Pathogens, including Carbapenem-Resistant Acinetobacter, Enterobacterales, and Pseudomonas (#690)

Mariana Castanheira, Jill Lindley, Holly Juynh, Rodrigo Mendes, and Olga Lomovskaya

QPX9003 had potent activity against the collection of highly resistant gram-negative isolates that included multidrug resistant Pseudomonas aeruginosa, carbapenem-resistant Acinetobacter baumannii and CRE. Against the PSA and CRAB isolates, QPX9003 was four-fold more active than colistin.

QPX9003: Pharmacology of a Novel Polymyxin in Mice and Rats (#707)

Mojgan Sabet, Ziad Tarazi, Jonathan Parkinson, Kade D. Roberts, Philip E. Thompson, Roger L. Nation, Tony Velkov, Scott J. Hecker, Olga Lomovskaya, Michael N. Dudley, Jian Li, and David C. Griffith

The activity and the safety of QPX9003 and polymyxin B was studied in animal models of infection and toxicology. QPX9003 was found to have a wider therapeutic index in being more effective and less toxic than polymyxin B,. 

 

About Qpex Biopharma, Inc. 

Qpex Biopharma (www.qpexbio.com) is a San Diego-based biopharmaceutical company with a pipeline of best-in-class agents addressing critical needs for treatment of infectious diseases in the inpatient and outpatient settings. Qpex was launched in October 2018 with investments from New Enterprise Associates, Adams Street Partners, LYZZ Capital, Hatteras Venture Partners and Stanford University Draper Fund. The company’s scientists and clinicians have a record of deep expertise in the discovery and development of anti-infective agents, and an extensive record of working with public-private partnerships, including a previous contract with the Biomedical Advanced Research and Development Authority (BARDA) that led to the first approved antimicrobial drug product under that program in 2017. 

About BARDA
Qpex’s partnership with BARDA is funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. The agreement provides support for the development of a portfolio of new antibiotics to fight drug- resistant, gram-negative infections. The initial award was for $32 million in funding, and up to an additional $100 million (pending the availability of funding) is available if all options to extend the partnership are exercised by BARDA.

Contact:
Katherine Smith
Canale Communications 619-849-5378 katherine@canalecomm.com

Qpex Biopharma to Provide First Public Presentations of Preclinical Data on the Novel Ultra-Broad-Spectrum Beta-lactamase Inhibitor QPX7728 for IV and Oral Products at 2019 ASM Microbe Meeting

 

SAN DIEGO, June 13, 2019 – Qpex Biopharma today announced that preclinical data on its investigational beta-lactamase inhibitor QPX7728 will be featured in several presentations at the 2019 ASM Microbe Meeting to be held June 20-24 in San Francisco, CA.

“We are pleased to be making the first public presentations on our next generation beta- lactamase inhibitor QPX7728 that exceeds the profile of other agents recently approved or in clinical development.” said Michael Dudley, PharmD, President and CEO of Qpex Biopharma. “QPX7728’s potent inhibition of major beta-lactamases, including metallo enzymes, and activity in multi-drug resistant Acinetobacter as well as Enterobacteriaceae and Pseudomonas aeruginosa represents a major advance in the field. QPX7728 has the potential for use in combination with multiple beta-lactam antibiotics, including oral agents.”

Eight presentations on the discovery, microbiological properties, and preclinical pharmacology of the clinical candidate beta-lactamase inhibitor QPX7728 will be provided by Qpex scientists and external collaborators. Data show that QPX7728 has potent inhibition of clinically important beta-lactamases from Classes A, B, C, and D that are often present in multi-drug resistant (MDR) bacteria. Notably, QPX7728 activity is minimally affected by resistance mechanisms that impede entry of antibiotics or other beta-lactamase inhibitors into bacteria. In preclinical species, QPX7728 has excellent pharmacokinetic properties, including oral bioavailability. Of note, the company will summarize data on QPX7728 in an oral presentation session that showcases important new antimicrobial agents in early development.

 

In addition to QPX7728 presentations, Qpex will present a summary of its pipeline, including QPX7728 and the company’s next generation polymyxin program that are part of its BARDA portfolio collaboration, in a separate oral presentation session.

The American Society for Microbiology’s ASM Microbe 2019 showcases the best microbial sciences in the world, and provides a one-of-a-kind forum to explore the complete spectrum of microbiology from basic science to clinical trials.

 

The Qpex Biopharma presentations are listed below; additional information may be found at the ASM Microbe 2019 website at https://www.asm.org. All times listed below are in Pacific Daylight Time.

Date: Friday, June 21, 2019
Presentation Title: Broad-Spectrum Orally Bioavailable Beta-lactamase Inhibitor QPX7728
Presenter: Olga Lomovskaya, PhD, Qpex Biopharma
Oral Session: S020- New Agents Discovery Summary Session: Early New Antimicrobial Agents
Time: 9:10am-9:30am
Place: 207/208 South
Summary: The discovery and microbiological properties of QPX7728, an ultra-broad- spectrum beta-lactamase inhibitor with inhibitory activity against clinically important enzymes in Classes A-D in drug-resistant Enterobacteriaceae, Pseudomonas, and Acinetobacter spp. will be reviewed.

Date: Saturday, June 22, 2019
Presentation Title: Qpex Biopharma Pipeline
Presenter: David Griffith, Qpex Biopharma
Oral Session: Pharma Pipeline Updates: Part 2
Time: 11:33am-11:44am
Place: AAR Track Hub (Booth 5053) - Learn - Exhibit and Poster Hall
Summary: A corporate overview of Qpex Biopharma and its development pipeline will be reviewed.

Date: Sunday, June 23, 2019
Poster Session: P588 - AAR08 - New Antimicrobial Agents (pre-Phase 2): Early Beta- Lactams and Beta-Lactamase Inhibitor Combinations
Time: 10:30am-4:00pm
Place: Exhibit and Poster Hall


Presentation Titles (abstract numbers), authors, and summary:

Discovery of QPX7728, an Ultra-Broad-Spectrum Inhibitor of Serine and Metallo Beta-lactamases (AAR706)
Scott J. Hecker, K. Raja Reddy, Olga Lomovskaya, David C. Griffith, Debora Rubio-Aparicio, Kirk Nelson, Ruslan Tsivkovski, Dongxu Sun, Mojgan Sabet, Ziad Tarazi, Maxim Totrov, Orville Pemberton, Yu Chen, and Michael N. Dudley

The path to discovery of the ultra-broad-spectrum beta-lactamase inhibitor QPX7728, including an overview of microbiology and structural biology, will be described.

QPX7728: Spectrum of Beta-Lactamase Inhibition and Impact of Resistance Mechanisms on Activity in Gram-Negative Bacteria (AAR-707)
Olga Lomovskaya, Debora Rubio-Aparicio, Kirk Nelson, Dongxu Sun and Michael Dudley

QPX7728 restores activity of multiple beta-lactam antibiotics in bacteria producing class A, C and D serine BLs, including class D carbapenemases from Acinetobacter, and major class B metallo-beta-lactamases. Excellent activity is observed in pathogens with multiple porin mutations and is not affected by efflux pumps.

QPX7728: Biochemical Characterization of Inhibitory Activity against Serine and Metallo beta-lactamases from Enterobacteriaceae and Acinetobacter (AAR-708)
Ruslan Tsivkovski and Olga Lomovskaya

QPX7728 is a potent reversible inhibitor of serine and metallo-beta-lactamases. It shows slow, tight-binding inhibition of serine beta-lactamases with high enzyme inactivation efficiency and low off-rate with residence times reaching values of several hours for some enzymes.

 

QPX7728: In Vitro Activity in Combination with Meropenem against Carbapenem-Resistant Enterobacteriaceae (CRE) (AAR-709)
Kirk Nelson, Debora Rubio-Aparicio, and Olga Lomovskaya 

QPX7728 restored the potency of meropenem against CRE, with >95% of strains inhibited by QPX7728 + meropenem. Outer membrane porin mutations that restrict entry of many drugs had a lower effect on QPX7728 + meropenem compared to other recently approved beta-lactamase inhibitor combination products.

QPX7728: In Vitro Activity in Combination with Oral Beta-Lactam Antibiotics against Enterobacteriaceae (ENT) (AAR-710)
Debora Rubio-Aparicio, Kirk Nelson, David C Griffith, Michael N Dudley, and Olga Lomovskaya

QPX7728 enhanced the potency of the oral beta-lactam antibiotics ceftibuten and tebipenem against Enterobacteriaceae with the ESBL phenotype as well as CRE (including KPC, OXA-48-like, and MBL producing strains).

 

In Vitro Activity of the β-lactamase Inhibitor QPX7728 Combined with Several β-lactams When Tested against Acinetobacter baumannii (AB) and Pseudomonas aeruginosa (PA) (AAR-711)

Mariana Castanheira, Jill Lindley, Kirk Nelson, Debora Rubio-Aparicio, and Olga Lomovskaya
QPX7728 restored the potency of meropenem against carbapenem- resistant Acinetobacter baumannii, with >90% of isolates were inhibited by ≤8 μg/ml of meropenem with QPX7728 (at 4 or 8 μg/ml). In Pseudomonas, QPX7728 combinations showed high potency against a representative panel that reflects current MIC distributions for clinical isolates; in highly meropenem, ceftazidime- avibactam and ceftolozane-tazobactam resistant isolates, QPX7728 combined with meropenem or ceftolozane were the most potent combinations.

 

In Vivo Activity of QPX7728 in Combination with Meropenem against Carbapenem-resistant K. pneumoniae, A. baumannii, and P. aeruginosa (AAR-712)
Mojgan Sabet, Ziad Tarazi, and David C. Griffith

QPX7728 plus meropenem produces dose-dependent bacterial killing of carbapenem-resistant Enterobacteriaceae (CRE), A. baumannii, and P. aeruginosa in mouse models of infection.

Pharmacokinetics of QPX7728 following IV Dosing in Non-Clinical Species (AAR-713)

Ziad Tarazi, Mojgan Sabet, Jonathan Parkinson, and David C. Griffith

The pharmacokinetics of QPX7728 following IV dosing in non-clinical species show properties consistent with co-administration with beta-lactam antibiotics.

About Qpex Biopharma, Inc.

Qpex Biopharma (www.qpexbio.com) is a San Diego-based biopharmaceutical company with a pipeline of best-in-class agents addressing critical needs for treatment of infectious diseases in the inpatient and outpatient settings. Qpex was launched in October 2018 with investments from New Enterprise Associates, Adams Street Partners, LYZZ Capital, Hatteras Venture Partners and Stanford University Draper Fund. The company’s scientists and clinicians have a record of deep expertise in the discovery and development of anti-infective agents, and an extensive record of working with public-private partnerships, including a previous contract with the Biomedical Advanced Research and Development Authority (BARDA) that led to the first approved antimicrobial drug product under that program in 2017.

About BARDA

Qpex’s partnership with BARDA is funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. The agreement provides support for the development of a portfolio of new antibiotics to fight drug- resistant, gram-negative infections. The initial award was for $32 million in funding, and up to an additional $100 million (pending the availability of funding) is available if all options to extend the partnership are exercised by BARDA.

Contact:
Pam Lord
Canale Communications 619-849-6003

pam@canalecomm.com

 

Qpex Biopharma Licenses Polymyxin Antimicrobial Program from Monash University to Address Drug-Resistant Infections 

SAN DIEGO, April 30, 2019 – Qpex Biopharma today announced the closing of a license agreement from Monash University providing Qpex a portfolio of next-generation polymyxin antimicrobials focused against highly drug-resistant gram-negative pathogens. The exclusive license includes worldwide rights to develop and commercialize polymyxin antimicrobials in multiple territories.

 

The polymyxin class of antibiotics, including the drug colistin, was first introduced into clinical use in the 1950s but was largely abandoned in later years due to toxicity and the introduction of improved and safer classes of antibiotics. However, with increasing resistance to first-line agents, polymyxins have been increasingly relied upon as “last resort” agents, despite their pharmacological and safety limitations. Therefore, an improved new generation of the polymyxin class of drugs is desirable.

“Our collaboration with world-class experts in polymyxin antimicrobials at Monash University was highly successful in discovering new polymyxins with enhanced pharmacological properties and safety in preclinical studies,” said Michael Dudley, PharmD, President and CEO of Qpex Biopharma. “We believe the new polymyxin clinical drug candidate emerging from this collaboration will have an improved profile over other members of this class. This program joins our internal pipeline of products under development to address serious and urgent resistance threats. We look forward to advancing these programs in development within our partnership with the Biomedical Advanced Research and Development Authority (BARDA).” 

The Monash-Qpex polymyxin drug discovery collaboration was funded by a Partnerships for Biodefense grant (R01AI098771) awarded to Professor Jian Li, Ph.D. of Monash University by the National Institutes of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). Scientists from Qpex collaborated as the designated industrial partner with Monash University on this grant. 

“The world desperately needs better polymyxins and in animal studies our novel synthetic polymyxins show improved efficacy and safety over the currently used polymyxin drugs. It is very exciting to see a clinical candidate successfully identified from this five-year project. We are thrilled with the partnership with the highly experienced and proven Qpex team that will progress the development of a clinical candidate. We are very grateful to the NIAID/NIH for funding this program,” said Professor Li.

About Qpex Biopharma, Inc. 

Qpex Biopharma (www.qpexbio.com) is a San Diego-based biopharmaceutical company with a pipeline of best-in-class agents addressing critical needs for treatment of infectious diseases in the inpatient and outpatient settings. Qpex was launched in October 2018 with investment from New Enterprise Associates, Adams Street Partners, LYZZ Capital, Hatteras Venture Partners and Stanford University Draper Fund. The company’s scientists and clinicians have a record of deep expertise in the discovery and development of anti-infective agents, and an extensive record of working with public-private partnerships, including a previous contract with the Biomedical Advanced Research and Development Authority (BARDA) that led to the first approved antimicrobial drug product under that program in 2017. 

About BARDA

Qpex’s partnership with BARDA is funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. The agreement provides support for the development of a portfolio of new antibiotics to fight drug-resistant, gram-negative infections. The initial award was for $32 million in funding, and up to an additional $100 million (pending the availability of funding) is available if all options to extend the partnership are exercised by BARDA. 

​​

About NIAID/NIH

In response to threats presented by bioterrorism and emerging infectious diseases, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established research programs to facilitate development of countermeasures for certain pathogens and toxins. The NIAID/NIH Partnerships for Biodefense grants support the development of therapeutics, vaccines or medical diagnostics that address designated priority pathogens and toxins.  A Partnerships for Biodefense grant (R01AI098771) was awarded to Professor Jian Li, Ph.D. of Monash University to collaborate with Qpex to develop improved polymyxin drugs that are effective against Gram-negative ‘superbugs.’

​​

About Monash University

Monash University is the largest university in Australia, ranked in the world’s top 100 and a member of the prestigious Group of Eight. The University is named after Sir John Monash and is fueled by his desire for its students to leave with a greater sense of purpose and the skills and confidence to create positive change.

 

Contact: Pam Lord

Canale Communications

619-849-6003

pam@canalecomm.com

Qpex Biopharma Announces Closing of $33 Million Series A Financing and Launch of Company to Address Worldwide Problem of Drug-Resistant Infections

Qpex to continue partnership with BARDA with total award up to $132 million

SAN DIEGO, October 22, 2018 – Qpex Biopharma today announced the closing of a $33 million Series A financing and launch of the infectious disease company. Qpex is focused on developing new antibiotics to combat the growing threat of global antimicrobial resistance. Upon closing of the transaction, Qpex acquired the preclinical-stage anti-infective assets of The Medicines Company (MDCO), including proprietary beta-lactamase inhibitor technology with unique pharmacological properties, including broad spectrum of coverage.

New Enterprise Associates led the financing syndicate and was accompanied by Adams Street Partners, LYZZ Capital, Hatteras Venture Partners and Stanford University Draper Fund. Additional funding is being provided through an agreement with the Biomedical Advanced Research and Development Authority (BARDA).

“Qpex has a strong portfolio of drug candidates and is led by an experienced, industry-leading management team with a proven track record of innovation,” said Carol Gallagher, PharmD, Partner at New Enterprise Associates. “We see great potential in the company and look forward to working with the Qpex team and our fellow investors to advance novel products to address the growing antimicrobial resistance that impacts many patients worldwide,” she added.
 

The Qpex management team is comprised of former executives from The Medicines Company’s infectious disease business unit who were integral in the development/approval of four antibiotics in the last five years, including three products while at The Medicines Company, and previously were executives at the successful antibiotic companies Rempex Pharmaceuticals and Mpex Pharmaceuticals.

“We are very pleased to form Qpex around the validated beta-lactamase inhibitor technology our team pioneered and to attract such an experienced group of healthcare investors,” said Michael Dudley, PharmD, Qpex’s President and CEO. “The urgent, global threat of antimicrobial resistance demands innovation and we’re responding again to the calls sounded by the CDC and WHO for solutions by developing clinical candidates that we believe will be best-in-class anti-infective products. Our progress will be fueled by our proven established R&D partnership

with BARDA that has the potential to drive our new programs deep into late-stage development.”

Qpex, through its wholly-owned subsidiary, has a strategic partnership with BARDA that provides the potential for up to $132 million to support the development of a portfolio of new antibiotics to fight drug-resistant, gram-negative infections (HHSO100201600026C). The partnership was established under an Other Transactional Authority (OTA) and is a distinctive, flexible, portfolio-based cost-share approach to funding drug development. The initial award in 2016 was for $32 million, with up to an additional $100 million available if all options to extend the partnership are exercised by BARDA.

About Qpex Biopharma, Inc.​​

Qpex Biopharma is developing a pipeline of agents addressing critical needs for the treatment of infectious diseases in the inpatient and outpatient settings. Qpex management has a record of deep expertise in the discovery, development and regulatory approval of anti-infective medicines, including an extensive record of working with public/private partnerships focused on new antibiotics to combat antimicrobial resistance.

About BARDA

Qpex’s partnership with BARDA is funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C.

Contact:
Pam Lord
Canale Communications 619-849-6003

pam@canalecomm.com

 

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