Synereca Pharmaceuticals Announces Financing Led by Accele Venture Partners

Funding to Support Development of New Treatments for Drug-Resistant Gram-Negative Bacterial Infections

OKLAHOMA CITY, Sept. 16, 2014 /PRNewswire/ — Synereca Pharmaceutics, Inc. (SPI), a research-stage biopharmaceutical company developing novel orally active drugs that restore or increase the effectiveness of existing antibiotics, announced today a $1.4 million convertible debt financing. Accele Venture Partners, the investing arm of life sciences accelerator Accele Biopharma, Inc., led the financing with participation from i2E, Inc., a nationally recognized private not-for-profit corporation focused on growing innovative small businesses in Oklahoma and private investors. Proceeds of the financing will be used to advance SPI’s research focused on compounds to potentiate the effectiveness of existing antibiotics against drug-resistant Gram-negative bacteria. Terms of the financing were not disclosed.

Clayton Duncan, Accele Biopharma CEO and acting CEO of Synereca, stated, “Despite the growing need to treat life-threatening infections caused by drug-resistant bacteria, development of new antibiotics has plummeted due to a combination of technical, regulatory and economic factors. Only two new antibiotics with novel mechanisms have been approved since 1998. SPI’s programs to restore the effectiveness of existing antibiotic offer a much-needed response to this intensifying public health crisis.”

Need for Novel Approaches to Drug-Resistant Bacterial Infections

There are more than 218 million bacterial infections in the US, Japan, and Europe annually. Worldwide antibiotic revenues exceed $43 billion per year. In the US alone, approximately 2 million people acquire bacterial infections in hospitals each year, and 95,000 die as a result. About 70% of those infections are resistant to at least one of the major classes of antibiotics.

Synereca’s lead programs are advancing compounds that potentiate the effects of fluoroquinolones (such as Ciprofloxacin), and polymixins (such as Colistin) – antibiotic classes with over $7 billion in global sales annually. The use of Colistin in particular has increased, often being used as an antibiotic of last resort since it remains effective against life-threatening infections caused by multi-drug resistant gram-negative bacteria. Unfortunately, as Colistin use increases, resistant strains are now emerging.

About Synereca Pharmaceuticals, Inc.

Synereca Pharmaceuticals was founded to address the growing problem of bacterial resistance to current antibiotics by developing orally active drugs that restore or increase the effectiveness of existing antibiotics. Synereca has two lead research programs. The first focuses on compounds that potentiate the effectiveness of Colistin without enhancing toxicity. The Colistin potentiation program’s lead compound shifts the MIC of Colistin in multidrug resistant Acinetobacter baumanni at least 128-fold in vitro and has been shown to improve the potency of Colsitin in an in vivo preclinical model of infection caused by a Colistin-resistant strain of A baumanni. Synereca’s second program focuses on the inhibition of RecA, a key enzyme in bacterial DNA repair and the development and transmission of antibiotic resistance. Synereca’s protype RecA inhibitors potentiate the killing of a wide variety of pathogenic bacteria by a broad range of bactericidal antibiotics.

For additional information on Synereca, an Accele Biopharma portfolio company, please visit www.synereca.com.

About Accele Biopharma, Inc.

Accele Biopharma (“Accele”) and Accele Venture Partners 1 LP, a related special purpose venture fund, were formed to create a capital-efficient mechanism to identify, finance and manage groundbreaking, early-stage life science technologies that have the potential to dramatically improve human healthcare, have strong commercial promise and have the potential for generating early proof of concept data. To achieve this goal, Accele has assembled an experienced management team, a group of sophisticated investors, a nationally recognized advisory board, leading research facilities and the broad scientific expertise necessary to evaluate and manage such opportunities.

Founded in 2011, Accele is located on the University of Oklahoma Health Sciences Center Research Park in Oklahoma City.

For more information on Accele Biopharma, please visit www.accelebio.com.

About i2E, Inc.

With more than $40 million of investment capital under management, i2E focuses on serving companies in all phases of the business life cycle, from startups looking for their first round of capital all the way to established businesses seeking funding to expand their markets or products. They also are helping lead new business developments into the marketplace more efficiently and more quickly while providing guidance to bring more funding to Oklahoma’s researchers and entrepreneurs.

In the past year i2E launched several new initiatives that more quickly identify promising new technologies developed on state research campuses and working with new companies at the earliest stages of their development to identify a viable product and market. The Oklahoma Bioscience Association recently became part of i2E, a development that means they will carry on the organization’s mission of supporting and enhancing the biotechnology industry in Oklahoma. Through their proven business and venture development process, i2E turns ideas into successful enterprises.

For more information on i2E, Inc., please visit www.i2E.org.

CONTACTS:
Clayton Duncan
Accele Biopharma Inc.
(405) 319-8165
cduncan@accelebio.com

Sara Seagraves
I2E Inc.
(405) 813-2403
seagraves@i2E.org

Accele Venture Partners Invests $1 Million in Pamlico BioPharma for Fully-Human Monoclonal Antibodies for Infectious Disease and Cancer

Oklahoma City, OK – Pamlico BioPharma, Inc., a research-stage biopharmaceutical company committed to developing fully-human monoclonal antibody therapeutics and point-of-care diagnostics, announced a second closing of a $1.0 million convertible debt financing. Accele Venture Partners, the investing arm of life sciences accelerator Accele Biopharma, Inc., led the financing. Proceeds of the financing will be used to advance Pamlico’s research and development of fully-human monoclonal antibodies for infectious disease and cancer, particularly the company’s lead program in Streptococcus pneumoniae, called Pneumomab™.

Clayton Duncan, Accele Biopharma CEO, stated, “Accele is dedicated to supporting groundbreaking approaches to improve human healthcare. We believe Pamlico has an integral technology to enable programs for a wide range of infectious diseases and cancer using fully-human monoclonal antibodies. These products have the potential to address the growing need for novel approaches to treat life-threatening infections caused by drug resistant bacteria such as pneumococcal pneumonia, which affects more than 900,000 people in the U.S. alone each year.”

Pneumomab is targeted at S. pneumoniae, recently classified as a “Qualifying Pathogen” under FDA’s recent GAIN Act to accelerate development of anti-infectives. If PneumoMab is indeed registered as a “Qualified Infectious Disease Product,” it would confer Fast-Track status on the product, and an additional 5 years of market exclusivity.

About Streptococcus pneumoniae and Pneumococcal Pneumonia
In the United States and Europe, Community-Acquired Pneumonia (CAP) caused by SPN affects over 50% of the more than 5 million cases, 1.1 million hospitalizations, 170,000 ICU admissions, and 68,000 deaths annually, and is subject to increasing concern related to multi-drug (beta-lactam and macrolide) resistance strains. Severe SPN-related CAP (PSI grade IV-V) has a 20-40% mortality rate. Patients over 65 years old represent 65% of hospitalizations and over 90% of deaths from pneumonia, and vaccination rates in adult patients are under 60%, leaving more than 70 million US adults unvaccinated to SPN.

About Pamlico BioPharma, Inc.
Pamlico BioPharma develops fully-human monoclonal antibody (hmAb) therapeutics for the rapid diagnosis and treatment of infectious diseases and cancer. Pamlico’s lead program is focused on severe pneumonia caused by Streptococcus pneumoniae (SPN), and is in preclinical IND-directed activities for a mAb cocktail and a companion point-of-care (POC) diagnostic against three serotypes that account for over 40% of SPN infections. Pamlico was founded on technologies from the Oklahoma Medical Research Foundation (OMRF) and from Emory University, and is anticipated to enter clinical trials in late 2015.

For additional information please visit www.pamlicobio.com.

About Accele Biopharma, Inc. (Accele) and Accele Venture Partners I, LP (AVP)
Accele Biopharma, Inc., and Accele Venture Partners I, LP, a related special purpose venture fund, were formed to create a capital-efficient mechanism to identify, finance and manage groundbreaking, early-stage life science technologies that have the potential to dramatically improve human healthcare, have strong commercial promise and have the potential for generating early proof of concept data. To achieve this goal Accele has assembled an experienced management team, a group of sophisticated investors, a nationally recognized advisory board, leading research facilities and the broad scientific expertise necessary to evaluate and manage such opportunities. Founded in 2011, Accele is located on the University of Oklahoma Health Sciences Center Research Park in Oklahoma City.

For more information on Accele Biopharma, please visit www.accelebio.com.

Accele Venture Partners Announces Series A Financing of Otologic Pharmaceutics (OPI)

Financing to Support Entry of OPI’s Lead Product Candidate – NHPN-1010 – into Clinical Testing First Half of 2014

OKLAHOMA CITY, April 3, 2014 /PRNewswire/ — Accele Venture Partners, the investing arm of life sciences accelerator Accele Biopharma, Inc., announced today that it has co-led a $4.1 million Series A private equity financing of Otologic Pharmaceutics, Inc. (OPI), a development-stage biopharmaceutical company committed to developing and commercializing novel pharmacological solutions and approaches to treat hearing disorders. Accele Venture Partners co-led the Series A with i2E, Inc., a nationally recognized private not-for-profit corporation focused on growing innovative small businesses in Oklahoma. Other investors included the Oklahoma Life Science Fund. Proceeds of the Series A financing will be used to advance the development of OPI’s lead product candidate, NHPN-1010, for the treatment of noise-induced hearing loss (NIHL), which is expected to enter Phase 1 clinical testing in the first half of 2014.

In connection with the financing Accele Biopharma’s Chairman and CEO Clayton I. Duncan has been appointed as OPI’s CEO, replacing David Karlman in this position. Additional members of the OPI senior management team include: Richard Gammans, Ph.D., also of Accele Biopharma and recently appointed to the newly created positions of OPI’s Chief Operating Officer and Head of R&D; OPI Co-Founder and Chief Medical Officer Richard Kopke, M.D.; Company Co-Founder and Chief Science Officer Robert Floyd, Ph.D., and Kelle Jones, Vice President-Finance.

Mr. Duncan stated, “Accele is dedicated to supporting groundbreaking approaches to improve human healthcare, and we believe OPI’s programs have the potential to address substantial unmet needs for patients with hearing loss. Currently, there are no FDA-approved drugs on the market for hearing loss, and OPI’s lead product candidate, combining two well-characterized compounds, has shown promising activity in reducing hearing loss in IND-enabling preclinical studies. Applications may include hearing loss experienced by individuals in a number of occupations, such as construction and manufacturing, as well as those who have served our country in military service, in addition to hearing loss associated with cancer treatments, such as cisplatin.”

Mr. Duncan added, “I am excited to join the OPI team and also am grateful for the service of David Karlman and for the progress the Company has made in advancing its lead program toward the clinic.”

Mr. Duncan has over 20 years’ experience as a biopharmaceutical CEO, heading seven biopharmaceutical companies – Synereca Pharmaceuticals, Vindica Therapeutics, Ercole Biotech, Entegrion, Incara Pharmaceuticals Corporation, Sphinx Pharmaceuticals Corporation and CRX Medical. As a CEO, Mr. Duncan has raised over $150 million in venture and public capital markets, including two successful IPOs, and has built operational biopharmaceutical companies from initiation, negotiating seven R & D collaborations with major pharmaceutical and biotech companies and profitable exits through the sale of three biopharmaceutical companies.

Dr. Gammans has managed a broad array of product development activities, including market evaluation, clinical research, biometrics, regulatory affairs and manufacturing. He has extensive experience in supporting investor relations and business development efforts and more than 30 years’ experience in all aspects of drug R&D and scientific support of marketed products. He has contributed to the development and regulatory approval of seven new molecular entities with over 50 national marketing authorizations in Western Europe and North America, including seven approved United States NDAs.

About Hearing Loss

The World Health Organization estimates that more than 600 million individuals worldwide suffer from some form of hearing loss. Approximately 10% of Americans (22 million people) between ages 20 and 69 already may have suffered permanent damage to their hearing from excessive noise exposure. This exposure can occur in the workplace, in recreational settings, and at home. Noise-induced hearing loss is the single largest addressable cause of hearing loss problems. Cancer therapy-induced hearing loss also is a major addressable cause of hearing loss. Hearing loss costs the US up to $56 billion per year in lost productivity, retraining and health care for the hard of hearing.

About Otologic Pharmaceutics, Inc.

OPI’s lead product, HPN1010, an oral treatment for Acute Hearing Loss, is scheduled to enter clinical trials in 2014. Extensive pre-clinical research, done collaboratively through OMRF and HEI supported by nearly $ 5.4 million from the Department of Defense, has demonstrated the potential effectiveness of HPN1010 to treat Acute Noise Induced Hearing Loss (NIHL) by reducing acute damage and promoting healing and recovery of the injured cochlea. NIHL is a major cause of disability in the military and for workers in certain industry settings, including oil and gas extraction and refining, manufacturing, farming and others. OPI also plans to initiate studies on the use of HPN1010 to treat Cisplatin Induced Hearing Loss (CIHL). Cisplatin, a widely used cancer treatment, causes marked hearing loss in over 75% of the nearly 700000 patients treated each year.

See www.otologicpharmaceutic.com for additional information about HPN1010.

About Accele Biopharma, Inc.

Accele Biopharma (“Accele”) and Accele Venture Partners, a related special purpose venture fund, were formed to create a capital-efficient mechanism to identify, finance and manage groundbreaking, early-stage life science technologies that have the potential to dramatically improve human healthcare, have strong commercial promise and have the potential for generating early proof of concept data. To achieve this goal Accele has assembled an experienced management team, a group of sophisticated investors, a nationally recognized advisory board, leading research facilities and the broad scientific expertise necessary to evaluate and manage such opportunities.

Founded in 2011, Accele is located on the Oklahoma Health Sciences University Campus in Oklahoma City. For more information on Accele Biopharma, please visit www.accelebio.com.

About i2E, Inc.

With more than $40 million of investment capital under management, i2E focuses on serving companies in all phases of the business life cycle, from startups looking for their first round of capital all the way to established businesses seeking funding to expand their markets or products.

They also are helping lead new business developments into the marketplace more efficiently and more quickly while providing guidance to bring more funding to Oklahoma’s researchers and entrepreneurs.

In the past year they have launched several new initiatives that more quickly identify promising new technologies developed on state research campuses and working with new companies at the earliest stages of their development to identify a viable product and market.

The Oklahoma Bioscience Association recently became part of i2E, a development that means they will carry on the organization’s mission of supporting and enhancing the biotechnology industry in Oklahoma.

Through their proven business and venture development process, i2E turns ideas into successful enterprises.

For more information on i2E, Inc., please visit www.i2E.org.

CONTACTS:

Clayton I. Duncan
Accele Biopharma, Inc.
(405) 319-8165
cduncan@accelebio.com

Sara Seagraves
I2E Inc.
(405) 813-2403
seagraves@i2E.org

Accele Biopharma Announces Executive Management Team at Synereca Pharmaceutics (SPI)

Accele Venture Partners I LP invests $500,000 in SPI.

OKLAHOMA CITY, OK, February 26, 2014 — Accele Biopharma, Inc. (Accele), an accelerator of early-stage biotechnology companies, today announced that the Company has assumed the management of Synereca Pharmaceutics, Inc. (SPI) in conjunction with an investment of approximately $500,000 to advance SPI’s research programs to discover and develop novel antibiotic products to treat resistant gram-negative infections. The investment was made by Accele Venture Partners 1 LP, the investing arm of Accele Biopharma.

Clayton I. Duncan, Accele Biopharma’s Chairman and Chief Executive Officer, will serve as Chairman and Chief Executive Officer of Synereca. Mr. Duncan has over 20 years’ experience as a biopharmaceutical CEO, heading six companies – Vindica Therapeutics, Ercole Biotech, Entegrion, Incara Pharmaceuticals Corporation, Sphinx Pharmaceuticals Corporation and CRX Medical.

“According to the CDC and WHO, antibiotic resistance is an imminent public health crisis,” said Mr. Duncan. “We are excited about Synereca’s novel programs to help restore the effectiveness of antibiotics in fighting resistant gram-negative infections.”

Additional members of SPI’s executive management team include:

  • Scott Singleton, PhD, Associate Professor of Pharmacy and Division Vice Chair at the UNC Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill, will serve as SPI’s Chief Scientific Officer. Dr. Singleton’s laboratory at UNC focuses on the chemical biology of DNA metabolism as it relates to antibiotic resistance in bacterial pathogens.
  • Richard E. Gammans, PhD, will serve as SPI’s President and Chief Operating Officer. Dr. Gammans has more than 30 years’ experience in all aspects of drug R&D and scientific support of marketed products and has contributed to the development and regulatory approval of seven new molecular entities with over 50 national marketing authorizations in Western Europe and North America.
  • Kelle Jones, CPA, is SPI’s Chief Financial Officer. Ms. Jones has over 17 years of experience as an accountant or controller in a variety of business settings and previously spent nine years as senior accountant and then as site controller for Genzyme’s Oklahoma glycobiology research facility.
  • W. Bennett Love is SPI’s VP Business Operations. Mr. Love has held financial, strategic and general senior management positions in biotech companies since 1990.
  • Steven Bocckino PhD is SPI’s VP Pre-clinical Research. Dr. Bocckino has 20 years experience in the pharmaceutical industry and has held a variety of positions in drug discovery and development.

Synereca will maintain its current research facilities in Chapel Hill, NC. The Company’s corporate headquarters and additional research laboratories will relocate to the Accele Biopharma Inc. biotechnology accelerator facilities in Oklahoma City, OK.

About Synereca Pharmaceutics, Inc. (SPI)
SPI focuses on the discovery and development of compounds that increase or restore the effectiveness of existing antibiotics for infections caused by Gram-negative bacteria. SPI’s lead program focuses on inhibiting RecA-dependent SOS, the pathway primarily responsible for the bacteria’s abilities to escape antibiotic killing and to evolve resistance. Reducing or eliminating RecA activity in pathogenic bacteria allows the antibiotic to remain effective. SPI is also examining compounds that restore the effect of Colistin (polymyxin E) in bacterial strains that have become resistant to other frontline antibiotics. See www.synereca.com for additional information about SPI.

About Accele Biopharma, Inc.
Accele Biopharma (“Accele”) and Accele Venture Partners 1 LP, a related special purpose venture fund, were formed to create a capital-efficient mechanism to identify, finance and manage groundbreaking, early-stage life science technologies that have the potential to dramatically improve human healthcare, have strong commercial promise and have the potential for generating early proof of concept data. To achieve this goal Accele has assembled an experienced management team, a group of sophisticated investors, a nationally recognized advisory board, leading research facilities and the broad scientific expertise necessary to evaluate and manage such opportunities.

Founded in 2011, Accele is located on the Oklahoma Health Sciences University Campus in Oklahoma City. For more information on Accele Biopharma, please visit www.accelebio.com.

Cytovance Biologics, Inc. and Pamlico Biopharma Announce Development and cGMP Manufacturing Agreement

Oklahoma City, OK (February 18, 2014)– Cytovance Biologics, a leading full-service contract manufacturer (“CMO”) of mammalian and microbial biologics, announces that they have entered into a development and manufacturing agreement with Pamlico BioPharma, Inc., an Oklahoma City-based clinical stage biopharmaceutical company.

Pamlico BioPharma has developed a group of three human IgG monoclonal antibodies intended for the treatment of Streptococcus pneumoniae infections. Pamlico has contracted Cytovance Biologics as its CMO to develop a production cell line from the protein’s amino acid sequence for GMP manufacture of phase I clinical material.

“With this agreement, Pamlico BioPharma has reached a milestone in the development of a therapeutic antibody product for the treatment of Streptoccocus pneumoniae, a leading cause of Severe Community Acquired Pneumonia (SCAP) which can lead to hospitalization and death,” said Clayton Duncan, CEO of Pamlico BioPharma, Inc.

“Cytovance’s state-of-the-art facilities and experienced staff are prepared to deliver the highest quality of development and manufacturing services for Pamlico BioPharma,” said Darren Head, President and Chief Executive Officer of Cytovance Biologics. “We are delighted to be working with such an innovative company that uses technologies from the Oklahoma Medical Research Foundation and advance the treatment of Streptococcus pneumonia infections that are associated with over 50,000 deaths annually.”

About Pamlico BioPharma, Inc.
Pamlico Biopharma, Inc., an Accele Biopharma Inc. client company, was founded around human monoclonal antibody therapeutics and technologies from the Oklahoma Medical Research Foundation and from Emory University. PAMLICO focuses on human monoclonal antibody therapeutics for human pathogens, cancer and autoimmune diseases. The lead project will address SCAP caused by S pneumoniae. Pneumococcal pneumonia remains a major cause of morbidity and mortality worldwide.

About Accele Biopharma Inc.
Accele Biopharma (“Accele”) and Accele Venture Partners, a related special purpose venture fund, were formed to create a capital-efficient mechanism to identify, finance and manage groundbreaking, early-stage life science technologies that have the potential to dramatically improve human healthcare, have strong commercial promise and have the potential for generating early proof of concept data. To achieve this goal Accele has assembled an experienced management team, a group of sophisticated investors, a nationally recognized advisory board, research facilities and the broad scientific expertise necessary to evaluate and manage such opportunities.

Accele currently has four companies under management: Otologic Pharmaceutics, Inc. focusing on a clinical stage treatment for hearing loss; Pamlico Biopharma, Inc., focusing on human monoclonal antibody therapeutics for human pathogens, cancer and autoimmune diseases, with a lead project addressing pneumonia caused by S pneumoniae; Synereca Pharmaceuticals, Inc., developing novel drugs that inhibit the bacterial enzyme RecA to address the growing problem of antibiotic resistance; and Jortan Pharmaceuticals, Inc., pursuing the discovery and development of BACE-2 (Memapsin 1) inhibitors as a novel approach to the treatment of type 2 diabetes.
For further information regarding Accele Biopharma Inc. and Pamlico Biopharma, Inc., see http://www.accelebio.com

About Cytovance Biologics
Cytovance Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City state-of-the-art facilities.

Learn more about Cytovance Biologics at www.cytovance.com.

Media Contact
Jodie Gutkowski
Marketing/Communications Manager
jgutkowski@cytovance.com

Richard Gammans PhD
President and COO
Pamlico Biopharma Inc
rgammans@accelebio.com