Category Archives: Pamlico

Pamlico BioPharma Elects Dr. Mark Corrigan to Its Board of Directors

Pamlico BioPharma, Inc., a research-stage biopharmaceutical company developing fully human monoclonal antibody (hmAb) therapeutics and diagnostics for infectious disease and cancer, announced today the election of Mark H. N. Corrigan, M.D., to the Company’s Board of Directors.  Dr. Corrigan is a seasoned life sciences executive with broad operational and clinical development experience at leading pharmaceutical and biotechnology companies.  His election to the Pamlico Board is effective immediately.

“Mark brings extensive experience in clinical research and development of novel therapeutic agents that have successfully navigated clinical testing and FDA filing,” stated Clayton Duncan, Pamlico’s Chairman and CEO.  “His knowledge, combined with his experience in guiding the growth of biopharma companies, will be vital as we continue to advance our lead programs through development and into clinical testing.”

Pamlico’s lead clinical program, PneumomAb™, consists of serotype-specific human monoclonal antibodies against the predominant serotypes of Streptococcus pneumoniae (SPN) that account for over 70% of SPN infections.  PneumomAb™ is currently in preclinical activities for both hmAb therapeutics and a companion point-of-care (POC) diagnostic for severe community-acquired pneumococcal pneumonia (SPN-CAP) and is anticipated to enter clinical testing in 2016.  Pamlico is pursuing additional hard-to-treat infections using its RAPIDmAb™ platform, and the Company expects to announce further progress on its programs through 2015 and into 2016.

Dr. Corrigan commented, “I am excited to work with the leadership team at Pamlico and to contribute to their mission of addressing important pathogens with significant unmet clinical needs.  The Company has demonstrated strong preclinical evidence that their RAPIDmAb™ platform offers an important therapeutic option for hard-to-treat diseases, while dramatically reducing costs and improving the speed of antibody discovery.  I look forward to the progress of their lead program as it enters the clinic next year.”

About Dr. Mark Corrigan

Dr. Corrigan is the former President and Chief Executive Officer of Zalicus, Inc., which in 2014 merged with EPIRUS Biopharmaceuticals, a developer of biosimilar agents for global markets.  He currently serves as Chairman of EPIRUS’ Board.  Previously, Dr. Corrigan was Executive Vice President of Research and Development at the specialty pharmaceutical company Sepracor Inc., and prior to this, he spent 10 years with Pharmacia & Upjohn, most recently as Group Vice President of Global Clinical Research and Experimental Medicine.  Before entering the healthcare industry, Dr. Corrigan was in academic research at the University of North Carolina at Chapel Hill School of Medicine, where he maintains a faculty appointment as Adjunct Professor in the Psychiatry Department.  Dr. Corrigan served on the Board of Directors for Cubist Pharmaceuticals, chairing the Scientific and Clinical Oversight Committee, and of Avanir Pharmaceuticals prior to these companies’ acquisitions by Merck and Otsuka Holdings, respectively. Dr. Corrigan presently serves on the Board of Cardiome Pharma and Synereca Pharmaceuticals.  Dr. Corrigan holds an M.D. from the University of Virginia and received specialty training in psychiatry at Maine Medical Center and Cornell University.

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 has used its proprietary RAPIDmAb platform to isolate high-affinity antibodies to all 24 vaccine serotypes of Streptococcus pneumoniae, influenza, Varicella zoster, rabies virus, and other infectious diseases, with a speed and cost advantage unprecedented in antibody discovery. Pamlico’s lead program is focused on severe pneumonia caused by S. pneumoniae (SPN) and is developing hmAb therapeutics and a companion point-of-care (POC) diagnostic against the predominant serotypes that account for over 70% of SPN infections in pneumococcal community-acquired pneumonia. Pamlico and a major international health authority are collaborating on a laboratory diagnostic for serotype-surveillance of pneumococcal infection. Additional discovery programs are underway for Hepatitis B, human papillomavirus, tuberculosis, and other infectious disease and cancer targets. Pamlico was founded on technologies from the Oklahoma Medical Research Foundation (OMRF) and Emory University, and its first program is anticipated to enter clinical trials in 2016. For additional information, please visit www.pamlicobio.com.

Pamlico BioPharma Announces Financing Led by Accele Venture Partners

Financing to Support Research and Development of Pamlico’s Lead Clinical Candidate  Pneumomab™ — for the Treatment of Streptococcus pneumoniae Infections and Human Antibody Discovery Platform for Infectious Disease

OKLAHOMA CITY, April 28, 2015 /PRNewswire/ — Pamlico BioPharma, Inc., a research-stage biopharmaceutical company developing fully human monoclonal antibody (hmAb) therapeutics and point-of-care diagnostics, announced today a $2.2 million Series A equity financing led by Accele Venture Partners, the investing arm of life sciences accelerator Accele Biopharma, and the Oklahoma Seed Capital Fund, managed by i2E, Inc. Proceeds of the Series A financing will be used to advance Pamlico’s research and development of human antibody therapeutics and diagnostics for infectious diseases and cancer. Pamlico’s lead clinical candidate, PneumomAb™, is a mixture of serotype-specific human monoclonal antibodies against Streptococcus pneumoniae (SPN). PneumomAb™ is in preclinical development for the treatment of severe community-acquired pneumococcal pneumonia (SPN-CAP).

Clayton Duncan, Pamlico’s Chairman and CEO, stated, “We are very pleased with the progress of Pamlico and the additional support of our investors in the Series A financing.  Currently we have one candidate, PneumomAb™, poised to enter clinical testing in 2016, and we are pursuing additional discovery and antibody isolation programs in important infectious diseases such as Hepatitis B, tuberculosis, human papillomavirus (HPV), and others. Pamlico’s proprietary RAPIDmAb™ technology platform leverages the natural “memory” immune response to yield high-affinity, neutralizing hmAbs with broad application for infectious disease. These antibodies are useful in the laboratory as reagents in manufacturing and diagnostics, and in the clinic as point-of-care diagnostics and targeted therapeutics. We have strong preclinical evidence that antibody therapeutics can be an important therapeutic option in pneumococcal pneumonia. If we can reproduce that in the clinic, PneumoMab™ could address at least two-fifths of pneumococcal infections, particularly for patients with moderate-to-severe community-acquired pneumococcal pneumonia that causes 500,000 hospitalizations of adults over 65 in the U.S. each year.”

Pamlico will continue to pursue multiple infectious disease targets using the RAPIDmAb™ platform, addressing a number of additional, hard-to-treat infections and expect to announce further programs through 2015 and into 2016.  Mr. Duncan continued, “Our goal is to address important pathogens with unmet clinical needs using human antibody diagnostics and therapeutics. Antibodies have established products for auto-immune and cancer indications, and now the stage is set for antibodies to show they can do the same for infectious diseases. RAPIDmAb™ is a valuable discovery platform that allows us to go after multiple targets with dramatically reduced cost and improved speed compared to other antibody platforms.”

About Streptococcus pneumoniae and Pneumococcal Pneumonia

In the United States and Europe, Community-Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (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. SPN-CAP hospitalizes over 500,000 adults over 65 in the U.S. each year. S. pneumoniae is classified as a “Qualifying Pathogen” under the recent GAIN Act to accelerate development of anti-infectives. PneumoMab™ may qualify as a “Qualified Infectious Disease Product,” which can confer Fast Track status on the product and an additional five years of market exclusivity from the Food and Drug Administration (FDA).

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 isolated antibodies to all 24 vaccine serotypes of Streptococcus pneumoniae, influenza, varicella zoster, and rabies virus. Pamlico’s lead program is focused on severe pneumonia caused by Streptococcus pneumoniae (SPN). and is in IND-enabling studies for a mAb cocktail and a companion point-of-care (POC) diagnostic against three serotypes that account for over 40% of SPN infections in pneumococcal CAP. Additional discovery programs are underway for Hepatitis B, tuberculosis, human papillomavirus, and other ID targets. Pamlico was founded on technologies from the Oklahoma Medical Research Foundation (OMRF) and from Emory University, and its first program is anticipated to enter clinical trials in 2016. For additional information please visit www.pamlicobio.com.

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.

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