Pamlico BioPharma, Inc. develops fully-human monoclonal antibody (hmAb) therapeutics for the rapid diagnosis and treatment of infectious diseases and cancer.
RAPIDmAb™ Technology – Fully Human Monoclonal Antibody Platform
Pamlico has licensed RAPIDmAb™ Technology platform based on a patented method for rapidly isolating and cloning fully-human monoclonal antibodies for infectious diseases. The RAPIDmAb platform leverages the natural “memory” response to isolate a broad range of high affinity antibodies to the target pathogen following vaccination or infection. This technology yields human monoclonal antibodies (hmAb) for use in diagnostics, vaccine reference standards, or targeted therapeutics, and offers the ability to move quickly as new threats or resistance emerge. In many cases, confirmation of antibody in vitro efficacy via opsonophagocytosis (OPA) titers offers a well-validated surrogate efficacy measure prior to initiation of in vivo testing. Other neutralization assays are also utilized where appropriate for confirmation. Pamlico is able to work with existing vaccines for antibody characterization, as well as partnering with vaccine companies during clinical development. Current RAPIDmAb antibody characterization activities completed, in process, or planned are:
|Pathogen Type||Completed||In Process/Planned|
|Viral||Influenza (H3N2, both A & B lineages)
S. aureus (MRSA)
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.
In the United States alone, 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. 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.
Pamlico’s lead program is a mixture of fully-human serotype-specific monoclonal antibodies, called PneumoMab™, for the treatment of severe community-acquired pneumococcal pneumonia (SPN-CAP). Pamlico has in hand antibodies for all 24 SPN serotypes currently vaccinated against and has selected for development three antibodies for serotypes that account for over 40% of infections and that are largely resistant to antibiotics. PneumoMab is in preclinical IND-directed toxicology activities. In animal models of pneumonia, Pamlico’s antibodies have repeatedly demonstrated reduced mortality. Clinical trials will be designed to show superiority versus standard of care antibiotics alone in the treatment of severe SPN-CAP (PSI grade IV-V). In parallel is development of a companion point-of-care (POC) lateral-flow diagnostic to identify patients eligible for PneumoMab within 20 minutes.
Since 1 in 5 hospitalizations for CAP are caused by the three strains of S. pneumoniae currently targeted by our therapeutic, PneumoMab’s POC diagnostic could be utilized across the 1 million
hospitalized patients as physicians work quickly to pinpoint the cause of pneumonia and treat an estimated 68k – 200k patients. Total US market is estimated to be $600M – $1.1B annually, with significant market expansion in the EU, Japan, and developing countries.
Pamlico’s mAb mixture is targeted at S. pneumoniae, recently classified as a “Qualifying Pathogen” under the GAIN Act. PneumoMab will be submitted to FDA as a “Qualified Infectious Disease Product,” which confers an additional 5 years of exclusivity Fast-Track status, for a total eligible market exclusivity of 12-17 years.