Peptilogics | January 11, 2022
Peptilogics, a biotech company that engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases, announced that the U.S. Food and Drug Administration as accepted the company's Investigational New Drug Application for PLG0206 to treat periprosthetic joint infection allowing the Phase 1b study to proceed.
Peptilogics will evaluate the safety and efficacy of PLG0206 in a Phase 1b open-label, dose-escalating study in patients undergoing debridement, antibiotics and implant retention surgery for the treatment of PJI occurring after total knee arthroplasty.
“PJI is a devastating condition with limited treatment options, since systemic antibiotics frequently fail to eliminate the infection and surgery to remove the infected hardware is then required. Based on our promising preclinical efficacy and healthy volunteer Phase 1 study data with PLG0206, we are excited to explore its safety and efficacy as a potential treatment for patients with PJI.”
Jonathan Steckbeck, Ph.D., Founder and CEO of Peptilogics
PLG0206 is an investigational broad-spectrum, anti-biofilm, anti-infective peptide therapeutic. The current standard of care for PJI includes numerous high-risk surgical procedures coupled with systemic antibiotic treatment, which are often ineffective due to device-associated biofilms. PLG0206 was designed with a unique mechanism of action that allows it to directly addresses biofilm bacteria and persistent pathogens that evade standard of care antibiotics by targeting and disrupting bacterial membranes to trigger bacterial cell death. PLG0206 has demonstrated best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of pathogens, regardless of resistance phenotype, identified by the World Health Organization and the Centers for Disease Control as critical, urgent or high priority targets. PLG0206 has previously been granted FDA Orphan Drug Designation for the treatment of PJI and has been designated as a Qualified Infectious Disease Product (QIDP) as well.
In December, Peptilogics announced the publication of two peer-reviewed studies on PLG0206. Data from a first-in-human Phase 1 study of PLG0206, published in Antimicrobial Agents and Chemotherapy, showed the investigational therapeutic was safe and well tolerated and has favorable pharmacokinetics when intravenously administered as a single dose. These data were presented in September at ID Week. Data from a clinical proxy study of PLG0206, published in Microbiology Spectrum, showed the investigational therapeutics’ ability to reduce bacteria on chronically infected prosthetic knee joints, which may translate to improved clinical outcomes.
About Periprosthetic Joint Infection (PJI)
More than one million total joint replacements are performed annually in the U.S., a number that is expected to grow to four million annual procedures by 2030 due to an aging and active population. Following joint replacement, 1-2% of patients will develop a PJI, a serious life-threatening condition which often necessitates continuous antibiotic usage and high-risk surgical procedures with limited ability to resolve the infection. The current standard of care has up to a 60% failure rate and results in a substantial number of patient deaths, evidenced by a 25% five-year mortality rate.
Peptilogics engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases. Through biological and pharmaceutical expertise, novel artificial intelligence algorithms, and purpose-built super-computing, Peptilogics is developing an extensive therapeutic pipeline and accelerating discovery efforts at a pace and scale that was previously impossible. Peptilogics is backed by visionary investors in life science and technology including Peter Thiel, Presight Capital, CARB-X, and Founders Fund.
Slate Bio | January 20, 2021
Slate Bio, Inc., reports the closing of a $1.75 million venture financing. Epidarex Capital drove the speculation round with cooperation from the UVA Licensing and Ventures Group Seed Fund, Center for Innovative Technology's GAP BioLife Fund, VTC Seed Fund, PharmaDirections, Inc., the board and others. Record is a pre-clinical biotechnology organization creating outlook changing IL-2 mixes dependent on examination directed at the University of Virginia School of Medicine. IL233, Slate's lead candidate, is a first in class drug that initiates constant abatement in animal models of autoimmune and inflammatory diseases.
Slate's IL233 is a bifunctional IL-2 combination cytokine that increases Regulatory T cells (Tregs) and tissue resident Tregs for autoimmune and provocative infections. IL233 joins the de-gambling certainty of IL-2 and the collaboration and toughness of IL-33. IL233 goes about as a pharmacological kick off to revive the body's inherent pathways to stop inflammation, end mal-adaptive repair and promote regeneration of damaged tissues to restore homeostasis.
Maravai Lifesciences | August 25, 2020
Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech innovators, is expanding its contract development and manufacturing organization (CDMO) capabilities at TriLink BioTechnologies for the second time in less than a year. The expansion is expected to be completed in the first quarter of 2021 and will increase TriLink's small molecule manufacturing capacity with a focus on additional scale-up of CleanCap®, its proprietary messenger RNA (mRNA) capping technology, for global mRNA vaccine and therapeutic programs. To further address the increasing demand for mRNA development and clinical programs, the company is currently completing the construction of its plasmid DNA production facility as well. Last November, TriLink opened their new headquarters in San Diego, CA and expanded mRNA and small molecule capacity as it opened five Current Good Manufacturing Practice (cGMP) suites. The current investment will further expand the operation with an additional three cGMP suites and four cGMP manufacturing support suites.