PGN

Longhorn Vaccines and Diagnostics Presents New Data on its Best-In-Class Infectious Disease Vaccine and Antibody Portfolio at ECCMID 2024

Retrieved on: 
Saturday, April 27, 2024
Science, Other Science, Research, Pharmaceutical, General Health, Health, Infectious Diseases, Other Health, Infection, Immunoglobulin G, PGN, University, Public, Hook effect, Coronavirus, Mouse, Gram-positive bacteria, Risk, ECCMID, MTB, Vaccine, Human, GA4, Immunodeficiency, Mycobacterium tuberculosis, Virus, Pig, Immune system, Antibody, Tuberculosis, Bird

Longhorn Vaccines and Diagnostics , a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, presented positive data from three key studies of its infectious disease franchise at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2024.

Key Points: 
  • Longhorn Vaccines and Diagnostics , a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, presented positive data from three key studies of its infectious disease franchise at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2024.
  • ECCMID is taking place online and in-person in Barcelona, Spain from April 27-30, 2024.
  • Longhorn’s vaccine and antibody product candidates focus on rapidly mutating viruses that include influenza, coronavirus, and antimicrobial resistant pathogens.
  • “We are very excited to present the first data from our universal influenza vaccine in pigs,” said Jeff Fischer, President Longhorn Vaccines and Diagnostics.

PepGen Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, March 6, 2024
CONNECT, SAD, Research, Dystrophin, Clinical trial, Food, DMD, Common, DM1, Safety, Health care, Patient, MHRA, Disease, Three Months, Male, IND, Enrollment, PGN, U.K, MBNL1, CTA, Medication, Pharmaceutical industry

BOSTON, March 06, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent corporate developments.

Key Points: 
  • “With important data readouts expected from our two lead programs, 2024 has the potential to be a transformational year for PepGen.
  • People with myotonic dystrophy type 1 (DM1) currently have no approved treatment options that target the root cause of the disease.
  • Financial Results for the Three Months and Twelve Months ended December 31, 2023
    Cash and cash equivalents were $110.4 million as of December 31, 2023.
  • Net loss was $78.6 million for the year ended December 31, 2023, compared to $69.1 million for the same period in 2022.

PepGen Receives U.S. FDA Fast Track Designation for PGN-EDODM1 for the Treatment of Myotonic Dystrophy Type 1

Retrieved on: 
Tuesday, February 20, 2024
Fast Track, FDA, Food, Drug development, Communication, DM1, Life expectancy, Patient, Disease, PGN, Plasma protein binding, Pharmaceutical industry

“Receiving Fast Track designation from the FDA for PGN-EDODM1 is a significant milestone in our efforts to deliver a potentially transformative therapy to the DM1 community,” said James McArthur, Ph.D., President and CEO of PepGen.

Key Points: 
  • “Receiving Fast Track designation from the FDA for PGN-EDODM1 is a significant milestone in our efforts to deliver a potentially transformative therapy to the DM1 community,” said James McArthur, Ph.D., President and CEO of PepGen.
  • Once a drug candidate receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and regulatory review process.
  • For more information about Fast Track designation, please visit the FDA website ( www.fda.gov ).
  • (ClinicalTrials.gov identifier: NCT06204809)
    The Company previously announced that the FDA granted Orphan Drug Designation to PGN-EDODM1 in September 2023.

PepGen Announces First Patient Dosed in Phase 1 FREEDOM-DM1 Clinical Trial of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)

Retrieved on: 
Monday, December 18, 2023
DM1, Patient, Safety, Food, PGN, SAD, Pharmaceutical industry

BOSTON, Dec. 18, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the first patient has been dosed in its Phase 1 clinical trial, FREEDOM-DM1, evaluating PGN-EDODM1 for the treatment of DM1.

Key Points: 
  • “We are pleased to announce we have dosed the first patient in our FREEDOM-DM1 clinical trial, which marks a significant milestone in our commitment to developing transformative therapies with potentially meaningful clinical outcomes for people living with DM1.
  • We anticipate proof-of-concept data in patients in 2024, including safety, transcript splicing and clinical outcome measures, at the 5 mg/kg PGN-EDODM1 dose level,” said James McArthur, Ph.D., President and CEO of PepGen.
  • Per the protocol, the dose will escalate from the starting dose of 5 mg/kg to 10 mg/kg and then 20 mg/kg.
  • Each dose escalation will be determined based upon evaluation of safety data from the prior dose cohorts.

Longhorn Vaccines and Diagnostics Presents Targeted Vaccine Approach for Mycobacterium Tuberculosis with LHNVD-301

Retrieved on: 
Wednesday, November 15, 2023
Science, Veterinary, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Clinical Trials, Pandemic, Peptide, MTB, Lung, Safety, Peptidoglycan, The Union, Serum, PGN, Immunoglobulin G, Risk, Gram-positive bacteria, Epitope, Staphylococcus aureus, ELISA, Infection, Staphylococcus, Staphylococcus epidermidis, Vaccine, Mycobacterium tuberculosis, Bacillus subtilis, Cell wall, AMR, Conference, Streptococcus, Virus, Antibody, Bacilli, Mycobacterium smegmatis, Tuberculosis, Public, TB, ICR, Bacteria, Longhorn, MD

Longhorn Vaccines and Diagnostics , a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, today presented new data from an animal study of LHNVD-301, the company’s lead tuberculosis vaccine candidate.

Key Points: 
  • Longhorn Vaccines and Diagnostics , a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, today presented new data from an animal study of LHNVD-301, the company’s lead tuberculosis vaccine candidate.
  • The data showed that a mycobacterium tuberculosis (MTB) vaccine could generate broader protection against other pathogens susceptible to antimicrobial resistance (AMR).
  • LHNVD-301 is an unconjugated, peptide-based vaccine that combines a MTB heat shock protein epitope and a peptidoglycan (PGN) epitope.
  • It represents a novel approach that combats AMR, while targeting tuberculosis by combining multiple epitopes specific to MTB and common to gram-positive bacteria into a peptide vaccine.

PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, November 8, 2023
DM1, FDA, Research, EDO, Clinical trial, Food, Three Months, Therapy, Health Canada, News, Conference, CTA, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Development, Clinical, BioCompute Object, PGN, Myotonia, Biology, Duchenne muscular dystrophy, Research and development, Letter, Safety, DMD, Patient, Administration, NHP, Investigational New Drug, Neuromuscular disease, Pharmaceutical industry, Cryptocurrency, Rare-earth element

BOSTON, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the third quarter ended September 30, 2023 and highlighted recent corporate developments.

Key Points: 
  • Orphan Drug Designation granted to PGN-EDODM1: In September 2023, the FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of DM1.
  • PepGen expects to report initial results from this study in 2024.
  • Financial Results for the Three Months Ended September 30, 2023
    Cash and cash equivalents were $129.5 million as of September 30, 2023, which is anticipated to fund currently planned operations into 2025.
  • PepGen had approximately 23.8 million shares outstanding on September 30, 2023.

PepGen Inc. Announces FDA has Lifted the Clinical Hold on its Investigational New Drug Application for FREEDOM-DM1 Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)

Retrieved on: 
Thursday, October 12, 2023
EDO, Food, DMD, RNA, PGN, Myotonia, IND, Safety, Lifting, Disease, FDA, SAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DM1, Patient, Dietary supplement, Pharmaceutical industry

BOSTON, Oct. 12, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold and cleared the Company’s Investigational New Drug Application (IND) to initiate the FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1) in the U.S.

Key Points: 
  • FREEDOM-DM1 is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study, designed to assess PGN-EDODM1 safety and tolerability, correction of mis-splicing of transcripts, and clinical functional outcome measures.
  • Sites in both the U.S. and Canada will evaluate PGN-EDODM1 in 3 cohorts of 5 mg/kg, 10 mg/kg, and 20 mg/kg dose levels.
  • The decision to advance to the next dose level will be contingent upon the evaluation of safety data derived from previous dose cohorts.
  • The Company continues to expect its cash and cash equivalents to be sufficient to fund currently planned operations into 2025.

PepGen Inc. Announces Clearance of CTA by Health Canada to Begin the FREEDOM-DM1 Phase 1 Study of PGN-EDODM1 in Patients with Myotonic Dystrophy Type 1

Retrieved on: 
Wednesday, September 6, 2023
Orphan Drug Act of 1983, Neuromuscular disease, PGN, Myotonic Dystrophy Foundation, NOL, NMD, DM1, Health Canada, CTA, SAD, Patient, FDA, Conference, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MDF, IND, Food, Safety, D.C, Disease, Pharmaceutical industry, Biology

In addition, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PGN-EDODM1 for the treatment of myotonic dystrophy type 1.

Key Points: 
  • In addition, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PGN-EDODM1 for the treatment of myotonic dystrophy type 1.
  • The FREEDOM-DM1 clinical trial is a randomized, placebo-controlled, single ascending dose (SAD) study, intended to enroll approximately 24 adult patients with DM1 to evaluate the safety and tolerability of PGN-EDODM1.
  • We expect to report initial results from this study in 2024,” said James McArthur, Ph.D., President and CEO of PepGen.
  • PepGen continues to work closely with the FDA to resolve the clinical hold in the United States as quickly as feasible.

PepGen Inc. Presents PGN-EDODM1 Preclinical Data Supporting the Company’s Enhanced Delivery Oligonucleotide Platform and PGN-EDODM1 Program at Two Medical Conferences

Retrieved on: 
Wednesday, September 6, 2023
Neuromuscular disease, PGN, Heart, Human, Myotonic Dystrophy Foundation, Duchenne muscular dystrophy, Therapy, NMD, DM1, Safety, Peptide, Cell, RNA, Duchenne, Myotonic dystrophy, Myotonia, EDO, DMD, Electrophysiology, NHP, Conference, MDF, Oligonucleotide, Potential, Disease, Pharmaceutical industry, Fine chemical, Tolerability, Pharmacokinetics, Biology

BOSTON, Sept. 06, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced key highlights from the upcoming presentation of preclinical non-human primate (NHP) data supporting PepGen’s proprietary Enhanced Delivery Oligonucleotide (EDO) platform at the 6th Ottawa International Conference on Neuromuscular Disease and Biology (NMD) being held on September 7-9, 2023 in Ottawa, ON, Canada, and at the 2023 Myotonic Dystrophy Foundation (MDF) Annual Conference being held on September 7-9, 2023 in Washington, D.C.

Key Points: 
  • Additionally, the presentation reported that EDO technology was also shown to improve in vivo nuclear delivery, with 72% of skeletal muscle nuclei in NHPs positive for oligonucleotide following two doses at 30mg/kg.
  • PepGen previously demonstrated that a single dose of 30 mg/kg of PGN-EDODM1 corrected myotonia in the DM1 HSALR mouse model as measured by electrophysiology.
  • Treatment emergent adverse events in this study at these dose levels were transient, mild (grade 1), and reversible and did not require intervention.
  • “We have previously demonstrated the ability of the EDO technology to deliver up to 50 nM of oligonucleotide to biceps in humans following a single dose.

PepGen Announces Presentations at the 2023 Myotonic Dystrophy Foundation Annual Conference, Ottawa Neuromuscular Disease Meeting, and H.C. Wainwright 25th Annual Global Investment Conference

Retrieved on: 
Friday, September 1, 2023
PGN, Event, DM1, Pharmacokinetics, Preclinical development, Poster, Conference, Safety, Pharmaceutical industry, D.C

Ashling Holland, Director of Preclinical Development at PepGen, will be giving a talk titled “PGN-EDODM1 nonclinical data demonstrated mechanistic and meaningful activity for the potential treatment of myotonic dystrophy type 1 (DM1)”, at the 2023 Myotonic Dystrophy Foundation Annual Conference, on September 9, 2023, in Washington, D.C.

Key Points: 
  • Ashling Holland, Director of Preclinical Development at PepGen, will be giving a talk titled “PGN-EDODM1 nonclinical data demonstrated mechanistic and meaningful activity for the potential treatment of myotonic dystrophy type 1 (DM1)”, at the 2023 Myotonic Dystrophy Foundation Annual Conference, on September 9, 2023, in Washington, D.C.
    PepGen will also be making three poster presentations at the 2023 Ottawa Neuromuscular Disease Meeting, being held September 7-9, 2023, in Ottawa, ON, Canada.
  • In addition, James McArthur, Ph.D., President and CEO of PepGen will present at the H.C. Wainwright 25th Annual Global Investment Conference on Monday, September 11th at 10:30am ET being held in New York.
  • The corporate presentation made at the H.C. Wainwright conference will be webcast live on the Events & Presentations section of the Investor Relations section of PepGen’s website.
  • Title: FREEDOM-DM1: Nonclinical data support the Phase 1 study design to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of PGN-EDODM1 in adults with myotonic dystrophy Type 1 (DM1)