Cystic fibrosis

Clarametyx Biosciences Announces $33M Series A Financing to Advance Anti-Biofilm Biologics for Serious Bacterial Infections

Retrieved on: 
Friday, January 5, 2024

(“Clarametyx”), a clinical stage company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the successful completion of a $33 million Series A round.

Key Points: 
  • (“Clarametyx”), a clinical stage company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the successful completion of a $33 million Series A round.
  • Clarametyx was launched in 2020 to advance a novel, immune-enabling antibody technology licensed from Nationwide Children’s Hospital.
  • The company is evaluating its anti-biofilm technology in both therapeutic and preventive settings to address the global challenge of persistent bacterial infection and antibiotic resistance.
  • “We graciously welcome our new investors and appreciate the continued commitment of our existing investors.

Sail Biomedicines Provides Update on Research with Cystic Fibrosis Foundation and Pioneering Medicines

Retrieved on: 
Friday, January 5, 2024

Sail Biomedicines, Inc., a Flagship Pioneering company and leader in RNA-based programmable medicines, today provided an update on its research funded by the Cystic Fibrosis Foundation (CF Foundation), with preclinical data that suggest that Sail’s Endless RNA™ (eRNA™) may offer the potential to treat the 10%-15% of people with CF for whom existing treatments are not an option.

Key Points: 
  • Sail Biomedicines, Inc., a Flagship Pioneering company and leader in RNA-based programmable medicines, today provided an update on its research funded by the Cystic Fibrosis Foundation (CF Foundation), with preclinical data that suggest that Sail’s Endless RNA™ (eRNA™) may offer the potential to treat the 10%-15% of people with CF for whom existing treatments are not an option.
  • Sail’s programmable eRNA platform is designed to enable the in vivo expression of any protein, potentially targeting any tissue.
  • Cystic fibrosis is a progressive, genetic disease caused by mutations in the CFTR gene that affect the lungs, pancreas, and other organs.
  • “We are extremely hopeful about the impact this work could have for the CF community.”
    “The collaboration between Pioneering Medicines and the Cystic Fibrosis Foundation aims to accelerate the path to potential treatments and cures for all people living with cystic fibrosis,” said Paul Biondi, President, Pioneering Medicines and Executive Partner, Flagship Pioneering.

BiomX Receives Orphan Drug Designation from the U.S. Food and Drug Administration for BX004 for the Treatment of Chronic Pulmonary Infection Caused by Pseudomonas aeruginosa in Patients with Cystic Fibrosis

Retrieved on: 
Thursday, January 4, 2024

and NESS ZIONA, Israel, Jan. 04, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that its phage cocktail, BX004, has been granted Orphan Drug Designation (“ODD”) by the United States Food and Drug Administration (“FDA”), for the treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”).

Key Points: 
  • and NESS ZIONA, Israel, Jan. 04, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that its phage cocktail, BX004, has been granted Orphan Drug Designation (“ODD”) by the United States Food and Drug Administration (“FDA”), for the treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”).
  • As a reminder, in August 2023, the FDA granted BX004 Fast Track designation for the treatment of chronic pulmonary infections caused by P. aeruginosa bacterial strains in patients with CF.
  • “We are pleased to announce that the FDA has granted BX004 Orphan Drug Designation, which underscores the pressing need to develop new and innovative treatment options for this vulnerable patient population,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • “Persistent and deadly pulmonary infections from P. aeruginosaremain a major source of morbidity and mortality for CF patients, andBX004 has been designed to address this significant unmet need.

First Wave BioPharma Chairman and CEO Issues Letter to Shareholders Highlighting Recent Accomplishments and Outlook for 2024

Retrieved on: 
Thursday, January 4, 2024

BOCA RATON, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman and CEO of First Wave BioPharma, has issued a Letter to Stockholders highlighting the Company’s recent accomplishments and plans for 2024.

Key Points: 
  • BOCA RATON, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman and CEO of First Wave BioPharma, has issued a Letter to Stockholders highlighting the Company’s recent accomplishments and plans for 2024.
  • The close of 2023 has been an exciting period for First Wave BioPharma, highlighted by the recently announced potential business combination with ImmunogenX.
  • The non-binding term sheet includes a low seven-figure payment to First Wave BioPharma along with economics related to future milestones and royalties.
  • 2024 has the potential to be a year of significant growth for First Wave BioPharma, and once again, I thank all of our stockholders for your continued support.

Cystic Fibrosis Rescued by Reprogramming the Cell’s Secretory Machinery

Retrieved on: 
Wednesday, January 3, 2024

Porosome Therapeutics, Inc. (Porosome Therapeutics) today announced the publishing of a study that brings promise for a cure to cystic fibrosis (CF).

Key Points: 
  • Porosome Therapeutics, Inc. (Porosome Therapeutics) today announced the publishing of a study that brings promise for a cure to cystic fibrosis (CF).
  • “We look forward to bringing such new, novel, safe, and curative treatments to market for people living with cystic fibrosis, diabetes, and other secretory disorders.”
    On December 9, 2023, the preprint entitled “ Reprogramming the Cells Secretory Machinery: A Cystic Fibrosis Rescue ” was published on bioRxiv.
  • Results demonstrate that mutation in porosome-associated CFTR also affects other proteins within the porosome secretory machine, thereby reducing mucus secretion.
  • “Our company research has aided in the ability to identify the critical role CFTR plays within the porosome secretory machinery.

4DMT and Arbor Biotechnologies Establish Partnership to Co-Develop and Co-Commercialize Next-Generation Genetic Medicines for CNS Diseases

Retrieved on: 
Wednesday, January 3, 2024

Arbor also has expertise in CNS biology, CNS drug development and CNS therapeutic development.

Key Points: 
  • Arbor also has expertise in CNS biology, CNS drug development and CNS therapeutic development.
  • 4DMT has utilized its platform to invent customized AAV vectors for CNS tissues, and these vectors will be deployed in the partnership.
  • “CNS disorders include some of the most devastating diseases, many of which have a genetic origin.
  • We look forward to combining our complementary technologies and capabilities to power a new generation of potential genetic medicines.

4DMT and Arbor Biotechnologies Establish Partnership to Co-Develop and Co-Commercialize Next-Generation Genetic Medicines for CNS Diseases

Retrieved on: 
Wednesday, January 3, 2024

Arbor also has expertise in CNS biology, CNS drug development and CNS therapeutic development.

Key Points: 
  • Arbor also has expertise in CNS biology, CNS drug development and CNS therapeutic development.
  • 4DMT has utilized its platform to invent customized AAV vectors for CNS tissues, and these vectors will be deployed in the partnership.
  • “CNS disorders include some of the most devastating diseases, many of which have a genetic origin.
  • We look forward to combining our complementary technologies and capabilities to power a new generation of potential genetic medicines.

Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), tobramycin, Date of authorisation: 18/02/2019, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), tobramycin, Date of authorisation: 18/02/2019, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), tobramycin, Date of authorisation: 18/02/2019, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor,ivacaftor, Date of authorisation: 31/10/2018, Revision: 13, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor,ivacaftor, Date of authorisation: 31/10/2018, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor,ivacaftor, Date of authorisation: 31/10/2018, Revision: 13, Status: Authorised

Sales Tips and Mindset Shifts: Klyn Elsbury Relaunches Website with a Brand Refresh and Upcoming Virtual Workshop

Retrieved on: 
Tuesday, December 5, 2023

Featured in hundreds of media programs and periodicals, including Forbes, NBC Nightly News with Lester Holt, and Success Magazine.

Key Points: 
  • Featured in hundreds of media programs and periodicals, including Forbes, NBC Nightly News with Lester Holt, and Success Magazine.
  • The Total Reset equips sales, high-performance, and leadership teams with tools to improve focus, productivity, and resilience.
  • Companies will spend time getting to know each other on a more intimate level and learning how to optimize the performance of their sales teams.
  • Visit Kyln’s website , klynelsbury.com, to learn more about her upcoming Virtual Workshop on Friday, December 15th, which is designed to help recruit salespeople and the 72 tour dates she’s already booked for 2024.