Pulmonary fibrosis

MannKind to Establish Boston-Area Research & Development Foothold and Expand Portfolio of Dry Powder Inhalation Technology in Transaction With Pulmatrix

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水曜日, 5月 29, 2024
Patient, Technosphere, Dihydroergotamine, Research and development, DHE, FDA, Migraine, Doctor of Pharmacy, DSM-IV codes, Cricket, Professional corporation, Idiopathic pulmonary fibrosis, Insulin, MannKind Corporation, Pulmonary fibrosis, NTM, IPF, ILD, PFF, Development, Pharmaceutical industry

The two companies also agreed that Pulmatrix will transfer its Bedford, Mass.

Key Points: 
  • The two companies also agreed that Pulmatrix will transfer its Bedford, Mass.
  • R&D facility to MannKind, along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory in non-cash transaction.
  • MannKind expects to consolidate its Boston presence by transitioning its Marlborough staff into the newly renovated, fully outfitted R&D facility in Bedford.
  • To maintain continuity of iSPERSE platform knowledge, MannKind plans to hire some members of current Pulmatrix R&D staff.

Avalyn Presents Clinical Data on AP01 for Pulmonary Fibrosis, Including Long-Term Efficacy and Imaging Biomarker Data, at ATS 2024

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月曜日, 5月 20, 2024
Lazarus, Rash, Patient, Diarrhea, Theme, Data, Risk, FVC, Nausea, PPF, FCCP, Disease, Safety, Poster, Conference, American Thoracic Society, Efficacy, Idiopathic pulmonary fibrosis, Indigestion, Pulmonary fibrosis, Biomarker, ATLAS, ATS, B48, Fatigue, IPF, WRVS, Vomiting, Pharmaceutical industry

CAMBRIDGE, Mass., May 20, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Avalyn), a clinical-stage biopharmaceutical company focused on development of inhaled therapies for treatment of life-threatening pulmonary diseases, today presented clinical data for AP01, its novel formulation of inhaled pirfenidone, for the treatment of pulmonary fibrosis, supporting the Company’s planned Phase 2b trial in patients with progressive pulmonary fibrosis (PPF). Analysis from Avalyn’s ongoing ATLAS open-label extension study demonstrated that treatment with AP01 stabilized forced vital capacity (FVC) in patients with both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), with enhanced safety and tolerability compared to oral pirfenidone. Furthermore, findings from post-hoc analyses examining disease progression and Brainomix’s e-Lung biomarker scores support the Company’s selected dosing of 100 mg twice-daily and 50 mg twice-daily in the planned Phase 2b study.

Key Points: 
  • The data were presented in multiple poster presentations and featured events during the 2024 American Thoracic Society (ATS) International Conference held May 17-22, 2024, in San Diego, CA.
  • “Having dedicated decades to treating patients with respiratory diseases, I’ve seen firsthand the pressing need for new treatments.
  • Our excitement stems from the long-term data with AP01 that shows treatment of patients out to nearly four years, surpassing the average survival rates for patients with progressive disease.
  • These data support Avalyn’s selection of AP01 100 mg twice-daily and 50 mg twice-daily for the Company’s planned Phase 2b clinical trial.

New Phase 2a Clinical Trial Results Demonstrate Endeavor BioMedicines’ ENV-101 Improved Lung Function and Reversed Key Measures of Lung Fibrosis in Patients With Idiopathic Pulmonary Fibrosis

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日曜日, 5月 19, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Taste, Patient, Physical examination, Spasm, Lung, Vital signs, American Thoracic Society, PPF, University, TLC, Disease, Conference, University of Southern California, Idiopathic pulmonary fibrosis, QLF, Pulmonary fibrosis, ATS, IPF, Pharmaceutical industry

Endeavor BioMedicines, a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, announced results from a completed Phase 2a clinical trial that demonstrate the company’s lead investigational candidate, ENV-101, improved lung function and reversed key measures of lung fibrosis in patients with idiopathic pulmonary fibrosis (IPF) over a 12-week period.

Key Points: 
  • Endeavor BioMedicines, a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, announced results from a completed Phase 2a clinical trial that demonstrate the company’s lead investigational candidate, ENV-101, improved lung function and reversed key measures of lung fibrosis in patients with idiopathic pulmonary fibrosis (IPF) over a 12-week period.
  • They slow the decline of lung function, but do not stop or reverse it, and they have tolerability issues that limit their long-term use in most patients.
  • In ENV-101-treated patients, 80% experienced an increase in TLC while 70% of patients who received placebo showed a decrease in TLC.
  • Endeavor BioMedicines recently announced the closing of a $132.5 million Series C financing that will support clinical development of ENV-101 in IPF and PPF.

Therapeutic Solutions International Receives Notice of Allowance for Landmark Patent Covering Cellular Therapy of Lung Diseases

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木曜日, 5月 16, 2024
Science, Stem Cells, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, COVID-19, Patent, FDA, Sale, Regeneron Pharmaceuticals, Traction, Stem cell, Pulmonary fibrosis, COPD, Precigen, Inflammation, TSOI, History, Pharmaceutical industry

Additionally, the Company has filed a Phase I/II clinical trial for COPD and possesses preclinical data for pulmonary fibrosis.

Key Points: 
  • Additionally, the Company has filed a Phase I/II clinical trial for COPD and possesses preclinical data for pulmonary fibrosis.
  • “We anticipate significant value in the current patent based on other companies working in the area of T regulatory cells.
  • “At Therapeutic Solutions International we are building a critical mass of clinical data, scientific discoveries, and patents4,” said Timothy Dixon, President, and CEO of the Company and co-inventor.
  • “We believe we are developing significant traction which will result in partnerships and co-development deals.”

Gyre Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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木曜日, 5月 9, 2024
FDA, Idiopathic pulmonary fibrosis, Common, Chronic obstructive pulmonary disease, Safety, Republic, Food, Ocean gyre, IPF, Research, IND, NASH, Pulmonary fibrosis, Patient, CHB, Quarter, Toxicity, Marketing, Clinical trial, Fatty liver disease, Therapy, GAAP, SAN, Orthostatic hypertension, COPD, Pharmaceutical industry

SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced financial results for the first quarter ended March 31, 2024, and provided a business update.

Key Points: 
  • In October 2023, Gyre Pharmaceuticals completed enrollment of its Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC.
  • Gyre expects to file an investigational new drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) by the end of 2024.
  • Financial Results for the Quarter Ended March 31, 2024
    Revenues: For the three months ended March 31, 2024, revenues were $27.2 million as a result of Gyre’s indirect controlling interest in Gyre Pharmaceuticals.
  • Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
    Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

Surrozen Provides First Quarter 2024 Financial Results and Business Update

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水曜日, 5月 8, 2024
Respiratory Research, Telecanthus, Liver disease, Boehringer Ingelheim, Publication, Research, Partnership, Development, Administration, ARVO, Therapy, Pulmonary fibrosis, Retina, Patient, Liver, Eye, Fibrosis, Regeneration, SWAP

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today provided first quarter 2024 financial results and business updates.

Key Points: 
  • Financial Results for the First Quarter Ended March 31, 2024
    Cash Position: Cash and cash equivalents were $27.3 million as of March 31, 2024, compared to $36.0 million as of December 31, 2023.
  • However, inclusive of proceeds from a financing completed in April 2024, the proforma cash for March 31, 2024 would be $43.2M.
  • Restructuring: Restructuring charges for the first quarter ended March 31, 2024 were zero, as compared to $1.2 million for the same period in 2023.
  • Net Loss: Net loss for the first quarter ended March 31, 2024 was $8.8 million, as compared to $14.3 million for the same period in 2023.

Carisma Therapeutics Presents Preclinical Proof of Concept Data Demonstrating the Anti-Fibrotic Potential of Engineered Macrophages at ASGCT 2024

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水曜日, 5月 8, 2024
Doctor of Philosophy, Cell, IL10, Pulmonary fibrosis, Cirrhosis, Liver, Doctor of Pharmacy, Society, Gene, Fibrosis, Macrophage, Lung, CARM, Therapy, Bleomycin, MASH, Medical imaging

PHILADELPHIA, May 8, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced new data demonstrating preclinical proof of concept using engineered anti-fibrotic macrophages for the treatment of liver fibrosis. The data was presented in a poster session at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting on May 8, 2024, in Baltimore, MD.

Key Points: 
  • PHILADELPHIA, May 8, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM ) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced new data demonstrating preclinical proof of concept using engineered anti-fibrotic macrophages for the treatment of liver fibrosis.
  • The data was presented in a poster session at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting on May 8, 2024, in Baltimore, MD.
  • "The data, from two independent models, demonstrate that engineered macrophages trafficked to fibrotic tissues, expressed genetically encoded disease-modifying payloads, and significantly reduced fibrosis in the liver.
  • In the presentation titled "Genetically Engineered Macrophage Cell Therapy Reverses Liver and Lung Fibrosis in Preclinical Models," Carisma presented preclinical proof-of-concept data for engineered macrophage cell therapy in liver fibrosis.

Endeavor BioMedicines Raises $132.5 Million Oversubscribed Series C Financing to Advance Pipeline of Transformational Medicines

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水曜日, 4月 24, 2024
Biotechnology, Health, Oncology, Clinical Trials, Idiopathic pulmonary fibrosis, PPF, ATS, HER3, IPF, Conference, Matrix, Entrepreneurship, ADC, Senior, Pulmonary fibrosis, Patient, Associate, Neoplasm, Symbiosis, Toxicity, American Thoracic Society, Series, Cancer, Spacecraft

Endeavor BioMedicines, Inc. (“Endeavor”), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced the closing of a $132.5 million Series C financing, including the conversion of a $5 million convertible instrument.

Key Points: 
  • Endeavor BioMedicines, Inc. (“Endeavor”), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced the closing of a $132.5 million Series C financing, including the conversion of a $5 million convertible instrument.
  • Endeavor plans to initiate a Phase 2b trial in patients with IPF and in parallel a cohort of patients with PPF in 2024.
  • “Endeavor BioMedicines’ novel drug candidates have the potential to disrupt the underlying mechanisms that cause serious, life-threatening diseases,” said Karan Takhar, Senior Managing Director at Matrix, who will join Endeavor BioMedicines’ Board of Directors as part of the Series C financing.
  • “I look forward to collaborating with Endeavor BioMedicines’ executive team and other members of the board to support the company’s clinical execution as it pursues significant milestones in 2024 and beyond.”

United Therapeutics to Feature Clinical Data Across its Commercial and Development Portfolio at the American Thoracic Society 2024 International Conference

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火曜日, 4月 16, 2024
Biotechnology, Pharmaceutical, Health, Cardiology, Rationale, University, Idiopathic pulmonary fibrosis, ATSF, ATS, Pulmonary hypertension, Route of administration, High Risk, PAH, Conference, Research, Electronic health record, Idiopathic disease, Orthostatic hypertension, University of North Carolina, Intelligence, Data, Pulmonary fibrosis, UTHR, Treatment, Doctor of Pharmacy, Inova Fairfax Hospital, University of Lagos, Prevalence, University of Florida, Creativity, American Thoracic Society, Medicine, PBC, Therapy, Theme, Incident, Pharmaceutical industry

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent research across its commercial and development portfolio will be presented at the American Thoracic Society (ATS) International Conference in San Diego on May 17-22, 2024.

Key Points: 
  • United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent research across its commercial and development portfolio will be presented at the American Thoracic Society (ATS) International Conference in San Diego on May 17-22, 2024.
  • At ATS, United Therapeutics will host an educational industry theater on implementing treprostinil induction strategies in pulmonary hypertension, and the company is sponsoring the ATS 2024 Women’s Forum.
  • “We look forward to presenting the latest data on several of our key products and development programs,” said Andrew Nelsen, PharmD, Vice President, Global Medical Affairs at United Therapeutics.
  • We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC).

Gordian Biotechnology Introduces High-Throughput In Vivo Screening Platform to Discover Therapies and Better Predict Human Outcomes for Age-Related Diseases

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金曜日, 4月 26, 2024
Founders Fund, FDA, OA, Patient, Horse, Cell, Notifiable disease, Animal, OARSI, Osteoarthritis Research Society International, Infection, Entrepreneurship, Research, Pathology, Artificial intelligence, Disease, Human, Novartis, Therapy, Ageing, Pulmonary fibrosis, Osteoarthritis, Gene, Biology, Drug discovery, Longevity, World Congress, MASH, Heart failure, Pharmaceutical industry

SAN FRANCISCO, April 26, 2024 /PRNewswire/ -- Gordian Biotechnology, an in vivo drug discovery and development company, today announced its platform that enables patient predictive, in vivo screening of hundreds of gene targets for FDA-recognized diseases of aging at a scale never before possible.

Key Points: 
  • Gordian's Osteoarthritis (OA) program has screened hundreds of therapies in horses that acquired OA naturally and advanced dozens of therapies into human ex vivo validation studies.
  • In proof of concept experiments during initial development, Gordian introduced a pooled library of 50 gene therapies into a mouse model of metabolic-associated steatohepatitis (MASH).
  • The therapies were evaluated using the company's proprietary in vivo screening platform, which successfully recapitulated 13 out of 16 clinical outcomes for targets where clinical data exists.
  • Mosaic Screening™ is pooled in vivo screening that tests hundreds of therapies simultaneously in a single sick animal, the Patient Avatar.