TFF Pharmaceuticals announced the Cleveland Clinic Florida will perform additional preclinical studies of 3 dry powder hemagglutinin antigen/adjuvent vaccine candidates produced under a 2023 SBIR grant to TFF for preclinical development of a dry powder pan-influenza vaccine formulation for inhaled and/or nasal delivery. The vaccine developed in Ted Ross's lab at the … [Read more...] about Cleveland Clinic to perform additional preclinical testing of dry powder universal flu vaccine candidates formulated with TFF technology
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Inimmune announces results from Phase 1b trial of INI-2004 intranasal TLR4 agonist
According to Inimmune, a Phase 1b trial of its INI-2004 TLR4 agonist in people with allergic rhinitis demonstrated dose dependent reduction of nasal congestion compared to placebo in a ragweed challenge test, with a reduction of 53% for the highest dose. The company also said that all doses were well tolerated, with no difference in adverse events between the INI-2004 … [Read more...] about Inimmune announces results from Phase 1b trial of INI-2004 intranasal TLR4 agonist
EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
EVŌQ Bio said that it had positive feedback from the FDA following a pre-IND meeting about EVQ-218 inhaled non-ionic silver nanoparticle, which the company is developing for the treatment of pulmonary bacterial infections in cystic fibrosis patients with funding from the Cystic Fibrosis Foundation. According to parent company EVŌQ Nano's web site, an IND submission … [Read more...] about EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
DPI developers Iconovo have announced plans to develop inhaled GLP-1 receptor agonists for the treatment of obesity and, potentially, related metabolic diseases. The company says that it plans to conduct preclinical proof-of-concept studies itself and then will look to out-license the inhalers. As part of its efforts in this area, the company said that it had filed "a … [Read more...] about Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
Bespak and DevPro developing HFO-1234ze albuterol MDI
CDMO Bespak and DevPro Biopharma have revealed their partnership on development of DevPro's DP007 albuterol MDI, which is formulated with Honeywell's Solstice Air HFO-1234ze(E) propellant. According to the companies, DP007 is expected to provide a lower global warming potential alternative to Ventolin HFA MDI. Bespak and DevPro say that they plan to initiate clinical … [Read more...] about Bespak and DevPro developing HFO-1234ze albuterol MDI
Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
Gossamer Bio and Chiesi Farmaceutici have partnered to develop and commercialize Gossamer's seralutinib inhalation powder for the treatment of pulmonary hypertension, the companies announced. Chiesi, which will get 50% of US commercial profit and ex-US rights to seralutinib, will pay Gossamer $160 million for development reimbursement; up to $146 million in regulatory … [Read more...] about Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
MannKind announces plans for Phase 1 study of MNKD-201 nintedanib DPI
MannKind Corporation says that it will move ahead with a Phase 1 SAD/MAD study of MNKD-201 dry powder nintedanib for inhalation, which the company is developing for the treatment of fibrotic diseases of the lung, including idiopathic pulmonary fibrosis (IPF). The trial is expected to begin enrolling healthy volunteers in June 2024. MannKind CEO Michael Castagna … [Read more...] about MannKind announces plans for Phase 1 study of MNKD-201 nintedanib DPI
FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM
MannKind Corporation announced that the FDA has cleared the company's IND for the ICoN-1 Phase 3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). The company said that it expects to initiate the study in the US by mid-2024 and elsewhere by the end of the … [Read more...] about FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM
FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
According to ENA Respiratory, the FDA has cleared the company's IND for a Phase 1b study of a dry powder formulation of INNA-051, a TLR2/6 agonist, which the company has been developing as a pan-viral nasal spray. ENA said that it expects the study to begin in mid-2024. Development of the dry powder formulation is partially funded by the US Department of Defense … [Read more...] about FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
Krystal Biotech initiates Phase 1 trial of inhaled KB707 gene therapy in patients with solid lung tumors
Krystal Biotech has announced the initiation of the KYANITE-1 Phase 1 trial of inhaled KB707 gene therapy in patients with advanced solid lung tumors. Inhaled KB707 received Fast Track designation from the FDA for this indication earlier this year. The open-label KYANITE-1 dose escalation and dose expansion study is expected to enroll 80 patients who will received … [Read more...] about Krystal Biotech initiates Phase 1 trial of inhaled KB707 gene therapy in patients with solid lung tumors