Oragenics said that results from a toxicology study of its NT-CoV2-1 intranasal vaccine conducted in rabbits "confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study." In June 2022, the company published data from preclinical studies of NT-CoV2-1 in mice and hamsters … [Read more...] about Oragenics says no indication of toxicity for its NT-CoV2-1 intranasal vaccine candidate
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DDL 2022 looked to the future of OINDP development
In its return to the Edinburgh International Conference Centre after two years of online-only meetings, the Drug Delivery to the Lungs conference looked toward the future, focusing on scientific and technical innovations that will influence inhaled and nasal drug development for years to come. The meeting drew a record crowd, with approximately 130 virtual … [Read more...] about DDL 2022 looked to the future of OINDP development
Orgenesis and Kurve say preclinical study demonstrated that intranasal cell therapy reduced tumors by 50% in a mouse model of glioblastoma
Biotech Orgenesis and nasal delivery specialist Kurve Therapeutics have announced results from a preclinical study of an intranasal "cell-based oncolytic virus bearing product" in a mouse model of glioblastoma. Orgenesis says that it manufactured the product on behalf of "a premier cell therapy development company." According to the companies, delivery of the product … [Read more...] about Orgenesis and Kurve say preclinical study demonstrated that intranasal cell therapy reduced tumors by 50% in a mouse model of glioblastoma
Beckley Psytech initiates Phase 2a study of BPL-003 intranasal dry powder 5-MeO-DMT for treatment-resistant depression
According to Beckley Psytech, the company has initiated a Phase 2a study of its BPL-003 intranasal dry powder 5-MeO-DMT for the treatment of moderate-to-severe treatment-resistant depression. Beckley Psytech recently reported results from a Phase 1 study showing a dose proportional PK profile for BPL-003; that study also found that any consciousness-altering effects … [Read more...] about Beckley Psytech initiates Phase 2a study of BPL-003 intranasal dry powder 5-MeO-DMT for treatment-resistant depression
Aerami Therapeutics names Lisa Yañez as CEO
Aerami Therapeutics has announced that its current Chief Operating Officer Lisa Yañez will succeed Steve Thornton as CEO, effective January 1, 2023. Thornton will continue as a member of the Board of Directors. Prior to joining Aerami in June 2022, Yañez was VP of Global Strategic Marketing at Acceleron Pharma and previously held marketing positions at United … [Read more...] about Aerami Therapeutics names Lisa Yañez as CEO
SpliSense initiates Phase 1/2 trial of SPL84 inhaled antisense oligonucleotide for CF
Israel-based SpliSense said that it has initiated a Phase 1/2 trial of its SPL84 inhaled anti sense oligonucleotide for the treatment of cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has been granted Orphan Drug designation from both the EMA and the FDA. The company said that the SAD portion of the trial will evaluate SPL84 in healthy … [Read more...] about SpliSense initiates Phase 1/2 trial of SPL84 inhaled antisense oligonucleotide for CF
Vistagen announces agreement to acquire Pherin Pharmaceuticals
Vistagen, which is developing two pherine-based nasal sprays licensed from Pherin Pharmaceuticals (PH10 and PH94B), announced that it has reached an agreement to acquire Pherin and its entire pipeline. According to Vistagen, the deal includes ~12.4 million shares of the company's common stock as well as "a nominal amount of cash." PH10 was recently granted Fast … [Read more...] about Vistagen announces agreement to acquire Pherin Pharmaceuticals
Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine
Verona Pharma announced that the Phase 3 ENHANCE-1 trial of nebulized ensifentrine for the treatment of COPD met its primary endpoint, demonstrating an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 87 ml at week 12, as well as consistent improvement for all subgroups. Patients receiving ensifentrine also had a 36% lower rate of moderate to severe … [Read more...] about Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine
Formulated Solutions to expand its aerosol manufacturing capacity with acquisition of Tennessee facility
Florida-based CDMO Formulated Solutions announced that it has acquired a 455,000 sq ft production facility in Cleveland, TN, USA that includes two buildings fitted with pharmaceutical production and packaging lines for a variety of dose forms such as liquids, bag-on-valve aerosols, and nasal sprays. The Tennessee facility was most recently owned by German skincare … [Read more...] about Formulated Solutions to expand its aerosol manufacturing capacity with acquisition of Tennessee facility
Third Pole gets $32 million to support development of eNOcare inhaled nitric oxide device
Inhaled nitric oxide (iNO) delivery device developer Third Pole Therapeutics announced that it has received a $32 million equity investment "from a large medical device innovator." In February 2022, the company announced the closing of a $25 million financing. Chiesi acquired global rights to develop and commercialize Third Pole's tankless iNO technology in April … [Read more...] about Third Pole gets $32 million to support development of eNOcare inhaled nitric oxide device