Drug & Device Pipeline News

October 24, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Biomea Fusion	BMF-219	KRAS solid tumors	IND approved by the FDA
Decibel Therapeutics	DB-OTO	Congenital hearing loss due to an otoferlin deficiency	IND approved by the FDA
NKGen Biotech	SNK02	Solid tumors	IND approved by the FDA
Phanes Therapeutics	PT217	Small cell lung cancer and other neuroendocrine cancers	IND approved by the FDA
Prelude Therapeutics	PRT3789	Advanced solid tumors in biomarker-selected patients	IND approved by the FDA
Vitti Labs	EV-Pure	Primary ovarian insufficiency	IND approved by the FDA
Zhiyi Biotechnology	SK10	Chemotherapy-induced diarrhea	IND approved by the FDA
Alterity Therapeutics	ATH434	Multiple system atrophy	Approval for a phase 2 trial granted by Australia’s regulatory authority
Akeso Bio	Ivonescimab plus drebuxelimab	Advanced solid tumors	Approval for a phase 1/2 trial granted by China’s regulatory authority
Telix Pharmaceuticals	TLX591-CDx	Imaging of prostate cancer	Approval for a phase 3 trial granted by China’s regulatory authority
Clairvoyant Therapeutics	Psilocybin	Alcohol use disorder	Approval for a phase 2 trial granted by Finland’s regulatory authority
Trials Initiated
atai Life Sciences	INB-01	Central nervous system	Initiation of phase 1 trial
Attralus	AT-02	Systemic amyloidosis	Initiation of phase 1 trial
Enanta Pharmaceuticals	EDP-323	Respiratory syncytial virus	Initiation of phase 1 trial
Harbour Biomed	HBM7008	Solid tumors	Initiation of phase 1 trial
Instil Bio	ITIL-306	Solid tumors	Initiation of phase 1 trial
XBiotech	Natrunix	Colorectal cancer	Initiation of phase 1/2/3 trial in France
Eirion Therapeutics	AI-09	Glabellar wrinkles	Initiation of phase 1/2 trial
Smart Immune Greater Paris University Hospitals	SMART102	Hematological malignancies	Initiation of phase 1/2 trial
T-knife Therapeutics	TK-8001	MAGE-A1 positive solid tumors	Initiation of phase 1/2 trial
Gracell Biotechnologies	GC007g	Relapsed/refractory B-cell acute lymphoblastic leukemia	Initiation of phase 2 portion of phase 1/2 trial in China
Leap Therapeutics	DKN-01	Advanced colorectal cancer	Initiation of phase 2 trial
Palatin Technologies	PL8177	Ulcerative colitis	Initiation of phase 2 trial
Sofie Biosciences	Fibroblast Activation Protein Inhibitor (FAPI)	Pancreatic ductal adenocarcinoma	Initiation of phase 2 trial
Vir Biotechnology	VIR-2482	Influenza A	Initiation of phase 3 trial
IBSA Group Granata Bio	Progesterone-IBSA	Infertility	Initiation of phase 3 trial
Iterum Therapeutics	Oral sulopenem	Uncomplicated urinary tract infections	Initiation of phase 3 trial
ViewRay	LAP-ABLATE	Pancreatic cancer	Initiation of phase 3 trial
Approvals
Novavax	Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373)	COVID-19	Emergency Use Authorization granted by the FDA as a booster