Drug & Device Pipeline News

March 14, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Aravax	PVX108	Peanut allergy	IND approved by the FDA
Inventiva	Lanifibranor plus empagliflozin	Type 2 diabetes and noncirrhotic nonalcoholic steatohepatitis (NASH)	IND approved by the FDA
Insightec	Exablate Neuro ultrasound system	Nonsmall-cell lung cancer and brain cancer	IDE approved by the FDA
Akeso	Cadonilimab plus docetaxel	Nonsmall-cell lung cancer	IND approved by China’s regulatory authority
Antengene	ATG-101	Solid tumors and B-cell nonHodgkin’s lymphoma	IND approved by China’s regulatory authority
CARsgen Therapeutics	CLDN18.2	Gastric and pancreatic cancer	Approval for a phase 2 trial granted by China’s regulatory authority
Biomind Labs	N, N-dimethyltryptamine (DMT)	Treatment-resistant depression	Approval for a phase 2 trial granted by Brazil’s regulatory authority
Altamira Therapeutics	Bentrio preventive nasal spray	COVID-19	Approval for a clinical trial granted by Bulgaria’s regulatory authority
Trials Initiated
Pionyr Immunotherapeutics	PY314	Solid tumors	Initiation of phase 1b trial
Confo Therapeutics	CFTX-1554	Neuropathic pain	Initiation of phase 1 trial
Digestome Therapeutics	DGX-001	Schizophrenia and Parkinson’s disease	Initiation of phase 1 trial
MiNK Therapeutics	AgenT-797	Solid tumors	Initiation of phase 1 trial
Eucure Biopharma	YH002 plus YH001	Solid tumors	Initiation of phase 1 trial in Australia and China
Denali Therapeutics	DNL593	Frontotemporal dementia-granulin	Initiation of phase 1/2 trial
Freeline Therapeutics	FLT180a	Hemophilia B	Initiation of phase 1/2 trial
Palleon Pharmaceuticals	E-602	Advanced cancers	Initiation of phase 1/2 trial
Aldeyra Therapeutics	ADX-2191	Retinitis pigmentosa	Initiation of phase 2 trial
Pfizer	Paxlovid	COVID-19	Initiation of phase 2/3 pediatric trial
Equillium	Itolizumab	Acute graft-versus-host disease	Initiation of phase 3 trial
KalVista Pharmaceuticals	KVD900	Hereditary angioedema	Initiation of phase 3 trial
Approvals
Bristol Myers Squibb	Opdivo (nivolumab)	Nonsmall-cell lung cancer in the neoadjuvant setting	Approved by the FDA for expanded indication
Antengene	Xpovio (selinexor)	Relapsed and/or refractory multiple myeloma and triple-class refractory multiple myeloma	Approved in Australia