Drug & Device Pipeline News

November 7, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Antengene	ATG-017 plus nivolumab	Advanced solid tumors	IND approved by the FDA
Aulos Bioscience	AU-007	Advanced solid tumors	IND approved by the FDA
Brexogen	BRE-AD01	Atopic dermatitis	IND approved by the FDA
Turnstone Biologics	TIDAL-01	Advanced solid tumors	IND approved by the FDA
Alzamend Neuro	ALZN002	Mild-to-moderate Alzheimer’s dementia	Study May Proceed letter from the FDA
Small Pharma	SPL028	Depressive disorders	Approval for a phase 1 trial granted by the UK’s regulatory authority
Dyadic	DYAI-100 COVID-19 booster vaccine	COVID-19	CTA approved by the South African regulatory authority
Trials Initiated
Equillium	EQ102	Celiac disease	Initiation of phase 1 trial
Orum Therapeutics	ORM-5029	HER2-expressing advanced solid tumors	Initiation of phase 1 trial
Verge Genomics	VRG50635	Amyotrophic lateral sclerosis	Initiation of phase 1 trial
Regulus Therapeutics	RGLS8429	Autosomal dominant polycystic kidney disease	Initiation of phase 1b trial
Innovent Biologics	IBI343	Advanced solid tumors	Initiation of phase 1 trial in Australia
Senhwa Biosciences	Pidnarulex plus talazoparib	Metastatic castration-resistant prostate cancer	Initiation of phase 1 trial in Australia
Biomea Fusion	BMF-219	Type 2 diabetes	Initiation of phase 2 portion of phase 1/2 trial
Monte Rosa Therapeutics	MRT-2359	MYC-driven solid tumors, including lung cancer	Initiation of phase 1/2 trial
Omega Therapeutics	OTX-2002	Relapsed or refractory hepatocellular carcinoma and solid tumors with MYC oncogene overexpression	Initiation of phase 1/2 trial
Teon Therapeutics	TT-816	Advanced solid tumors	Initiation of phase 1/2 trial
Disc Medicine	Bitopertin	Erythropoietic protoporphyria in adults	Initiation of phase 2 trial
Edgewise Therapeutics	EDG-5506	Duchenne muscular dystrophy	Initiation of phase 2 trial
Q32 Bio Horizon Therapeutics	ADX-914	Atopic dermatitis	Initiation of phase 2 trial
Renovion	ARINA-1	Non-cystic fibrosis bronchiectasis	Initiation of phase 2 trial
InnoCare Pharma	ICP-723	Advanced or metastatic solid tumors with NTRK fusion genes	Initiation of phase 2 trial in China
Vaccitech	VTP-300	Chronic hepatitis B infection	Initiation of phase 2b trial in the Asia-Pacific region
LianBio	TP-03	Demodex blepharitis	Initiation of phase 3 trial in China
Approvals
Gilead	Vemlidy (tenofovir alafenamide)	Chronic hepatitis B virus in patients age 12 years and older with compensated liver disease	Approved by the FDA for expanded age indication