Drug & Device Pipeline News

August 8, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Ascletis Pharma	ASC10	Mild-to-moderate COVID-19	IND approved by the FDA
Astria Therapeutics	STAR-0215	Hereditary angioedema	IND approved by the FDA
Avenge Bio	AVB-001	Peritoneal malignancies	IND approved by the FDA
Calidi Biotherapeutics	NeuroNova	Recurrent high-grade glioma	IND approved by the FDA
Cellectis	UCART20x22	B-cell malignancies	IND approved by the FDA
Eccogene	ECC4703	Non-alcoholic steatohepatitis and dyslipidemia	IND approved by the FDA
ImmunAbs	IM-101	Autoimmune diseases	IND approved by the FDA
OliX Pharmaceuticals	OLX10212	Age-related macular degeneration	IND approved by the FDA
Zenas BioPharma	ZB001	Thyroid eye disease	IND approved by China’s regulatory authority
Eledon Pharmaceuticals	Tegoprubart	Prevention of organ rejection in patients receiving a kidney transplant	IND approved by the FDA for a phase 2 trial
Renovion	ARINA-1	Bronchiolitis obliterans syndrome in bilateral lung transplant patients	Study May Proceed letter issued by the FDA for a phase 3 trial
Trials Initiated
ACM Biolabs	ACM-001 COVID-19 vaccine	COVID-19	Initiation of phase 1 trial
Agenus	AGEN1571	Advanced solid tumors	Initiation of phase 1 trial
Astria Therapeutics	STAR-0215	Hereditary angioedema	Initiation of phase 1 trial
Bio-Thera Solutions	BAT8009	Advanced solid tumors	Initiation of phase 1 trial
CytoImmune Therapeutics	CYTO-102	Relapsed/refractory non-small cell lung cancer	Initiation of phase 1 trial
Antengene	ATG-101	Solid tumors and B-cell non-Hodgkin lymphoma	Initiation of phase 1 trial in China
Lynk Pharmaceuticals	LNK01004	Mild-to-moderate plaque psoriasis	Initiation of phase 1 trial in China
BioInvent International	BI-1607 plus trastuzumab	HER2+ solid tumors	Initiation of phase 1/2a trial
Celularity	CYNK-101	Advanced HER2+ gastric cancer	Initiation of phase 1/2a trial
Innovent Biologics Laekna Therapeutics	Afuresertib plus sintilimab plus chemotherapy	Solid tumors resistant to anti-PD-1/PD-L1 therapy	Initiation of phase 1/2 trial
Tallac Therapeutics	TAC-001	Advanced solid tumors	Initiation of phase 1/2 trial
Cardiol Therapeutics	CardiolRx	Acute myocarditis	Initiation of phase 2 trial
EyePoint Pharmaceuticals	EYP-1901	Maintenance treatment of wet age-related macular degeneration	Initiation of phase 2 trial
OcuTerra Therapeutics	OTT166	Diabetic retinopathy	Initiation of phase 2 trial
Denovo Biopharma	DB104 (liafensine)	Treatment-resistant depression	Initiation of phase 2b trial
Union Therapeutics	Orismilast MR tablet	Atopic dermatitis	Initiation of phase 2b trial
Novavax	NVX-CoV2373 COVID-19 vaccine	COVID-19 in patients age six months through 11 years	Initiation of phase 2b/3 trial
Aerie Pharmaceuticals	AR-15512	Dry eye disease	Initiation of phase 3 trial
Avalo Therapeutics	AVTX-803	Leukocyte adhesion deficiency type II	Initiation of phase 3 trial
NewAmsterdam Pharma	Obicetrapib	Heterozygous familial hypercholesterolemia	Initiation of phase 3 trial
Orca Biosystems	Orca-T	Hematologic malignancies	Initiation of phase 3 trial
Sound Pharmaceuticals	SPI-1005	Meniere's disease	Initiation of phase 3 trial
Shionogi	SDT-001	Attention-deficit/hyperactivity disorder	Initiation of phase 3 trial in Japan
Torii Pharmaceutical	VP-102 (TO-208)	Molluscum contagiosum	Initiation of phase 3 trial in Japan
Approvals
Allergan Aesthetics	Juvéderm Volux XC	Improvement of jawline definition in adults over age 21	Approved by the FDA for new indication
Arcutis Biotherapeutics	Zoryve (roflumilast) cream 0.3 percent	Plaque psoriasis in patients age 12 and over	Approved by the FDA
Marius Pharmaceuticals	Kyzatrex (testosterone undecanoate)	Hypogonadism	Approved by the FDA
AbbVie	Rinvoq (upadacitinib)	Adults with active nonradiographic axial spondyloarthritis	Approved by the European Commission