Drug & Device Pipeline News

January 24, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
AN2 Therapeutics	Epetraborole	Nontuberculous mycobacterial lung disease	IND approved by the FDA
Ascletis Pharma	ASC22 (envafolimab)	Chronic hepatitis B	IND approved by the FDA
CytomX	CX-904	Advanced solid tumors	IND approved by the FDA
Green Valley Pharmaceuticals	Oligomannate (GV-971)	Alzheimer's disease	IND approved by the FDA
Jacobio	JAB-2485	Advanced solid tumors	IND approved by the FDA
Kinnate Biopharma	KIN-3248	Intrahepatic cholangiocarcinoma and urothelial carcinoma	IND approved by the FDA
Neurophth Therapeutics	NR082 (rAAV2-ND4)	Leber hereditary optic neuropathy associated with ND4 mutation	IND approved by the FDA
Palleon Pharmaceuticals	E-602	Solid tumors	IND approved by the FDA
PolarityTE	SkinTE	Chronic cutaneous ulcers	IND approved by the FDA
AB Science	Masitinib	Severe mast cell activation syndrome	Approval for a phase 2 trial granted by France’s regulatory authority
Akeso	Ligufalimab (AK117) plus ivonescimab (AK112)	Advanced malignant tumors	Approval for a phase 1b/2 trial granted by China’s regulatory authority
Clairvoyant Therapeutics	Psilocybin	Alcohol use disorder	Approval for a phase 2 trial granted by Canada’s regulatory authority
Evaxion Biotech	EVX-01 in combination with Keytruda	Melanoma	Approval for a phase 2 trial granted by Australia’s regulatory authority
Jiangsu Recbio Technology	ReCov recombinant two-component COVID-19 vaccine	COVID-19	Approval for a phase 2/3 trial granted by the regulatory authority of Philippines
Trials Initiated
Angel Pharmaceuticals	CPI-818	Relapsed/refractory T-cell lymphomas	Initiation of phase 1/1b trial in China
HutchMed	HMPL-653	Advanced/metastatic solid tumors and tenosynovial giant cell tumors	Initiation of phase 1 trial in China
Arecor Therapeutics	AT247	Type 1 diabetes	Initiation of phase 1 trial
Profound Medical	TULSA Procedure	Prostate cancer	Initiation of phase 1 trial
SparX Group	SPX-101	Tumors	Initiation of phase 1 trial
Revelation Biosciences	REVTx-99	Allergic rhinitis and chronic nasal congestion without polyps	Initiation of phase 1b trial in Australia
ESSA Pharmaceuticals	EPI-7386 in combination with enzalutamide	Metastatic castration-resistant prostate cancer	Initiation of phase 1/2 trial
HOOKIPA	HB-200 in combination with Keytruda	1st-line advanced/metastatic HPV16+ squamous cell head and neck cancers	Initiation of phase 2 portion of phase 1/2 trial
Xilio Therapeutics	XTX202	Solid tumors	Initiation of phase 1/2 trial
Lynk Pharmaceuticals	LNK01001	Active ankylosing spondylitis	Initiation of phase 2 trial
Resverlogix	Apabetalone	COVID-19 treatment	Initiation of phase 2b trial
Eisai	E2814	Dominantly inherited Alzheimer's disease	Initiation of phase 2/3 trial
Vigeo Therapeutics	VT1021	Glioblastoma	Initiation of phase 2/3 trial
Approvals
AbbVie	Rinvoq (upadacitinib)	Refractory, moderate-to-severe atopic dermatitis in patients 12 years and older	Approved by the FDA for new indication
Glenmark Pharma/Glenmark Specialty	Ryaltris nasal spray	Seasonal allergic rhinitis in patients 12 years and older	Approved by the FDA
Pfizer	Cibinqo (abrocitinib)	Refractory, moderate-to-severe atopic dermatitis	Approved by the FDA
Amgen	Lumakras (sotorasib)	KRAS G12C-mutated positive, unresectable, advanced and/or recurrent nonsmall-cell lung cancer	Approved in Japan
argenx	Vyvgart (efgartigimod alfa)	Generalized myasthenia gravis	Approved in Japan
Galapagos	Jyseleca (filgotinib 200mg tablets)	Ulcerative colitis	Approved in the United Kingdom
Novavax	Nuvaxovid (NVX-CoV2373)	COVID-19 vaccine	Approved for provisional registration in Australia
Rockwell Medical Jeil Pharmaceutical	Triferic injection	Hemodialysis-dependent chronic kidney disease	Approved in South Korea
Vifor Fresenius Medical Care Renal Pharma	Tavneos	ANCA-associated vasculitis	Approved by the European Commission