Drug & Device Pipeline News

October 18, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Homology Medicines	HMI-103	Phenylketonuria	IND approved by the FDA
Landos Biopharma	LABP-104	Systemic lupus erythematosus	IND approved by the FDA
Sorrento Therapeutics	resiniferatoxin	Intractable pain associated with advanced cancer	Approval for a phase 2 trial granted by the FDA
Asieris Pharma	APL-1202 in combination with tislelizumab	Muscle-invasive bladder cancer	IND approved by China’s regulatory authority
Kintor Pharma	GT90001C and Opdivo (nivolumab)	Advanced hepatocellular carcinoma	Approval for a phase 2 trial granted by China’s regulatory authority
Arcturus Therapeutics	ARCT-154 STARR mRNA Vaccine	Vaccine targeting SARS-CoV-2 Delta variant	Approval for a phase 3b trial granted by Vietnam’s regulatory authority
Tonghua Dongbao Pharmaceutical	BioChaperone Lispro	Type 1 and Type 2 diabetes	Approval for a phase 3 trial granted by China’s regulatory authority
Trials Initiated
TC BioPharm	ImmuniStim, allogeneic gamma-delta T-cell product	COVID-19	Initiation of phase 1/2 trial in the UK
VistaGen Therapeutics	PH94B	Anxiety in adults with adjustment disorder and anxiety	Initiation of phase 2a trial
Faraday Pharmaceuticals	FDY-5301	ICU-acquired weakness and other muscle-related conditions	Initiation of phase 2 trial
Oxurion	THR-687	Diabetic macular edema	Initiation of phase 2 trial
Union Therapeutics	orismilast oral tablet	Hidradenitis suppurativa	Initiation of phase 2 trial
Veru Pharma	enobosarm	AR+ER+HER2- metastatic breast cancer	Initiation of phase 3 trial
Approvals
ChemoCentryx	Tavneos (avacopan)	ANCA-associated vasculitis	Approved by the FDA
Eli Lilly	Verzenio (abemaciclib)	HR+ HER2-, node-positive, high-risk early breast cancer	Approved by the FDA
Enzyvant Therapeutics	Rethymic human allogeneic (donor-derived) thymus tissue	Pediatric congenital athymia	Approved by the FDA
Merck	Keytruda in combination with chemotherapy, with or without bevacizumab	PD-L1+ persistent, recurrent or metastatic cervical cancer	Approved by the FDA for expanded indication
Ocular Therapeutix	Dextenza (dexamethasone ophthalmic insert)	Ocular itching associated with allergic conjunctivitis	Approved by the FDA for additional indication
BeiGene	Brukinsa (zanubrutinib)	adults with mantle-cell lymphoma who have received at least one prior therapy	Approved by Australia’s regulatory authority
Sanofi	Sarclisa (isatuximab for injection)	Relapsed or refractory multiple myeloma	Approved by Canada’s regulatory authority