Drug & Device Pipeline News

November 8, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Antengene	ATG-101	Metastatic/advanced solid tumors and B-cell nonHodgkin’s lymphoma	IND for a phase 1 trial approved by the FDA and by China’s regulatory authority
Oravax Medical	Oral COVID-19 vaccine	COVID-19	Phase 1 trial approved by South Africa’s regulatory authority
BioTheryX	BTX-1188	Hematologic and solid malignancies	IND for a phase 1 trial approved by the FDA
Antengene	onatasertib in combination with selinexor	Relapsed/refractory diffuse large B-cell lymphoma	IND for a phase 1b trial approved by China’s regulatory authority
Memgen	MEM-288	Multiple solid tumors	IND for a phase 1 trial approved by the FDA
Ikena Oncology	IK-930	Therapy for cancer patients who exhibit genetic alterations across the Hippo pathway	IND for a phase 1 trial approved by the FDA
Theseus Pharmaceuticals	THE-630	Gastrointestinal stromal tumors	IND for phase 1/2 dose-escalation and expansion trial approved by the FDA
Landos Biopharma	LABP-104	Rheumatoid arthritis	IND for a phase 1 trial approved by the FDA
Impact Therapeutics	IMP9064 as a monotherapy and in combination with senaparib (IMP4297)	Patients with advanced solid tumors	IND for a phase 1/2 trial approved by the FDA
Bionomics	BNC210	Social anxiety disorder	IND for a phase 2 trial approved by the FDA
Akeso	AK112 as a monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy	Resectable nonsmall-cell lung cancer	IND for a phase 2 trial approved by China’s regulatory authority
Rapid Medical	Interventional stroke treatment	Distal thrombectomy	Investigational device exemption approved by the FDA
Gannex Pharma Ascletis Pharma	ASC43F	Nonalcoholic steatohepatitis	IND approved by the FDA
Trials Initiated
OncoResponse	OR2805	Patients with advanced cancer	Initiation of a phase 1/2 trial
Talaris Therapeutics	FCR001	Kidney transplantation	Initiation of a phase 2 trial
HutchMed AstraZeneca	savolitinib in combination with Imfinzi (durvalumab)	MET-driven advanced papillary renal-cell carcinoma	Initiation of a phase 3 trial
Ionis	olezarsen	Severe hypertriglyceridemia	Initiation of a phase 3 trial
Approvals
Pfizer BioNTech	Pfizer-BioNTech COVID-19 Vaccine	COVID-19	Emergency Use Authorization (EUA) granted for children age five through 11 years as a two-dose regimen given 21 days apart
ANI Pharmaceuticals	Purified Cortrophin Gel (repository corticotropin injection USP)	Chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis and excess urinary protein due to nephrotic syndrome	Approved by the FDA
Novartis	Scemblix (asciminib)	Chronic myeloid leukemia (CML)	Approved by the FDA for adults with Philadelphia chromosome-positive CML in chronic phase with T315I mutation; accelerated approval for adults with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors based on molecular response rate at 24 weeks
AbbVie	Vuity (pilocarpine HCl ophthalmic solution) 1.25 percent	Adults with presbyopia (age-related farsightedness)	Approved by the FDA
Insightec	Exablate Neuro	Advanced Parkinson's disease with mobility, rigidity or dyskinesia symptoms	Approved by the FDA
GenBody America	Visually readable COVID-19 antigen test kit	COVID-19	EUA granted by the FDA