Drug & Device Pipeline News

August 29, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
DynamiCure	DCBY02	Adults with advanced cancers	IND approved by the FDA
K36 Therapeutics	KTX-1001	Relapsed and refractory multiple myeloma	IND approved by the FDA
GenFleet Therapeutics	GFH312	Peripheral artery disease with intermittent claudication	IND approved by the FDA for phase 2 trial
Miracor Medical	Pressure-controlled intermittent coronary sinus occlusion technology	Anterior ST-segment elevation myocardial infarction	IDE approved by the FDA
Ascletis Pharma	ASC10	COVID-19	IND approved by China’s regulatory authority
IASO Biotherapeutics	Equecabtagene Autoleucel	Neuromyelitis optica spectrum disorder	IND approved by China’s regulatory authority
Sorrento Therapeutics	STI-1558	COVID-19	IND approved by China’s regulatory authority
Asklepios BioPharmaceutical	BV-101 gene therapy	Huntington's disease	Approval for phase 1/2 trial granted by France’s regulatory authority
Trials Initiated
Beyond Cancer	Ultra-high-concentration nitric oxide	Solid tumors	Initiation of phase 1 trial
Cue Biopharma	CUE-102	Wilms’ tumor 1-positive recurrent/metastatic cancers	Initiation of phase 1 trial
Geron	Imetelstat plus Jakafi (ruxolitinib)	Frontline myelofibrosis	Initiation of phase 1 trial
Phanes Therapeutics	PT199	Advanced solid tumors	Initiation of phase 1 trial
Innovent Biologics	IBI363	Advanced solid tumors or lymphomas	Initiation of phase 1 trial in Australia
Ranok Therapeutics	RNK05047	Advanced solid tumors or diffuse large B-cell lymphoma	Initiation of phase 1/2 trial
Sirnaomics	STP705	Facial squamous cell skin cancer in situ	Initiation of phase 1/2 trial
Ranok Therapeutics	RNK05047	Advanced solid tumors or diffuse large B-cell lymphoma	Initiation of phase 1/2 trial
CG Pharmaceuticals	Ivaltinostat and capecitabine	Pancreatic adenocarcinoma	Initiation of phase 1b/2 trial
Dermaliq Therapeutics	DLQ02	Plaque psoriasis	Initiation of phase 1b/2 trial
Kronos Bio	Lanraplenib plus gilteritinib	Relapsed/refractory FLT3-mutated acute myeloid leukemia	Initiation of phase 1b/2 trial
AIM ImmunoTech	Ampligen (rintatolimod)	Locally advanced pancreatic cancer	Initiation of phase 2 trial
Inhibikase Therapeutics	IkT-148009	Parkinson's disease	Initiation of phase 2 trial
Tonix Pharmaceuticals	TNX-102 SL	Patients with long COVID whose symptoms overlap with fibromyalgia	Initiation of phase 2 trial
Valo Health	OPL-0401	Mild, moderate and severe nonproliferative diabetic retinopathy	Initiation of phase 2 trial
Alume Biosciences	ALM-488 (peptide-dye conjugate)	For use during head and neck surgery	Initiation of phase 3 trial
Annovis Bio	Buntanetap	Early Parkinson's disease	Initiation of phase 3 trial
Anthos Therapeutics	Abelacimab	Venous thromboembolism recurrence and bleeding in cancer-associated thrombosis in patients with GI/GU cancers	Initiation of phase 3 trial
Belite Bio	LBS-008	Stargardt disease	Initiation of phase 3 trial
Jazz Pharmaceuticals	Epidiolex (cannabidiol)	Children and adolescents with epilepsy with myoclonic-atonic seizures	Initiation of phase 3 trial
Approvals
Axsome Therapeutics	Auvelity (dextromethorphan HBr- bupropion HCl) extended-release tablets	Major depressive disorder in adults	Approved by the FDA
Janssen	Imbruvica (ibrutinib)	Chronic graft-vs.-host disease in patients one year and older after failure of one or more lines of systemic therapy	Approved by the FDA for expanded age indication
Novavax	Novavax COVID-19 vaccine, adjuvanted (NVX-CoV2373)	Immunization against COVID-19 in adolescents age 12 through 17 years	Expanded emergency use authorization granted by the FDA
Abbott	Proclaim Plus spinal cord stimulation system	Multisite and evolving pain	Approved by the FDA
AstraZeneca Merck	Lynparza (olaparib)	Adjuvant treatment for BRCA-mutated, HER2-negative early breast cancer at high risk of recurrence	Approved in Japan
CSL Vifor Cara Therapeutics	Kapruvia (difelikefalin)	Chronic kidney disease-associated pruritus in hemodialysis patients	Approved in Switzerland
Gilead Sciences	Sunlenca (lenacapavir)	Adults with multidrug- resistant HIV infection	Approved by the European Commission