Drug & Device Pipeline News

November 1, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Precigen	PRGN-3007	ROR1+ hematological and solid tumors	IND approved by the FDA
Bio-Path	Prexigebersen-A	Solid tumors	IND approved by the FDA for a phase 1/1b trial
Angel Pharmaceuticals	CPI-818	Relapsed/refractory T-cell lymphoma	IND for a phase 1/1b trial approved by China’s regulatory authority
Medicenna	MDNA11	Advanced, relapsed or refractory solid tumors	IND for expansion of a phase 1/2 trial approved by the FDA
TFF Pharmaceuticals	Inhaled formulation of Niclosamide	COVID-19	Phase 1 trial approved by Canada’s regulatory authority
HCW Biologics	HCW9218	Advanced pancreatic cancer	Phase 1b trial approved by the FDA
Huyabio International	HBI-2376	KRAS and EGFR mutated tumors	IND for a phase 1 trial approved by the FDA
BioVie	NE3107	Parkinson’s disease	Phase 2 trial approved by the FDA
Vitti Labs	Umbilical cord mesenchymal stem cells in combination with umbilical cord mesenchymal stem cell exosomes	Acute respiratory distress syndrome associated with the COVID-19	IND for a phase 2 trial approved by the FDA
Axial Therapeutics	AB-2004	Irritability associated with autism spectrum disorder	IND for a phase 2b trial approved by the FDA
Trials Initiated
Cleveland Clinic Anixa Biosciences	Breast cancer vaccine	Early-stage triple-negative breast cancer	Initiation of a phase 1 trial
Akeso	AK127 + Cadonilimab	Advanced or metastatic solid tumors	Initiation of phase 1 trial in Australia
Dice Therapeutics	S011806	Psoriasis	Initiation of phase 1 trial
Matinas Biopharma	MAT2501	Nontuberculous mycobacterial infection	Initiation of phase 1 trial
Sumitomo Dainippon Pharma	DSP-0390	Recurrent high-grade glioma	Initiation of phase 1 trial
EsoCap	ESO-101	Active eosinophilic esophagitis	Initiation of phase 2 trial
Gilead Merck	islatravir and lenacapavir	HIV treatment for patients who are virologically suppressed and on antiretroviral therapy	Initiation of phase 2 trial
Revolo Biotherapeutics	‘1104	Allergy	Initiation of phase 2 trial in the UK
Alkermes	nemvaleukin alfa with pembrolizumab	Platinum-resistant ovarian cancer	Initiation of a phase 3 trial
HutchMed	HMPL-523	Primary immune thrombocytopenia	Initiation of a phase 3 trial in China
Approvals
Bausch + Lomb Clearside Biomedical	XIPERE (triamcinolone acetonide injectable suspension)	Macular edema associated with uveitis	Approved by the FDA
Genentech	Susvimo (ranibizumab injection)	Patients with wet, or neovascular, age-related macular degeneration who have previously responded to at least two anti- VEGF injections	Approved by the FDA
Moderna Janssen	COVID-19 vaccines	Immunization against COVID-19	Booster dose following primary immunization approved by the FDA
Merck	Keytruda in combination with chemotherapy	First-line treatment of locally recurrent unresectable or metastatic PD-L1-expressing triple-negative breast cancer in adults who have not received prior chemotherapy for metastatic disease	Approved by the European Commission