Drug & Device Pipeline News

January 9, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Arugula Sciences	Signature Cord Prime (SIG001)	Knee osteoarthritis	IND for a phase 1 trial approved by the FDA
ProfoundBio	PRO1160	Metastatic renal cell carcinoma, metastatic or relapsed nasopharyngeal carcinoma or advanced non-Hodgkin lymphoma	IND for a phase 1 trial approved by the FDA
Tempero Bio	TMP-301	Alcohol and substance use disorders	IND for a phase 1 trial approved by the FDA
HotSpot Therapeutics	HST-1011	Advanced solid tumors in patients who are relapsed or refractory to anti-PD-L1 therapy	IND for a phase 1/2 trial approved by the FDA
SURGE Therapeutics	STM-416	Non-muscle-invasive bladder cancer	IND for a phase 1/2 trial approved by the FDA
Hoth Therapeutics	HT-001	Rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy	IND for a phase 2a trial approved by the FDA
Azafaros	AZ-3102	GM2 gangliosidosis and Niemann-Pick disease type C	IND for a phase 2 trial approved by the FDA
Evaxion Biotech	EVX-01 plus Keytruda	Metastatic melanoma	IND for a phase 2b trial approved by the FDA
AB Science	Masitinib	Progressive forms of multiple sclerosis	IND for a phase 3 trial approved by the FDA
Trials Initiated
ArsenalBio	AB-1015	Platinum-resistant ovarian cancer	Initiation of phase 1 trial
JS InnoPharm	JSI-1187 plus dabrafenib	Locally advanced or metastatic solid tumors with confirmed BRAF V600E/K mutations	Initiation of phase 1 trial
Orano Med	212Pb-GRPR	Advanced solid tumors that express gastrin-releasing peptide receptor	Initiation of a phase 1 trial
ProfoundBio	PRO1184	Ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma	Initiation of phase 1 trial
Biomea Fusion	BMF-219	Type 2 diabetes	Initiation of phase 2 portion of a phase 1/2 trial
Immunitas Therapeutics	IMT-009	Solid tumors and hematologic malignancies	Initiation of a phase 1/2a trial
Surface Oncology	SRF114	Advanced solid tumors	Initiation of a phase 1/2 trial
Sensorion	SENS-401 (arazasetron)	Cisplatin-induced ototoxicity	Initiation of a phase 2a trial
Acer Therapeutics	ACER-801 (osanetant)	To reduce severity of hot flashes in men with adenocarcinoma of the prostate	Initiation of a phase 2 trial
Acer Therapeutics	ACER-801 (osanetant)	To reduce testosterone in men with adenocarcinoma of the prostate	Initiation of a phase 2 trial
Horizon Therapeutics	Daxdilimab	Moderate-to-severe primary discoid lupus erythematosus	Initiation of a phase 2 trial
Novavax	COVID-19-Influenza combination and stand-alone influenza vaccines	COVID-19 and influenza	Initiation of a phase 2 trial
OncoC4	ONC-392 plus Keytruda	Platinum-resistant ovarian cancer	Initiation of a phase 2 trial
Wex Pharmaceuticals	Tetrodotoxin	Chemotherapy-induced neuropathic pain	Initiation of a phase 2b trial
Anthos Therapeutics	Abelacimab	High-risk patients with atrial fibrillation deemed unsuitable for current anticoagulants	Initiation of a phase 3 trial
AriBio USA	AR1001	Early Alzheimer’s disease	Initiation of a phase 3 trial
Cingulate Therapeutics	CTx-1301	Attention deficit/hyperactivity disorder in adults	Initiation of a phase 3 trial
NRx Pharmaceuticals	NRX-101	Severe bipolar depression with acute suicidal ideation and behavior	Initiation of a phase 3 trial
Approvals
Vericel	NexoBrid (anacaulase-bcdb)	Eschar removal in patients with deep partial- and/or full- thickness thermal burns	Approved by the FDA