Drug & Device Pipeline News

February 7, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Altimmune	Pemvidutide	Obesity	IND approved by the FDA
Denovo Biopharma	DB104 (liafensine)	Treatment-resistant depression	IND approved by the FDA
Immune-Onc Therapeutics	IO-202	Solid tumors	IND approved by the FDA
Akeso	Ligufalimab and ivonescimab	Triple-negative breast cancer	Approval for a phase 2 trial granted by China’s regulatory authority
Sellas Life Science 3D Medicines	3D189 (galinpepimut-S)	Hematological malignancies	IND approved by China’s regulatory authority
Trials Initiated
CRISPR Therapeutics ViaCyte	VCTX210	Type 1 diabetes	Initiation of phase 1 trial
Kintor Pharma	GT20029 gel	Androgenetic alopecia and acne	Initiation of phase 1 trial
NorthSea Therapeutics	SEFA-6179	Intestinal failure-associated liver disease	Initiation of phase 1 trial
Synthekine	STK-012	Solid tumors	Initiation of phase 1 trial
Lava Therapeutics	LAVA-1207	Metastatic castration-resistant prostate cancer	Initiation of phase 1/2 trial
Minerva Biotechnologies	huMNC2-CAR44 T cells	Metastatic breast cancer in patients with MUC1-reactive tumors.	Initiation of phase 1/2 trial
Oncorena	Orellanine	Advanced kidney cancer in patients on dialysis	Initiation of phase 1/2 trial in Sweden
Viracta Therapeutics	Nana-val (nanatinostat and valganciclovir)	Epstein-Barr virus-positive solid tumors	Initiation of phase 1/2 trial
Aardvark Therapeutics	ARD-101	Obesity	Initiation of phase 2 trial
Aardvark Therapeutics	ARD-101	Refractory weight gain after bariatric surgery	Initiation of phase 2 trial
Aardvark Therapeutics	ARD-101	Prader-Willi syndrome	Initiation of phase 2 trial
TRACON Pharmaceuticals	TRC102	Stage III nonsquamous, nonsmall-cell lung cancer	Initiation of phase 2 trial
Can-Fite BioPharma	Namodenoson	NASH	Initiation of phase 2b trial
Akeso	Ivonescimab	EGFR-TKI-resistant EGFR mutation advanced nonsquamous, nonsmall-cell lung cancer	Initiation of phase 3 trial
Reviva Pharmaceuticals	Brilaroxazine	Acute exacerbation of schizophrenia	Initiation of phase 3 trial
Valneva	VLA1553 vaccine	Chikungunya	Initiation of phase 3 trial
Approvals
Genenetech	Vabysmo (faricimab-svoa)	Neovascular, age-related macular degeneration and diabetic macular edema	Approved by the FDA
Moderna	Spikevax (COVID-19 Vaccine, mRNA)	COVID-19	Full approval granted by the FDA
Takeda	Vonvendi	Routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 Von Willebrand disease receiving on-demand therapy	Approved by the FDA for expanded indication
ViiV Healthcare	Cabenuva (cabotegravir, rilpivirine)	HIV	Approved by the FDA for a new dosing regimen