Drug & Device Pipeline News

September 12, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
TRACON Pharmaceuticals	YH001 with envafolimab and doxorubicin	Alveolar soft part sarcoma and chondrosarcoma	IND approved by the FDA
Junshi Biosciences	JS110	Advanced tumors	IND approved by the FDA
Monte Rosa Therapeutics	MRT-2359	MYC-driven solid tumors	IND approved by the FDA
Aston Sci.	AST-301 (HER2-hICD vaccine)	HER2-low breast cancer	IND approved by the FDA for a phase 2 trial
StemCyte	Umbilical cord blood stem cell therapy	Long COVID	IND approved by the FDA for a phase 2 trial
Edgewise Therapeutics	EDG-5506	Duchenne muscular dystrophy in children	IND approved by the FDA for a phase 2 trial
United Biopharma	UB-421	Multidrug-resistant HIV-1	IND approved by the FDA for a phase 2 trial
FSD Pharma	FSD201	Mast cell activation syndrome	IND approved by the FDA, approval granted by Canada’s regulatory authority for a phase 2 trial
B.More	Synthetic psilocybin (SYNP-101)	Alcohol use disorder	IND approved by the FDA for a phase 2b trial
Jacobio Pharmaceuticals	JAB-21822	Second line treatment of non-small cell lung cancer with KRAS G12C mutation	Approval for a phase 2 trial granted by China’s regulatory authority
Lytix Biopharma	LTX-315 and pembrolizumab	Advanced melanoma	Approval for a phase 2 trial granted in France, Spain and Norway by the European regulatory authority
Pharmazz	Sovateltide	Hypoxic-ischemic encephalopathy in neonates	IND approved by India’s regulatory authority for a phase 2 trial
YishengBio	PIKA COVID-19 vaccine booster injection	COVID-19	Approval for a phase 2/3 trial granted by the United Arab Emirates’ and the Philippines’ regulatory authorities
Trials Initiated
Tenaya Therapeutics	TN-301	Heart failure with preserved ejection fraction	Initiation of phase 1 trial
Bright Minds Biosciences	BMB-101	Dravet Syndrome	Initiation of phase 1 trial in Australia
Emergent BioSolutions	EBS-LASV recombinant VSV-vectored Lassa virus vaccine	Lassa fever	Initiation of phase 1 trial in Ghana
International AIDS Vaccine Initiative	Lassa virus vaccine	Lassa fever	Initiation of phase 1 trial in Liberia
Cybin	CYB003 (psilocybin)	Major depressive disorder	Initiation of phase 1/2a trial
Fusion Pharmaceuticals	FPI-1966	Advanced solid tumors expressing FGFR3	Initiation of phase 1/2 trial
Laekna Therapeutics	LAE001 and LAE002 (afuresertib)	Metastatic castration-resistant prostate cancer	Initiation of phase 1/2 trial in South Korea
Aristea Therapeutics	RIST4721	Hidradenitis suppurativa	Initiation of phase 2a trial
CuraSen Therapeutics	CST-2032/CST-107	Mild cognitive impairment or mild dementia due to Parkinson’s or Alzheimer’s disease	Initiation of phase 2a trial
AIM ImmunoTech Roswell Park Comprehensive Cancer Center	Ampligen (rintatolimod) in combination with Roswell’s polarized dendritic cell vaccine plus interferon	PD-1/PD-L1 resistant melanoma	Initiation of phase 2 trial
Ashvattha Therapeutics	D-4517.2	Wet age-related macular degeneration or diabetic macular edema	Initiation of phase 2 trial
Clarity Pharmaceuticals	64Cu-labelled SAR-Bombesin	Diagnosis of PSMA-negative prostate cancer	Initiation of phase 2 trial
InxMed	IN10018	Platinum-resistant recurrent ovarian cancer	Initiation of phase 2 trial
OncXerna Therapeutics	Navicixizumab	Colorectal and triple-negative breast cancer	Initiation of phase 2 trial
Palatin Technologies	PL8177	Ulcerative colitis	Initiation of phase 2 trial
Yingli Pharmaceutical	Linperlisib	Peripheral T/NK cell lymphoma	Initiation of phase 2 trial
Hepion Pharmaceuticals	Rencofilstat	Non-alcoholic steatohepatitis	Initiation of phase 2b trial
Bayer	Asundexian (BAY 2433334)	Atrial fibrillation	Initiation of phase 3 trial
Bayer	Asundexian (BAY 2433334)	Non-cardioembolic eschemic stroke	Initiation of phase 3 trial
DBV Technologies	Modified Viaskin Peanut Patch	Peanut allergy in patients aged four to seven	Initiation of phase 3 trial
Madrigal Pharmaceuticals	Resmetirom	Non-alcoholic steatohepatitis cirrhosis	Initiation of phase 3 trial
Spine BioPharma	SB-01	Chronic low back pain and related disability caused by degenerative disc disease	Initiation of phase 3 trial
Teva Pharmaceuticals MedinCell	Subcutaneous long-acting injectable formulation of olanzapine	Schizophrenia	Initiation of phase 3 trial
Nanobiotix LianBio	NBTXR3	Head and neck cancer	Initiation of phase 3 trial in Asia
Approvals
AstraZeneca	Imfinzi (durvalumab) with chemotherapy (gemcitabine plus cisplatin)	Locally advanced or metastatic biliary tract cancer	Approved by the FDA
Azurity Pharmaceuticals	Konvomep (omeprazole and sodium bicarbonate for oral suspension)	Active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill patients	Approved by the FDA
Boehringer Ingelheim	Spevigo (spesolimab-sbzo)	Generalized pustular psoriasis flares in adults	Approved by the FDA
Sanofi	Xenpozyme (olipudase alfa-rpcp)	Non-central nervous system manifestations of acid sphingomyelinase deficiency in adults and pediatrics	Approved by the FDA
Incyte	Pemazyre (pemigatinib)	Relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement in adults	Approved by the FDA for new indication
Vertex Pharmaceuticals	Orkambi (lumacaftor/ivacaftor)	Cystic fibrosis in children aged 12 to less than 24 months with two copies of the F508del mutation	Approved by the FDA for expanded age indication
Moderna Therapeutics	BA.4/.5 Omicron-targeting bivalent COVID-19 booster vaccine mRNA-1273.222	COVID-19	Emergency Use Authorization granted by the FDA for use in adults over 18
Quest Diagnostics	Quest Monkeypox PCR	Monkeypox virus diagnostic test	Emergency Use Authorization granted by the FDA
Moderna Therapeutics	Omicron-containing bivalent booster vaccine, mRNA-1273.214	COVID-19	Provisionally approved in Australia
Moderna Therapeutics	Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222	COVID-19	Approved in Canada