Drug & Device Pipeline News

May 23, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Angion Biomedica	ANG-3070	Idiopathic pulmonary fibrosis	IND approved by the FDA
Indaptus Therapeutics	Decoy 20	Advanced solid tumors	IND approved by the FDA
Cardiol Therapeutics	CardiolRx	Recurrent pericarditis	IND approved by the FDA for phase 2 trial
Inmagene Biopharmaceuticals	IMG-004	Immunological diseases	IND approved by the FDA
Lava Therapeutics	LAVA-051	Hematologic malignancies	IND approved by the FDA
Faron Pharmaceuticals	Bexmarilimab	Hematologic malignancies	IND approved by the FDA and Finland’s regulatory authority
Sorrento Therapeutics	Abivertinib plus abiraterone	Metastatic castration-resistant prostate cancer	IND approved by the FDA for a phase 2 trial
GeneQuantum Healthcare	GQ1005 and GQ1007	Cancer	IND approved by Australia’s regulatory authority
Trials Initiated
Aileron Therapeutics	ALRN-6924	P53-mutated neoadjuvant breast cancer	Initiation of phase 1b trial
IAVI Moderna Therapeutics	mRNA HIV vaccine antigen (mRNA-1644)	HIV	Initiation of phase 1 trial in Africa
Imugene	CF33-hNIS (Vaxinia)	Advanced solid tumors	Initiation of phase 1 trial
ReHeva Biosciences	RH324	Advanced nonsmall-cell lung cancer	Initiation of phase 1 trial
Surrozen	SZN-1326	Moderate-to- severe ulcerative colitis	Initiation of phase 1 trial
Veloxis Pharmaceuticals	VEL-101	Prevention of acute rejection in kidney transplant recipients	Initiation of phase 1 trial
NGM Biopharmaceuticals	NGM438	Advanced solid tumors	Initiation of phase 1/1b trial
Nurix Therapeutics	NX-5948	Relapsed B-cell malignancies	Initiation of phase 1a/1b trial
Adaptive Phage Therapeutics	Bacteriophage therapy	Diabetic foot osteomyelitis	Initiation of phase 1/2 trial
C4 Therapeutics	CFT8634	SMARCB1-perturbed cancers	Initiation of phase 1/2 trial
Purple Biotech	CM24	Pancreatic ductal adenocarcinoma	Initiation of phase 2 portion of phase 1/2 trial
Akston Biosciences	AKS-452 COVID-19 vaccine booster	COVID-19	Initiation of phase 2 trial
Avalo Therapeutics	AVTX-002	Noneosinophilic asthma	Initiation of phase 2 trial
Calliditas Therapeutics	Setanaxib plus Keytruda	Squamous-cell carcinoma of the head and neck	Initiation of phase 2 trial
Horizon Therapeutics	Daxdilimab	Alopecia areata	Initiation of phase 2 trial
MoonLake Immunotherapeutics	Sonelokimab	Hidradenitis suppurativa	Initiation of phase 2 trial
NRx Pharmaceuticals	NRX-101	Bipolar depression and subacute suicidality not requiring hospitalization	Initiation of phase 2 trial
Scilex	SP-103	Acute lower back pain	Initiation of phase 2 trial
IO Biotech	IO102-IO103 in combination with Keytruda	Previously untreated, unresectable or advanced melanoma	Initiation of phase 3 trial
Approvals
Eli Lilly	Mounjaro (tirzepatide)	Adults with type 2 diabetes	Approved by the FDA
Mitsubishi Tanabe Pharma America	Radicava ORS (edaravone)	Amyotrophic lateral sclerosis	Approved by the FDA for new formulation
Medtronic	Onyx Frontier drug-eluting stent	Coronary artery disease	Approved by the FDA
Shanghai Junshi Biosciences	Toripalimab	First-line treatment for advanced or distant metastatic esophageal squamous-cell carcinoma	Approved in China for expanded indication