Drug & Device Pipeline News

October 17, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Humanetics	BIO 300	Erectile dysfunction in men undergoing radiation treatment for prostate cancer	IND approved by the FDA
Lyell Immunopharma	LYL845	Relapsed/refractory metastatic or locally advanced melanoma, non-small cell lung cancer and colorectal cancer	IND approved by the FDA
TeraImmune	TI-168	Hemophilia A with refractory inhibitors	IND approved by the FDA for phase 1/2a trial
AIM ImmunoTech	Ampligen	Post-COVID conditions	IND approved by the FDA for phase 2 trial
Galectin Therapeutics	Belapectin in combination with a checkpoint inhibitor	Head and neck cancer	IND approved by the FDA for phase 2 trial
Annovis	Buntanetap	Alzheimer's disease	IND approved by the FDA for phase 2/3 trial
Lixte Biotechnology	LB-100 plus doxorubicin	Advanced soft tissue sarcomas	Approval for phase 1b/2 trial granted by Spain’s regulatory authority
AB Science	Masitinib	Alzheimer's Disease	Approval for a phase 3 trial granted by France’s and Greece’s regulatory authorities
Trials Initiated
Janux Therapeutics	JANX007	Metastatic castration-resistant prostate cancer	Initiation of phase 1 trial
Sciwind Biosciences	XW014	Obesity and type 2 diabetes	Initiation of phase 1 trial
4Moving Biotech	Liraglutide	Osteoarthritis	Initiation of phase 1 trial in Belgium
Accutar Biotechnology	AC0682	ER-positive breast cancer	Initiation of phase 1 trial in China
SELLAS Life Sciences 3D Medicines	Galinpepimut-S	Patients with acute myeloid leukemia in complete response and patients with multiple myeloma, non-Hodgkin’s lymphoma or higher-risk myelodysplastic syndrome who have received first-line standard therapy and are in complete or partial response	Initiation of phase 1 trial in China
Peptilogics	PLG0206	Periprosthetic joint infections after total knee arthroplasty	Initiation of phase 1b trial
Avidity Biosciences	AOC 1044	Duchenne muscular dystrophy amenable to exon 44 skipping	Initiation of phase 1/2 trial
BerGenBio	Bemcentinib	First-line non-small cell lung cancer with STK11 mutations	Initiation of phase 1b/2a trial
BridgeBio Pharma	BBP-398 plus Lumakras (sotorasib)	Non-small cell lung cancer solid tumors with the KRAS G12C mutation	Initiation of phase 1/2 trial
Allogene Therapeutics	ALLO-501A	Relapsed/refractory large B-cell lymphoma	Initiation of phase 2 trial
Corcept Therapeutics	Dazucorilant	Amyotrophic lateral sclerosis	Initiation of phase 2 trial
ProLynx	PLX038	Platinum-resistant ovarian cancer	Initiation of phase 2 trial
HUTCHMED	Sovleplenib	Warm antibody autoimmune hemolytic anemia	Initiation of phase 2/3 trial in China
Abivax	Obefazimod	Moderate-to-severe ulcerative colitis	Initiation of phase 3 trial
United Therapeutics	Tyvaso (treprostinil) inhalation	Idiopathic pulmonary fibrosis	Initiation of phase 3 trial
EpicentRx SciClone Pharmaceuticals	RRx-001	Third-line and beyond extensive-stage small cell lung cancer	Initiation of phase 3 trial In China
Approvals
Alnylam Pharmaceuticals	Oxlumo (lumasiran)	Primary hyperoxaluria type 1 in pediatric and adult patients with severe renal impairment, including those on hemodialysis	Approved by the FDA for expanded patient population
GSK	Boostrix (whooping cough vaccine)	Whooping cough in infants under the age of two months	Approved by the FDA for expanded age indication
Moderna Therapeutics	BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine (mRNA-1273.222)	COVID-19	Emergency Use Authorization granted by the FDA for children age six through 17 years
Pfizer BioNTech	Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster	COVID-19	Emergency Use Authorization granted by the FDA for children age five through 11 years
scPharmaceuticals	Furoscix (furosemide injection)	Congestion in chronic heart failure	Approved by the FDA
Innovent Biologics	Cyramza (ramucirumab)	Hepatocellular carcinoma	Approved in China for expanded indication
Innovent Biologics	Selpercatinib	Non-small cell lung cancer and thyroid cancer	Approved in China