Drug & Device Pipeline News

August 22, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Daewoong Pharmaceutical	DWP213388	Autoimmune diseases	IND approved by the FDA
Enlivex Therapeutics	Allocetra	Advanced solid tumors	Approval for a phase 1/2 trial granted by Israel’s regulatory authority
Trials Initiated
BridgeBio Pharma	BBP-671	Propionic acidemia and methylmalonic acidemia	Initiation of phase 1 trial
CureVac	CV0501 COVID-19 booster	COVID-19	Initiation of phase 1 trial
Innovent Biologics	IBI311	Active thyroid associated ophthalmopathy	Initiation of phase 1 trial
Mersana Therapeutics	XMT-1660	Breast, endometrial and ovarian cancer	Initiation of phase 1 trial
Tessa Therapeutics	TT11 plus Opdivo (nivolumab)	Relapsed or refractory CD30-positive classical Hodgkin lymphoma	Initiation of phase 1b trial
Passage Bio	PBFT02	Frontotemporal dementia with granulin mutations	Initiation of phase 1/2 trial
ALX Oncology	Evorpacept in combination with Erbitux (cetuximab) and Keytruda (pembrolizumab)	Refractory microsatellite stable metastatic colorectal cancer in patients who have progressed on at least two lines of systemic therapy	Initiation of phase 2 trial
Genexine	GX-188E, GX-I7 and nivolumab	Head and neck squamous cell carcinoma	Initiation of phase 2 trial
Greenwich LifeSciences	GLSI-100	HER2/neu-positive breast cancer in patients with residual disease or high-risk pathologic complete response at surgery who completed neoadjuvant and postoperative adjuvant trastuzumab treatment	Initiation of phase 3 trial
Palisade Bio	LB1148	Return of bowel function in adults undergoing gastrointestinal surgery	Initiation of phase 3 trial
Approvals
Bluebird bio	Zynteglo (betibeglogene autotemcel)	Beta thalassemia in adult and pediatric patients who require regular red blood cell transfusions	Approved by the FDA
Daiichi Sankyo AstraZeneca	Enhertu (fam-trastuzumab deruxtecan-nxki)	Previously treated HER2-mutant metastatic non-small cell lung cancer	Approved by the FDA for new indication
Roche	Xofluza (baloxavir marboxil)	Treatment of acute uncomplicated influenza in otherwise healthy children age five to less than 12 years who have been symptomatic for no more than 48 hours	Approved by the FDA for expanded indication
Roche	Xofluza	Postexposure prophylaxis of influenza in children age five to less than 12 years after contact with someone with influenza	Approved by the FDA for expanded indication
Moderna	mRNA-1273.214 (Spikevax Bivalent Original/Omicron)	Omicron-specific COVID-19 booster in patients age 18 years and older	Conditional authorization in the UK