Pipeline

January 25, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
EuBiologics	EuCorVac-19	COVID-19 vaccine	IND approved by the Ministry of Food and Drug Safety in Japan for a phase 1/2 trial
ImmunityBio	hAd5 T-cell COVID-19 vaccine	COVID-19 vaccine	authorization from the South Africa Health Products Regulatory Authority to begin a phase I trial
Moderna Takeda	COVID-19 vaccine (mRNA-1273 or TAK-919)	COVID-19 vaccine	first patient dosed in phase 1/2 trial
Cyxone	rabeximod	hospitalized COVID-19 patients	first patient screened in phase 2 trial
Debiopharm	alisporivir (Debio 025)	early-stage hospitalized COVID-19 patients not requiring medical ventilation nor exhibiting signs of acute respiratory distress syndrome	first patient dosed in phase 2 trial
Algernon Pharmaceuticals	NP-120 (Ifenprodil)	COVID-19 cytokine storm	approval to begin phase 3 portion of phase 2b/3 trial
Dr. Reddy’s Labs	Sputnik V vaccine	COVID-19 vaccine	approval from the Drugs Controller General of India to conduct phase 3 trial
SML Genetree	Ezplex SARS-CoV-2 G Kit	molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2	Emergency Use Authorization (EUA) granted by the FDA
Other Trials and Actions
EdiGene	ET-01, CRISPR/Cas 9 gene-editing therapy	patients with transfusion dependent ?-thalassemia	IND approved by the FDA
Molecular Templates	MT-6402	relapsed/refractory patients with PD-L1-positive solid tumors	IND approved by the FDA
Precision Biosciences	PBCAR19B	relapsed/refractory nonHodgkin lymphoma	IND approved by the FDA
Terns Pharmaceuticals	TERN-501	nonalcoholic steatohepatitis	IND approved by the FDA
Aptorum Group	ALS-4	staphylococcus aureus infections, including MRSA	phase 1 trial approved by the Public Health Agency of Canada
BioEclipse Therapeutics	CRX100	refractory solid tumors	initiation of patient enrollment in phase 1 trial
Bio-Thera Solutions	BAT1308	advanced solid tumors	first patients dosed in phase 1 trial
Forma Therapeutics	FT-7051	metastatic castration-resistant prostate cancer	first patient dosed in phase 1 trial
Lyndra Therapeutics	LYN-047 (rosuvastatin extended-release capsule)	dyslipidemia	first patient dosed in phase 1 trial
Sutro Biopharma	STRO-002	ovarian cancer	first patient dosed in dose-expansion cohort of phase 1 trial
Sumitomo Dainippon Pharma Oncology	TP-0184	anemia in adult patients with low- or intermediate-risk myelodysplastic syndromes	first patient dosed in phase 1/2 trial
Sirnaomics	STP705	cutaneous basal cell carcinoma	first patient dosed in phase 2a trial
Apnimed	AD109	mild-to-moderate obstructive sleep apnea	first patient dosed in phase 2 trial
AriBio	AR1001	mild-to-moderate Alzheimer’s disease	completion of last patient, last visit in phase 2 trial
InCarda Therapeutics	InRhythm (flecainide for inhalation)	recent-onset paroxysmal atrial fibrillation	first patient dosed in the U.S. in phase 2 trial
AzurRx BioPharma	MS1819 immediate release capsules	exocrine pancreatic insufficiency in patients with cystic fibrosis	first two patients dosed in phase 2b extension study
Caladrius Biosciences	CLBS16	coronary microvascular dysfunction	first patient dosed in phase 2b trial
Cellectar Biosciences	CLR 131	Waldenstrom’s macroglobulinemia	initiation of phase 3 trial
Bausch + Lomb	NOV03	dry-eye disease associated with meibomian gland dysfunction	patient enrollment complete in phase 3 trial
Calliditas	NefIgArd	primary IgA nephropathy	patient enrollment complete in phase 3 trial
Oramed	ORMD-0801, oral insulin capsule	type 2 diabetes	first patients enrolled in phase 3 trial
Phathom Pharmaceuticals	vonoprazan in combination with amoxicillin (dual therapy) or with amoxicillin and clarithromycin (triple therapy)	h. pylori infection	patient enrollment complete in phase 3 trial
Tessa Therapeutics	autologous CD30 CAR-T therapy	relapsed or refractory classical Hodgkin lymphoma	PRiority MEdicines (PRIME) designation granted by the European Medicines Agency
Taysha Gene Therapies	TSHA-105, AAV9-based gene therapy	SLC13A5-related epilepsy	Rare Pediatric Disease and Orphan Drug designations granted by the FDA
Occlutech	implantable Atrial Flow Regulator	heart failure patients with preserved or reduced ejection fraction	Breakthrough Device designation granted by the FDA
Swedish Orphan Biovitrum	Doptelet (avatrombopag)	primary chronic immune thrombocytopenia refractory to other treatments	approved by the European Commission
AstraZeneca Daiichi Sankyo	Enhertu (fam-trastuzumab deruxtecan-nxki)	patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen	approved by the FDA for expanded indication
Janssen	Darzalex Faspro in combination with bortezomib, cyclophosphamide and dexamethasone	adults with newly diagnosed light chain amyloidosis	approved by the FDA for expanded indication
Merck	Verquvo (vericiguat)	to reduce the risk of cardiovascular death and heart failure hospitalization or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45 percent	approved by the FDA
Orthocell	Striate+	collagen medical device for dental bone and tissue regeneration procedures	approved by the FDA
Pfizer	Xalkori (crizotinib)	pediatric patients one year of age and older and young adults with relapsed or refractory systemic anaplastic large-cell lymphoma that is anaplastic lymphoma kinase-positive	approved by the FDA for expanded indication