Pipeline

April 5, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
University of California Centers for Integrative Medicine & Health	agarikon and turkey tail mushroom varieties	patients with early-stage COVID-19	initiation of clinical trial
Gritstone Oncology	COVID-19 vaccine	COVID-19	first patients dosed in phase 1 trial
Foresee Pharmaceuticals	FP-025	adult patients with severe-to-critical COVID-19 with associated acute respiratory distress syndrome	first patients dosed in phase 2/3 trial
Becton Dickenson	BD Veritor Plus System rapid antigen test	detection of SARS-CoV-2, influenza A and influenza B	Emergency Use Authorization (EUA) granted by the FDA
Escher Biomedical Diagnostics	Escher BT-MED COV19 Saliva Test	detection of SARS-CoV-2 virus	EUA granted by the FDA
Other Trials and Actions
Everest Medicines	Trodelvy (sacituzumab govitecan-hziy)	cancers with high TROP-2 expression	trial authorized by the China National Medical Products Administration
Stoke Therapeutics	STK-001	Dravet syndrome	trial authorized by the UK Medicines and Healthcare products Regulatory Agency
Curevo Vaccine	CRV-101, varicella (chickenpox) vaccine	vaccine for immunocompromised pediatrics infected with HIV	trial authorized by the South African Health Products Regulatory Authority
Airway Therapeutics	AT-100 (rhSP-D)	bronchopulmonary dysplasia	IND approved by the FDA
Antibe Therapeutics	otenaproxesul	osteoarthritis pain	IND approved by the FDA
Enterome	EO2463	indolent nonHodgkin B-cell lymphomas	IND approved by the FDA
I-Mab ABL Bio	TJ-CD4B/ABL111	advanced or metastatic solid tumors	IND approved by the FDA
Attgeno	Supernitro	patients with life-threatening conditions associated with acute lung injury	first patients dosed in phase 1 trial
Aptorum Group	ALS-4	infections caused by staphylococcus aureus, including MRSA	first patient dosed in phase 1 trial
D&D Pharmatech	DD01	obese patients with diabetes and nonalcoholic fatty liver disease	first patient dosed in phase 1 trial
Hutchison Meditech	HMPL-306	advanced solid tumors	initiation of phase 1 trial
Hutchison Meditech	HMPL-306	hematological malignancies	initiation of phase 1 trial
Theratechnologies	TH1902	sortilin-positive (SORT1+) solid tumors	first patient dosed in phase 1 trial
CohBar	CB4211	nonalcoholic steatohepatitis and obesity	patient enrollment complete in phase 1b trial
Dermata Therapeutics	DMT310	mild-to-moderate psoriasis	first patient dosed in phase 1b trial
Flexion Therapeutics	FX301	postoperative pain following bunionectomy	first patient dosed in phase 1b trial
Daiichi Sankyo AstraZeneca	Enhertu (trastuzumab deruxtecan)	patients with HER2 mutated metastatic nonsmall-cell lung cancer with disease recurrence or progression during or after at least one prior platinum-containing treatment regimen	first patient dosed in phase 2 trial
Intensity Therapeutics Portage Biotech	INT230-6 (PORT-1)	early-stage breast cancer	initiation of phase 2 trial
Istari Oncology	PVSRIPO alone or in combination with a programmed death receptor-1/ligand 1 (PD-1/L1) inhibitor	melanoma resistant to these checkpoint therapies	first patient dosed in phase 2 trial
Milestone Therapeutics	etripamil nasal spray	atrial fibrillation and rapid ventricular rate	first patient enrolled in phase 2 trial
NeoImmuneTech	NT-I7 (efineptakin alfa)	newly diagnosed, nonsevere lymphopenic high-grade glioma following standard radiation therapy and temozolomide	first patient dosed in phase 2 trial
ORYZON Genomics	vafidemstat	borderline personality disorder	first patient enrolled in phase 2b trial
Biohaven Pharmaceuticals	oral zavegepant	preventive treatment of migraine	first patient enrolled in phase 2/3 trial
Exelixis	cabozantinib (Cabometyx), nivolumab (Opdivo) and ipilimumab (Yervoy)	previously untreated advanced intermediate- or poor-risk renal cell carcinoma	patient enrollment complete in phase 3 trial
Pharnext	PXT3003	Charcot-Marie tooth disease type 1A	first patient enrolled in phase 3 trial
Fractyl Laboratories	Revita DMR (duodenal mucosal resurfacing) device	type 2 diabetes	initiation of pivotal trial
Moleculin Biotech	Annamycin	soft tissue sarcoma lung metastases	Fast Track designation granted by the FDA
Syndax Pharmaceuticals	axatilimab	chronic graft vs. host disease	Orphan Drug designation granted by the FDA
Premia Spine	TOPS facet arthroplasty system	joint replacement system for the lumbar spine	Breakthrough Device designation granted by the FDA
Astellas	Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension)	neurogenic detrusor overactivity in children age three and older	approved by the FDA for expanded indication
Celgene/Bristol-Myers Squibb	Abecma (idecabtagene vicleucel)	adult multiple myeloma that has not responded to or has returned after at least four prior lines of therapy	approved by the FDA
Jazz Pharmaceuticals	Vyxeos (daunorubicin and cytarabine)	newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients age one and older	approved by the FDA for expanded indication
Guardant Health	Guardant360 CDx test	liquid biopsy for comprehensive tumor mutation profiling across all solid cancers	approved by the FDA
Medtronic	Harmony Transcatheter Pulmonary Valve	congenital heart disease	approved by the FDA
Amarin	Vazkepa (icosapent ethyl)	risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (?150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor	approved by the European Commission
Ipsen Bristol Myers Squibb	Cabometyx (cabozantinib) plus Opdivo (nivolumab)	first-line treatment of advanced renal cell carcinoma	approved by the European Commission
PTC Therapeutics	Evrysdi (risdiplam)	spinal muscular atrophy in patients age two months and older	approved by the European Commission