Pipeline

November 23, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
RedHill Biopharma	orally administered RHB-107 (upamostat)	patients with symptomatic COVID-19 who do not require hospitalization	IND approved by the FDA for phase 2/3 trial
Ampio Pharmaceuticals	inhaled Ampion	COVID-19	third cohort treated in phase 1 trial
Selva Therapeutics	SLV213	treatment of COVID-19	first patients dosed in phase 1 trial
Revelation Biosciences	REVTx 99	treatment and prevention of respiratory viral infection, including SARS CoV 2 infection	dosing complete in first cohort of phase 1 trial
BioLineRx	Motixafortide	acute respiratory distress syndrome secondary to COVID-19 and other respiratory viral infections	initiation of phase 1b trial
Nordic Nanovector	Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab i	second-line follicular lymphoma	final two patients enrolled into second safety cohort of phase 1trial
NorthSea Therapeutics	SEFA-1024	hypertriglyceridemia	first patient dosed in phase 1 trial
Biological E. Dynavax Baylor College of Medicine	COVID-19 subunit vaccine candidate	COVID-19 vaccine	initiation of phase 1/2 trial in India
Inovio	INO-4800	COVID-19 vaccine	initiation of phase 2 portion of phase 2/3 trial
RedHill Biopharma	opaganib (Yeliva, ABC294640)	patients hospitalized with severe COVID-19 pneumonia	enrollment complete in phase 2 trial
BioNTech Pfizer	BNT162b2	mRNA-based COVID-19 vaccine candidate	completion of phase 3 trial
Tulip Medical	autologous stem/stromal cells derived from fat	restoration of respiratory function in adults with lung damage from COVID-19	initiation of clinical trial
Lucira Health	Lucira COVID-19 All-In-One Test Kit	COVID-19 rapid diagnostic test for self-testing at home	Emergency Use Authorization granted by the FDA
Other Trials and Actions
ATAI Life Sciences Neuronasal	N-acetylcysteine (NAC)	acute mild traumatic brain injury	IND approved by the FDA
Dicerna Pharmaceuticals Eli Lilly	LY3561774	cardiometabolic disease	IND approved by the FDA
Istari Oncology	PVSRIPO immunotherapy	treatment-refractory melanoma	IND approved by the FDA
Jounce Therapeutics	JTX-8064	solid tumors	IND approved by the FDA
Nanobiotix	NBTXR3 activated by radiation therapy	patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression or refractory to PD-1 blockade	IND approved by the FDA
Nanobiotix	NBTXR3 activated by SBRT re-irradiation	patients with inoperable, locoregional recurrent head and neck squamous cell carcinoma (HNSCC) or second primary HNSCC, previously treated with definitive radiation therapy and without radiographic evidence of metastases	IND approved by the FDA
NeoImmuneTech	NT-I7 (efineptakin alfa) and atezolizumab (Tecentriq)	patients with previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer	IND approved by the FDA
TISSIUM	vascular sealant	achieving hemostasis and preventing postoperative bleeding following peripheral vascular surgeries	IDE approved by the FDA
AlzeCure Pharma	ACD856	Alzheimer's disease	approval from the regulatory authorities in Sweden to initiate a phase 1 study
EicOsis Human Health	EC5026	moderate to severe pain	phase 1a trial complete
BridgeBio Navire Pharma	BBP-398	solid tumors driven by mutations in the MAPK signaling pathway	first patient dosed in phase 1 trial
Nkarta	NKX101 immunotherapy	relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes	first patient dosed in phase 1 trial
PTC Therapeutics	PTC518	Huntington's disease	initiation of phase 1 trial
Pionyr Immunotherapeutics	PY314	solid tumors	initiation of phase 1 trial
Precigen	PRGN-3005 UltraCAR-T cells	advanced ovarian cancer	first patients dosed in the intraperitoneal arm of ongoing phase 1 trial
Precigen	PRGN-3006 UltraCAR-T cells	relapsed or refractory acute myeloid leukemia and higher risk myelodysplastic syndrome	first patients dosed in phase 1/1b trial
CG Oncology	CG0070 in combination with Opdivo (nivolumab)	muscle-invasive bladder cancer in cisplatin-ineligible patients	first patient treated in phase 1b trial
Kangpu Biopharmaceuticals	KPG-818	systemic lupus erythematosus	initiation of phase 1b/2a trial
KAHR Roche	DSP107	solid tumors	first patient dosed in phase 1/2 trial
Takeda Pharmaceuticals	mezagitamab (TAK-079)	generalized myasthenia gravis	first patient dosed in phase 2 trial
Cerebral Therapeutics	intracerebroventricular drug delivery of CT-010	medically refractory epilepsy	first patient enrolled in phase 2b trial
Kodiak Sciences	KSI-301	neovascular (wet) age-related macular degeneration	enrollment complete in phase 2b/3 trial
AZTherapies	ALZT-OP1	early stage Alzheimer’s disease	completion of last patient/last visit in phase 3 trial
Corvia Medical	Corvia Atrial Shunt (IASD)	to reduce elevated left atrial pressures	randomization complete in phase 3 trial
DeNovo Biopharma	DB102	newly diagnosed high-risk diffuse large B-cell lymphoma patients with the biomarker DGM1	enrollment complete in phase 3 trial
Milestone Pharmaceuticals	etripamil nasal spray	paroxysmal supraventricular tachycardia	first patient enrolled in phase 3 trial
Palladio Biosciences	lixivaptan	patients with autosomal dominant polycystic kidney disease who previously discontinued therapy with tolvaptan due to liver toxicity	first patient dosed in phase 3 trial
SIFI	polihexanide 0.08%	acanthamoeba keratitis	enrollment complete in phase 3 trial
TissueTech	TTAX01	advanced nonhealing diabetic foot ulcers	initiation of phase 3 trial
Sommetrics	aerSleep II	sleep apnea	Breakthrough Device designation granted by the FDA
Kiniksa Pharmaceuticals	vixarelimab	pruritus associated with prurigo nodularis	Breakthrough Therapy designation granted by the FDA
ViiV Healthcare	cabotegravir	HIV pre-exposure prophylaxis	Breakthrough Therapy designation granted by the FDA
Agios Pharmaceuticals	mitapivat	sickle cell disease	Orphan Drug designation granted by the FDA
Amylyx Pharmaceuticals	AMX0035	Wolfram syndrome	Orphan Drug designation granted by the FDA
Sanofi	rilzabrutinib	immune thrombocytopenia	Fast Track designation granted by the FDA
Agilent Technologies	PD-L1 IHC 22C3 pharmDx	companion diagnostic to aid in identification of TNBC patients eligible for treatment with Keytruda	approved by the FDA
Merck	Keytruda (pembrolizumab)	patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1	approved by the FDA
SafKan Health	OtoSet Ear Cleaning System	removal of impacted earwax	approved by the FDA
UCB Pharma	Vimpat (lacosamide) CV	adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older	approved by the FDA for expanded indication
UCB Pharma	Vimpat injection	intravenous use in children four years of age and older with PGTCS	approved by the FDA for expanded indication