Pipeline

November 2, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Nektar Therapeutics	bempegaldesleukin (NKTR-214)	adults diagnosed with mild COVID-19 infection	IND approved by the FDA for phase 1b trial
Nitric Oxide Innovations	NOviricid, 30 mg sodium nitrite oral lozenge	African Americans diagnosed with COVID-19	IND approved by the FDA for phase 2b/3 trial
Ampio Pharmaceuticals	inhaled Ampion added to the standard of care	COVID-19 infected patients hospitalized for respiratory distress	initiation of phase 1 trial
HiFiBiO Therapeutics	HFB30132A	treatment and prevention of COVID-19	dosing complete in first cohort of phase 1 trial
aTyr Pharma	ATYR1923	COVID-19 patients with severe respiratory complications	patient enrollment complete in phase 2 trial
Boehringer Ingelheim	BI 764198	patients hospitalized with SARS-CoV-2 with severe respiratory complications	initiation of phase 2 trial
Immutep	eftilagimod alpha (IMP321)	hospitalized patients with COVID-19	initiation of phase 2 trial
Olatec Therapeutics	dapansutrile capsules	patients with moderate COVID-19 symptoms and evidence of early Cytokine Release Syndrome	initiation of phase 2 trial
ANA Therapeutics	oral niclosamide (ANA001)	patients with moderate COVID-19	initiation of phase 2/3 trial
Biophytis SA	Sarconeos (BIO101)	patients with COVID-19-related respiratory failure	first patient enrolled in Brazil in phase 2/3 trial
AstraZeneca	AZD1222	COVID-19 vaccine	U.S portion of phase 3 trial resumed
Moderna	mRNA-1273	COVID-19 vaccine	patient enrollment complete in phase 3 trial
Agena Bioscience	assARRAY SARS-CoV-2 Panel	qualitative detection of the SARS-CoV-2 coronavirus	Emergency Use Authorization (EUA) granted by the FDA
Gilead Sciences	Veklury (remdesivir)	patients with COVID-19 requiring hospitalization	approved by the FDA
Other Trials and Actions
ATAI Life Sciences	Neuronasal (intranasal delivery of low doses of N-acetylcysteine)	acute mild traumatic brain injury	IND approved by FDA
BioXcel Therapeutics	BXCL501	agitation associated with delirium	IND approved by the FDA
Insignis Therapeutics HLK Pharmacin	N-001(oral epinephrine prodrug)	allergic reactions, including anaphylaxis	IND approved by the FDA
Vanda Pharmaceuticals	VSJ-110	allergic conjunctivitis	IND approved by the FDA
Y-mAbs Therapeutics	177Lu-omburtamab-DTPA	B7-H3 positive central nervous system and leptomeningeal metastasis tumors	IND approved by the FDA
Asieris Pharmaceuticals	APL-1501	bladder cancer, urinary tract infection	clinical trial approved in Australia
BioInvent International	BI-1808	ovarian cancer, nonsmall-cell lung cancer and cutaneous T-cell lymphoma	clinical trial approved in Europe
Exelixis	XL092 alone and in combination with atezolizumab (Tecentriq)	advanced solid tumors	first patient enrolled in phase 1 trial
Plus Therapeutics	Rhenium NanoLiposomes	recurrent glioblastoma	first patient treated in final cohort of phase 1 trial
Genome & Company	GEN-001	solid tumors	first patient dosed in phase 1/1b trial
Gmax Biopharm	GMA301	pulmonary arterial hypertension	first patient dosed in phase 1b trial
ImmunoMolecular Therapeutics	IMT-002	patients with HLA-DQ8 positive type 1 diabetes	initiation of phase 1b trial
ALX Oncology	ALX148	higher-risk myelodysplastic syndrome	first patient dosed in the phase 1/2 trial
HOOKIPA Pharma	HB-202/HB-201 alternating vector therapy	human papillomavirus 16-positive (HPV16+) cancers	first patient dosed in phase 1/2 trial
Oncolytis Biotech Roche	pelareorep plus atezolizumab (Tecentriq)	metastatic pancreatic and colorectal and advanced anal cancers	initiation of phase 1/2 trial
Syntrix Pharmaceuticals	SX-682	myelodysplastic syndromes and metastatic melanoma	patient dosing complete in phase 1/2 trial
Arcutis Biotherapeutics	ARQ-252	adults with chronic hand eczema	patient enrollment complete in phase 1b/2 trial
Sumitomo Dainippon Pharma Oncology	dubermatinib (TP-0903) plus decitabine	patients 60 years or older with newly diagnosed acute myeloid leukemia with TP53 mutations and/or complex karyotype	first patient dosed in phase 1b/2 trial
Annovis Bio	ANVS401	early Alzheimer’s disease	patient enrollment resumed following suspension of phase 2 trial due to COVID-19
BioLineRx	motixafortide	first-line metastatic pancreatic ductal adenocarcinoma	initiation of phase 2 trial
Novartis	NIS793	first-line metastatic pancreatic ductal adenocarcinoma	initiation of phase 2 trial
PDS Biotech	PDS0101	locally advanced cervical cancer	initiation of phase 2 trial
Phosplatin Therapeutics	PT-112	metastatic castration-resistant prostate cancer	first patient dosed in phase 2 trial
Aerie Pharmaceuticals	AR-15512	dry eye disease	initiation of phase 2b trial
PTC Therapeutics	vatiquinone (PTC743)	mitochondrial epilepsy	initiation of phase 2/3 trial
Castle Creek Biosciences	debcoemagene autofice (FCX-007)	recessive dystrophic epidermolysis bullosa	first patient dosed in phase 3 trial
Innate Pharma AstraZeneca	monalizumab plus cetuximab	recurrent or metastatic squamous cell carcinoma of the head and neck in patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors	first patient dosed in phase 3 trial
MediWound	NexoBrid	hospitalized children with severe thermal burns	patient enrollment complete in phase 3 trial
Polyphor	balixafortide	metastatic breast cancer	patient enrollment complete in phase 3 trial
Prilenia Therapeutics	pridopidine	patients with early stage Huntington’s disease	first patients enrolled in phase 3 trial
RegeneRx ReGenTree	0.1% RGN-259 eye drops	dry eye syndrome	last patient enrolled in phase 3 trial
Prevail Therapeutics	PR001	neuronopathic Gaucher disease	Fast-Track designation granted by the FDA
Passage Bio	PBKR03	Krabbe disease (Globoid Cell Leukodystrophy)	Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA
reVision Therapeutics	REV-0100	Stargardt disease	Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA
Taysha Gene Therapies	TSHA-104	SURF1-associated Leigh syndrome	Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA
Adaptive Phage Therapeutics	PhageBank	prosthetic joint infections	Orphan Drug designation granted by the FDA
Kezar Life Sciences	KZR-616	polymyositis and dermatomyositis	Orphan Drug designation granted by the FDA
Cala Health	Cala Trio	action tremors in the hands of adults with Parkinson’s disease	Breakthrough Device designation granted by the FDA
Abiomed	Abiomed Breethe OXY-1 System	cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation	approved by the FDA
Bayer	FoundationOneCDx	companion diagnostic for Vitrakvi (larotrectinib) to help identify NTRK gene fusion-positive patients	approved by the FDA
Kala Pharmaceuticals	Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25%	short-term (up to two weeks) treatment for dry eye disease	approved by the FDA
Medtronic	Abre venous self-expanding stent system	use in the iliofemoral veins in patients with symptomatic deep venous obstruction	approved by the FDA