Pipeline

June 29, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Clover Biopharma GlaxoSmithKline	COVID-19 vaccine	COVID-19	initiation of phase 1 trial
Theravance Biopharma	TD-0903	hospitalized patients with acute lung injury caused by COVID-19.	dosing of first patient in phase 2 trial
Fulcrum Therapeutics	losmapimod	higher-risk hospitalized adults with COVID-19	initiation of phase 3 trial
Ridgeback Biotherapeutics	EIDD-2801	Study 2003: recently symptomatic, newly diagnosed nonhospitalized patients. Study 2004: hospitalized patients with COVID-19	initiation of two phase 3 trials
Ampio Pharmaceutical	intravenous Ampion	SARS-CoV-2 virus	IND approved by the FDA
NeuroRx Relief Therapeutics	RLF-100 (Aviptadil)	acute lung injury/acute respiratory distress syndrome associated with COVID-19	Fast Track designation granted by the FDA
OmniPathology	Omni-COVID-19 Assay PCR test	detection of SARS-CoV-2	Emergency Use Authorization (EUA) granted by the FDA
Gencurix	GenePro SARS-CoV-2 RT-PCR Test	detection of SARS-CoV-2	EUA granted by the FDA
Other Trials and Actions
Allied Corp. MGC Pharmaceutical	proprietary cannabis-derived drug candidate	post-traumatic stress disorder	initiation of phase 1 trial
ABM Therapeutics	ABM-1310	BRAF mutant advanced solid tumor and BRAF mutant patients with brain metastases	dosing of first patient in phase 1 trial
Aduro Biotech	BION-1301	IgA nephropathy	dosing of first patient in phase 1 trial
Alpine Immune Sciences	ALPN 202	advanced malignancies	dosing of first patient in phase 1 trial
Heat Biologics/Pelican Therapeutics	PTX-35	advanced refractory solid tumors	dosing of first patient in phase 1 trial
Revolution Medicines	RMC-4630 (SAR442720) in combination with Keytruda (pembrolizumab)	advanced malignancies	dosing of first patient in phase 1 trial
Seattle Genetics	SEA-TGT/ SGN-TGT	solid tumors and lymphomas	dosing of first patient in phase 1 trial
Seattle Genetics	SGN-B6A	solid tumors	dosing of first patient in phase 1 trial
Springworks Therapeutics	nirogacestat and belantamab mafodotin	relapsed or refractory multiple myeloma	dosing of first patient in phase 1b trial
BioInvent	BI-1206 in combination with Keytruda	solid tumors	enrollment of first patient in phase 1/2 trial
Grid Therapeutics	GT103	refractory NSCLC	dosing of first patient in phase 1/2 trial
NeoImmuneTech	NT-I7 (efineptakin alfa) in combination with Keytruda	relapsed/refractory advanced solid tumors	dosing of first patient in phase 1/2 trial
Tarsius Pharma	TRS01	active anterior noninfectious uveitis	completion of patient enrollment in phase 1/2 trial
Aerpio Therapeutics	topical formulation of razuprotafib	elevated intraocular pressure associated with open angle glaucoma or ocular hypertension	initiation of phase 2 trial
Oncolytics Biotech	pelareorep-based combination therapies	HR+/HER2- metastatic breast cancer	dosing of first patient in phase 2 trial
Reistone Biopharma	SHR0302	moderate and severe Alopecia Areata	dosing of first patient in phase 2 trial
Arcutis Pharma	roflumilast foam	seborrheic dermatitis	completion of patient enrollment in phase 2 trial
Ziopharm	Ad-RTS-hIL-12 with veledimex in combination with Libtayo (cemiplimab-rwlc)	recurrent or progressive glioblastoma	completion of patient enrollment in phase 2 trial
Aurinia Pharma	voclosporin ophthalmic solution	dry eye syndrome	completion of patient enrollment in phase 2/3 trial
Mitsubishi Tanabe Pharma Development America	MT-7117 (dersimelagon)	erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP)	initiation of phase 3 trial
Pfizer	20vPnC vaccine	pneumococcal disease	initiation of two phase 3 trials
Pfizer	RSVpreF vaccine	respiratory syncytial virus	initiation of phase 3 trial
Pfizer	MenABCWY vaccine	meningitis	initiation of phase 3 trial
Sanofi	SAR442168	relapsing multiple sclerosis	first patient enrolled in phase 3 trial
Soligenix	SGX942 (dusquetide)	oral mucositis in head and neck cancer patients	completion of patient enrollment in phase 3 trial
Altimmune	HepTcell	chronic hepatitis B	IND approved by the FDA
HemoShear Therapeutic	HST5040	methylmalonic acidemia and propionic acidemia	IND approved by the FDA
Novaremed AG	NRD135S.E1	painful diabetic peripheral neuropathy	IND approved by the FDA
Polynoma	seviprotimut-L	adjuvant treatment of stage IIB/IIC melanoma patients post-resection	Fast Track designation granted by the FDA
Viracta Therapeutics	nanatinostat and valganciclovir combination treatment	T-cell lymphoma	Orphan Drug designation granted by the FDA
TFF Pharmaceutical	tacrolimus inhalation powder	prophylaxis of lung allograft rejection	Orphan Drug designation granted by the FDA
IMARA	IMR-687	beta-thalassemia	Orphan Drug designation granted by the FDA
Dicerna Pharmaceutical	nedosiran	primary hyperoxaluria	Rare Pediatric Disease designation granted by the FDA
Ovid Pharmaceutical	OV101 (gaboxadol)	Angelman syndrome	Rare Pediatric Disease designation granted by the FDA
preCARDIA	preCARDIA catheter system	acutely decompensated heart failure	Breakthrough Device designation granted by the FDA
Karyopharm Therapeutics	Xpovio (selinexor)	relapsed or refractory diffuse large B-cell lymphoma	approved by the FDA
Epizyme	Tazverik (tazemetostat)	adults with relapsed or refractory follicular lymphoma (FL) with EZH2+ tumors and who have received at least two prior systemic therapies and adults with relapsed or refractory FL with no satisfactory alternative treatment options	approved by the FDA for two new indications
Merck	Keytruda (pembrolizumab)	recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation	approved by the FDA for two new indications
Evoke Pharma	Gimoti (metoclopramide) nasal spray	adults with acute and recurrent diabetic gastroparesis	approved by the FDA
Regeneron Sanofi	Dupixent (dupilumab) single-dose pre-filled pen	atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis	approved by the FDA for new formulation
Ultragenyx Kyowa Kirin	Crysvita (burosumab)	FGF23-related tumor-induced osteomalacia in patients <2 years of age	approved by the FDA