Pipeline

May 3, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Reven Holdings	RJX	high-risk COVID-19 patients	first patient dosed in phase 1/2 trial
Partner Therapeutics	inhaled Leukine (sargramostim, rhu-GM-CSF)	treatment of nonhospitalized COVID-19 patients at high risk for progression to more severe COVID-19	first patient enrolled in phase 2 trial
Brii Bioscoences	BRII-196 and BRII-198	treatment of ambulatory COVID-19 patients	phase 3 portion of phase 2/3 trial expanding to international trial sites
Cardiol Therapeutics	CardiolRx, pharmaceutically produced oral cannabidiol formulation	cardiovascular disease (CVD) complications in hospitalized patients with a confirmed diagnosis of COVID-19 and who have pre-existing or significant risk factors for CVD	first patient enrolled in phase 2/3 trial
Atea Pharmaceuticals	AT-527	mild or moderate COVID-19	first patient dosed in phase 3 trial
Kintor Pharmaceutical	proxalutamide	mild or moderate COVID-19 in male patients	first patient enrolled and dosed in phase 3 trial
Celltrion	DiaTrust	COVID-19 Ag Rapid Test	Emergency Use Authorization (EUA) granted by the FDA
Other Trials and Actions
Hillhurst Biopharmaceuticals	HBI-002	sickle cell disease	IND approved by the FDA
Neoleukin Therapeutics	NL-201	advanced, relapsed or refractory solid tumors	IND approved by the FDA
Nkarta	NKX019, NK cells engineered with a CD19-directed chimeric antigen receptor	relapsed or refractory B-cell malignancies	IND approved by the FDA
Voyager Therapeutics	VY-HTT01	Huntington’s disease	IND approved by the FDA
Medtronic	implantable tibial neuromodulation device	bladder incontinence	investigational device exemption (IDE) approved by the FDA
Hope Biosciences Stem Cell Research Foundation	autologous adipose-derived mesenchymal stem cells	Parkinson’s disease	FDA authorization for a phase 2 trial
Candel Therapeutics	CAN-2409 in combination with Opdivo (nivolumab)	newly diagnosed high-grade glioma	patient enrollment complete in phase 1 trial
ProtoKinetix	AAGP (PKX-001) treated islet cells	type 1 diabetes	phase I trial resumed at the University of Alberta, Edmonton
Xencor	XmAb564	autoimmune diseases	first patient dosed in phase 1 trial
Monopteros Therapeutics	MPT-0118	solid tumors	first patient dosed in phase 1/1b trial
Trillium Therapeutics	TTI-622 (SIRP?-IgG4 Fc)	relapsed/refractory multiple myeloma	first patient dosed in phase 1b trial
Alladapt Immunotherapeutics	ADP101	allergy to one food or to multiple foods	first patients dosed in phase 1/2 trial
OBI Pharma SWOG Cancer Research Network	OBI-3424	relapsed/refractory T-Cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma	first patient enrolled in phase 1 trial
Delpor	DLP-114, a long-acting risperidone	schizophrenia maintenance	first patient dosed in phase 1b/2a trial
Chemomab Therapeutics	CM-101	nonalcoholic steatohepatitis	enrollment of first patient in phase 2a trial
Angion Vifor Pharma	ANG-3777	treatment of patients at risk of cardiac surgery associated acute kidney injury	patient enrollment complete in phase 2 trial
Hutchison China MediTech	HMPL-689	relapsed or refractory follicular lymphoma and marginal zone lymphoma	first patient dosed in phase 2 trial in China
ImmunityBio	Anktiva (N-803) in combination with antiretroviral therapy	acute HIV infection	initiation of phase 2 trial
Innovent Biologics	IBI302	active subfoveal or parafoveal choroidal neovascularization secondary to neovascular age-related macular degeneration	first patient dosed in phase 2 trial
MediWound	EscharEx	enzymatic debridement agent for chronic wounds	first patient dosed in phase 2 trial
Onconova	rigosertib	recessive dystrophic epidermolysis bullosa-associated locally advanced/metastatic squamous-cell carcinoma	first patient dosed in phase 2 trial
Protagonist Therapeutics	rusfertide (PTG-300)	polycythemia vera	patient enrollment complete in phase 2 trial
Aerie Pharmaceutical	AR-15512 ophthalmic solution	dry eye disease	patient enrollment complete in phase 2b trial
Sirnaomics	STP705	squamous-cell skin cancer	initiation of phase 2b trial
Aravive	AVB-500	platinum resistant ovarian cancer	first patient dosed in phase 3 trial
Brickell Biotech	sofpironium bromide gel	primary axillary hyperhidrosis	patient enrollment complete in phase 3 Cardigan I study
G1 Therapeutics	Cosela (trilaciclib)	treatment of patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer	initiation of phase 3 trial
Fractyl	Revita DMR	insulin-treated type 2 diabetes	Breakthrough Device designation granted by the FDA
Akari Therapeutics	nomacopan	moderate and severe bullous pemphigoid	Fast-Track designation granted by the FDA
Instil Bio	ITIL-168	melanoma stages IIB to IV	Orphan Drug designation granted by the FDA
PharmaDrug Sairiyo Therapeutics	dimethyltryptamine	prevention of ischemia-reperfusion injury in patients undergoing solid organ transplantation	Orphan Drug designation granted by the FDA
ADC Therapeutics	Zynlonta (loncastuximab tesirine-lpyl)	patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy	approved by the FDA
GlaxoSmithKline	Jemperli (dostarlimab)	recurrent or advanced dMMR-positive endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy	accelerated approval granted by the FDA
AtriCure	EPi-Sense System	patients diagnosed with longstanding persistent atrial fibrillation	approved by the FDA
Neurolutions	Neurolutions IpsiHand Upper Extremity Rehabilitation System	rehabilitation for stroke patients with upper-extremity disability	approved by the FDA
Soundbite Medical Solutions	SoundBite Crossing System - Peripheral (SCS-P)	recanalization of heavily calcified above-the-knee and below-the-knee peripheral artery disease	approved by the FDA