Pipeline

February 22, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Altimmune	AdCOVID	single-dose intranasal COVID-19 vaccine	IND approved by the FDA
AIM ImmunoTech	Ampligen intranasal therapy	prophylaxis or treatment for COVID-19 and other respiratory viral diseases	approval from the Ethics Committee in the Netherlands to begin phase 1 trial
Adagio Therapeutics	ADG20	treatment and prevention of COVID-19	initiation of phase 1 trial
ImmunityBio NantKwest	bivalent hAd5 T-cell COVID-19 vaccine	COVID-19 vaccine	approval to expand phase 1 trial to include subcutaneous, oral and sublingual boost
ReAlta Life Sciences	RLS-0071	acute lung injury as a result of viral infection, including COVID-19, RSV and influenza	first patient dosed in phase 1 trial
Diffusion Pharmaceuticals	trans sodium crocetinate	hospitalized COVID-19 patients with confirmed hypoxemia	completion of phase 1b trial
Clene Nanomedicine	CNM-ZnAg liquid solution	acutely symptomatic, nonhospitalized COVID-19 patients	initiation of phase 2 trial
RedHill Biopharma	RHB-107 (upamostat)	patients with symptomatic COVID-19 who do not require hospital care	first patient dosed in phase 2/3 trial
AstraZeneca-Oxford	COVID-19 vaccine	COVID-19	Emergency Use Authorization (EUA) granted by the World Health Organization
Becton, Dickinson and Company	BD SARS-CoV-2/Flu assay	molecular diagnostic test for both SARS-CoV-2 and influenza A+B	EUA granted by the FDA
Everlywell	Everlywell COVID-19 Test Home Collection Kit	detection of COVID-19 in asymptomatic individuals who have no suspected exposure to COVID-19	EUA granted by the FDA for direct-to-consumer distribution
GenScript	cPass SARS-CoV-2 Neutralization Antibody Detection Kit	detection of COVID-19 neutralizing antibodies without the use of live virus	EUA granted by the FDA
Luminostics	Clip COVID Rapid Antigen Test	detection of COVID-19	EUA granted by the FDA
Other Trials and Actions
Akan Biosciences	StroMel	osteoarthritis of the knee	IND approved by the FDA
Lysogene	LYS-GM101	GM1 gangliosidosis	IND approved by the FDA
Signature Biologics	Signature Cord Prime	osteoarthritis of the knee	IND approved by the FDA
Avacta Group	AVA6000 pro-doxorubicin	FAP-positive locally advanced or metastatic solid tumors	clinical trial authorization granted by the UK Medicines and Healthcare products Regulatory Agency
Asklepios Bio Selecta Bio	SEL-399 combined with ImmTOR	mitigate unwanted immune responses associated with gene therapies	initiation of phase 1 trial
Inhibikase Therapeutics	IkT-148009	Parkinson’s disease	first patients dosed in phase 1 trial
Ultimovacs	Tetanus-Epitope Targeting (TET)-platform	relapsed prostate cancer	first patient dosed in phase 1 trial
vTv Therapeutics	HPP737	psoriasis	initiation of phase 1 trial
Salarius Pharma	seclidemstat	relapsed/refractory Ewing sarcoma	completion of phase 1 portion of phase 1/2 trial
Kintara Therapeutics	VAL-083	recurrent glioblastoma multiforme	final patient enrolled in phase 2 trial
NeoImmuneTech	NT-I7 (efineptakin alfa) in combinarion with Opdivo (nivolumab)	patients with previously treated advanced or metastatic gastric, gastro-esophageal junction or esophageal adenocarcinoma	first patient dosed in phase 2 trial
Pfizer	elranatamab (PF-06863135)	relapsed/refractory multiple myeloma	first patient dosed in phase 2 trial
Valbiotis	TOTUM-070	patients with untreated mild to moderate LDL-hypercholesterolemia	approval from French regulatory authorities to initiate phase 2 trial
Moebius Medical	MM-II	pain due to knee osteoarthritis	first patient dosed in phase 2b trial
Monopar	Validive	prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer	first patient dosed in phase 2b/3 trial
Forge Biologics	FBX-101	Krabbe disease	Fast-Track, Orphan Drug and Rare Pediatric Disease designations granted by the FDA
Oryzon	iadademstat	acute myeloid leukemia	Orphan Drug designation granted by the FDA
Targovax	ONCOS-102	malignant pleural mesothelioma	Fast-Track designation granted by the FDA
G1 Therapeutics	Cosela (trilaciclib)	decrease the incidence of chemotherapy-induced myelosuppression in patients with extensive-stage small-cell lung cancer	approved by the FDA
Novartis	Entresto (sacubitril/valsartan)	reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure	approved by the FDA for expanded indication
Pfizer	Panzyga (Immune Globulin Intravenous [Human] – ifas 10% Liquid Preparation)	chronic inflammatory demyelinating polyneuropathy	approved by the FDA for expanded indication
Regeneron	Evkeeza (evinacumab-dgnb)	adult and pediatric patients age 12 and older with homozygous familial hypercholesterolemia	approved by the FDA
Additive Orthopaedics	Patient Specific Talus Spacer	patient-specific total talus replacement implant	approved by the FDA
Delta International Service & Logistics	Scrambler Therapy Technology ST-5A	symptomatic relief of chronic opioid-resistant pain and chronic neuropathic and cancer pain	approved by the FDA
Shockwave Medical	Intravascular Lithotripsy	severely calcified coronary artery disease	approved by the FDA