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Pipeline

June 1, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Novavax	NVX CoV2373	coronavirus vaccine	initiation of phase 1/2 trial
RE-Stem Biotech	umbilical cord mesenchymal stem cells	severe cases of COVID-19	initiation of phase 1/2 trial
ORYZON Genomics	vafidemstat	severe cases of COVID-19	enrollment of first patient in phase 2 trial
SaNOtize Research and Development	Nitric Oxide Releasing Solution	prevention and early treatment of COVID-19	enrollment of first patient in phase 2 trial
Genentech Gilead	Actemra (tocilizumab) plus remdesivir	hospitalized patients with severe COVID-19 pneumonia	initiation of phase 3 trial
Covis Pharma	Alvesco (ciclesonide)	non-hospitalized patients 12 years of age and older with symptomatic COVID-19	initiation of phase 3 trial
BioSig Technologies and ViralClear Pharmaceuticals	merimepodib oral solution	adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high-flow oxygen devices	IND approved by the FDA
Leading Biosciences	LB1148	pulmonary dysfunction associated with COVID-19 pneumonia	IND approved by the FDA
NantKwest	BM-Allo.MSC	acute respiratory distress syndrome (ARDS) caused by COVID-19	IND approved by the FDA
Octapharma USA	Octagam 10% [Immune Globulin Intravenous (Human)]	COVID-19 patients with severe disease progression	IND approved by the FDA
Color	LAMP technology	Covid-19 testing	Emergency Use Authorization (EUA) granted by the FDA
Fulgent Therapeutics	RT-PCR test	detection of SARS-CoV-2	EUA granted by the FDA
G Medical Innovations Holdings	Vital Signs Monitoring System ECG Patch	remote monitoring of the QT interval of an ECG for hospitalized patients with COVID-19 being treated with drugs that can prolong QT intervals and may cause fatal arrhythmias	EUA granted by the FDA
Hologic	Aptima SARS-CoV-2 assay	detection of SARS-CoV-2	EUA granted by the FDA
Other Trials and Actions
Anavex Life Sciences	ANAVEX 3-71 (AF710B)	neurodegenerative diseases	initiation of phase 1 trial
Vir Biotechnology	VIR-3434	hepatitis B virus	initiation of phase 1 trial
Daiichi Sankyo	DS-6157	patients with advanced gastrointestinal stromal tumor who have progressed on, or are intolerant to, standard treatment	first patient dosed in phase 1 trial
Innovent	IBI939	advanced malignancies	first patient dosed in phase 1 trial
Poseida Therapeutics	P-PSMA-101	metastatic castration-resistant prostate cancer	first patient dosed in phase 1 trial
Heron Therapeutics	HTX-034	postoperative pain	initiation of phase 1/2 trial
Apollomics	APL-101	non-small cell lung cancer MET exon 14 skipping mutation, and tumors with MET amplification or fusions	initiation of phase 2 trial
Arena Pharma	etrasimod	moderate-to-severe atopic dermatitis	completion of patient enrollment in phase 2b trial
Amplyx Pharmaceuticals	fosmanogepix (APX001)	Candida infections	completion of patient enrollment in phase 2 trial
KBP Biosciences	KBP-5074	patients with moderate-to-severe chronic kidney disease and uncontrolled hypertension	completion of patient enrollment in phase 2b trial
Cidara Therapeutics	rezafungin	prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation	first patient dosed in phase 3 trial
Oncopeptides AB	Melflufen (melphalan flufenamide)	relapsed refractory multiple myeloma	completion of patient enrollment in phase 3 trial
BioXcel Therapeutics	BXCL501	agitation in patients with schizophrenia and bipolar disorder	completion of patient enrollment in phase 3 trial
Alethia Biotherapeutics	AB-16B5 in combination with docetaxel	previously treated subjects with metastatic non-small cell lung cancer with disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody	IND approved by the FDA
CARsgen Therapeutics	CT041 claudin18.2-targeted CAR-T cell therapy	claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction or pancreas	IND approved by the FDA
Expression Therapeutics	ET3	hemophilia A	IND approved by the FDA
Novaremed	NRD135S.E1	painful diabetic peripheral neuropathy	IND approved by the FDA
Qurient	Q702	patients with advanced solid tumors for whom standard of care therapies are currently ineffective	IND approved by the FDA
Sorrento Therapeutics	STI-6129	advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis	IND approved by the FDA
Passage Bio	PBGM01	GM1 gangliosidosis	Rare Pediatric Disease designation granted by the FDA
Azitra	ATR-12	Netherton syndrome	Rare Pediatric Disease designation granted by the FDA
Seelos Therapeutics	SLS-005	Sanfilippo syndrome	Rare Pediatric Disease Designation granted by the FDA
Daiichi Sankyo AstraZeneca	ENHERTU (fam-trastuzumab deruxtecan-nxki)	gastric cancer, including gastroesophageal junction cancer	Orphan Drug designation granted by the FDA
Daiichi Sankyo AstraZeneca	ENHERTU (fam-trastuzumab deruxtecan-nxki)	patients with metastatic non-small cell lung cancer whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy	Breakthrough Therapy designation granted by the FDA
Orphayzme	arimoclomol	amyotrophic lateral sclerosis	Fast Track designation granted by the FDA
Protara Therapeutics	intravenous Choline Chloride	intestinal failure-associated liver disease	Fast Track designation granted by the FDA
Neuraptive Therapeutics	NTX-001	peripheral nerve injuries	Fast Track designation granted by the FDA
AstraZeneca Merck	Lynparza	adults with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone	approved by the FDA for additional indication
Bristol-Myers Squibb	Pomalyst (pomalidomide)	patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy or patients with Kaposi sarcoma who are HIV-negative	approved by the FDA
Bristol-Myers Squibb	Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use)	first-line treatment of adults with metastatic non-small cell lung cancer whose tumors express PD-L1with no EGFR or ALK genomic tumor aberrations	approved by the FDA for new indication
Clovis Oncology	Rubraca (rucaparib)	patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy	approved by the FDA for new indication
Deciphera Pharmaceuticals	QINLOCK (ripretinib)	fourth line treatment for adults with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib	approved by the FDA
Genentech	Tecentriq (atezolizumab)	first-line treatment for metastatic non-small cell lung cancer tumors with high PD-L1 expression or PD-L1 stained tumor-infiltrating with no EGFR or ALK genomic tumor aberrations	approved by the FDA for additional indication
Amivas	artesunate for injection	severe malaria	approved by the FDA
Astellas Pharma	VESIcare LS (solifenacin succinate) oral suspension	neurogenic detrusor overactivity in children <2 years of age	approved by the FDA
Chiesi Group	Ferriprox (deferiprone) twice daily tablets	patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate	approved by the FDA for new formulation
Evofem Biosciences	Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel	prevention of pregnancy in females for use as on-demand contraception	approved by the FDA
Microbion	inhaled pravibismane (BisEDT antimicrobial suspension)	pulmonary infections in patients with cystic fibrosis	approved by the FDA
Sanofi Regeneron	Dupixent (dupilumab)	children ages 6 to 11 years with moderate-to-severe atopic dermatitis	approved by the FDA
Sunovion Pharma	Kynmobi (apomorphine HCl)	acute, intermittent treatment of OFF episodes in Parkinson’s patients	approved by the FDA
Takeda	ALUNBRIG (brigatinib)	adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer	approved by the FDA