Home » Pipeline

Pipeline

January 4, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Kentucky BioProcessing	KBP-COVID-19	COVID-19 vaccine	IND approved by the FDA
Hepion Pharmaceuticals	CRV431	treatment of COVID-19	IND approved by the FDA
Innovation Pharmaceuticals	Brilacidin	hospitalized patients with COVID-19	IND approved by the FDA
Emergent BioSolutions Mount Sinai Health System	COVID-19 Human Hyperimmune Globulin (COVID-HIG)	postexposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2	initiation of phase 1 trial
Ology Bioservices	ADM03820, anti-SARS-CoV-2 monoclonal antibodies	COVID-19	patient dosing commenced in phase 1 trial
Vasomune	AV-001	patients hospitalized with COVID-19	patient dosing commenced in phase 1 trial
Serum Institute of India Dynavax	adjuvanted COVID-19 vaccine with Dynavax’s CpG 1018	prevention of COVID-19	first patients dosed in phase 1/2 trial
Aldeyra Therapeutics	ADX-629	COVID-19	initiation of phase 2 trial
Acticor Biotech	glenzocimab	COVID-19-related acute respiratory distress syndrome (ARDS)	first patient enrolled in phase 2 trial
Algernon Pharmaceuticals	NP-120 (Ifenprodil)	COVID-19	last patient treated in phase 2b portion of phase 2b/3 trial
NeuroRx Relief Therapeutics	Zyesami (RLF-100: aviptadil)	respiratory failure in patients with critical COVID-19	patient enrollment complete in phase 2b/3 trial
CureVac	CVnCoV	COVID-19 vaccine	first patient dosed in phase 3 trial
EUSA Pharma	siltuximab	hospitalized patients with COVID-19 previously treated with corticosteroids, or another respiratory virus infection-associated case of ARDS	first patient enrolled in phase 3 trial
Novavax	NVX-CoV2373	COVID-19 vaccine candidate	initiation of phase 3 trial
Shenyang Tonglian Group	carrimycin	severe COVID-19 in hospitalized patients	approval by the FDA to proceed with phase 3 trial
Vir Biotech GlaxoSmithKline	VIR-7831 (GSK4182136)	hospitalized adults with COVID-19	first patient dosed in a new subtrial of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program phase 3 trial
Moderna	mRNA-1273	COVID-19 vaccine	Emergency Use Authorization granted by the FDA
Other Trials and Actions
AlloVir	ALVR106	allogeneic and autologous hematopoietic stem-cell transplant patients with respiratory infections caused by RSV, influenza, PIV or hMPV	IND approved by the FDA
Cerecor	CERC-007	Still’s disease	IND approved by the FDA
LyGenesis	novel cell therapy	end-stage liver disease	IND approved by the FDA
Moebius Medical	MM-II	pain-in-knee osteoarthritis	IND approved by the FDA
Onconova Therapeutics	ON 123300	patients with relapsed/refractory advanced cancer	IND approved by the FDA
Senhwa Biosciences	CX-5461	solid tumors with BRCA2 or PALB2 mutations	IND approved by the FDA
Ziopharm Eden BioCell	patient-derived CD19-specific CAR-T	patients with relapsed CD19+ leukemias and lymphomas	IND approved in Taiwan
BioInvent Transgene	BT-001	solid tumors	clinical trial approved to begin in Belgium
Polyphor	murepavadin inhaled antibiotic	pseudomonas aeruginosa lung infections in people with cystic fibrosis	clinical trial approved by the UK Medicines and Healthcare products Regulatory Agency
Amphivena Therapeutics	AMV564	selected solid tumors	first patients dosed in phase 1 trial
BioEclipse Therapeutics	CRX100	refractory solid tumors	first patients enrolled in phase 1 trial
Ascletis Pharma/Gannex	ASC42	nonalcoholic steatohepatitis	first patient dosed in phase 1 trial
Humanigen	ifabotuzumab	recurrent glioblastoma multiforme	enrollment complete in phase 1 trial
Mustang Bio	MB-101 (autologous IL13R?2-CAR T-cells)	leptomeningeal brain tumors	initiation of phase 1 trial
Gannex/Ascletis	ASC41	nonalcoholic steatohepatitis	first patients dosed in phase 1b trial
MODAG	anle138b	mild-to-moderate Parkinson´s disease	initiation of phase 1b trial
ORIC Pharmaceuticals	ORIC-101	advanced solid tumors	initiation of second dose expansion portion of phase 1b trial
aTyr Pharma	ATYR1923	pulmonary sarcoidosis	patient enrollment complete in phase 1b/2a trial
Evaxion Biotech	EVX-02	adjuvant therapy in patients with advanced melanoma	first patient dosed in phase 1/2 trial
Aldeyra Therapeutics	ADX-629	adults with mild asthma induced by bronchial asthma challenge	initiation of phase 2 trial
Aldeyra Therapeutics	ADX-629	adults with mild-to-moderate plaque psoriasis	initiation of phase 2 trial
Altimmune	HepTcell	chronic hepatitis B	initiation of phase 2 trial
Athersys Memorial Hermann-Texas Medical Center	MultiStem cell therapy	early treatment of traumatic injuries and subsequent complications	first patient enrolled in phase 2 trial
Brainstorm Cell Therapeutics	NurOwn (MSC-NTF cells)	progressive multiple sclerosis	patient dosing complete in phase 2 trials
Ultimovacs	UV1 universal cancer vaccine	patients with recurrent or metastatic head and neck cancer	initiation of phase 2 trial
Annexon	ANX005	Guillain-Barré syndrome	first patients dosed in phase 2/3 trial
Albireo Pharma	odevixibat	Alagille syndrome	initiation of phase 3 trial
Fibrogen	pamrevlumab	idiopathic pulmonary fibrosis	first patient dosed in phase 3 trial
Neurana Pharmaceutical	tolperisone	symptoms associated with acute and painful muscle spasms of the back	first patient enrolled in phase 3 trial
Oncopeptides	melflufen plus dexamethasone and subcutaneous daratumumab	patients with relapsed, refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents	first patients dosed in phase 3 trial
Novaremed	NRD135S.E1	painful diabetic peripheral neuropathy	Fast-Track designation granted by the FDA
Moleculin Biotech	annamycin	soft-tissue sarcomas	Orphan Drug designation granted by the FDA
Sigilon	SIG-005	mucopolysaccharidosis type I	Orphan Drug designation granted by the FDA
Antengene Karyopharm	oral Xpovio (selinexor)	patients with multiple myeloma who have received at least one prior therapy	approved by the FDA for expanded indication
AstraZeneca	Tagrisso (osimertinib)	adjuvant treatment for patients with nonsmall-cell lung cancer whose tumors have a specific type of genetic mutation	approved by the FDA for expanded indication
Almirall Athenex	Klisyri (tirbanibulin)	topical treatment of actinic keratosis of the face or scalp	approved by the FDA
Bracco Diagnostics	ProHance (Gadoteridol) Injection, 279.3 mg/mL for intravenous use with magnetic resonance imaging	children under two years for visualization of areas with disrupted blood-brain barrier and/or abnormal vascularity throughout the brain, spine and associated tissues	approved by the FDA
Genentech	Ocrevus (ocrelizumab)	shorter, two-hour infusion time for relapsing and primary progressive multiple sclerosis	approved by the FDA for new formulation
Integrum AB	Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System	adults who have transfemoral amputations	approved by the FDA
Myovant Sciences	Orgovyx (relugolix)	adults with advanced prostate cancer	approved by the FDA
Ridgeback Therapeutics	Ebanga (ansuvimab-zykl)	Zaire ebolavirus infection in adults and children	approved by the FDA
Urovant Sciences	Gemtesa (vibegron)	overactive bladder	approved by the FDA