Pipeline

May 17, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Abcellera Eli Lilly	LY-CoV1404 alone and together with other monoclonal antibodies	patients with mild-to-moderate COVID-19	initiation of phase 2 trial
Cerecor	CERC-002	treatment of hospitalized patients with COVID-19	Fast-Track designation granted by the FDA
Pfizer BioNTech	COVID-19 vaccine	COVID-19	Emergency Use Authorization granted by the FDA to include adolescents age 12 to 15
Other Trials and Actions
Antengene	selinexor (Xpovio)	advanced or recurrent endometrial cancer	IND approved by China's National Medical Products Administration for a phase 3 trial
Mustang Bio	MB-106	relapsed or refractory CD20+ B-cell nonHodgkins lymphoma and chronic lymphocytic leukemia	IND approved by the FDA
Samus Therapeutics	PU-AD (icapamespib)	recurrent malignant glioma	IND approved by the FDA
Smart Immune	SMART 101 (ProTcell)	acute lymphocytic leukemia and acute myelocytic leukemia	IND approved by the FDA
Zoll Medical	TherOx SSO2 Therapy	supersaturated oxygen therapy for treatment of patients with ST elevation myocardial infarction and cardiogenic shock	Investigational Device Exemption approved by the FDA
Goldfinch Bio	GFB-024	severe insulin-resistant diabetic nephropathy and CB1 pathway overactivation	first patient dosed in phase 1 trial
QPex Biopharma	ORAvance	drug resistant, gram-negative bacterial infections	first patient dosed in phase 1 trial
TILT Biotherapeutics	TILT-123	patients with injectable solid tumors	first patients dosed in phase 1 trial
Cybrexa Therapeutics	CBX-12 (alphalex-exatecan)	advanced or metastatic refractory solid tumors	first patient dosed in phase 1/2 trial
Harbour Biomed	HBM4003	multiple solid tumor types	first patient dosed in part 2 of phase 1 of phase 1b/2a trial
Gemini Therapeutics	GEM103 added to anti-VEGF treatment	treatment of neovascular age-related macular degeneration patients with or at risk for macular atrophy	recruitment complete in phase 2a trial
Hepion Pharmaceuticals	CRV431	nonalcoholic steatohepatitis	recruitment complete in phase 2a trial
ALX Oncology Merck	ALX148 in combination with Keytruda (pembrolizumab)	first-line metastatic or unresectable, recurrent PD-L1 positive advanced head-and-neck squamous cell carcinoma	first patient dosed in phase 2 trial
Connect Biopharma	CBP-201	moderate-to-severe persistent asthma	first patient dosed in phase 2 trial
Context Therapeutics	onapristone extended-release (ONA-XR)	metastatic endometrial cancer	first patient dosed in phase 2 trial
Day One Biopharmaceuticals	DAY101	treatment of pediatric, adolescent and young adult patients with recurrent or progressive low-grade glioma harboring a known BRAF alteration	first patient dosed in phase 2 trial
G1 Therapeutics	Cosela (trilaciclib) administered prior to docetaxel	treatment of patients with metastatic nonsmall-cell lung cancer in the 2nd- and 3rd-line setting who have previously been treated with a checkpoint inhibitor and chemotherapy	initiation of phase 2 trial
Ocuphire Pharma	Nyxol and low-dose pilocarpine	presbyopia	recruitment complete in phase 2 trial
Palisade Bio Newsoara	LB1148	accelerating return of bowel function associated with gastrointestinal surgery	completion of phase 2 trial
Axcella	AXA1125	nonalcoholic steatohepatitis	initiation of phase 2b trial
BioSight	aspacytarabine (BST-236)	first-line acute myeloid leukemia therapy for patients unfit for standard intensive chemotherapy	recruitment complete in phase 2b trial
Prothena Roche	prasinezumab	early Parkinson's disease	first patient dosed in phase 2b trial
Aeterna Zentaris	macimorelin acetate	diagnosis of childhood-onset growth hormone deficiency	initiation of phase 3 trial
Incyte MorphoSys	tafasitamab and lenalidomide in addition to R-CHOP	first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma	first patient dosed in phase 3 trial
Medeor Therapeutics	MDR-101	HLA-matched living donor kidney transplant recipients	recruitment and kidney transplantation complete in phase 3 trial
Reistone Biopharma	SHR0302	moderate-to-severe atopic dermatitis	first patient dosed in phase 3 trial
SBI ALApharma Canada	PD G 506 A (5-ALA HCl) plus EagleT imaging technology	margin assessment during breast-conserving surgery	first patient enrolled in phase 3 trial
Tarsus Pharmaceuticals	TP-03 (lotilaner ophthalmic solution, 0.25%)	demodex blepharitis	initiation of phase 3 trial
Telix Pharmaceuticals	TLX591 (177Lu-DOTA-rosopatamab)	advanced metastatic castrate-resistant prostate cancer	initiation of phase 3 trial
XOMA Janssen Biotech	cetrelimab	cancer	first patient dosed in phase 3 trial
Bold Therapeutics	BOLD-100	gastric cancer	Orphan Drug designation granted by the FDA
Alume Biosciences	ALM-488	adjunct for the visualization of nerves at risk for injury during head and neck surgery	Fast-Track designation granted by the FDA
Fulcrum Therapeutics	losmapimod	facioscapulohumeral muscular dystrophy	Fast-Track designation granted by the FDA
Smart Immune	SMART 101 (ProTcell)	acute lymphocytic leukemia and acute myelocytic leukemia	Fast-Track designation granted by the FDA
DermaSensor	DermaSensor device	assessment of lesions suggestive of skin cancer	Breakthrough Device designation granted by the FDA
Daiichi Sankyo American Regent	single 1,000-mg dose option of Injectafer (ferric carboxymaltose injection)	iron-deficiency anemia in adult patients who have intolerance to oral iron, have had unsatisfactory response to oral iron or have nondialysis-dependent chronic kidney disease	approved by the FDA for new dose formulation
Heron Therapeutics	Zynrelief (bupivacaine and meloxicam) extended-release solution	postoperative pain management for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty	approved by the FDA
Zealand Pharma	Zegalogue (dasiglucagon) injection	severe hypoglycemia in patients with diabetes age six and older	approved by the FDA
Bigfoot Biomedical	Bigfoot Unity diabetes management system	smart-pen caps for insulin pens used to treat Type 1 and Type 2 diabetes	approved by the FDA
ConforMIS	Identity Imprint knee replacement system	total knee replacement system	approved by the FDA
Johnson and Johnson Vision	Acuvue Abiliti Overnight Therapeutic Lenses	management of myopia	approved by the FDA
Johnson and Johnson Vision	TECNIS Synergy	implantation for the visual correction of aphakia in adult patients	approved by the FDA
Johnson and Johnson Vision	TECNIS Synergy Toric II IOLs	primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed	approved by the FDA