Drug & Device Pipeline News

January 2, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
IASO Biotherapeutics	CT103A (equecabtagene autoleucel)	Relapsed/refractory multiple myeloma	IND for a phase 1 trial approved by the FDA
Recbio	REC610	Shingles vaccine	Phase 1 trial authorized by the Philippines regulatory authority
Biocytogen Pharmaceuticals	YH008	PD-L1-resistant advanced solid tumors or hematological malignancies	IND for a phase 1 trial approved by the FDA
TG ImmunoPharma	TGI-2/NM1F	Advanced solid tumors	IND for a phase 1 trial approved by the FDA
Affimed	AFM28	Relapsed/refractory acute myeloid leukemia	Phase 1 trial authorized by France’s regulatory authority
Elpiscience Biopharmaceuticals	ES014	Advanced solid tumors	IND for a phase 1 trial approved by China’s regulatory authority
Invectys	IVS-3001	Solid tumors	IND for a phase 1/2 trial approved by the FDA
Ceapro	Avenanthramide	Low-grade inflammation	Phase 1/2 trial authorized by Canada’s regulatory authority
Moleculin	Annamycin plus ARA-C	Acute myeloid leukemia	Phase 1/2 trial authorized by Italy’s regulatory authority
Nova Mentis Life Science	NM-1001 oral microdose psilocybin	Fragile X syndrome	Phase 2a trial authorized by Canada’s regulatory authority
Immuron	Travelan	Prevention of infectious diarrhea caused by enterotoxigenicE. coli	IND for a phase 2 trial approved by the FDA
OKYO Pharma	OK-101	Dry eye disease	IND for a phase 2 trial approved by the FDA
Skye Bioscience	SBI-100 Ophthalmic Emulsion	Primary open angle glaucoma or ocular hypertension	IND for a phase 2 trial approved by the FDA
InnoCare Pharma	Orelabrutinib plus tafasitamab and lenalidomide	Relapsed or refractory non-Hodgkin's lymphoma	IND for a phase 2 trial approved by China’s regulatory authority
Kira Pharmaceuticals	KP104	IgA nephropathy and complement 3 glomerulopathy	Phase 2 trial authorized by Australia’s and China’s regulatory authorities
Kala Pharmaceuticals	KPI-012	Persistent corneal epithelial defect	IND for a phase 2b trial approved by the FDA
Gradalis	Vigil (gemogenovatucel-T)	Advanced ovarian cancer	Study May Proceed letter issued by the FDA for a phase 3 study
Trials Initiated
BioNTech	BNT165b1 mRNA-based malaria vaccine	Malaria prevention	Initiation of a phase 1 trial
BioNTech	BNT163 herpes simplex virus (HSV) vaccine	Prevention of genital lesions caused by HSV	Initiation of a phase 1 trial
BioInvent	BI-1206 subcutaneous formulation	Lymphoma and solid tumors	Initiation of a phase 1 trial
Erasca	ERAS-007 plus ERAS-601	RAS/MAPK pathway-altered solid tumors	Initiation of a phase 1b trial
Nuvation Bio	NUV-868 plus olaparib	Advanced solid tumors	Initiation of a phase 1b trial
Immunis	IMM01-STEM	Muscle atrophy related to knee osteoarthritis	Initiation of a phase 1/2a trial
Soligenix	SGX302 (synthetic hypericin)	Mild-to-moderate psoriasis	Initiation of a phase 2a trial
Tarsus Pharmaceuticals	TP-05	Lyme disease prevention	Initiation of a phase 2a trial
Biocon	Itolizumab	Ulcerative colitis	Initiation of a phase 2 trial
Imago Bioscience	Bomedemstat plus ruxolitinib	Myelofibrosis	Initiation of a phase 2 trial
InFlectis BioScience	IFB-088 plus riluzole	Bulbar-onset amyotrophic lateral sclerosis	Initiation of a phase 2 trial
KemPharm	KP1077	Idiopathic hypersomnia	Initiation of a phase 2 trial
atai Life Sciences	RL-007	Cognitive impairment associated with schizophrenia	Initiation of a phase 2b trial
BioXcel Therapeutics	BXCL501 (dexmedetomidine) sublingual film	Acute treatment of agitation in patients with Alzheimer’s disease	Initiation of a phase 3 trial
BridgeBio Pharma	Encaleret	Autosomal dominant hypocalcemia type 1	Initiation of a phase 3 trial
Exelixis	Zanzalintinib plus nivolumab	Advanced non-clear cell renal cell carcinoma	Initiation of a phase 3 trial
Viridian Therapeutics	VRDN-001	Active thyroid eye disease	Initiation of a phase 3 trial
Approvals
AbbVie	Vraylar (cariprazine)	Major depressive disorder	Approved by the FDA for new indication
Ferring Pharmaceuticals	Adstiladrin (nadofaragene firadenovec-vncg)	High-risk BCG-unresponsive non-muscle-invasive bladder cancer	Approved by the FDA
Genentech	Actemra (tocilizumab) intravenous	COVID-19 in hospitalized adults	Approved by the FDA for expanded indication
Genentech	Lunsumio (mosunetuzumab-axgb)	Relapsed/refractory follicular lymphoma	Approved by the FDA
Gilead	Sunlenca (lenacapavir)	Multidrug-resistant HIV-1 infection	Approved by the FDA
Radius Health	Tymlos (abaloparatide)	Bone density in men with osteoporosis at high risk of fracture	Approved by the FDA for new indication
TG Therapeutics	Briumvi (ublituximab-xiiy)	Relapsing forms of multiple sclerosis in adults	Approved by the FDA
Polarean Imaging	XENOVIEW contrast agent with MRI	Evaluation of lung ventilation	Approved by the FDA
ADC Therapeutics Swedish Orphan Biovitrum	Zynlonta (loncastuximab tesirine)	Relapsed/refractory diffuse large B-cell lymphoma	Approved by the European Commission