Drug & Device Pipeline News

December 20, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Cellular Biomedicine	C-CAR039	Relapsed or refractory nonHodgkin’s lymphoma	IND approved by the FDA
Sparrow Pharmaceuticals	SPI-62	Cushing’s disease	IND approved by the FDA
Tonix Pharmaceuticals	TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration)	Skin test to measure SARS-CoV-2 exposure and T-cell immunity	IND approved by the FDA
Trevana	TRV045	Diabetic neuropathic pain	Permission to proceed with phase 1 trial granted by the FDA
xBiotech	Natrunix	Rheumatological disease	IND approved by the FDA
Bridge to Life	VitaSmart liver machine-perfusion system	Liver transplantation	Investigational device exemption approved by the FDA
I-Mab Biopharma	ABL111	Solid tumors	IND approved by China’s regulatory authority
Ascentage Pharma	Lisaftoclax (APG-2575)	Relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma	Phase 2 trial approved by China’s regulatory authority
Alterity Therapeutics	ATH434	Multiple-system atrophy	Phase 2 trial approved by New Zealand’s regulatory authority
Nurix Therapeutics	NX-5948	Relapsed and refractory B-cell malignancies	Phase 1 trial approved by the UK’s regulatory authority
Trials Initiated
Ensysce Biosciences	PF614-MPAR	Opioid overdose	Initiation of phase 1 trial
Oravax Medical	VLP COVID-19 vaccine	COVID-19	Initiation of phase 1 trial in South Africa
Recce Pharmaceuticals	RECCE 327	Sepsis	Initiation of phase 1 trial in Australia
Exelixis	XL092 in combination with immuno-oncology therapies	Advanced solid tumors	Initiation of phase 1b trial
Freeline Therapeutics	FLT180a	Hemophilia B	Initiation of phase 1/2 trial
Mallinckrodt Pharmaceuticals	StrataGraft	Adults with third-degree full-thickness thermal burns	Initiation of phase 1/2 trial
Nykode Therapeutics	DNA-based COVID-19 vaccine	SARS-CoV-2	Initiation of phase 1/2 trial
Axcella	AXA1125	Long-COVID/post-COVID-19 condition	Initiation of phase 2a trial
Vifor Pharma	Vamifeport	Adult patients with sickle cell disease	Initiation of phase 2a trial
Fortress Biotech Helocyte	Triplex cytomegalovirus (CMV) vaccine	Adults co-infected with HIV and CMV	Initiation of phase 2 trial
Ultimovacs	Telomerase vaccine, UV1	Ovarian cancer	Initiation of phase 2 trial
Aptinyx	NYX-783	Post-traumatic stress disorder	Initiation of phase 2b trial
Biofrontera	Ameluz in combination with the red-light lamp BF-RhodoLED	Moderate-to-severe acne	Initiation of phase 2b trial
Jazz Pharma	Suvecaltamide (JZP385)	Moderate-to-severe essential tremor	Initiation of phase 2b trial
Aerovate Therapeutics	AV-101 (dry-powder inhaled imatinib)	Pulmonary arterial hypertension	Initiation of phase 2b/3 trial
Applied Therapeutics	AT-007	Sorbitol dehydrogenase deficiency	Initiation of phase 2/3 trial
BioXcel Therapeutics	BXCL501	Treatment of acute agitation in patients with Alzheimer’s disease	Initiation of phase 3 trial
Centessa Pharmaceuticals	Lixivaptan	Autosomal dominant polycystic kidney disease	Initiation of phase 3 trial
PharmaMar Jazz Pharmaceuticals	Zepzelca (lurbinectedin)	Relapsed small-cell lung cancer	Initiation of phase 3 trial
Approvals
Pfizer BioNTech	Pfizer-BioNTech COVID-19 vaccine	Booster dose to include individuals 16 years of age and older	Emergency Use Authorization granted by the FDA
AbbVie	Rinvoq (upadacitinib)	Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers	Approved by the FDA for new indication
Allergan	Vuity (pilocarpine HCI ophthalmic solution)	Age-related presbyopia	Approved by the FDA
Bristol Myers Squibb	Orencia	Prevention of moderate-to-severe acute graft vs. host disease in patients older than two years of age who have received unrelated donor hematopoietic stem cell transplantation	Approved by the FDA
Pfizer	Xeljanz/Xeljanz XR (tofacitinib)	Active ankylosing spondylitis in adults who have had an inadequate response or intolerance to one or more TNF blockers	Approved by the FDA for new indication
Veru	Entadfi (finasteride and tadalafil) capsule	Benign prostatic hyperplasia	Approved by the FDA
Urotronic	Optilume urethral drug-coated balloon	Male urethral strictures	Approved by the FDA
Moderna	Spikevax	COVID-19 vaccine	Approved in Korea