Drug & Device Pipeline News

October 25, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
First Wave BioPharma	FW-ICI-AC	Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors	IND approved by the FDA for a phase 2a trial
Plus Therapeutics	Rhenium-186 NanoLiposome (186RNL)	Leptomeningeal metastases	IND approved by the FDA
Processa Pharmaceuticals	PCS12852	Moderate-to-severe gastroparesis	IND approved by the FDA for a phase 2a trial
VectivBio Holding	apraglutide	Steroid-refractory acute graft vs. host disease	IND approved by the FDA
Xilio Therapeutics	XTX202	Solid tumors	IND approved by the FDA
I-Mab	efineptakin alfa	Advanced solid tumors	IND approved by China’s regulatory authority for a phase 2 trial
Akeso	AK120	Moderate-to-severe asthma	Approval for a phase 2 trial granted by China’s regulatory authority
Moleculin Biotech	WP1122	Treatment of COVID-19	Approval for a phase 1a trial granted by the UK’s regulatory authority
Trials Initiated
Apeiron Biologics	Inhaled APN01	SARS-CoV-2	Initiation of phase 1 trial
Blade Therapeutics	cudetaxestat	Idiopathic pulmonary fibrosis	Initiation of phase 1 trial
Homology Medicines	HMI-203	Mucopolysaccharidosis type II or Hunter syndrome	Initiation of phase 1 trial
Iterion Therapeutics	Tegavivint	Acute myeloid leukemia	Initiation of phase 1 trial
Synthetic Biologics	SYN-020	Intestinal disorders	Initiation of phase 1 trial
Ono Pharmaceutical	ONO-4685	Relapsed or refractory T-cell lymphoma	Initiation of phase 1b trial
Tizona Therapeutics	TTX-080	Advanced refractory or resistant solid tumor	Initiation of phase 1b trial
Vyne Therapeutics	FMX114	Mild-to-moderate atopic dermatitis	Initiation of phase 1b/2a trial
Active Biotech NeoTX Therapeutics	naptumomab estafenatox	Advanced nonsmall-cell lung cancer	Initiation of phase 2a trial
Oryzon Genomics	vafidemstat	Borderline personality disorder	Initiation of phase 2b trial
Paratek Pharmaceuticals	Nuzyra (omadacycline)	Nontuberculous mycobacterial pulmonary disease caused by mycobacterium abscessus complex	Initiation of phase 2b trial
Ultragenyx Pharmaceuticals	UX701	Wilson disease	Initiation of phase 3 trial
Approvals
Adamis Pharma	ZIMHI (high-dose naloxone)	Opioid overdose	Approved by the FDA for new formulation
Genentech/Roche	Tecentriq (atezolizumab)	Adjuvant treatment for PD-L1?1-expressing stage II-IIIA nonsmall-cell lung cancer	Approved by the FDA for expanded indication
Gilead	Biktarvy	HIV treatment in virologically suppressed children weighing at least 14 kg	Approved by the FDA for expanded indication
Oyster Point Pharma	Tyrvaya (varenicline solution) nasal spray 0.03 mg	Dry eye disease	Approved by the FDA
Regeneron	Dupixent (dupilumab)	Patients age six to 11 years with moderate-to-severe asthma	Approved by the FDA for expanded indication
Seqirus	Flucelvax Quadrivalent	Influenza vaccine in patients as young as six months	Approved by the FDA for expanded indication
Kerecis	Omega3 SurgiBind	Implantable fish skin graft for use in plastic and reconstructive surgery	Approved by the FDA