Drug & Device Pipeline News

August 1, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
HOOKIPA Pharma	HB-300	Metastatic castration-resistant prostate cancer	IND approved by the FDA
Obsidian Therapeutics	OBX-115	Solid tumors	IND approved by the FDA
Ascentage Pharma	Olverembatinib (HQP1351)	Refractory chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia	CTA approved in Canada
Sirnaomics	STP705	Advanced liver tumors	IND approved by Taiwan’s regulatory authority
Incannex	IHL-675A	Inflammation	Approval for a phase 1 trial granted by Australia’s regulatory authority
Trials Initiated
I-Mab Biopharma	TJ-CD4B	Solid tumors	Initiation of phase 1 trial
Blue Lake Biotechnology	Intranasal BLB-201 vaccine	Respiratory syncytial virus	Initiation of phase 1 trial
Sonnet BioTherapeutics	Advanced solid tumors	SON-1010	Initiation of phase 1 trial in Australia
ADC Therapeutics	ADCT-601 (mipasetamab uzoptirine)	Advanced solid tumors	Initiation of phase 1b trial
Ortho Regenerative Technologies	ORTHO-R	Rotator cuff tear repair	Initiation of phase 1/2 trial
Sonnet BioTherapeutics	SON-080	Persistent chemotherapy-induced peripheral neuropathy	Initiation of phase 1b/2a trial in Australia
Neuraptive Therapeutics	NTX-001	Facial paralysis	Initiation of phase 2a trial
Celldex Therapeutics	Barzolvolimab	Chronic inducible urticaria	Initiation of phase 2 trial
MediciNova	MN-001 (tipelukast)	Nonalcoholic fatty liver disease, type 2 diabetes mellitus and hypertriglyceridemia	Initiation of phase 2 trial
Nanoscope Therapeutics	MCO-010	Stargardt disease	Initiation of phase 2 trial
SOTIO Biotech	SOT101 plus Keytruda	Advanced/refractory solid tumors	Initiation of phase 2 trial
Synaptogenix	Bryostatin	Alzheimer's disease	Initiation of phase 2 trial
Sling Therapeutics	Linsitinib	Active moderate-to-severe thyroid eye disease	Initiation of phase 2b trial
Palisade Bio	LB1148	Return of bowel function following gastrointestinal surgery	Initiation of phase 3 trial
Approvals
GlaxoSmithKline	Benlysta (belimumab)	Children age five to 17 years with active lupus nephritis	Approved by the FDA for expanded age indication
AcuFocus	IC-8 Apthera intraocular lens	Cataracts	Approved by the FDA
Biotronik	Pulsar-18 T3 peripheral self-expanding stent system	Endovascular treatments	Approved by the FDA
ilooda	Secret Duo	Monkeypox scarring	Approved by the FDA
Global Blood Therapeutics	Oxbryta (voxelotor)	Hemolytic anemia in sickle cell disease patients age 12 years and older	Approved in UK