Drug & Device Pipeline News

January 22, 2024

This week’s Pipeline features a phase 1 trial approval for pancreatic cancer, a phase 2 trial start for cardiac surgery-associated renal damage, and another FDA approval for Keytruda in cervical cancer.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Amplia Therapeutics	Narmafotinib plus folfirinox	Pancreatic cancer	IND for a phase 1 trial approved by the FDA
InnoCare Pharma	ICP-248	Hematologic malignancies	IND for a phase 1 trial approved by the FDA
Enlivex Therapeutics	Allocetra cell therapy	Moderate-to-severe knee osteoarthritis	Approval for a phase 1/2 granted by Israel’s regulatory authority
Trials Initiated
Chipscreen NewWay Biosciences	NWY001	Advanced solid tumors	Initiation of a phase 1 trial in China
Indapta Therapeutics	IDP-023 cell therapy	Multiple myeloma and non-Hodgkin’s lymphoma	Initiation of a phase 1 trial
Kairos Pharma	ENV105 plus osimertinib	EGFR-driven non-small cell lung cancer	Initiation of a phase 1 trial
Oxford BioTherapeutics	OBT076	Adenoid cystic carcinoma of the head and neck	Initiation of a phase 1b trial in Europe
Vor Bio	VBP301	Relapsed/refractory acute myeloid leukemia	Initiation of a phase 1/2 trial
AM-Pharma	Ilofotase alfa	Cardiac surgery-associated renal damage	Initiation of a phase 2 trial
Elicio Therapeutics	ELI-002 7P cancer vaccine	KRAS-mutated pancreatic ductal adenocarcinoma	Initiation of a phase 2 trial
Lisata Therapeutics	LSTA1	Newly diagnosed glioblastoma multiforme	Initiation of a phase 2a trial in Estonia and Latvia
Approvals
CRISPR Therapeutics	Casgevy (exagamglogene autotemcel)	Transfusion-dependent beta thalassemia in patients age 12 and older	Approved by the FDA
Merck	Keytruda (pembrolizumab) plus chemotherapy	FIGO 2014 Stage III-IVA cervical cancer	Approved by the FDA for additional indication
Takeda	Hyqvia [immune globulin infusion 10% (human)]	Chronic inflammatory demyelinating polyneuropathy	Approved by the FDA for additional indication
argenx	Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) injection	Generalized myasthenia gravis in adults	Approved in Japan