Drug & Device Pipeline News

March 28, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
AIM ImmunoTech	Ampligen	Locally advanced pancreatic cancer	Approval for a phase 2 trial granted by the FDA
NeuroSense Therapeutics	PrimeC (ciprofloxacin and celecoxib)	Amyotrophic lateral sclerosis	IND approved by the FDA
Oryzon Genomics	Iadademstat	Relapsed/refractory acute myeloid leukemia with FLT3 mutation	IND approved by the FDA
Phanes Therapeutics	PT199	Advanced solid tumors	IND approved by the FDA
Palisade Bio	LB1148	Return of bowel function in patients undergoing abdominal surgery	Study-may-proceed letter issued by the FDA
TC BioPharm	OmnImmune	Acute myeloid leukemia	Approval for a phase 2/3 study granted by the UK’s regulatory authority
Trials Initiated
Evommune	EVO101	Inflammatory skin diseases	Initiation of phase 1 trial
Rani Therapeutics	RT-102	Osteoporosis	Initiation of phase 1 trial
Ribon Therapeutics	RBN-3143	Atopic dermatitis	Initiation of phase 1 trial
South Rampart Pharma	SRP-3D (DA)	Acute and chronic pain	Initiation of phase 1 trial
Plus Therapeutics	Rhenium-186 NanoLiposome	Leptomeningeal metastases	Initiation of phase 1/2 trial
Zentalis Pharmaceuticals	ZN-d5	Relapsed or refractory light chain amyloidosis	Initiation of phase 1/2 trial
Bayer	BAY 2395840	Diabetic neuropathic pain	Initiation of phase 2 trial
Jazz Pharmaceuticals	Zepzelca (lurbinectedin)	Select advanced or metastatic solid tumors	Initiation of phase 2 trial
Recursion	REC-994	Cerebral cavernous malformation	Initiation of phase 2 trial
CARsgen Therapeutics	CT041	CLDN18.2-positive advanced gastric/gastroesophageal junction cancer	Initiation of phase 2 trial in China
XNK Therapeutics	Autologous natural killer cell-based therapy plus isatuximab	Newly diagnosed multiple myeloma	Initiation of phase 2 trial in Sweden
AlloVir	Posoleucel	Prevention of infections from six common viruses in high-risk, allogeneic hematopoietic-cell transplant patients	Initiation of phase 3 trial
Visus Therapeutics	Brimochol PF	Presbyopia	Initiation of two phase 3 trials
Approvals
Bristol Myers Squibb	Opdualag (nivolumab and relatlimab-rmbw)	Metastatic melanoma patients age 12 years and older	Approved by the FDA
Marinus Pharmaceuticals	Ztalmy (ganaxolone)	Seizures associated with CDKL5-deficiency disorder	Approved by the FDA
Merck	Keytruda (pembrolizumab)	MSI H/dMMR advanced endometrial carcinoma	Approved by the FDA
Novartis	Pluvicto (lutetium Lu 177 vipivotide tetraxetan)	Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer	Approved by the FDA
Advanced Oxygen Therapy	Topical wound oxygen (TWO2) therapy	Diabetic foot ulcer	Approved in China
Moderna Therapeutics	Spikevax	COVID-19	Approved in Canada for expanded age indication
CanSino Biologics	Convidecia	COVID-19 booster	Approved in Malaysia and Indonesia