Drug & Device Pipeline News

December 5, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Ananda Scientific	Nantheia A1002N5S	Social anxiety disorder	IND approved by the FDA
Ascletis	ASC11	COVID-19 treatment	IND approved by the FDA
Immorna	JCXH-221	mRNA-based COVID vaccine	IND approved by the FDA for phase 1/2 trial
Mabwell	9MW3011	Polycythemia vera	IND approved by the FDA
Marker Therapeutics	MT-601	Pancreatic cancer	IND approved by the FDA
Triastek	T21	Ulcerative colitis	IND approved by the FDA
Praxis Precision Medicines	PRAX-562	Pediatric patients with developmental and epileptic encephalopathies	IND approved by the FDA for phase 2 trial
SOFIE Biosciences	[18F]FAPI-74	Gastric cancer, cholangiocarcinoma, hepatocellular carcinoma, pancreatic cancer and colorectal cancer	IND approved by the FDA for phase 2 trial
AB Science	Masitinib	Mild-to-moderate Alzheimer’s disease	IND approved by the FDA for phase 3 trial
Vistagen	PH10	Major depressive disorder	Study May Proceed letter issued by the FDA
Exscientia	EXS-21546	Advanced solid tumors	CTA approved by the EU for phase 1/2 trial
Trials Initiated
Autobahn Therapeutics	ABX-002	Major depressive disorder	Initiation of phase 1 trial
Dianthus Therapeutics	DNTH103	Severe autoimmune diseases	Initiation of phase 1 trial
Gate Neurosciences	Apimostinel	Acute depressive disorders	Initiation of phase 1 trial
Imago Biosciences	Bomedemstat plus venetoclax	Relapsed/refractory acute myeloid leukemia	Initiation of phase 1 trial
Spirita Oncology	E6201 plus dabrafenib	Patients with central nervous system metastases from BRAF V600 mutated metastatic melanoma	Initiation of phase 1 trial
VYNE Therapeutics	VYN201	Vitiligo	Initiation of phase 1a/b trial
Kiora Pharmaceuticals	KIO-301	Retinitis pigmentosa	Initiation of phase 1b trial in Australia
Clarametyx Biosciences	CMTX-101	Community-acquired bacterial pneumonia	Initiation of phase 1a trial
Compass Therapeutics	CTX-471 plus Keytruda	Advanced solid tumors	Initiation of phase 1b trial
ImmunoMet Therapeutics	IM156	Pancreatic cancer	Initiation of phase 1b trial
AstraZeneca	AZD2936	Stage III unresectable or stage IV non-small cell lung cancer	Initiation of phase 2 trial
BioSight	Aspacytarabine (BST-236) in combination with venetoclax	Acute myeloid leukemia	Initiation of phase 1/2 trial
Immuneering	IMM-1-104	Advanced solid tumors with RAS mutations	Initiation of phase 1/2a trial
TRACON Pharmaceuticals	YH001 plus envafolimab and doxorubicin	Sarcoma	Initiation of phase 1/2 trial
Tyra Biosciences	TYRA-300	Metastatic urothelial carcinoma	Initiation of phase 1/2 trial
Genentech	RG6501 (OpRegen)	Geographic atrophy secondary to age-related macular degeneration	Initiation of phase 2a trial
EmbarkNeuro	ANC-501	Major depressive disorder	Initiation of phase 2 trial
Escient Pharmaceuticals	EP547	Cholestatic pruritus	Initiation of phase 2 trial
India Globalization Capital	IGC-AD1	Agitation in dementia from Alzheimer’s disease	Initiation of phase 2 trial
Inversago Pharma	INV-202	Diabetic kidney disease	Initiation of phase 2 trial
Kinevant Sciences	Namilumab	Pulmonary sarcoidosis	Initiation of phase 2 trial
NETRIS Pharma	NP137	Advanced/metastatic solid tumors	Initiation of phase 2 trial
Telix Pharmaceuticals	TLX101	Recurrent high-grade gliomas	Initiation of phase 2 trial
Morphic Therapeutics	MORF-057	Moderate-to-severe ulcerative colitis	Initiation of phase 2b trial
TC Biopharm	OmnImmune	Acute myeloid leukemia	Initiation of phase 2b trial
Atea Pharmaceuticals	Bemnifosbuvir (AT-527)	Treatment of COVID-19 in non-hospitalized patients at high risk for disease progression	Initiation of phase 3 trial
Biofrontera Bioscience	Ameluz and BF-RhodoLED XL	Actinic keratosis on the extremities, neck and trunk	Initiation of phase 3 trial
Approvals
CSL	Hemgenix (etranacogene dezaparvovec-drlb)	Hemophilia B	Approved by the FDA
Ferring Pharmaceuticals	Rebyota (fecal microbiota, live-jslm)	Prevention of recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI	Approved by the FDA
Jazz Pharmaceuticals	Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)	Acute lymphoblastic leukemia or lymphoblastic lymphoma	Approved by the FDA for new dosing formulation
Provention Bio	Tzield (teplizumab-mzwv)	To delay the onset of stage 3 type 1 diabetes in patients 8 years and older who currently have stage 2 type 1 diabetes	Approved by the FDA
InnoCare Pharma	Hibruka (orelabrutinib)	Mantle cell lymphoma	Approved in Singapore
Rhythm Pharmaceuticals	Imcivree (setmelanotide)	Treatment of obesity and control of hunger in patients 6 years and older with Bardet-Biedl syndrome	Approved in UK
Roche	Polivy (polatuzumab vedotin for injection)	Large B-cell lymphoma	Approved in Canada