New Pipeline Updates from XBiotech Inc., BeyondSpring Inc. and GlaxoSmithKline

November 4, 2019

Company Drug/Device Medical Condition Status
Mustang Bio, Inc. MB-108 (oncolytic virus C134) recurrent glioblastoma multiforme Phase 1 trial initiated enrolling 24 subjects at the University of Alabama at Birmingham
Replimune Group Inc. RP2 as a single agent and in combination with Opdivo (nivolumab) advanced solid tumors Phase 1 trial initiated
Linnaeus Therapeutics, Inc. LNS8801 advanced solid and hematologic cancers Phase 1/2 trial initiated
XBiotech Inc. bermekimab moderate to severe Hidradenitis Suppurativa (HS) Phase 2 trial initiated enrolling 150 subjects at multiple international sites
Arena Pharmaceuticals, Inc. etrasimod moderate-to-severe atopic dermatitis (AD) Phase 2 trial initiated enrolling 120 subjects at sites across the U.S., Canada and Australia
CytomX Therapeutics, Inc. CX-072 in combination with the anti-CTLA-4 antibody YERVOY (ipilimumab) relapsed or refractory melanoma Phase 2 trial initiated enrolling subjects with unresectable or metastatic melanoma whose disease has progressed or relapsed following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
SpringWorks Therapeutics, Inc. mirdametinib (formerly PD-0325901) neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NF1-PN) Phase 2b trial initiated enrolling subjects two years of age and older with an inoperable NF1-associated PN causing significant morbidity
Zosano Pharma Corporation C213 cluster headache Phase 2/3 trial initiated enrolling 120 subjects
BeyondSpring Inc. Plinabulin prevention of chemotherapy-induced neutropenia (CIN) Phase 3 trial initiated enrolling subjects receiving TAC (taxotere, doxorubicin and cyclophosphamide) chemotherapy plus Neulasta vs. TAC plus Plinabulin and Neulasta
Talaris Therapeutics, Inc. FCR001 living donor kidney transplant (LDKT) Phase 3 trial initiated enrolling 120 adult LDKT recipients at multiple sites across the U.S.
Rafael Pharmaceuticals, Inc. CPI-613 (devimistat) metastatic pancreatic cancer Phase 3 trial initiated enrolling subjects at four sites in South Korea
AVROBIO, Inc. AVR-RD-02 Gaucher disease Orphan Drug designation granted by the FDA
Mirum Pharmaceuticals, Inc. maralixibat pruritus associated with Alagille syndrome (ALGS) in subjects one year of age and older Breakthrough Therapy designation granted by the FDA
SurModics, Inc. Sundance sirolimus-coated balloon (SCB) catheter below-the-knee (BTK) arterial lesions in subjects suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease Breakthrough Device designation granted by the FDA
Allergan plc BOTOX (onabotulinumtoxinA) lower limb spasticity, excluding spasticity caused by cerebral palsy (CP) in pediatric subjects two to 17 years of age sBLA approval granted by the FDA
SunGen Pharmaceuticals Lidocaine Ointment USP, 5%, Package size: 1 ½ oz tube (35.44 g) production of anesthesia of accessible mucous membranes of the oropharynx, an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin and insect bites ANDA approval granted by the FDA
GlaxoSmithKline Zejula (niraparib) advanced ovarian, fallopian tube or primary peritoneal cancer Approval granted by the FDA
Melinta Therapeutics BAXDELA (delafloxacin) adult subjects with community-acquired bacterial pneumonia (CABP) Approval granted by the FDA

Biogen Inc.

Alkermes plc

VUMERITY (diroximel fumarate) relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease Approval granted by the FDA