Pipeline

May 3, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Reven Holdings RJX high-risk COVID-19 patients first patient dosed in phase 1/2 trial
Partner Therapeutics inhaled Leukine (sargramostim, rhu-GM-CSF) treatment of nonhospitalized COVID-19 patients at high risk for progression to more severe COVID-19 first patient enrolled in phase 2 trial
Brii Bioscoences BRII-196 and BRII-198 treatment of ambulatory COVID-19 patients phase 3 portion of phase 2/3 trial expanding to international trial sites
Cardiol Therapeutics CardiolRx, pharmaceutically produced oral cannabidiol formulation cardiovascular disease (CVD) complications in hospitalized patients with a confirmed diagnosis of COVID-19 and who have pre-existing or significant risk factors for CVD first patient enrolled in phase 2/3 trial
Atea Pharmaceuticals AT-527 mild or moderate COVID-19 first patient dosed in phase 3 trial
Kintor Pharmaceutical proxalutamide mild or moderate COVID-19 in male patients first patient enrolled and dosed in phase 3 trial
Celltrion DiaTrust COVID-19 Ag Rapid Test Emergency Use Authorization (EUA) granted by the FDA
Other Trials and Actions
Hillhurst Biopharmaceuticals HBI-002 sickle cell disease IND approved by the FDA
Neoleukin Therapeutics NL-201 advanced, relapsed or refractory solid tumors IND approved by the FDA
Nkarta NKX019, NK cells engineered with a CD19-directed chimeric antigen receptor relapsed or refractory B-cell malignancies IND approved by the FDA
Voyager Therapeutics VY-HTT01 Huntington’s disease IND approved by the FDA
Medtronic implantable tibial neuromodulation device bladder incontinence investigational device exemption (IDE) approved by the FDA
Hope Biosciences Stem Cell Research Foundation autologous adipose-derived mesenchymal stem cells Parkinson’s disease FDA authorization for a phase 2 trial
Candel Therapeutics CAN-2409 in combination with Opdivo (nivolumab) newly diagnosed high-grade glioma patient enrollment complete in phase 1 trial
ProtoKinetix AAGP (PKX-001) treated islet cells type 1 diabetes phase I trial resumed at the University of Alberta, Edmonton
Xencor XmAb564 autoimmune diseases first patient dosed in phase 1 trial
Monopteros Therapeutics MPT-0118 solid tumors first patient dosed in phase 1/1b trial
Trillium Therapeutics TTI-622 (SIRP?-IgG4 Fc) relapsed/refractory multiple myeloma first patient dosed in phase 1b trial
Alladapt Immunotherapeutics ADP101 allergy to one food or to multiple foods first patients dosed in phase 1/2 trial
OBI Pharma

SWOG Cancer Research Network		 OBI-3424 relapsed/refractory T-Cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma first patient enrolled in phase 1 trial
Delpor DLP-114, a long-acting risperidone schizophrenia maintenance first patient dosed in phase 1b/2a trial
Chemomab Therapeutics CM-101 nonalcoholic steatohepatitis enrollment of first patient in phase 2a trial
Angion

Vifor Pharma		 ANG-3777 treatment of patients at risk of cardiac surgery associated acute kidney injury patient enrollment complete in phase 2 trial
Hutchison China MediTech HMPL-689 relapsed or refractory follicular lymphoma and marginal zone lymphoma first patient dosed in phase 2 trial in China
ImmunityBio Anktiva (N-803) in combination with antiretroviral therapy acute HIV infection initiation of phase 2 trial
Innovent Biologics IBI302 active subfoveal or parafoveal choroidal neovascularization secondary to neovascular age-related macular degeneration first patient dosed in phase 2 trial
MediWound EscharEx enzymatic debridement agent for chronic wounds first patient dosed in phase 2 trial
Onconova rigosertib recessive dystrophic epidermolysis bullosa-associated locally advanced/metastatic squamous-cell carcinoma first patient dosed in phase 2 trial
Protagonist Therapeutics rusfertide (PTG-300) polycythemia vera patient enrollment complete in phase 2 trial
Aerie Pharmaceutical AR-15512 ophthalmic solution dry eye disease patient enrollment complete in phase 2b trial
Sirnaomics STP705 squamous-cell skin cancer initiation of phase 2b trial
Aravive AVB-500 platinum resistant ovarian cancer first patient dosed in phase 3 trial
Brickell Biotech sofpironium bromide gel primary axillary hyperhidrosis patient enrollment complete in phase 3 Cardigan I study
G1 Therapeutics Cosela (trilaciclib) treatment of patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer initiation of phase 3 trial
Fractyl Revita DMR insulin-treated type 2 diabetes Breakthrough Device designation granted by the FDA
Akari Therapeutics nomacopan moderate and severe bullous pemphigoid Fast-Track designation granted by the FDA
Instil Bio ITIL-168 melanoma stages IIB to IV Orphan Drug designation granted by the FDA
PharmaDrug

Sairiyo Therapeutics		 dimethyltryptamine prevention of ischemia-reperfusion injury in patients undergoing solid organ transplantation Orphan Drug designation granted by the FDA
ADC Therapeutics Zynlonta (loncastuximab tesirine-lpyl) patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy approved by the FDA
GlaxoSmithKline Jemperli (dostarlimab) recurrent or advanced dMMR-positive endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy accelerated approval granted by the FDA
AtriCure EPi-Sense System patients diagnosed with longstanding persistent atrial fibrillation approved by the FDA
Neurolutions Neurolutions IpsiHand Upper Extremity Rehabilitation System rehabilitation for stroke patients with upper-extremity disability approved by the FDA
Soundbite Medical Solutions SoundBite Crossing System - Peripheral (SCS-P) recanalization of heavily calcified above-the-knee and below-the-knee peripheral artery disease approved by the FDA

 

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