Company Product Description Indication Status
Phase I
Bioinvent International AB, of Lund, Sweden BI-1206 Immunoglobulin gamma Fc receptor IIB antagonist Non-Hodgkin lymphoma Interim data from 9 people who completed induction cycle in phase I/IIa combination trial with anti-CD20 monoclonal antibody rituximab in indolent relapsed/refractory B-cell disease showed 6 had complete or partial responses, with 2 (30-mg and 70-mg dose) achieving complete response sustained 12 and 24 months later
Catalym GmbH, of Munich CTL-002 GDF-15 neutralizing antibody Solid tumors First of about 149 participants dosed in 2-part Gdfather trial assessing agent as monotherapy and with anti-PD-1 in people with advanced disease relapsed/refractory to previous anti-PD-1/PD-L1 therapy
Evotec SE, of Hamburg EVT-894 Fully human monoclonal antibody Chikungunya virus infection First healthy volunteer dosed in NIAID-sponsored trial; agent gained in transfer of Sanofi SA's Lyon-based infectious disease R&D unit in July 2018
Eyepoint Pharmaceuticals Inc., of Watertown, Mass. EYP-1901 VEGF-1/2 receptor antagonist; TKI Wet age-related macular degeneration  First of 13 participants responsive to previous anti-VEGF treatments dosed in trial delivering agent via single intravitreal injection; key efficacy endpoints are changes in BCVA and central subfield thickness
Kura Oncology Inc., of La Jolla, Calif. KB-947 Selective small-molecule inhibitor of extracellular signal-regulated kinases 1 and 2 Non-hematological malignancies Study terminated due to strategic business decision; neither safety nor efficacy reasons were cause of termination
Medicure Inc., of Winnipeg, Manitoba Aggrastat (tirofiban hydrochloride) GP IIb/IIIa inhibitor Aneurysmal subarachnoid hemorrhage  Phase I/IIa Ispasm trial completed enrollment of 30 participants ahead of schedule; primary endpoint is hemorrhagic changes on head CT and/or MRI assessed by rates of symptomatic and asymptomatic bleeding, with top-line data expected at undisclosed upcoming conference
Takeda Pharmaceutical Co. Ltd., of Tokyo Mobocertinib (TAK-788) TKI/EGFR inhibitor Non-small-cell lung cancer  Phase I/II trial in previously treated people with EGFR exon20 insertion metastatic disease (n=114) showed confirmed objective response rate per investigator of 35%, median duration of response of 17.5 months and median progression-free survival of 7.3 months 
United Therapeutics Corp., of Silver Spring, Md. Tyvaso DPI (inhaled treprostinil)  PGI2 agonist Pulmonary arterial hypertension Phase Ib Breeze study met primary endpoint of safety and tolerability in people transitioning to dry powder formulation from Tyvaso inhalation solution; NDA submission expected in April 2021
Valneva SE, of Saint-Herblain, France VLA-2001 Inactivated whole virus vaccine COVID-19 infection Phase I/II study fully enrolled 150 healthy participants; initial results expected in April 2021
Zymeworks Inc., of Vancouver, British Columbia ZW-49 HER2-targeted antibody-drug conjugate Breast cancer At highest doses tested in every 3-week cohort of 2.5 or 3 mg/kg, 6 response-evaluable participants with centrally confirmed HER2‑positive disease in several tumor types showed 2 with confirmed partial responses and 2 with stable disease, with 3 of 4 still active in study; expansion cohort, including HER2-positive breast and gastroesophageal and basket cohort of other HER2-positive cancers, initiated enrollment
Phase II
Alkahest Inc., of San Carlos, Calif. GRF-6019 Plasma fraction Mild to moderate Alzheimer’s disease Trial met its primary endpoint, showing dose levels were safe and well-tolerated; treated patients showed a lack of cognitive decline and limited functional decline over the 24-week study period
Amgen Inc., of Thousand Oaks, Calif. Sotorasib (AMG-510) KRAS G12C inhibitor KRAS G12C-mutated advanced non-small-cell lung cancer Results from phase II cohort of Codebreak 100 study showed confirmed objective response rate and disease control rate of 37.1% and 80.6%, respectively, and a median duration of response of 10 months (data cutoff of Dec.1, 2020; median follow-up time was 12.2 months)
Azurrx Biopharma Inc., of Delray Beach, Fla. MS-1819 Lipase modulator Exocrine pancreatic insufficiency First cohort of phase IIb Option 2 extension study completed enrollment; top-line data expected by end of first quarter of 2021
Ayala Pharmaceuticals Inc., of Rehovot, Israel AAL-101 Gamma secretase inhibitor  Breast cancer First of up to 26 participants dosed in Tenacity trial to treat Notch-activated recurrent/metastatic triple-negative disease; preliminary data expected by year-end 2021
Dimerix Ltd., of Melbourne, Australia DMX-200 (irbesartan + propagermanium) Angiotensin II AT-1 receptor antagonist; CCR2 chemokine antagonist Diabetic kidney disease Patients taking DMX-200 had a 22% mean decrease in albuminuria compared to placebo in the second period of the crossover study; for patients with higher albuminuria in the second period, there was a 37% mean decrease in albuminuria compared to placebo
Follicum AB, of Lund, Sweden OL-005  Short version of osteopontin  Hair loss All patients have made their final visit to the clinic; top-line data expected in the spring of 2021
Hemostemix Inc., of Calgary, Alberta ACP-01 Autologous cell therapy Critical limb ischemia All follow-up visits of the patients in the HS 12 -01 clinical trial will be completed by March 31, 2021
Immunitybio Inc., of Culver City, Calif. Anktiva (N-803) Interleukin-15 superagonist complex Non-small-cell lung cancer In the QUILT-3.055 study, clinical benefit was seen in a majority of the 78 patients
Omniseq, of Buffalo, N.Y. Yervoy (ipilimumab) or relatlimab Monoclonal antibodies targeting CTLA4 or LAG-3 Recurrent/metastatic head and neck squamous cell carcinoma Launching a study with the University of Pittsburgh Medical Center using its RNA sequencing gene expression profile assay to select which immunotherapy to use with Opdivo (nivolumab)
Phase III
Appili Therapeutics Inc., of Halifax, Nova Scotia Favipiravir Antiviral Outpatient COVID-19 In the Preseco study, 12 out of 20 planned sites are recruiting patients
Beigene Ltd., of Beijing Tislelizumab  Monoclonal antibody targeting PD-1 Advanced unresectable or metastatic esophageal squamous cell carcinoma The Rationale 302 study met its primary endpoint with tislelizumab improving overall survival compared to chemotherapy; data to be presented at an upcoming medical conference
Phasebio Pharmaceuticals Inc., of Malvern, Pa. Bentracimab  Monoclonal antibody fragment targeting ticagrelor Uncontrolled major or life-threatening bleeding or patients who require urgent surgery or invasive procedure Expanded the ongoing Reverse-it study into the EU
Prilenia Therapeutics BV, of Naarden, the Netherlands Pridopidine  Sigma 1-receptor agonist Huntington’s disease Enrolled first European patient in the ongoing Proof-HD study

Notes

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