Company Product Description Indication Status
Phase I
Auris Medical Holding Ltd., of Hamilton, Bermuda AM-301 Nasal spray gel Allergic rhinitis Started the 36-patient phase Ib/II/III study testing exposure to pollen in an allergen challenge chamber; primary endpoint is the Total Nasal Symptom Score over 4 hours of exposure
Daiichi Sankyo Co. Ltd., of Tokyo, and Astrazeneca plc, of Cambridge, U.K. Enhertu  (trastuzumab deruxtecan) Antibody-drug conjugate targeting HER2 Advanced or metastatic non-small-cell lung cancer In the phase I/II TROPION-PanTumor01 study, objective response rate was 21% to 25% for doses between 4 mg/kg and 8 mg/kg; median progression-free survival ranged from 4.3 months to 8.2 months
Daiichi Sankyo Co. Ltd., of Tokyo Patritumab deruxtecan Antibody-drug conjugate targeting HER3 Previously treated EGFR-mutated metastatic/unresectable non-small-cell lung cancer Median membrane H score for HER3 expression was 180 at baseline; preliminary assessments suggest there's a correlation between higher HER3 membrane expression and response rate
Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson Amivantamab  EGFR and MET bispecific antibody Metastatic or unresectable non-small-cell lung cancer with EGFR exon 20 insertion mutations after progression on or after platinum-based chemotherapy In the Chrysalis study, the overall response rate was 40% for the 32 patients, including 4% complete responses; median duration of response was 11.1 months; median progression-free survival was 8.3 months; median overall survival was 22.8 months
Nanobiotix SA, of Paris NBTXR-3   Hafnium oxide nanoparticles Esophageal cancer Treated first of up to 24 patients in the study that includes a dose-escalation phase and an expansion cohort at the recommended phase II dose
Orion Biotechnology Canada Ltd., of Ottawa, Ontario OB-002H CCR5 antagonist Healthy volunteers (eventually HIV prophylaxis) OB-002H gel was safe and well-tolerated; no evidence of systemic absorption of OB-002
Phase II
Innovation Pharmaceuticals Inc., of Wakefield, Mass. Brilacidin  Dual PDE3/4 inhibitor Moderate to severe COVID-19 The 120-patient study is scheduled to start the week of Feb. 1; primary endpoint is time to sustained recovery through day 29 based on the National Institute of Allergy and Infectious Diseases Adaptive COVID-19 Treatment Trial clinical status ordinal scale
Novavax Inc., of Gaithersburg, Md. CoV-2373 Recombinant nanoparticle-based vaccine with saponin-based Matrix-M adjuvant COVID-19 prophylaxis In the phase IIb South African study, vaccine had 60% efficacy for preventing mild, moderate and severe COVID-19 in HIV negative patients; efficacy was 49.4% for total population of HIV-positive and negative participants
Ovoca Bio plc, of Dublin BP-101 Synthetic peptide Hypoactive sexual desire disorder in premenopausal women  First of 476 patients enrolled in the study comparing 3 dose levels to placebo; co-primary endpoints are changes in the Female Sexual Function Index desire domain and the Female Sexual Distress Scale after 4 weeks of daily dosing
Puma Biotechnology Inc., of Los Angeles Nerlynx (neratinib) Kinase inhibitor Metastatic non-small-cell lung cancer In the Summit basket study, there were 6 partial responses among the 10 evaluable patients with EFGR exon 18 mutations who had been treated with an EGFR-targeted tyrosine kinase inhibitor; median duration of response was 7.5 months; median progression-free survival was 9.1 months
Redhill Biopharma Ltd., of Tel Aviv, Israel Yeliva (opaganib) Sphingosine kinase-2 inhibitor Severe COVID-19 Following an interim review of safety and efficacy data, the independent data safety monitoring board unanimously recommended continuation of the global phase II/III study
Turning Point Therapeutics Inc., of San Diego Repotrectinib  Kinase inhibitor targeting the ROS1 and TRK ROS1-positive TKI-naïve non-small-cell lung cancer In the Trident-1 study, confirmed objective response rate was 93% for the 15 patients
Phase III
Astrazeneca, of Cambridge, U.K. Tagrisso (osimertinib) Tyrosine kinase inhibitor; epidermal growth factor receptor antagonist EGFR-mutated non-small-cell lung cancer Exploratory analysis of the Adaura study showed Tagrisso reduced the risk of disease recurrence or death by 84% in patients who had been treated with prior adjuvant chemotherapy and by 77% in patients who had not had the prior therapy
Humanigen Inc., of Burlingame, Calif. Lenzilumab Monoclonal antibody targeting granulocyte macrophage-colony stimulating factor COVID-19 Completed enrollment in the study; top-line data expected in March 2021
Johnson & Johnson, of New Brunswick, N.J. Janssen COVID-19 vaccine candidate Adenovirus-based vaccine COVID-19 prophylaxis In the Ensemble study, protection against moderate to severe COVID-19 infection was 72% in the U.S., 66% in Latin America and 57% in South Africa, 28 days post-vaccination; vaccine was 85% effective in preventing severe disease across all regions studied
Novavax Inc., of Gaithersburg, Md. CoV-2373 Recombinant nanoparticle-based vaccine with saponin-based Matrix-M adjuvant COVID-19 prophylaxis In the U.K. study, the vaccine had 89.3% efficacy at preventing mild, moderate or severe COVID-19; post hoc analysis showed 95.6% efficacy against the original COVID-19 strain and 85.6% efficacy against the U.K. variant strain

Notes

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