Company Product Description Indication Status
Phase I
Apellis Pharmaceuticals Inc., of Waltham, Mass. APL-9 Targeted C3 therapy Severe COVID-19 In a phase I/II study of APL-9, the independent data monitoring committee found there was no meaningful reduction in the overall mortality rate in patients treated with APL-9 in combination with standard-of-care therapy compared to standard of care alone; company will not pursue additional development of APL-9 for the indication
Bergenbio ASA, of Bergen, Norway Tilvestamab (BGB-149) Monoclonal antibody targeting AXL Platinum resistant high-grade serous ovarian cancer Treated first patient in a phase Ib study designed to confirm the safety, tolerability and determine a recommended phase II dose; serial biopsies will be performed to determine AXL expression in real time during the treatment period
Bioeclipse Therapeutics, of Mountain View, Calif. CRX-100  Cytokine-induced killer cells plus an oncolytic virus Refractory solid tumors First of up to 24 patients treated in the study exploring the safety, tolerability and pharmacokinetics of CRX-100 in patients with triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer and gastric cancer; secondary endpoints include measurements of tumor progression and overall immune response
GT Biopharma Inc., of Beverly Hills, Calif. GTB-3550 TriKE Fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15  CD33+ malignancies Added an additional clinical trial site at the Wisconsin – Madison Carbone Cancer Center to the ongoing phase I/II study
Longeveron Inc., of Miami Lomecel-B Allogeneic bone marrow-derived medicinal signaling cells Acute respiratory distress syndrome due to COVID-19 or influenza infection The enrollment criteria for the Recover study was modified to include mild ARDS, in addition to moderate and severe ARDS
Loxo Oncology at Lilly, a unit of Indianapolis-based Eli Lilly and Co. Pirtobrutinib (LOXO-305) Bruton's tyrosine kinase inhibitor Relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma and other non-Hodgkin lymphomas Data from the phase I/II Bruin study published in The Lancet showed pirtobrutinib produced an overall response rate of 62% among 121 efficacy evaluable patients with CLL or SLL treated with a previous covalent BTK inhibitor; ORR was 67% for the 79 CLL patients with previous covalent BTK inhibitor resistance, 52% for 42 patients with covalent BTK inhibitor intolerance, 71% for 24 patients with BTK C481-mutant tumors and 66% for 65 patients with wild-type BTK; ORR was 52% for 52 efficacy evaluable patients with mantle cell lymphoma previously treated with covalent BTK inhibitors
Macrogenics Inc., of Rockville, Md. MGD-009 B7-H3 × CD3 bispecific DART molecule B7-H3-expressing tumors Study terminated for business reasons
Phase II
Aerpio Pharmaceuticals Inc.. of Cincinnati Razuprotafib  Protein tyrosine phosphatase beta inhibitor Critically ill COVID-19 The Quantum Leap Healthcare Collaborative halted testing of the drug in the I-SPY COVID study because it was challenging to administer in the setting of COVID-19; 30% of patients discontinued due to disease-related hypotension, including protocol-mandated stopping rules; there was no indication that razuprotafib caused the hypotension
Brii Biosciences Ltd., of Durham, N.C., and Beijing, China BRII-196 and BRII-198 SARS-CoV-2 neutralizing antibodies  Hospitalized COVID-19 At the interim analysis of 300 patients in the Active-3 study, the antibody combination failed to meet prespecified efficacy criteria permitting expansion of the study; combination continues to be studied in the Activ-2 study in patients with ambulatory COVID-19
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson  A3 adenosine receptor agonist Hospitalized moderate to severe COVID-19 Enrolled first of 40 patients in the study measuring the clinical and respiratory status at day 29, including the proportion of patients alive and free of respiratory failure and the proportion discharged home without need for supplemental oxygen; safety and pharmacokinetics will also be measured
Immutep Ltd., of Sydney Eftilagimod alpha LAG-3 fusion protein Second-line non-small-cell lung cancer Following a preliminary safety and efficacy review by the data monitoring committee, company is expanding into stage 2 of part B of the TACTI-002 study, which will include an additional 13 patients treated with eftilagimod alpha plus Keytruda (pembrolizumab, Merck & Co. Inc.)
Ocuphire Pharma Inc., of Farming Hills, Mich. Nyxol (phentolamine mesylate eye drops) Alpha 1/alpha 2 adrenoceptor antagonist  Mydriasis  Data from the phase IIb study published in Optometry and Visual Science showed 29% of patients had a return to within 0.2 mm of their baseline pupil diameter at 2 hours, compared with 13% of patients treated with placebo; time to return to baseline pupil diameter was nearly 2 hours faster for Nyxol compared to placebo
Seelos Therapeutics Inc., of New York SLS-002 Intranasal racemic ketamine Acute suicidal ideation and behavior in patients with major depressive disorder Completed enrollment in the proof-of-concept study; data expected in the second quarter of 2021
Tersera Therapeutics LLC, of Deerfield, Ill. Quzyttir (cetirizine hydrochloride) H1 antihistamine Hypersensitivity infusion reactions in patients with breast cancer and other malignancies Infusion reactions occurred in 11.8% of 17 patients treated with cetirizine, compared to 17.6% of 17 patients treated with diphenhydramine; sedation scores at 1 hour, 2 hours and discharge for cetirizine were 0.5, 0.6 and 0.1, respectively, vs. 1.3, 0.9 and 0.4, respectively, for diphenhydramine; time for discharge was 24 minutes quicker with cetirizine vs. diphenhydramine

Notes

For more information about individual companies and/or products, see Cortellis.