Company Product Description Indication Status
Phase I
ABM Therapeutics Inc., of San Diego ABM-1310 Oral, brain-penetrant small-molecule BRAF inhibitor Solid tumors and brain metastases Enrolled and dosed first patient in trial of BRAF-mutant advanced solid tumors and BRAF-mutant patients with brain metastases; goal is to determine optimal dose for phase Ib/II studies
Achilles Therapeutics Ltd., of Stevenage, U.K. cNeT therapy Clonal neoantigen T-cell therapy Advanced non-small-cell lung cancer Dosed first patient in phase I/II Chiron study; 40-patient study due to report interim data in first half of 2021
Bioinvent International AB, of Lund, Sweden BI-1206 Monoclonal antibody targeting FcgRIIb Solid tumors Enrolled first patient in phase I/IIa trial in combination with Keytruda (pembrolizumab, Merck & Co. Inc.); part A of study will be dose-escalation design, while part B will explore activity in patients with advanced lung cancer, melanoma and other types of malignancies, who are refractory to or have progressed on previous treatments with anti-PD1/PD-L1-targeting agents
Kadmon Holdings Inc., of New York KD-033 Anti-PD-L1/IL-15 fusion protein Metastatic or locally advanced solid tumors Dosed first patient
Oppilan Pharma Ltd., of Encinitas, Calif., and Cambridge, U.K. OPL-002 Oral, once-daily S1P receptor modulator Inflammatory bowel disease Data from phase I healthy volunteer study showed drug was well-tolerated; in multiple ascending-dose portion, once-daily dosing led to dose-dependent steady state reduction in absolute lymphocyte count of up to 65%, which returned to normal 72 hours after last dose; no clinically significant heart rate reduction during treatment for up to 28 days
Reneo Pharmaceuticals Inc., of San Diego REN-001 Selective PPAR-delta agonist Primary mitochondrial myopathies 12-week study in PMM patients with mitochondrial gene defects and history of myopathy showed drug was safe and well-tolerated; preliminary walk data will aid design of 200-patient study set to start in early 2021
Seelos Therapeutics Inc., of New York SLS-002 Intranasal racemic ketamine Acute suicidal ideation and behavior in major depressive disorder Final safety data showed all doses safe and well-tolerated, with no new safety signals or serious adverse events; 120-patient proof-of-concept study set to start, to evaluate change from baseline on Montgomery-Asberg Depression Rating Scale at 24 hours after first dose and persistence of effect at day 16 vs. placebo
Sunesis Pharmaceuticals Inc., of South San Francisco Vecabrutinib Noncovalent BTK inhibitor Relapsed/refractory chronic lymphocytic leukemia and other B-cell malignancies Will not advance into planned phase II portion of phase Ib/II trial, after assessing totality of data, including the 500-mg cohort, the highest dose studied in the trial; 1 partial remission observed after 11 treatment cycles in a CLL patient in cohort 5 (300 mg BID), with no other remissions observed, though a number of patients had stable disease
Vaccitech Ltd., of Oxford, U.K. VTP-300 prime Comprises ChAdOx1 nonreplicating viral vector delivering 3 full-length HBV antigens  Chronic hepatitis B virus Dosed first subject in study testing safety and immunogenicity in both healthy participants and chronic HBV patients who are virally suppressed with oral antiviral medication; trial will evaluate drug’s ability to generate anti-HBV CD4+ and CD8+ T cells
Phase II
Fibrogen Inc., of San Francisco Pamrevlumab Antibody inhibiting CTGF COVID-19 Started study in hospitalized patients with acute COVID-19 infection; 130-patient trial will assess effect on blood oxygenation and primary endpoint will be proportion of patients who have not received mechanical ventilation and/or extracorporeal membrane oxygenation and remain alive at day 28
Oncolytics Biotech Inc., of San Diego Pelareorep Immuno-oncolytic virus Metastatic breast cancer Dosed first patient in study of combination therapies in HER2+/HER2- disease; participants in Bracelet-1 study will receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Bavencio (avelumab, Merck KGaA/Pfizer Inc.); primary endpoint is overall response rate
Phase III
Myovant Sciences Ltd., of Basel, Switzerland Relugolix Once-daily, oral gonadotropin-releasing hormone receptor antagonist Endometriosis Top-line results showed Spirit 1 study testing combination with estradiol 1 mg and norethindrone acetate 0.5 mg for pain associated with endometriosis met co-primary endpoints, demonstrating clinically meaningful pain reductions for 74.5% of women with dysmenorrhea and 58.5% with non-menstrual pelvic pain, compared to 26.9% and 39.6% in the placebo group, respectively (p<0.0001); on average, women receiving combination had 73.3% reduction on 11-point Numerical Rating Scale for dysmenorrhea from 7.3 (severe pain) to 1.8 (mild pain); study also met all 7 key secondary endpoints
Principia Biopharma Inc., of South San Francisco SAR-442168 (PRN-2246) BTK inhibitor Relapsing multiple sclerosis Enrolled first patient in partner Sanofi SA’s study comparing drug to Aubagio (teriflunomide) and assessing annualized adjudicated relapse rate

Notes

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

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