Company Product Description Indication Status
Phase I
Bellicum Pharmaceuticals Inc., of Houston BPX-601 GoCAR-T candidate Advanced pancreatic tumors Data from a cohort treated in combination with single dose of rimiducid showed immunomodulation in both the periphery and tumor microenvironment; BPX-601 GoCAR-T cells showed enhanced survival and persistence up to 9 months; activation of BPX-601 GoCAR-T cells mediated up-regulation of immunomodulatory cytokines in patients, and the cells infiltrated metastatic pancreatic tumors
Cstone Pharmaceuticals Co. Ltd., of Suzhou, China CS-1001 PD-L1 inhibitor Advanced solid tumors, including gastric cancer Dosed first patient in combination with regorafenib (Bayer AG); phase Ib/II trial is assessing safety, tolerability, pharmacokinetics and antitumor activity and will determine recommended dose for subsequent studies
Exelixis Inc., of Alameda, Calif. Cabometyx (cabozantinib) Multityrosine kinase inhibitor Advanced hepatocellular carcinoma Phase I/II results from the cabozantinib combination of Checkmate 040 trial testing Opdivo (nivolumab, Bristol-Myers Squibb Co.), with or without Yervoy (ipilimumab), showed for 36 patients treated with cabozantinib/nivolumab, investigator-assessed objective response rate was 19%, disease control rate was 75%, median progression-free survival was 5.4 months and median overall survival was 21.5 months; for 35 patients treated with triple combination, investigator-assessed ORR was 29%, DCR was 83%, median PFS was 6.8 months and median OS had not yet been reached
Tonix Pharmaceuticals Inc., of New York TNX-102 SL Cyclobenzaprine HCl sublingual tablets Post-traumatic stress disorder and fibromyalgia Completed required fed-fasting and dose proportionality tests in healthy volunteers to support NDAs in both indications; preliminary results showed no significant effect of a fatty meal on rate or extent of absorption of TNX-102 SL 5.6 mg administered as 2 x 2.8-mg sublingual tablets
Phase III
Erytech Pharma SA, of Lyon, France Eryaspase L-asparaginase encapsulated inside donor-derived red blood cell Pancreatic cancer Trybeca1 trial in second-line disease has enrolled more than 50% of patients; primary endpoint is overall survival, with interim efficacy analysis planned when about two-thirds of events have occurred
Ipsen SA, of Paris Palovarotene RARγ agonist Fibrodysplasia ossificans progressive Decided to pause dosing in PVO-1A-301 trial, as well as ongoing phase II extension studies, based on results from a futility analysis by the independent data monitoring committee, indicating the phase III FOP trial was unlikely to meet its primary endpoint of annualized change in new HO volume vs. natural history study
Isofol Medical AB, of Gothenburg, Sweden Arfolitixorin Folate-based therapy Metastatic colorectal cancer First patient in Australia initiated treatment in Agent study testing first-line treatment
Lipidor AB, of Stockholm AKP-01 Calcipotriol spray Mild to moderate plaque psoriasis Top-line results showed study met primary endpoint, demonstrating therapeutic equivalence to comparator, as measured by reduction of Psoriasis Area and Severity Index score; both AKP-01 and comparator had statistically significantly better efficacy vs. placebo
Roche Holding AG, of South San Francisco Tecentriq (atezolizumab) Antibody targeting PD-L1 Muscle-invasive urothelial cancer Imvigor010 study testing drug as adjuvant monotherapy did not meet primary endpoint of disease-free survival vs. observation

Notes

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