Clinical Catch-Up: January 17-21
Last week was a relatively quiet week for clinical trial news, particularly around COVID-19. Here’s a look.
Bonus BioGroup submitted results from its Phase II trial to the Israeli Ministry of Health. The MesenCure data demonstrated high levels of efficacy and safety for treatment of severe COVID-19. MesenCure is derived from mesenchymal stromal cells and appears to attenuate the hyper-inflammatory response known as a cytokine storm.
George Medicines initiated a Phase I trial with ICTU Global, an Academic Clinical Research Organization at Imperial College London of GMRx2 in hypertension. The drug is a triple low-dose combination of telmisartan, amlodipine and indapamide.
Dermavant Sciences announced results from a patient satisfaction survey in its long-term, open-label Phase III PSOARING 3 extension study of tapinarof cream 1% once daily for plaque psoriasis. The patients consistently expressed high rates of satisfaction and positive perception of the treatment.
EQRX and CStone Pharmaceuticals published data from two Phase III trials of sugemalimab for non-small cell lung cancer (NSCLC). The studies are GEMSTONE-301 and -302. Sugemalimab is an anti-PD-L1 checkpoint inhibitor. Both studies demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS).
UCB announced positive topline interim data from the Phase III BE MOBILE 1 trial of bimekizumab in adults with active non-radiographic axial spondyloarthritis. The trial hit the primary and all ranked secondary endpoints. Bimekizumab is a monoclonal IgG1 antibody that targets interleukin 17A and 17F.
Guardant Health enrolled the first patient in the SHIELD LUNG study. It is a nearly 10,000-patient prospective, registrational study to evaluate the performance of its next-generation Guardant SHIELD blood test in detecting lung cancer in high-risk individuals ages 50-80.
AstraZeneca announced results from the HIMALAYA Phase III trial of using a single priming dose of tremelimumab added to anti-PD-L1 checkpoint inhibitor Imfinzi (durvalumab) compared to Bayer’s Nexavar (sorafenib) as first-line treatment for unresectable hepatocellular carcinoma (HCC) patients who had not received previous systemic therapy and as a result, weren’t eligible for localized treatment. HIMALAYA uses an approach called STRIDE, involving a single dose of tremelimumab and Imfinzi with a 1,500 mg primer dose, followed by Imfinzi by itself every four weeks. This appears to decrease the risk of death by 22% over Nexavar alone. Patients survived a median 16.4 months on the combination therapy compared to 13.8 months on the Bayer drug.
Yumanity Therapeutics announced the FDA has placed a clinical hold on its trial of YTX-7739 for Parkinson’s disease. The drug is a potentially first-in-class small molecule inhibitor of stearoyl-CoA desaturase (SCD). It is a partial hold on multidose trials of the drug; the single dose trial is proceeding as planned.
CStone Pharmaceuticals reported that its Phase III trial of sugemalimab for non-small cell lung cancer (NSCLC) hit the endpoint of overall survival. It was for front-line treatment of metastatic NSCLC. The drug is a PD-L1 antibody.
ImmunityBio announced interim results from its Phase II QUILT 88 trial of Anktiva and aldoxorubicin and low-dose chemotherapy in metastatic pancreatic cancer. Anktiva is the company’s IL-15 receptor agonist; aldoxorubicin is an albumin-modulated agent. The combination is dubbed the Nant Cancer Vaccine.
HutchMed presented updated analysis of its ongoing Phase I/Ib trial of fruquintinib in refractory metastatic colorectal cancer. The drug is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3.
Merck reported that its blockbuster checkpoint inhibitor Keytruda (pembrolizumab) improved overall survival, progression-free survival and objective response rate in the Phase III KEYNOTE-394 trial of the drug with best supportive care in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib.
Abivax presented results from the dose escalation phase of its Phase I/II trial of ABX196 for HCC. The heavily pre-treated patients were dosed with ABX196 with Bristol Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab). The data supports further clinical development in this setting.
VolitionRX announced results from two large-scale clinical studies showing the company’s Nu.Q assays in conjunction with the Fecal Immunochemical Test (FIT) can detect colorectal cancer and all high-risk advanced adenomas in symptomatic patients. It also improved the detection of high-risk adenomas in asymptomatic patients.
Turning Point Therapeutics received the green light from the FDA for its Phase Ib/II SHIELD-2 combination study of elzovantinib and aumolertinib in EGFR mutant MET-amplified advanced non-small cell lung cancer (NSCLC). Elzovantinib targets MET, CSF1R and SRC. Aumolertinib is a novel, irreversible EGFR-TKI that selectively inhibits both EGFR sensitizing and resistance mutations with high selectivity over wild-type EGFR. Hansoh Pharma and EQRx are jointly developing aumolertinib.
Hutchmed initiated a Phase I study in China of HMPL-653 being developed for advanced malignant solid tumors and tenosynovial giant cell tumors (TGCT). HMPL-653 is a novel, highly selective and potent colony-stimulating factor 1 receptor (CSF-1R) inhibitor.