Out of the starting gate

Tokyo-based Eisai Co. Ltd. announced in late September the initiation of a global Phase 3 clinical study (Study 307, also known as the CLEAR Study) of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in respective combination regimens with the anticancer agent everolimus and the anti-PD-1 antibody pembrolizumab as a potential first-line treatment for advanced renal cell carcinoma.

The CLEAR study is a multicenter, randomized, open-label study to compare the efficacy and safety of lenvatinib/everolimus and lenvatinib/pembrolizumab vs. sunitinib alone in first-line treatment in patients with advanced renal cell carcinoma. The primary outcome measure will be progression-free survival.

Nonclinical research into the combination of lenvatinib and everolimus suggested synergistic enhancement of antiangiogenic activity and a stronger antitumor effect than either monotherapy in renal cell carcinoma models.

PALO ALTO, Calif.—In September, Orbus Therapeutics Inc., a private, clinical-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced that the first patient had been enrolled in a pivotal Phase 3 clinical trial, called STELLAR, of eflornithine in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant chemotherapy. STELLAR will include approximately 60 leading clinical trial centers in the United States and Europe.

Eflornithine is a novel cytostatic agent that the company is developing to treat patients with recurrent anaplastic astrocytoma, a subtype of anaplastic glioma, which is a rare form of brain cancer. Eflornithine is designated as an orphan drug in both the United States and Europe, and received Breakthrough Therapy Designation in the United States for the treatment of anaplastic glioma.

SAN DIEGO—Vical Inc. recently initiated a Phase 2 trial of the company’s Vaxfectin-formulated, bivalent, therapeutic DNA vaccine for herpes simplex virus type 2 (HSV-2) infection. The randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of the vaccine in approximately 225 healthy adults aged 18 to 50 years with symptomatic genital HSV-2 infection at up to 15 U.S. clinical sites.

After a four-dose vaccination series, subjects will be evaluated for recurrences over a 12-month period. Following discussions with the U.S. Food and Drug Administration, Vical has selected recurrence rate as the primary endpoint for the study.

“The endpoint of ‘annualized recurrence rate’ provides information on both the number and spacing of recurrences over time, which we believe makes it more informative in this chronic disease setting than the endpoints of ‘time to first recurrence’ and ‘proportion of subjects recurrence-free’, both of which only measure the recurrence of singular events,” said Dr. Mammen P. “Anza” Mammen Jr., vice president of clinical vaccines at Vical.

COVINGTON, Ky.—At the end of September, Bexion Pharmaceuticals LLC and the University of Cincinnati Cancer Institute announced the dosing of the first patient in their Phase 1 trial of BXQ-350, a novel anti-cancer therapeutic agent. This open-label trial will include adult patients with advanced solid tumors. The trial is designed to determine the maximum tolerated dose of BXQ-350 and to characterize its safety and pharmacokinetics. In preclinical animal studies, BXQ-350 was shown to induce tumor cell death in a variety of cancers, while leaving healthy cells unharmed.

“Dosing of our first ever patient with BXQ-350 is a significant milestone for Bexion,” stated Dr. Ray Takigiku, founder and CEO of Bexion. “This trial is designed to study the safety and tolerability of BXQ-350 in patients with advanced solid tumors including glioblastoma multiforme and may yield further insights into the potential anti-tumor activity of BXQ-350.”

LIVONIA, Mich.—Late September saw Gemphire Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of dyslipidemia and nonalcoholic fatty liver disease, announce enrollment of its first patient in COBALT-1, a Phase 2b trial designed to investigate gemcabene in the treatment of homozygous familial hypercholesterolemia (HoFH). The purpose of this study is to assess the efficacy, safety, and tolerability of multiple rising doses of gemcabene in patients with HoFH who are on stable, lipid-lowering therapy, including statins, ezetimibe and Repatha.

“Many patients with HoFH have high levels of LDL-C despite the use of statins and other approved medications and remain at high risk for cardiovascular disease,” said Mina Sooch, president and CEO of Gemphire. “We believe that gemcabene, which is being developed as a convenient, once-a-day, oral cost-effective medication, has the potential to be a complementary add-on therapy in this patient population. Gemcabene has been well tolerated in 895 subjects treated across 18 clinical trials both as monotherapy and in combination with statins and other cardiovascular agents.”