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Veru Announces Sabizabulin Shows Potent Efficacy in Drug-Resistant Pancreatic Cancer

Veru announced new preclinical data showing that sabizabulin can overcome drug resistance to daraxonrasib with potent anticancer efficacy in daraxonrasib resistant human pancreatic cancer cell line which is a drug concentration that can be achieved with current sabizabulin human dosing with good safety. Based on the new, positive preclinical data, and the previous preclinical and clinical sabizabulin studies, the company will advance sabizabulin into a planned Phase 2 clinical trial for metastatic KRAS-driven pancreatic cancer progression that has become resistant to the recent FDA approved daraxonrasib. Preclinical studies were performed using a 2D proliferation assay to evaluate the efficacy of sabizabulin in parental and daraxonrasib resistant KRAS driven pancreatic cancer cell line AsPC-1 and colon cancer HCT-116 cell line. It was confirmed that the reason for daraxonrasib resistance was the reactivation of the KRAS signaling pathway in both pancreatic and colon daraxonrasib resistant cell lines. The resistance index was calculated, which is the ratio of drug concentration required to inhibit 50% cell growth in resistant cell line compared to its parental cell line. The resistance index represents the fold-change in drug tolerance of the resistant cell line compared to its sensitive, parental cell line. An RI greater than 1 indicates resistance, while an RI below 1 indicates increased sensitivity to the drug. Like daraxonrasib, sabizabulin had potent anticancer activity for both pancreatic cancer and colon cancer parental cell lines regardless of the type of KRAS mutation. As expected, the daraxonrasib resistant cell lines were resistant to daraxonrasib with a RI of 68 for pancreatic cancer cell line and RI of greater than 128 for colon cancer cell line. In contrast, daraxonrasib resistant pancreatic cancer cell lines became more sensitive to sabizabulin with a RI of 0.25 and daraxonrasib resistant colon cell line retained sensitivity to sabizabulin with a RI of 1. In summary, sabizabulin retained highly potent anticancer efficacy in daraxonrasib resistant pancreatic and colon cancer cell lines that had reactivation of KRAS signaling pathway as the mechanism for drug resistance to daraxonrasib. These preclinical data may also support sabizabulin as a treatment of daraxonrasib resistant cancer types beyond pancreatic cancer. Sabizabulin's first-in-man study was a Phase 1/2b clinical trial evaluating safety and efficacy of sabizabulin in advanced metastatic prostate cancer. The company believes positive efficacy and safety clinical data from this Phase 1b/2 first-in-man clinical study of sabizabulin monotherapy conducted in 80 patients with heavily pretreated metastatic castration resistant and taxane resistant prostate cancer support the translational potential of sabizabulin treatment for daraxonrasib resistant metastatic pancreatic cancer. The Phase 1b portion utilized a 3+3 dose escalation design with escalating daily oral doses of 4.5 mg - 81 mg. The Phase 1b portion included 39 metastatic castration resistant cancer patients that were treated with one or more novel androgen receptor targeting agents. Most patients had bone-only disease (55%) with an additional 21% having both lymph node and bone involvement with 23% of patients with prior taxane-based chemotherapy. The Phase 2 portion tested a daily dose of 63 mg in 41 heavily pretreated similar patient population, but with no prior chemotherapy. Efficacy was assessed using PCWG3 and RECIST 1.1 criteria. The maximum tolerated dose was not defined in the Phase 1b as all doses tested were well tolerated. The recommended Phase 2 dose was set at 63 mg/day. The most common adverse events at the 63 mg oral daily dosing were predominantly Grade 1-2 events. Grade greater than or equal to 3 events included diarrhea, fatigue and ALT/AST elevations. Neurotoxicity and neutropenia were not observed at these dosage levels. Efficacy data in patients treated with greater than or equal to1 continuous cycle of 63 mg or higher had a Kaplan-Meier median radiographic progression-free survival that was estimated to be 11.4 months with durable responses lasting greater than 12 months, occurring in 14.5% patients. The objective response rate was 20.7% in patients with measurable disease and durable responses lasting greater than 2.75 years were observed. Compared to historical controls, the radiographic progression-free survival in similar patients was only 3.6 months and objective response rate was 2% with an alternative androgen receptor blocking agent. This Phase 1b/2 clinical trial had a favorable safety profile with promising preliminary antitumor activity and demonstrated that chronic oral daily dosing of sabizabulin was feasible up to 3 years.

Veru Completes Full Enrollment for PLATEAU Clinical Trial

"We are extremely pleased with the continued enobosarm progress during this past quarter," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. "We reached full enrollment of the Phase 2b PLATEAU clinical trial and entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.* In addition, we received from the USPTO a notice of allowance for a key U.S. patent for enobosarm with semaglutide for high quality weight loss which when issued, will provide U.S. patent protection until at least October 2044." Dr. Steiner added: "We believe these accomplishments mark important milestones in advancing enobosarm as a potential important combination therapy with GLP-1 receptor agonists. There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction especially in older patients who have low muscle reserves and obesity. I want to thank both the patients and the investigators for their enthusiasm to expeditiously reach full enrollment for this very important study. We remain on track to achieve the near-term milestone of reporting the interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027."

Veru Completes Enrollment in Phase 2b PLATEAU Clinical Study

Veru announced the completion of enrollment in the Phase 2b PLATEAU clinical study to evaluate the effect of oral enobosarm 3 mg versus placebo on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients who have obesity and are initiating semaglutide treatment for weight reduction. The interim analysis results from the study are expected in the first quarter of calendar year 2027 with final topline clinical data expected in the fourth quarter of calendar year 2027.