P1b/2, N=80, Terminated, Veru Inc. | N=58 --> 80 | Completed --> Terminated; Administrative decision

P3, N=105, Terminated, Veru Inc. | N=245 --> 105 | Trial completion date: Sep 2024 --> May 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> May 2023; Administrative reasons

P1b/2, N=58, Completed, Veru Inc. | Active, not recruiting --> Completed | N=41 --> 58

P2, N=0, Withdrawn, Veru Inc. | N=200 --> 0 | Not yet recruiting --> Withdrawn

This study developed a robust IGS model for survival prediction of HCC patients, providing new insights into integrating tailored risk stratification with precise immunotherapy and screening potentially targeted agents.

P3, N=245, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting

Preferred frontline treatment relies on anti-HER2 therapies, such as trastuzumab and pertuzumab, combined with microtubule inhibitors, such as taxanes. While sabizabulin shows promising results for treatment in HER2+ breast cancer, we further optimized the structure of sabizabulin to create a new class of anti-cancer molecules: 40a, CH-2-77, and 60c. Based on in vitro data, 60c showed higher potency in HER2+ breast cancer cell lines and was chosen as the lead compound to further study in a paclitaxel-resistant triple negative breast cancer in vivo study where it was able to effectively inhibit primary tumor growth compared to the vehicle group.

This clinical trial demonstrated that chronic oral daily dosing of sabizabulin has a favorable safety profile with significant preliminary cytotoxic and cytostatic antitumor activity. These data support the ongoing Phase 3 VERACITY trial of sabizabulin in men with mCRPC who have progressed on an androgen receptor targeting agent.

P2, N=200, Not yet recruiting, Veru Inc. | Trial completion date: Feb 2024 --> May 2024 | Trial primary completion date: Dec 2023 --> Mar 2024

P1b/2, N=41, Active, not recruiting, Veru Inc. | Trial completion date: Nov 2022 --> Apr 2023 | Trial primary completion date: Sep 2022 --> Feb 2023

Herein, we report a retrospective analysis of patients with newly diagnosed Ph+ ALL who received olverembatinib plus low-intensive regimen (VP: Vindesine + dexamethasone / prednisone ) at our institution.Olverembatinib was administered at a dose of 40 mg orally QOD continuously...The choice of sequentially consolidation treatment with allogeneic hematopoietic stem-cell transplantation (allo-HSCT), blinatumomab or intensive chemotherapy, was made by the investigators and patients preference. Prophylactic intrathecal chemotherapy with cytarabine and dexamethasone was administered in each cycle...Conclusion s : Olverembatinib was well tolerated and showed high early response in newly diagnosed Ph +ALL. These promising findings warrant further investigation in future trials.

Current frontline therapy for HER2+ metastatic breast cancer relies on targeted antibodies, trastuzumab and pertuzumab, combined with microtubule inhibitors in the taxane class (paclitaxel or docetaxel). In vivo, sabizabulin inhibits breast tumor growth in the BT474 (ER+/PR+/HER2+) xenograft model and a HER2+ (ER-/PR-) metastatic patient-derived xenograft (PDX) model, HCI-12. We demonstrate that sabizabulin is a promising alternative agent to target tubulin in HER2+ breast cancer with similar anti-metastatic efficacy to paclitaxel, but with the advantage of oral bioavailability and lower toxicity than taxanes.

Induction therapy in the Blina-CELL Phase 2 trial (NCT04554485) consisted of run-in phase (dexamethasone 10 mg/m2 days 1–7, cyclophosphamide 200 mg/m2 days 3–5, vincristine 2 mg day 6, and daunorubicin 45 mg/m2 days 6–7), first induction phase (blinatumomab 9 µg/day days 12–19 and 28 µg/day days 20–40), and second induction phase (dexamethasone 10 mg/m2 days 50–54, vindesine 3 mg/m2 day 50, methotrexate 1.5 g/m2 day 50, etoposide 250 mg/m2 days 53–54, and cytarabine 2x 2 g/m2 day 54). Remission induction strategy combining one cycle of blinatumomab with one cycle of high-dose chemotherapy provides a high molecular response rate (CMR or non-quantifiable MRD) of 92%. This approach translates into a low transplant rate due to a high MRD response and has a favourable safety profile. Longer follow-up is needed to evaluate survival benefit.

DNA flow cytometry analysis of compound 9 shows cell cycle disturbance at the G2/M phase and a significant increase in Annexin-V-positive cells compared with the untreated control. Compound 9 was further studied regarding its apoptotic potential in HepG2 cells; it decreased the level of MMP and Bcl-2 as well as boosted the level of p53 and Bax compared with the control HepG2 cells.

Conclusions This clinical trial demonstrated that chronic oral daily dosing of sabizabulin has a favorable safety profile with significant preliminary cytotoxic and cytostatic antitumor activity. These data support the ongoing phase 3 VERACITY trial of sabizabulin in men with mCRPC who have progressed on an androgen receptor targeting agent.

This clinical trial demonstrated that chronic oral daily dosing of sabizabulin has a favorable safety profile with preliminary antitumor activity. These data support the ongoing Phase 3 VERACITY trial of sabizabulin in men with mCRPC.

This clinical trial demonstrated that chronic oral daily dosing of sabizabulin has a favorable safety profile with significant preliminary cytotoxic and cytostatic antitumor activity. These data support the ongoing Phase 3 VERACITY trial of sabizabulin in men with mCRPC who have progressed on an androgen receptor targeting agent.

mCRPC that has progressed following ARTAs and prior to taxane chemotherapy, remains an urgent unmet medical need for patients with advanced disease. Sabizabulin is an exciting first-in-class agent that may add to the armamentarium for the treatment of mCRPC following progression on ARTA’s.

A total of 107 hospitalized children with AL were enrolled in this study and assigned to one group in each of the following categories: infected group (n = 52) and noninfected group (n = 55); treatment remission group (n = 56) and nonremission group (n = 51); high-risk (HR) group (n = 44), intermediate risk (IR) group (n = 53), and slight risk (SR) group (n = 8); cyclophosphamide + cytosine arabinoside+6-mercaptopurine + pegaspargase group (CAML, n = 15); methotrexate group (MTX, n = 9); and vindesine + daunomycin + L-asparaginasum + prednisone (VALP, n = 38). There are notable vitamins imbalances in children with AL. The imbalances influence disease-related factors and therefore provide some references for the prognosis and treatment of AL.

P2, N=200, Not yet recruiting, Veru Inc. | Initiation date: Apr 2022 --> Jun 2022

11 (37%) were previously treated with enzalutamide or apalutamide and 8 (27%) with abiraterone as single agents. Conclusions : In this analysis, sabizabulin has demonstrated not only cytotoxic, but also significant cytostatic activity with similar responses in men that have progressed on a single or multiple ARTA agents. Sabizabulin is a novel agent with the potential provide men with mCRPC a well-tolerated chronic treatment cytostatic option after progressing on an ARTA and is being tested in the open Phase 3 VERACITY trial.

P1b/2, N=41, Active, not recruiting, Veru Inc. | Trial completion date: Apr 2022 --> Nov 2022 | Trial primary completion date: Feb 2022 --> Sep 2022

P2, N=0, Withdrawn, Veru Inc. | N=216 --> 0 | Not yet recruiting --> Withdrawn

P2, N=200, Not yet recruiting, Veru Inc. | Trial primary completion date: Sep 2023 --> Dec 2023

11 (37%) were previously treated with enzalutamide or apalutamide and 8 (27%) with abiraterone as single agents. In this analysis, sabizabulin has demonstrated not only cytotoxic, but also significant cytostatic activity with similar responses in men that have progressed on a single or multiple ARTA agents. Sabizabulin is a novel agent with the potential provide men with mCRPC a well-tolerated chronic treatment cytostatic option after progressing on an ARTA and is being tested in the open phase 3 VERACITY trial.

Metastatic prostate cancer that has become refractory to newer generation ARTAs and prior to IV chemotherapy, remains an urgent unmet medical need for patients with advanced disease. Sabizabulin is an exciting first-in-class agent that will add to the armamentarium for the treatment of metastatic castration and ARTA resistant prostate cancer.

No abstract available

P3, N=160, Recruiting, Shandong Provincial Hospital

P1b/2, N=41, Active, not recruiting, Veru Inc. | Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Oct 2021 --> Feb 2022

P3, N=130, Recruiting, Shandong Provincial Hospital | N=100 --> 130

VR-DA-EPOCH was given as follow, venetoclax was administered with accelerated ramp-up from 20 mg per day to 400 mg per day, d1-10 during cycle 1, 400 mg daily on day1-10 of cycle 2-6, rituximab 375 mg/m 2 on day 0 of cycle 1 and 500 mg/m 2 on day 0 of cycle 2-6, plus etoposide (50 mg/m 2 ,day1-4), vincristine (0.4 mg/m 2 day 1-4) or vindesine 3 mg/m 2 day 1 , doxorubicin (10 mg/m 2 day 1-4), prednisone (60 mg/m 2 , day 1-5), cyclophosphamide (750 mg/m 2 day 5), 21 days per cycle，dose adjustment on the basis of nadir ANC and platelet count are as previously reported by Wison WH...5 patients received at least one prior line (range: 1-5) treatment for CLL/SLL, with 4 patients received ibrutinib as last prior therapy and one patient previously exposed to venetoclax...2 patients experience disease progression (PD) after cycle 2 and cycle 4 respectively, with one ceased after the addition of brentuximab and the other received CD20 UCAR-T and progressed 3 months later, transit to allo-hemapoietic stem cell transplant (allo-HCT). One patient received auto-hemapoietic stem cell transplant (auto-HCT) and CD19-CAR-T as consolidation and remains in CR, one patient experience PD after 6 cycles and attained CR with chidamide , programmed death-1 (PD-1) inhibitor Sintilimab and XPO1 inhibitor Selinexor, bridging to allo-HCT and remains in CR...Conclusion : VR-DA-EPOCH showed high response rate, impressive CR with uMRD and manageable toxicity in patients with RS, even with previous exposure to new target drugs. VR-DA-EPOCH could be recommended as an effective treatment choice for RS, CAR-T or allo-HCT should be considered as subsequent strategy for long term disease control.

The Phase 3, VERACITY registration clinical trial is current ongoing in approximately 45 clinical sites with enrollment anticipated to be completed in 2022 and with unblinded results presented in 2023.

P3, N=100, Recruiting, Shandong Provincial Hospital

P2, N=216, Not yet recruiting, Veru Inc. | Initiation date: Sep 2021 --> Dec 2021

P2, N=200, Not yet recruiting, Veru Inc.

P1b/2, N=41, Active, not recruiting, Veru Inc. | Trial completion date: Sep 2021 --> Dec 2021

P2, N=216, Not yet recruiting, Veru Inc.

Subtyping SKCM patients via glycolytic and cholesterogenic genes was effective, and patients in the glycolytic-gene enriched group were found to have the worst outcome. A robust prognostic algorithm was developed to enhance clinical decisions in relation to drug administration.

In the phase Ib/II clinical trial, oral 63mg daily dosing has a favorable safety profile and chronic dosing is feasible. Efficacy was observed with PSA declines and long term durable responses. The phase III VERACITY study evaluating sabizabulin in chemotherapy naïve men with mCRPC who have failed an AR targeting agent is ongoing.

P1b/2, N=41, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting

P3, N=245, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting

P1b/2, N=41, Recruiting, Veru Inc. | Trial completion date: Apr 2021 --> Sep 2021 | Trial primary completion date: Mar 2021 --> Aug 2021