Veru Inc. an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, announces the presentation of preclinical data demonstrating the efficacy of oral VERU-111 in the treatment of human-derived animal models of triple-negative breast cancer at the 2020 San Antonio Breast Cancer Symposium.

VERU-111 is an oral cytoskeleton disruptor that is currently being evaluated in both Phase 1b and Phase 2 clinical trials in men with metastatic castration-resistant prostate cancer. In the prostate cancer clinical trials, VERU-111 has significant antitumor efficacy and is well tolerated without neurotoxicity, neutropenia, or hair loss typically associated with taxane-based chemotherapies. Metastatic triple-negative breast cancer is an aggressive form of breast cancer that is present in approximately 15% of all breast cancers. This form of breast cancer does not express estrogen receptor, progesterone receptor, or HER2, and as a consequence, is resistant to endocrine therapies. The first line of treatment of metastatic triple-negative breast cancer usually includes IV taxane chemotherapy like paclitaxel. Almost all women will eventually develop taxane resistance. Overexpressing P-glycoprotein, a molecular protein that pumps the cancer drug back out of the cancer cell to avoid cancer cell death, is a common mechanism for taxane resistance in triple-negative breast cancer. As VERU-111 does not fit into the P-glycoprotein pump, it cannot be pumped out of the cancer cell. As a consequence, VERU-111 can overcome this mechanism of drug resistance. Triple-negative breast cancer is considered to be a highly aggressive form of the disease and typically patients do not have long-term responses to therapeutic agents including chemotherapy.

In a poster entitled “VERU-111 as an orally available tubulin inhibitor suppressing both taxane-sensitive and taxane-resistant triple-negative breast cancer”, preclinical findings on the effects of VERU-111 in inhibiting the growth of chemotherapy-sensitive and resistant triple-negative breast cancer were presented by Wei Li, Ph.D., Professor of Pharmaceutical Sciences and Director of the University of Tennessee Health Science Center and a consultant to Veru. In paclitaxel, sensitive MB231 triple-negative breast cancer cells implanted into mice, orally administered VERU-111 almost completely inhibited tumor growth (p<0.0001), whereas the placebo-treated tumors increased more than 10-fold. In triple-negative cancer cells that were resistant to paclitaxel, the placebo and paclitaxel treated tumors grew almost 10-fold whereas growth of the VERU-111 treated tumors was inhibited (p<0.0001). When tumor cells derived from patients with triple-negative breast cancer were implanted and grown in mice, oral VERU-111 completely inhibited the growth of the tumors ((p<0.001), whereas placebo-treated and paclitaxel treated animals had a significant and similar increase in tumor volume growth (approximately 4-fold). Further, the lung, bone, and liver metastases from paclitaxel-resistant triple-negative breast cancers were suppressed only in the VERU-111 treated animals. In these patient-derived models, paclitaxel was not effective.

These preclinical efficacy findings, together with the dosing and safety information obtained from the prostate cancer clinical trials, provide strong support for evaluating VERU-111 in a Phase 2b clinical trial in women with metastatic triple-negative breast cancer. The Company plans to meet with FDA in the first half of the calendar year 2021 to discuss the Phase 2b clinical trial design for possible accelerated approval for VERU-111 versus active control TRODELVY in patients who have taxane resistant metastatic triple-negative breast cancer, making the proposed trial a potential registration trial. The Phase 2b clinical trial is planned to commence in the second half of the calendar year 2021.

About Veru Inc.
Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer. The Veru prostate cancer pipeline includes VERU-111, VERU-100, and Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta-tubulin subunits of microtubules. VERU-111 is being evaluated in open-label Phase 1b and Phase 2 clinical trials in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer. Phase 1b clinical trials completed the enrollment of 39 men and is ongoing. The Phase 2 clinical trial has completed the enrollment of 40 men who have metastatic castration-resistant prostate cancer and who have also become resistant to at least one novel androgen receptors targetings agent, such as abiraterone or enzalutamide, but prior to IV chemotherapy, and is ongoing. The Company anticipates proceeding to its Phase 3 VERU-111 VERACITY registration clinical trial in the first quarter of calendar 2021.VERU-111 is also being evaluated in Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in subjects at high risk for ARDS. VERU-100 is a novel, proprietary peptide formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT) for advanced prostate cancer. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist administered as a small volume, subcutaneous 3-month depot injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration — a problem that occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonists commercially approved beyond a one-month injection. A Phase 2 trial to evaluate VERU-100 dosing is anticipated to begin in the first quarter of the calendar year 2021 and a Phase 3 registration clinical trial is anticipated to begin the second half of the calendar year 2021. Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. Following an End of Phase 2 meeting with the FDA, the Company plans to advance Zuclomiphene citrate to a Phase 3 clinical trial in men with advanced prostate cancer who experience moderate to severe hot flashes.

The Veru breast cancer pipeline includes enobosarm for hormone-sensitive metastatic ER+/HER2- metastatic breast cancer and VERU-111 for taxane resistant metastatic triple-negative breast cancer. Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets the androgen receptor (AR) in AR+/ER+/HER2- metastatic breast cancer without unwanted virilizing side effects. Enobosarm is the first new class targeting endocrine therapy in advanced breast cancer in decades. In October 2020, the FDA agreed to the Phase 3 registration clinical trial design evaluate the efficacy and safety of enobosarm, selective androgen receptor targeting agent, versus physician’s choice of either exemestane or tamoxifen as an active comparator for the treatment of metastatic ER+/HER2- breast cancer in approximately 240 patients who have failed a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor. The primary endpoint is radiographic progression-free survival. The pivotal Phase 3, open-label, randomized, active control trial is anticipated to commence in the first half of the calendar year 2021. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta-tubulin subunits of microtubules and is not a substrate for P-glycoprotein drug resistance protein. Overexpression of P-glycoprotein is a common mechanism that results in taxane resistance in TNBC. Using the safety information from the Phase 1b and Phase 2 VERU-111 prostate cancer clinical studies in a total of approximately 80 men, the Company plans to meet with the FDA in the first half of the calendar year 2021 and to commence a Phase 2b registration clinical trial in the second half of the calendar year 2021 to evaluate oral daily dosing of VERU-111 in approximately 100 women with metastatic TNBC that have become resistant to taxane IV chemotherapy.

Veru is also advancing a new drug formulation in its specialty pharmaceutical pipeline addressing unmet medical needs in urology such as the Tadalafil and Finasteride Combination (TADFYN®) for the administration of tadalafil 5mg and finasteride 5mg combination formulation dosed daily for benign prostatic hyperplasia (BPH). Tadalafil (CIALIS®) is currently approved for the treatment of BPH and erectile dysfunction and finasteride is currently approved for the treatment of BPH (finasteride 5mg PROSCAR®) and male pattern hair loss (finasteride 1mg PROPECIA®). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than by finasteride alone. The Company expects to submit the NDA for TADFYN® in early calendar year 2021.

The Company’s Sexual Health Business commercial product is the FC2 Female Condom / FC2 Internal Condom® (“FC2”), an FDA-approved product for dual protection against unintended pregnancy and the transmission of sexually transmitted infections. The Company’s Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the U.S. and globally. In the U.S., FC2 is available by prescription through multiple third-party telemedicine and internet pharmacy providers and retail pharmacies. In the global public health sector, the Company markets FC2 to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations, and commercial partners, that work to support and improve the lives, health, and well-being of women around the world.