Phase 2, Randomized, Trial of Maintenance Letrozole/Abemaciclib vs Pembrolizumab After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wild-type Endometrial Cancer

A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab.
The names of the study drugs involved in this study are:
Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)
Letrozole (a type of aromatase inhibitor)
Pembrolizumab (a type of monoclonal antibody)

Start Date01 Sep 2024

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06179303 / Not yet recruitingPhase 2IIT

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that "light up" with FFNP than a PET scan alone can provide.

Start Date06 Jul 2024

Sponsor / Collaborator

University of Washington

[+1]

NCT06025747 / Not yet recruitingPhase 1IIT

A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas

This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy before surgery may shrink tumors in patients with high-risk adipocytic retroperitoneal sarcoma.

Start Date01 Jul 2024

Sponsor / Collaborator

University of Washington

[+1]

100 Clinical Results associated with Abemaciclib

100 Translational Medicine associated with Abemaciclib

100 Patents (Medical) associated with Abemaciclib

718

Literatures (Medical) associated with Abemaciclib

01 Mar 2024·European journal of cancer (Oxford, England : 1990)

Long-term patient-reported outcomes from monarchE: Abemaciclib plus endocrine therapy as adjuvant therapy for HR+, HER2-, node-positive, high-risk, early breast cancer

Article

Author: Harbeck, Nadia ; Seo, Jae Hong ; Martin, Miguel ; Johnston, Stephen R D ; Tolaney, Sara M ; Guarneri, Valentina ; McIntyre, Kristi ; Kellokumpu-Lehtinen, Pirkko-Liisa ; Liepa, Astra M ; Cruz, Josefina ; Munoz, Maria ; Wei, Ran ; Abreu, Miguel Henriques ; Barrios, Carlos ; Takahashi, Masato ; Antonio, Belen San

BACKGROUND:

In monarchE, abemaciclib demonstrated a sustained benefit in invasive disease-free survival and a tolerable safety profile at 42-months median follow-up. With no expected disease-related symptoms, therapies in the adjuvant setting should preserve quality of life (QoL). With all patients off abemaciclib, we report updated patient-reported outcomes (PROs) for the full 2-year treatment period and follow-up.

METHODS:

Patients completed PROs including FACT-B, FACT-ES, and FACIT-Fatigue at baseline, 3, 6, 12, 18, and 24 months during treatment, and 1, 6, and 12 months after treatment discontinuation. Mixed effects repeated measures model estimated changes from baseline within and between arms for QoL scales and individual items. Meaningful changes were prespecified and no statistical testing was performed. Frequencies of responses to items associated with relevant adverse events and treatment bother were summarized.

RESULTS:

At baseline, completion rates for PRO instruments were >96 %. Mean changes from baseline for all QoL scales were numerically similar within and between arms (ie, less than prespecified thresholds). The same was observed for all individual items, except diarrhea. Within abemaciclib arm, meaningful differences for diarrhea were observed at 3 and 6 months (mean increases of 1.19 and 1.03 points on 5-point scale, respectively). During treatment, most patients in both arms (69-78 %) reported being bothered "a little bit" or "not at all" by side effects. Overall, patterns for fatigue were similar between arms. During post-treatment follow-up, PROs in both arms were similar to baseline.

CONCLUSION:

PRO findings confirm a tolerable and reversible toxicity profile for abemaciclib. QoL was preserved with the addition of adjuvant abemaciclib to endocrine therapy, supporting its use in patients with HR+, HER2-, high-risk early breast cancer.

16 Feb 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Therapy-Induced Senescence Contributes to the Efficacy of Abemaciclib in Patients with Dedifferentiated Liposarcoma

Article

Author: Seier, Kenneth ; Klein Dooley, Mary E ; Kelly, Ciara M ; Crago, Aimee M ; Delgado, Juliana I ; Gularte-Mérida, Rodrigo ; Firester, Daniel M ; Palafox, Marta ; Bradic, Martina ; Adamson, Travis E ; Gleason, Caroline E ; Manova-Todorova, Katia ; Gounder, Mrinal M ; Richards, Allison L ; Mehrara, Babak J ; Donoghue, Mark T A ; Movva, Sujana ; Antonescu, Cristina R ; Dickson, Mark A ; Kataru, Raghu P ; Barlas, Afsar ; Tan, Nguan Soon ; Chan, Eric ; Serra, Violetta ; Tan, Mark Wei Yi ; Turkekul, Mesruh ; Tap, William D ; Singer, Samuel ; Keohan, Mary Louise ; Benitez, Marimar ; Chi, Ping ; Kovatcheva, Marta ; Qin, Li-Xuan ; Koff, Andrew ; D'Angelo, Sandra P ; Landa, Jonathan

Abstract:

Purpose::

We conducted research on CDK4/6 inhibitors (CDK4/6i) simultaneously in the preclinical and clinical spaces to gain a deeper understanding of how senescence influences tumor growth in humans.

Patients and Methods::

We coordinated a first-in-kind phase II clinical trial of the CDK4/6i abemaciclib for patients with progressive dedifferentiated liposarcoma (DDLS) with cellular studies interrogating the molecular basis of geroconversion.

Results::

Thirty patients with progressing DDLS enrolled and were treated with 200 mg of abemaciclib twice daily. The median progression-free survival was 33 weeks at the time of the data lock, with 23 of 30 progression-free at 12 weeks (76.7%, two-sided 95% CI, 57.7%–90.1%). No new safety signals were identified. Concurrent preclinical work in liposarcoma cell lines identified ANGPTL4 as a necessary late regulator of geroconversion, the pathway from reversible cell-cycle exit to a stably arrested inflammation-provoking senescent cell. Using this insight, we were able to identify patients in which abemaciclib induced tumor cell senescence. Senescence correlated with increased leukocyte infiltration, primarily CD4-positive cells, within a month of therapy. However, those individuals with both senescence and increased TILs were also more likely to acquire resistance later in therapy. These suggest that combining senolytics with abemaciclib in a subset of patients may improve the duration of response.

Conclusions::

Abemaciclib was well tolerated and showed promising activity in DDLS. The discovery of ANGPTL4 as a late regulator of geroconversion helped to define how CDK4/6i-induced cellular senescence modulates the immune tumor microenvironment and contributes to both positive and negative clinical outcomes.See related commentary by Weiss et al., p. 649

01 Feb 2024·Cytokine & growth factor reviews

CDK4/6 inhibition in hormone receptor-positive/HER2-negative breast cancer: Biological and clinical aspects

Review

Author: Solinas, Cinzia ; Leoni, Vera Piera ; Scartozzi, Mario ; Lambertini, Matteo ; Dessì, Mariele ; Atzori, Luigi ; Cadoni, Andrea ; Pretta, Andrea ; Wekking, Demi

A dysregulated cell division, one of the key hallmarks of cancer, results in uncontrolled cellular proliferation. This aberrant process, mediated by a dysregulated cell-cycle machinery and overactivation of cyclin-dependent kinase (CDK) 4 and 6, can potentially promote tumorigenesis. The clinical application of CDK 4/6 inhibitors, developed to inhibit cell-cycle progression, in the treatment regimens of breast cancer (BC) patients is expanding. Currently, three agents, ribociclib, palbociclib, and abemaciclib, are approved for treating patients with hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative metastatic BC. In addition, abemaciclib is FDA and EMA-approved for patients with hormone receptor-positive HER2-negative, node-positive, early BC at high risk of recurrence. Emerging data suggest potential anti-tumor effects beyond cell cycle arrest, providing novel insights into the agent's mechanisms of action. As a result, a broader application of the CDK4/6 inhibitors in patients with cancer is achieved, contributing to enhanced optimized treatment in the adjuvant and neoadjuvant settings. Herein, the immunomodulatory activities of CDK4/6 inhibitors, their impact on the cell's metabolic state, and the effect on the decision of the cell to undergo quiescence or senescence are discussed. Moreover, this review provides an update on clinical trial outcomes and the differences in the underlying mechanisms between the distinct CDK4/6 inhibitors.

238

News (Medical) associated with Abemaciclib

24 Jun 2024

·www.globenewswire.com

Veru Announces Safety and Body Composition Data from Two Late-Breaker Presentations at the American Diabetes Association's 84th Scientific Sessions

MIAMI, FL, June 24, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced data from two late-breaker presentations at the American Diabetes Association's 84th Scientific Sessions, which took place on June 21-24, 2024, in Orlando, Florida. Late-Breaking Presentations: Poster # 2067-LB: Pooled Safety Analysis of Enobosarm from Phase 2 and Phase 3 Placebo-Controlled Clinical Trials Highlights from the presentation: In a pooled analysis of 1,027 older men, postmenopausal women, and older patients with advanced cancer, enobosarm was well tolerated with an adverse event profile comparable to the control patients. Notably, there was no increase in gastrointestinal side effects with enobosarm compared to placebo treatment. 3.7% of enobosarm treated subjects versus 1.4% of placebo subjects had elevated alanine transaminase (ALT) levels. In enobosarm treated subjects, these elevations in ALT were transient and mild (grade 1/2) with no evidence of drug induced liver injury by Hy’s Law observed. Cardiovascular adverse event rates were similar between the two groups (less than 2%). The incidence of deep vein thrombosis was higher (3.3%) in the placebo group compared to the enobosarm group (1.0%). Poster # 2066-LB: Potential to Optimize Weight Loss with Enobosarm—Meta-analysis of Body Composition from Three Randomized Clinical Trials Support the Ability of Enobosarm to Preserve Muscle while Reducing Fat Highlights from the presentation: In meta-analysis of 367 older men, postmenopausal women, and older patients with muscle loss from advanced cancer (clinical studies 501, 502, and 504), enobosarm therapy resulted in reductions in fat mass (-6.26% vs placebo; p=0.006) while preserving lean mass (+4.04% vs placebo; p=0.00007) at day 84. This meta-analysis supports the potential of enobosarm when combined with a GLP-1 receptor agonist to preserve muscle, while preferentially reducing fat to potentially result in a higher quality weight loss in overweight and obese patients. Additional information on the meeting can be found on the American Diabetes Association website: https://professional.diabetes.org/scientific-sessions About the Enobosarm Phase 2b clinical trialThe Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected by the end of calendar year 2024. After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025. About Sarcopenic ObesityAccording to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients. About EnobosarmEnobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass. Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources. The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company’s scientific advisors will make valuable contributions to the Company’s enobosarm program and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company’s existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. * Wegovy® is a registered trademark of Novo Nordisk A/S Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com

Phase 2Phase 3Clinical Result

18 Jun 2024

·www.globenewswire.com

Veru Adjourns 2024 Annual Meeting of Shareholders to June 27, 2024

MIAMI, FL, June 18, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that its Annual Meeting of Shareholders scheduled for today (Annual Meeting) was convened and adjourned without any business being conducted due to lack of a required quorum. The Annual Meeting has been adjourned to Thursday, June 27th at 9:00 a.m., local time, at 2916 N. Miami Avenue, Suite 1000, Miami, Florida 33127, with respect to all proposals described in the Company’s amended definitive proxy statement filed with the U.S. Securities and Exchange Commission on May 9, 2024. At the time the Annual Meeting was adjourned, proxies had been submitted by shareholders representing approximately 49.6% of the shares of the Company’s common stock outstanding and entitled to vote. These votes were insufficient for a quorum which requires a majority of the shares of the Company’s common stock outstanding and entitled to vote. The record date for the adjourned Annual Meeting continues to be April 29, 2024. Shareholders who have previously submitted a proxy or otherwise voted do not need to take any action and all previously submitted proxies will be voted at the adjourned Annual Meeting unless properly revoked. For any Veru Inc. shareholders who may not be sure if their shares have been voted, you should be able to see that information on your broker portal when you log in. If you cannot find that information, please reach out to your broker and ask them. If your shares have not been voted, please vote. You can accomplish this in one of three easy ways: Ask your broker to vote your shares.Request your 16-digit control number, and you can vote for the shares yourself by going to www.proxyvote.com.Log into your brokerage account and there should be a button to vote the shares. Regardless of whether you vote for or against the proposals presented, what is important is to vote. As a shareholder, it is in your best interests that the Company reaches a quorum so that it avoids costly procedures to complete the Annual Meeting. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources. The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the phase 2b trial of enobosarm, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company’s existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com

Phase 2Phase 3

17 Jun 2024

·www.globenewswire.com

Veru Reminds Shareholders to Vote in Advance of Tomorrow’s Deadline for 2024 Annual Meeting of Shareholders

MIAMI, FL, June 17, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, would like to remind shareholders to vote in connection with the Company’s upcoming annual meeting of shareholders, to be held on Tuesday, June 18, 2024, at 9:00 AM ET. Shareholders are advised to vote their shares in advance of the proxy voting deadline of tomorrow, Tuesday, June 18, 2024, at 9:00 AM ET. Shareholders are encouraged to read the materials relating to the Annual Shareholder Meeting, available on the Company’s website https://verupharma.com/. In the interest of time, shareholders may vote online or by telephone in accordance with the voting instructions found on their Form of Proxy or their Voting Instruction Form. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources. The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company’s scientific advisors will make valuable contributions to the Company’s enobosarm program and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company’s existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. * Wegovy® is a registered trademark of Novo Nordisk A/S Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com

Phase 2Phase 3

100 Deals associated with Abemaciclib

External Link

KEGG	Wiki	ATC	Drug Bank
D10688	Abemaciclib	L01XE50	DB12001

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HR Positive/HER2 Negative/Node positive breast cancer	US	Eli Lilly & Co.	12 Oct 2021
Advanced breast cancer	EU	Eli Lilly Nederland BV	26 Sep 2018
Advanced breast cancer	IS	Eli Lilly Nederland BV	26 Sep 2018
Advanced breast cancer	LI	Eli Lilly Nederland BV	26 Sep 2018
Advanced breast cancer	NO	Eli Lilly Nederland BV	26 Sep 2018
Early Stage Breast Carcinoma	EU	Eli Lilly Nederland BV	26 Sep 2018
Early Stage Breast Carcinoma	IS	Eli Lilly Nederland BV	26 Sep 2018
Early Stage Breast Carcinoma	LI	Eli Lilly Nederland BV	26 Sep 2018
Early Stage Breast Carcinoma	NO	Eli Lilly Nederland BV	26 Sep 2018
Metastatic breast cancer	EU	Eli Lilly Nederland BV	26 Sep 2018
Metastatic breast cancer	IS	Eli Lilly Nederland BV	26 Sep 2018
Metastatic breast cancer	LI	Eli Lilly Nederland BV	26 Sep 2018
Metastatic breast cancer	NO	Eli Lilly Nederland BV	26 Sep 2018
Hormone receptor positive HER2 negative breast cancer	US	Eli Lilly & Co.	28 Sep 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	Phase 3	US	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	CN	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	JP	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	AR	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	AU	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	BE	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	BR	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	CA	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	CZ	Eli Lilly & Co.	14 Apr 2022
Castration-Resistant Prostatic Cancer	Phase 3	FR	Eli Lilly & Co.	14 Apr 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05169567 (postMONARCH, ASCO2024) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Second line HR+ \| HER2-	368	Abemaciclib + Fulvestrant	nopbasawim(zeltzilqmj): HR = 0.73 (95% CI, 0.57 - 0.95) View more	Positive	02 Jun 2024
				Placebo + Fulvestrant
NCT05386108 (ELECTRA, ASCO2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer Second line HER2 Negative \| ER Positive \| ESR1 Mutation	26	Elacestrant + Abemaciclib	zopkdwmqpz(dirzzjhwit) = ivsbwqzmzw vmjgyukfjc (hyxgtqcwjx ) View more	Positive	24 May 2024
NCT03706365 (CYCLONE 2, ASCO2024) Manual	Phase 3	Metastatic castration-resistant prostate cancer	393	ABEMA + ABI group	lewljhsdjw(sbzhiafwju): HR = 0.829 (95% CI, 0.619 - 1.111), P-Value = 0.2123 Not Met View more	Negative	24 May 2024
				PBO + ABI group
NCT04188548 (EMBER, ASCO2024) Manual	Phase 1	Endometrial Carcinoma ER+	72	Imlunestrant	smyrheiebq(ofldpeycrj) = qlllfnyova fddudnmnup (hnghddmjrg ) View more	Positive	24 May 2024
				Imlunestrant + Abemaciclib	smyrheiebq(ofldpeycrj) = vikxfljukt fddudnmnup (hnghddmjrg ) View more
NCT02523014 (Alliance A071401, ASCO2024)	Phase 2	NF2mutations \| CDK pathway alterations	36	Abemaciclib 200 mg	zqwemjjjqi(ulhdqbpodg) = qlfpegtdms chqkejchtg (luhmzotilk, 33 - 75)	Positive	24 May 2024
NCT04049227 (Surgical window of opportunity clinical trial of abemaciclib and letrozole for endometrioid adenocarcinoma of the endometrium, ASCO2024)	Early Phase 1	Endometrial Endometrioid Adenocarcinoma estrogen receptor \| PTEN \| PI3K ... View more	27	Abemaciclib 150mg	uhggsifuzj(fiybsnugyp) = uxermpvfxa htuyhvmbbr (icuonbwzfq, 16)	Positive	24 May 2024
				Letrozole 2.5mg	uhggsifuzj(fiybsnugyp) = vmbrajridv htuyhvmbbr (icuonbwzfq, 22)
ASCO2024	Phase 2	Endometrial Carcinoma CTNNB1 \| KRAS \| CDKN2Amutation ... View more	28	Letrozole/abemaciclib	allwaaqbgy(usexuvzcwy) = gejqifefls ccqxiyvjml (tladrpzeur ) View more	Positive	24 May 2024
NCT04293393 (CARABELA, ASCO2024)	Phase 2	HER2-negative breast cancer Neoadjuvant Ki67 \| Recurrence Score (RS)	-	Letrozole/abemaciclib	czcrrwusvp(ojxfxwtyup) = jmiaafuzvb aveyhbfnnu (jqxuovnwbj ) View more	Negative	24 May 2024
				Chemotherapy	czcrrwusvp(ojxfxwtyup) = wvnmsidubg aveyhbfnnu (jqxuovnwbj ) View more
PALMARES-2 (ASCO2024)	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line Hormone Receptor-positive \| Human Epidermal growth factor Receptor 2-negative	1,850	Palbociclib	mckegdkmmy(hghqfzuebs) = nhjoakxzmz ndmkodnrwx (jhfkbyppfs, 32.0 - 37.4)	Positive	24 May 2024
				Abemaciclib	-
ESMO_BC2024 Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive	281	palbociclib+abemaciclib+proton pump inhibitors	ctjpyamsbd(jjwviwjqeh) = olpihxcrqb vbtzojqnge (cxnhoqiwph )	Positive	16 May 2024
				palbociclib+abemaciclib	ctjpyamsbd(jjwviwjqeh) = ncisxievpp vbtzojqnge (cxnhoqiwph )

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