Endometrioid carcinoma ovary

Phase 1 analysis from the PYNNACLE Phase 1/2 study showed promising efficacy of rezatapopt (PC14586) in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation featured in a late-breaking oral presentation at 2024 SGO Annual Meeting Of the 15 patients in the efficacy evaluable population, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile Rezatapopt is a first-in-class precision oncology investigational therapy in patients with advanced solid tumors with a TP53 Y220C mutation and KRAS wild-type which is being evaluated in a registrational Phase 2 study March 18, 2024 -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that a Phase 1 analysis reported promising anti-tumor activity of rezatapopt (PC14586) in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation. Rezatapopt is a first-in-class precision oncology small molecule investigational therapy that selectively targets the TP53 Y220C mutation in solid tumors. These data were featured today in a late-breaking oral presentation at the 2024 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer being held March 16-18, 2024 in San Diego, CA. The presentation entitled, “Phase 1 Analysis from the PYNNACLE Phase 1/2 Study PC14586 in the Subgroup of Patients with Advanced Ovarian Cancer Harboring a TP53 Y220C Mutation,” was delivered by Alison M. Schram, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center. “In this Phase 1 study, we observed promising efficacy of rezatapopt in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation. In addition, rezatapopt showed a favorable safety profile,” said Dr. Schram. “These data are encouraging given the significant unmet medical need for patients with advanced solid tumors, particularly in patients with ovarian cancer who are platinum resistant. Further study of rezatapopt as monotherapy in ovarian cancer is warranted.” Deepika Jalota, Pharm.D., Chief Development Officer of PMV Pharma added, “These Phase 1 PYNNACLE data presented at the SGO meeting showed that rezatapopt, a first-in-class precision oncology investigational therapy, continues to demonstrate clinical benefit in a patient population of high unmet need. Our registrational, tumor-agnostic PYNNACLE Phase 2 trial, which includes an ovarian cancer cohort, remains on track to initiate in the first quarter of this year. The trial will assess rezatapopt as monotherapy at the recommended Phase 2 dose of 2000 mg daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors.” Phase 1 data from the PYNNACLE trial (NCT04585750) demonstrated that rezatapopt has a favorable safety profile and induced responses in heavily pre-treated patients across multiple tumor types. This subgroup analysis investigated the efficacy of rezatapopt in patients with advanced ovarian cancer treated across the efficacious dose range (1150 mg daily to 1500 mg twice daily). As of September 5, 2023, the median age of patients with ovarian cancer (N=22) was 66 years (range 49 – 81 years) At baseline, 20 patients had high-grade serous ovarian cancer and two had endometrioid cancer Nineteen patients were platinum resistant and one was platinum refractory Two patients had a BRCA2 mutation Six patients were homologous recombination deficiency positive All patients were KRAS wild-type Median number of prior lines of systemic therapy was four (range 1 – 9) Efficacy The efficacy evaluable population consisted of 15 patients with measurable disease at baseline and ≥1 post-baseline tumor assessment. Seven patients achieved a confirmed partial response (PR), seven had stable disease (SD), and one had progressive disease Median duration of response was seven months Of the 15 patients with measurable serum CA-125 at baseline, six had a CA-125 response. Among these, five patients achieved radiographic PR and one had SD Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. The ongoing Phase 1/2 PYNNACLE study is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers will also be assessed. Phase 2 will be an expansion study with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750). PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. p53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit www.pmvpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

33% Response Rate and 100% Disease Control Rate Observed in Patients Evaluated for Efficacy Complete Response of Non-Target Tumor Also Observed Platinum-Resistant Ovarian Cancer is a Devastating Serious Condition of Unmet Medical Need with a Median Life Expectancy of Approximately One Year Fort Lee, NJ, March 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) today announced preliminary data from the ongoing Phase 1b clinical trial of NXP800 in patients with platinum resistant ARID1a-mutated ovarian cancer, a deadly disease of unmet medical need. The NXP800 development program in this disease was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”). The Phase 1b clinical trial is being conducted in top clinical centers in the United States and the United Kingdom. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We are pleased to share the preliminary results from the NXP800 Phase 1b study in the target patient population of platinum resistant, ARID1a-mutated ovarian cancer patients. The clinical activity observed thus far includes a 33% response rate and 100% disease control rate, defined as partial response (“PR”) plus stable disease (“SD”), in patients evaluated for efficacy. While the data presented today is early, we are encouraged by the achievement of a PR as well as a complete response (“CR”) of the non-target lymph node disease in a patient with a progressive malignancy after a surgical resection and two prior lines of systemic combination chemotherapy, and stable disease in patients with similar stage disease. We believe that this provides an important initial signal that NXP800 can potentially be effective in this devastating and difficult to treat cancer.” Mr. Bentsur continued, “After a cautious start to the study, we are now seeing a ramp up in the number of participating clinical sites, which is already translating into increased rates of patient identification and enrollment. Moreover, similar to what has been done with other classes of potent drugs, dosing management procedures have recently been implemented to better manage the key side effects associated with treatment with NXP800. We believe that we can now make significant progress with this clinical trial and unlock the full potential of NXP800 in this disease setting.” Preliminary Clinical Data Summary Encouraging preliminary efficacy data was observed and includes data from the first four patients enrolled in the study, two treated with 75 mg/day and two treated with 50 mg/day. All patients failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen. Three of the patients also failed prior treatment with bevacizumab (Avastin). Efficacy was evaluated in three of the four patients. One patient treated with 75 mg/day achieved a PR, unconfirmed, that also included a CR of her non-target lymph node disease. Both patients treated with 50 mg/day achieved SD and the fourth patient was not evaluated for efficacy. Three of these four patients experienced an adverse event of thrombocytopenia that was Grade 4 in intensity, these events were transient in nature with no concurrent bleeding events reported. Following these events, as mentioned above, a management procedure for the monitoring of platelets and dose adjustments, as necessary, has been implemented with the goal of minimizing dosing interruptions and increasing patient retention. No other ≥ Grade 3 hematological toxicities were reported. In addition, gastrointestinal adverse events were reported in all four patients, all Grade 1-2. About the Phase 1b Study The Phase 1b study is a multicenter, single arm, open-label clinical trial of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancer. The study is examining the safety and preliminary efficacy of NXP800 in this target patient population. The study is being conducted in the US and UK in collaboration with the European Network of Gynecological Oncological Trial Groups and the GOG Foundation, Inc., recognized as the world's leading gynecology oncology clinical trials consortia. About NXP800 NXP800 is an oral, small molecule, potentially first-in-class GCN2 kinase activator. NXP800 is also being evaluated in an investigator-initiated study conducted in collaboration with the Mayo Clinic for the treatment of cholangiocarcinoma, an indication for which the FDA granted NXP800 Orphan Drug Designation. The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian cancer was granted Fast Track Designation by the FDA. NXP800 completed a Phase 1a dose-escalation study in the first half of 2023. Nuvectis licensed exclusive world-wide rights to NXP800 from the Institute of Cancer Research in London, UK. About Platinum-Resistant, ARID1a-Mutated Ovarian Carcinoma ARID1a-mutated ovarian carcinoma is comprised almost exclusively of two histologies, ovarian clear cell carcinoma (“OCCC”) and ovarian endometrioid carcinoma (“OEC”), each representing about 10% of the overall ovarian cancer cases in the U.S. with an annual incidence of approximately 2,200 patients per histology. Platinum resistant ovarian carcinoma is recognized as a serious condition of unmet medical need, given the lack of effective treatments and the poor patient prognosis in this setting, with median life expectancy estimated to be approximately one year. It is estimated that approximately 66% of patients with OCCC and 40% of patients with OEC have the ARID1a mutation. About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor currently undergoing a Phase 1a dose escalation study. Forward Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the conclusions and interpretation of the Phase 1a data generated for NXP800 and the timing and clinical expectations for the NXP800 Phase 1b study, including statements regarding NXP800's potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma and cholangiocarcinoma; whether the preliminary safety and efficacy data reported today from the Phase 1b study will translate into data that can lead to the successful completion of the Phase 1b study, whether the dosing management algorithms that include dose modifications to better manage the key side effects associated with treatment with NXP800 that have been implemented will lead to longer treatment periods and better patient retention and whether patient enrollment into the study will be satisfactory and lead to a timely completion of the study. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in our 2023 Form 10-K filed with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact Ron Bentsur Chairman, Chief Executive Officer and President 201-614-3151 rbentsur@nuvectis.com Media Relations Contact Christopher M. Calabrese LifeSci Advisors Tel: 917-680-5608 ccalabrese@lifesciadvisors.com

NEW YORK and SAN DIEGO, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced the appointment of Kimberly Freeman as Chief Strategy Officer. In this role, she will support and implement Zentalis’ long-term portfolio strategy. Ms. Freeman joins Zentalis with over 25 years of clinical development and strategic leadership experience, including deep expertise in oncology, particularly in gynecologic malignancies and the DNA damage response (DDR) pathway. “Kimberly brings an outstanding track record of building and executing drug development and franchise strategies that will be invaluable to Zentalis as we seek to capitalize on the significant opportunity we see with azenosertib across a broad array of tumor types,” said Dr. Kimberly Blackwell, Chief Executive Officer of Zentalis. “We welcome her unique skill set, which is ideally suited to helping us advance azenosertib to patients with ovarian and uterine cancers, as well as expand to other Cyclin E1 positive tumor types where patients typically face poor prognosis. Kimberly has successfully driven multiple cancer programs from early clinical development to FDA approval, led a billion-dollar product franchise, and has a deep network in the gynecologic oncology community.” Prior to joining Zentalis, Ms. Freeman was Vice President, US Head of DDR Franchise, Oncology at AstraZeneca. She was responsible for overseeing the strategic direction and cross-functional efforts for LYNPARZA® (olaparib) and other therapies targeting the DDR pathway, which is an important hallmark in ovarian and other cancers. Previously, she held various leadership roles at biopharmaceutical companies including Adaptimmune, Boehringer Ingelheim and GlaxoSmithKline. Ms. Freeman has also served on the Alliance for Regenerative Medicine (ARM) Cell Therapy Advisory Committee and has been recognized by Women in Bio as a Female Pioneer in the Life Sciences. After receiving her Bachelor of Science in Biology from Cornell University, Ms. Freeman was a Research Scientist in the Department of Hematology/Medical Oncology at Weill Cornell Medical Center and later pursued Graduate Studies at SUNY Upstate Medical Center. Ms. Freeman also received Finance and Marketing Certificates from the Wharton School of the University of Pennsylvania. “It is a privilege to join the Zentalis management team at such an exciting time in the Company’s history. I look forward to working with the team to shape and advance the Company’s strategic priorities,” said Ms. Freeman. “I see tremendous opportunity for azenosertib to change the therapeutic paradigm in a number of solid tumor types as it continues to emerge as a promising new therapeutic for cancer patients.” About Zentalis Pharmaceuticals Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. Utilizing its Integrated Discovery Engine, the Company is developing a focused pipeline of potentially best-in-class oncology candidates, which include azenosertib (ZN-c3), a WEE1 inhibitor for advanced solid tumors, ZN-d5, a BCL-2 inhibitor for hematologic malignancies and related disorders, and a heterobifunctional degrader of BCL-xL for solid and hematological malignancies. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in both New York and San Diego. For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the anticipated contribution and value of management team members; our goal of capitalizing on the azenosertib opportunity; our goals of advancing azenosertib in ovarian and uterine cancer indications and expanding to other Cyclin E1 positive tumor types; and the potential opportunity with and benefits of azenosertib. The terms “advance,” “expand,” “look forward,” “opportunity,” “promising,” “seek,” “will,” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our plans, including the costs thereof, of development of any diagnostic tools, if needed; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. ZENTALIS® and its associated logos are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Contact:Katie Beach Oltsik Evoke CanaleKatherine.Beach@evokegroup.com