PMV Pharmaceuticals Announces First Patient Dosed in Global Tumor-Agnostic Phase 2 PYNNACLE Trial for Rezatapopt in TP53 Y220C-Positive Solid Tumors
PMV Pharmaceuticals Announces First Patient Dosed in Global Tumor-Agnostic Phase 2 PYNNACLE Trial for Rezatapopt in TP53 Y220C-Positive Solid Tumors
- Rezatapopt is a first-in-class precision oncology investigational therapy for patients with advanced solid tumors with a TP53 Y220C mutation and KRAS wild-type (WT)
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First patient dosed in Phase 2 portion of the PYNNACLE trial which will assess rezatapopt as monotherapy in patients with TP53 Y220C and KRAS WT advanced solid tumors
- Rezatapopt 是 首創的精準腫瘤學研究療法，適用於具有 TP53 Y220C 突變和 KRAS 野生型 (WT) 的晚期實體瘤患者
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在PYNACLE試驗的第二階段中，第一位患者給藥 將將 rezatapopt 評估爲單一療法，用於以下患者 TP53 Y220C 和 KRAS WT 晚期實體瘤
PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- 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 the first patient has been dosed in the registrational, tumor-agnostic PYNNACLE Phase 2 trial of rezatapopt (PC14586) in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type (WT). Rezatapopt is a first-in-class precision oncology small molecule investigational therapy that selectively targets mutated p53 Y220C proteins in solid tumors.
新澤西州普林斯頓，2024年3月27日（GLOBE NEWSWIRE）——PMV Pharmicals, Inc.（納斯達克股票代碼：PMVP）是一家率先發現和開發針對p53的小分子、與腫瘤無關的療法的精準腫瘤學公司，今天宣佈，在針對晚期患者的rezatapopt（PC14586）註冊性、與腫瘤無關的PYNNACLE 2期試驗中，首位患者已服藥包含 TP53 Y220C 突變和 KRAS 野生型 (WT) 的實體瘤。Rezatapopt 是一種首創的精準腫瘤學小分子研究療法，可選擇性地靶向實體瘤中突變的 p53 Y220C 蛋白。
"Building upon our promising Phase 1 data, we are pleased to announce the dosing of our first patient in the global Phase 2 PYNNACLE trial of rezatapopt as a monotherapy in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type," said Deepika Jalota, Pharm.D., Chief Development Officer of PMV Pharma. "This pivotal trial is a testament to PMV's commitment to developing new treatment options for patients with advanced solid tumors with a significant unmet medical need."
PMV Pharma首席開發官迪皮卡·賈洛塔說：“在我們令人鼓舞的1期數據基礎上，我們很高興地宣佈，在rezatapopt的全球2期PYNACLE試驗中，我們的第一位患者被用作單一療法，用於治療帶有TP53 Y220C 突變和KRAS野生型的晚期實體瘤患者。”“這項關鍵試驗證明了PMV致力於爲醫療需求未得到滿足的晚期實體瘤患者開發新的治療方案。”
The multi-center, single-arm, registrational, tumor-agnostic Phase 2 trial will assess rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C and KRAS WT advanced solid tumors. The primary endpoint of the trial is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites across the U.S., Europe, and Asia-Pacific.
這項多中心、單臂、註冊的、與腫瘤無關的2期試驗將評估rezatapopt作爲單一療法，對TP53 Y220C 和KRAS WT晚期實體瘤患者，每天一次，劑量爲2000 mg。該試驗的主要終點是每項盲目獨立中心審查的總體回覆率。該試驗旨在在美國、歐洲和亞太地區約60個地點招收五個隊列的114名患者。
About Rezatapopt
關於 Rezatapopt
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.
Rezatapopt（PC14586）是同類首款小分子 p53 反應劑，旨在選擇性地與 p53 Y220C 突變蛋白的口袋結合，恢復野生型或正常的 p53 蛋白結構和腫瘤抑制功能。美國食品藥品監督管理局（FDA）授予了快速通道資格，允許rezatapopt用於治療具有p53 Y220C 突變的局部晚期或轉移性實體瘤患者。
About the PYNNACLE Clinical Trial
關於 PYNNACLE 臨床試驗
The ongoing Phase 1/2 PYNNACLE clinical trial 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. The Phase 2 portion is a registrational, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to (NCT trial identifier NCT04585750).
正在進行的PYNACLE 1/2期臨床試驗正在評估攜帶TP53 Y220C 突變的晚期實體瘤患者中的rezatapopt。該試驗第一階段的主要目標是確定口服給患者rezatapopt的最大耐受劑量和推薦的2期劑量（RP2D）。還將評估安全性、耐受性、藥代動力學和對生物標誌物的影響。第二階段是一項註冊性擴展籃子臨床試驗，包括五個隊列（卵巢癌、肺癌、乳腺癌和子宮內膜癌以及其他實體瘤），主要目標是評估rezatapopt在RP2D對TP53 Y220C 和KRAS野生型晚期實體瘤患者的療效。有關 PYNNACLE 1/2 期臨床試驗的更多信息，請參閱（NCT 試驗標識符 NCT04585750）。
About PMV Pharma
關於 PMV Pharma
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 .
PMV Pharma是一家精準腫瘤學公司，率先發現和開發針對p53的小分子、與腫瘤無關的療法。p53突變存在於大約一半的癌症中。我們的聯合創始人阿諾德·萊文博士在1979年發現p53蛋白時開創了p53生物學領域。PMV Pharma彙集了該領域的領導者，利用超過四十年的p53生物學經驗，將獨特的生物學理解與藥物開發重點相結合。PMV Pharma總部位於新澤西州普林斯頓。欲了解更多信息，請訪問 。
Forward-Looking Statements
前瞻性陳述
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's future plans or expectations for rezatapopt, including our ability to obtain approval on a tumor agnostic basis, expectations regarding timing, expected trial design and success of the Phase 2 portion of its current clinical trial for rezatapopt, and potential market opportunity of rezatapopt. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned clinical trials, the Company's ability to execute on its strategy and operate as a clinical stage company, the potential for clinical trials of rezatapopt or any future clinical trials of other product candidates to differ from preclinical, preliminary, interim or expected results, the Company's ability to fund operations, and the impact that any current or future global pandemic or geopolitical emergency may have on the Company's clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 29, 2024, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
本新聞稿中有關非歷史事實事項的陳述是1995年《私人證券訴訟改革法》所指的 “前瞻性陳述”。由於此類陳述受風險和不確定性的影響，因此實際結果可能與此類前瞻性陳述所表達或暗示的結果存在重大差異。此類聲明包括但不限於有關公司未來對rezatapopt的計劃或預期的聲明，包括我們在與腫瘤無關的基礎上獲得批准的能力、對時機的預期、其當前rezatapopt臨床試驗第二階段的預期試驗設計和成功以及rezatapopt的潛在市場機會。本聲明中的任何前瞻性陳述均基於管理層當前對未來事件的預期，並存在許多風險和不確定性，這些風險和不確定性可能導致實際業績與此類前瞻性陳述中列出或暗示的業績存在重大不利差異。導致前瞻性陳述不確定性的風險包括：公司候選產品開發活動和計劃臨床試驗的成功、成本和時機、公司執行其戰略和作爲臨床階段公司運營的能力、rezatapopt的臨床試驗或其他候選產品的任何未來臨床試驗與臨床前、初步、中期或預期結果不同的可能性、公司爲運營提供資金的能力以及任何影響當前或未來的全球疫情或地緣政治緊急情況可能對公司的臨床試驗、供應鏈和運營造成影響，以及公司於2024年2月29日向美國證券交易委員會（“SEC”）提交的10-K表年度報告及其向美國證券交易委員會提交的其他文件中標題爲 “風險因素” 的部分中列出的風險和不確定性。本新聞稿中包含的所有前瞻性陳述僅代表其發佈之日。公司沒有義務更新此類聲明以反映自聲明發表之日後發生的事件或存在的情況。
Investors Contact:
Tim Smith
Senior Vice President, Head of Corporate Development and Investor Relations
investors@pmvpharma.com
投資者聯繫人：
蒂姆·史密斯
高級副總裁、企業發展和投資者關係主管
investors@pmvpharma.com
Media Contact:
Kathy Vincent
Greig Communications
kathy@greigcommunications.com
媒體聯繫人：
凱西·文森特
格雷格通訊
kathy@greigcommunications.com
譯文內容由第三人軟體翻譯。