Convergent Therapeutics and Point Biopharma Announce a Collaboration to Evaluate CONV 01-α (Rosopatamab-225Ac) in combination with PNT2002 for Progressive Metastatic Castration-Resistant Prostate Can
Convergent Therapeutics and Point Biopharma Announce a Collaboration to Evaluate CONV 01-α (Rosopatamab-225Ac) in combination with PNT2002 for Progressive Metastatic Castration-Resistant Prostate Can
CAMBRIDGE, Mass. and INDIANAPOLIS, Sept. 14, 2021 /PRNewswire/ -- Convergent Therapeutics Inc., a clinical stage radiopharmaceutical company, and POINT Biopharma Global Inc., (Nasdaq: PNT) ("POINT") a company accelerating the discovery, development and global access to life changing radiopharmaceuticals, today announced a collaboration to evaluate the combination of CONV 01-α (225Ac−J591, or rosopatamab-225Ac), Convergent's antibody directed at prostate-specific membrane antigen (PSMA) coupled with Actinium-225 (225Ac), an alpha particle emitter and POINT's PSMA radioligand PNT2002 linked to Lutetium-177 (177Lu), a beta particle emitter in men with progressive metastatic castration-resistant prostate cancer (mCRPC) in a Phase I/II investigator-initiated trial. The study has begun patient accrual and is being conducted at Weill Cornell Medicine with Dr. Scott T. Tagawa, Professor of Medicine and Professor of Medicine in Urology at Weill Cornell Medicine, as Principal Investigator.
馬薩諸塞州坎布里奇印第安納波利斯，9月2021年4月14日/美通社/--臨牀階段放射製藥公司Convergent Treateutics Inc.Point Biophma Global Inc.，(納斯達克股票代碼：PNT)(“POINT”)，一家加速發現、開發和全球獲得改變生命的放射性藥物的公司，今天宣佈了一項合作，以評估Conv01-α(225Ac−J591，或rosopatamab-225Ac)、Convergent針對前列腺特異性膜抗原的抗體與Actdium-225(225Ac)的組合，Actdium-225(225Ac)是一種α粒子發射體，POINT的PSMA放射寡核苷酸與這項研究已經開始患者積累，由威爾·康奈爾醫學院醫學教授、泌尿外科教授斯科特·T·田川博士擔任首席研究員，目前正在威爾·康奈爾醫學中心進行。
The Phase I/II trial is enrolling up to 33 patients with progressive mCRPC who have received a prior androgen receptor signaling inhibitor (ARSI) and taxane chemotherapy and are PSMA PET-positive. The open-label Phase I dose-escalation portion of the study is designed to determine the maximum tolerated dose (MTD) for the combination of CONV 01-α and PNT2002. PNT2002 will be administered at the dose utilized in POINT Biopharma's Phase III SPLASH trial. Escalating doses of CONV 01-α will be administered concurrently, starting with doses previously demonstrated to be well-tolerated. After the Phase I study has established the MTD of the CONV 01-α and PNT2002 combination, investigators will initiate the Phase II expansion study study at MTD. The primary objective of the Phase II study is to assess the number of patients who demonstrate a >50% prostate-specific antigen (PSA) decline following treatment.
I/II期試驗招募了33名進展性mCRPC患者，他們以前接受過雄激素受體信號抑制劑(ARSI)和紫杉烷化療，並且PSMA PET呈陽性。該研究的開放標籤I階段劑量遞增部分旨在確定Conv01-α和PNT2002聯合使用的最大耐受量。PNT2002將按照Point Biophma的第三階段飛濺試驗中使用的劑量使用。遞增劑量的Conv 01-α將同時給予，從先前證明耐受性良好的劑量開始。在第一階段研究確定了COV01-α和PNT2002組合的MTD後，研究人員將在MTD啟動第二階段擴展研究。第二階段研究的主要目標是評估治療後前列腺特異性抗原(PSA)下降>50%的患者數量。
The co-targeting treatment approach is based on the research of Dr. Neil Bander, the Bernard & Josephine Chaus Professor of Urologic Oncology at Weill Cornell Medicine, who discovered the synergy between radioligands and 225Ac−J591. The finding that antibodies synergistically improve the efficacy of ligand-targeted agents is the subject of patent filings by Cornell University that, in turn, have been exclusively licensed to Convergent Therapeutics, inc. At the ASCO 2021 Annual Meeting in June, Dr. Tagawa presented proof of concept data that demonstrated that a single dose of CONV 01-α had anti-tumor activity in heavily pretreated men with mCRPC.
聯合靶向治療方法基於威爾·康奈爾醫學院泌尿系統腫瘤學伯納德和約瑟芬·喬斯教授尼爾·班德博士的研究，他發現了放射性配體和225Ac−J591之間的協同作用。抗體協同提高配體靶向製劑的療效是康奈爾大學提交的專利申請的主題，而這些專利又被授予Convergent Treateutics公司獨家許可。在6月份的ASCO2021年年會上，田川博士提交了概念證明數據，證明單劑Conv 01-α在經過大量預處理的mCRPC男性患者中具有抗腫瘤活性。
Dr. Philip Kantoff, Chief Executive Officer of Convergent Therapeutics, stated, "Within the field, there is significant and growing interest in our differentiated approach that leverages the complementary advantages of co-targeting surface cancer molecules such as PSMA with both antibodies and small molecule ligands, as well as alpha and beta radiopharmaceuticals. This collaboration with POINT Biopharma will, therefore, help to facilitate and validate our disruptive strategy of combining radioligands and antibodies carrying different payloads, directed at a cancer target, in order to significantly improve the efficacy of radiopharmaceutical therapies. Our long-term goal is to meaningfully improve outcomes in patients with prostate cancer and to leverage this combinatorial platform to treat other cancers. We look forward to evaluating the results once they are available."
Convergent治療公司首席執行官菲利普·坎托夫博士説：“在這一領域，人們對我們的差異化方法越來越感興趣，這種方法利用了PSMA與抗體和小分子配體以及阿爾法和貝塔放射性藥物共同瞄準表面癌症分子的互補優勢。因此，與Point Biophma的合作將有助於促進和驗證我們的顛覆性戰略，即針對癌症靶點，結合攜帶不同有效載荷的放射性配體和抗體，以顯著提高放射性藥物療法的療效。我們的長期目標是有意義地改善前列腺癌患者的預後，並利用這一組合平台治療其他癌症。一旦結果出來，我們期待着對其進行評估。“
Dr. Joe McCann, Chief Executive Officer of POINT Biopharma, noted, "Combination therapies are a very exciting opportunity in the radiopharmecutical space, as demonstrated by Dr. Bander's research into combining different radioligand therapies to improve outcomes. To date, PNT2002 has shown promise as a monotherapy and we believe that this collaboration has the potential to not only improve patient outcomes, but also provide patients and physicians with new therapeutic options for advanced prostate cancers.
POINT Biophma公司首席執行官喬·麥肯博士指出：“聯合療法在放射性藥物領域是一個非常令人興奮的機會，班德博士將不同的放射性配體療法結合起來以改善結果的研究證明了這一點。迄今為止，PNT2002作為單一療法顯示出了希望，我們相信這種合作不僅有可能改善患者的結果，而且還為患者和醫生提供了治療晚期前列腺癌的新的治療選擇。
For additional information about this clinical trial, please visit www.clinicaltrials.gov, NCT04886986
有關這項臨牀試驗的更多信息，請訪問www.clinicaltrials.gov，NCT04886986。
Dr. Bander is a co-founder with equity and a paid scientific advisor for Convergent Therapeutics, Inc. Dr. Tagawa is a paid consultant and receives equity for Convergent Therapeutics, Inc.
班德博士是Convergent Treeutics公司的股權聯合創始人和付費科學顧問。田川博士是Convergent Treeutics公司的付費顧問，並獲得股權。
About PNT2002PNT2002 is a PSMA-targeted radioligand in development for the treatment of patients with metastatic castration-resistant prostate cancer who have progressed following treatment with ARSI therapy. The Phase 3 SPLASH study (NCT04647526) is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on ARSI therapy and refuse or not eligible for chemotherapy. The next phase of the study is expected to enroll approximately 400 patients across North America, Europe and the UK, and top-line data from the SPLASH study is expected to report in mid-2023.
關於PNT2002PNT2002是一種PSMA靶向放射性配體，正在開發中，用於治療經阿司匹林(Arsi)治療後進展的轉移性去勢抵抗前列腺癌患者。3期SPLASH研究(NCT04647526)是一項多中心、隨機、開放標籤的PNT2002評估，研究對象為PSMA表達的mCRPC患者，這些患者在ARSI治療中取得進展，拒絕或不符合接受化療的條件。下一階段的研究預計將在北美、歐洲和英國招募大約400名患者，SPLASH研究的頂級數據預計將在2023年年中報告。
About POINT BiopharmaPOINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (225Ac) and Lutetium-177 (177Lu), manufacturing technology and novel direct-to-patient targeting to revolutionize theragnostic drug development and radioligand commercialization. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com. Information about POINT Biopharma Global Inc.'s Phase 3 SPLASH trial for mCRPC patients can be found at https://www.splashtrial.com.
關於Point BiophmaPoint Biophma Global Inc.是一家專注於全球的放射性製藥公司，為抗癌放射配體的臨牀開發和商業化搭建了一個平台。Point Biophma Global Inc.正在將一流的放射性製藥資產組合、一支經驗豐富的管理團隊、Actdium-225(225Ac)和Lu-177(177 Lu)等放射性同位素方面的專業知識、製造技術和新穎的直接面向患者的目標結合在一起，以徹底改變不可知藥物的開發和放射性配體商業化。欲瞭解有關Point Biophma全球公司的更多信息，請訪問https://www.pointbiopharma.com.。有關POINT Biophma Global Inc.針對mCRPC患者的3期SPASH試驗的信息，請訪問https://www.splashtrial.com.。
About Convergent TherapeuticsConvergent Therapeutics, Inc. is a clinical stage pharmaceutical company focused on developing next generation radiopharmaceutical therapies for prostate and other cancers. The company's proprietary technology involves dual-targeted radionuclide therapy (RNT) developed by Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine and licensed to Convergent by Cornell University. CONV 01-α, a monoclonal antibody conjugated with 225Ac, a radioactive alpha particle emitter, was specifically designed to bind to the prostate-specific membrane antigen (PSMA). A key functional feature of CONV 01-α is that, once bound to PSMA, it becomes internalized, thereby delivering its powerful radioactive payload directly into the prostate cancer cells. CONV 01-α is covered by multiple issued U.S. and foreign patents. If FDA-approved, CONV 01-α would be the first antibody approved to direct a radioisotope to prostate cancer, and the first drug approved for the use of 225Ac in a cancer treatment.
關於會聚療法匯聚治療公司是一家臨牀階段的製藥公司，專注於為前列腺癌和其他癌症開發下一代放射藥物療法。該公司的專有技術涉及雙靶向放射性核素療法(RNT)，該療法由威爾·康奈爾醫學院泌尿腫瘤學教授尼爾·班德博士開發，並獲得康奈爾大學授權給Convergent公司。Conv01-α是一種與放射性α粒子發射體225Ac偶聯的單克隆抗體，專為結合前列腺特異性膜抗原而設計。Conv 01-α的一個關鍵功能特徵是，一旦與PSMA結合，它就會內化，從而將其強大的放射性有效載荷直接輸送到前列腺癌細胞中。Conv 01-α由多項已頒發的美國和外國專利涵蓋。如果FDA批准，Conv 01-α將成為第一個被批准將放射性同位素定向到前列腺癌的抗體，以及第一個被批准在癌症治療中使用225Ac的藥物。
Contact at Convergent Therapeutics: Rx Communications Group Paula Schwartz917-322-2216pschwartz@rxir.com
匯聚治療公司的聯繫人聯繫人：RX Communications Group Paula Schwartz917-322-2216pschwartz@rxir.com
Contact at POINT Biopharma:Alex LoboStern Investor Relationsinvestors@pointbiopharma.com
在Biophma點的接觸：Alex LoboStern Investor RelationsInvestors@pointbiharma.com
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SOURCE Convergent Therapeutics
源匯聚療法
譯文內容由第三人軟體翻譯。