EX-99.2 3 exh_992.htm PRESS RELEASE EdgarFiling

附件99.2

Molecular Partners和Orano Med在EANm 2024展示了支持DLL3靶向放射性DARPin治療候選藥MP0712的額外陽性臨床前數據

觀察到依賴劑量的療效,具有良好的安全性

生物分佈研究中顯示了腎臟和腫瘤之間吸引人的比例

對DLL3具有皮米摩爾親和力和高特異性,作爲α放射治療的精準屬性

Molecular Partners和Orano Med正準備在2025年進入臨床階段 

ZURICH-SCHLIEREN,瑞士,和科納克特,馬薩諸塞州,和巴黎,2024年10月22日(環球新聞社)-- 根據53號法規的臨時公告 - Molecular Partners AG(瑞士六交所:MOLN;納斯達克:MOLN),一家臨床階段的生物技術公司,正在開發一種名爲DARPin治療藥物的新型定製蛋白藥物類別,Orano Med是一家臨床階段的放射製藥公司,正在開發具有鉛-212(212Pb)的靶向α療法的最新臨床前數據支持MP0712作爲一種Radio-DARPin治療(RDT)在2024年10月19日至23日於德國漢堡舉行的歐洲核醫學協會(EANM)大會上進行口頭展示。MP0712是一種共同開發的 212Pb標記的RDt候選藥物,靶向δ-類配體3(DLL3)。Molecular Partners和Orano Med計劃在2025年在獲得監管審批後啓動首次人體研究。MP0712的初步臨床數據也預計將於2025年出現。

與Orano Med共同開發的帶有DLL3 RDt的MP0712的最新數據證實了在與人類癌症情景相匹配的模型中的高腫瘤攝取量,同時使腎臟暴露保持在低水平。額外的 ,爲抑鬱症、焦慮症和其他沉思性障礙提供了有前景的新療法。療效和安全數據進一步加強了我們計劃於明年開始臨床試驗的動力,可能構成第一個DLL3靶向 212Pb劑的開發,” Molecular Partners的首席執行官Patrick Amstutz博士說道。「與合作伙伴Orano Med一起,我們成功對我們的DARPins進行了腎臟隱形工程,並通過半衰期調節增加了腫瘤攝取量,從而使我們的Radio-DARPin平台不斷髮展。這些經驗教訓直接應用於我們RDt管線中的下一個候選藥物。」

「迄今爲止,我們對MP0712的結果感到非常滿意。通過α相機成像觀察到的均一分佈不僅支持我們的DLL3項目,還凸顯了Molecular Partners與Orano Med合作的潛在前景。他們的DARPin載體特別適用於鉛-212靶向α療法(TAT)。通過充分利用兩支團隊的專業知識,我們的目標是建立一個穩固的平台,並顯著縮短開發時間表,」 Orano Med首席科學官Julien Torgue博士如是說。

這個最佳口頭報告(TROP)的詳細信息:

  • 演示文稿標題: lead-212 的臨床前評估 (212Pb) 靶向小細胞肺癌 (SCLC) 中 delta-like 配體 3 (DLL3) 的 radio-Darpin 治療 (RDT)
  • 演示文稿編號: OP-535
  • 會議標題: M200萬 Track——TROP 會議:放射藥物科學 + 轉化分子成像與治療委員會:從放射性核素到臨床翻譯(會議編號:1204)
  • 會議日期、時間和地點: 2024 年 10 月 22 日;歐洲中部標準時間上午 8:00-9:30;X1-X4 大廳

演示強調在多個模型中可以實現優於2的腫瘤到腎臟(T:K)比值,在包括表達與臨床相關的DLL3水平的分佈研究中。這表明靶向組織具有強烈的攝取能力,同時對健康組織的影響很小。此外, ,爲抑鬱症、焦慮症和其他沉思性障礙提供了有前景的新療法。 數據顯示腫瘤攝取特異性與DLL3相關。

小鼠的劑量區間找到研究證實,以臨床相關劑量治療耐受良好,支持有利的安全性概況。最後,在承載臨床相關水平DLL3表達的建立瘤小鼠中,MP0712表現出強大且劑量相關的療效,在臨床相關劑量下表現良好,與放射標記的抗DLL3抗體Rova陽性對照相比。

由於DLL3在小基站-5g肺癌患者腫瘤(腫瘤中超過85%)和其他侵襲性神經內分泌腫瘤中表達豐富,而在健康組織中的表達較低,因此DLL3是放射藥物治療的一個非常相關的靶點。MP0712對人類DLL3具有皮秒親和力和高特異性。

Molecular Partners正在開發其RDt平台,用於將放射性荷載靶向輸送到實體腫瘤。由於它們體積小、高特異性和親和力強,DARPins非常適合作爲有效輸送治療性放射性核素的潛在載體。DARPins也容易設計爲多特異性,使得雙特異性(或更大)候選藥物成爲Molecular Partner的RDt組合中有前景增長的領域,因爲額外的靶向可能有助於解決許多腫瘤中的靶點異質性。該組合包括內部開發的項目以及與Orano Med和諾華的合作項目。

今天進行的演示將在Molecular Partner的網站科學文件部分提供。

關於DARPin治療
DARPin(設計的蛋白質螺旋重複體)治療是一種基於自然結合蛋白的新型定製蛋白藥物,打開了藥物設計中多功能性和多靶點特異性的新維度。 DARPin的靈活結構、內在的高親和力和特異性、小尺寸和高穩定性帶來了與其他當前可用的基於蛋白質的治療藥物相比的優勢。 DARPin候選藥物可以是根本簡單的,一個DARPin單位作爲傳遞載體到特定靶點;或者是多特異性的,可能涉及超過五個靶點,並結合多個和條件功能在一個獨特的DARPin藥物候選體中。 DARPin平台旨在成爲快速、經濟高效的藥物發現引擎,生產具有優化性能和高產量的候選藥物。 DARPin治療已經在幾個治療領域得到臨床驗證,並發展到註冊階段。

關於靶向α療法
靶向阿爾法治療(TAT)依賴於一個簡單的概念: 將生物分子定位癌細胞的能力與鉛-212等阿爾法放射性同位素的短距離和高能量的細胞殺傷能力相結合。阿爾法衰變包括氦核(阿爾法粒子)的排放,以及非常高的線性能量傳輸和區間排放僅有幾層細胞,導致相鄰阿爾法排放區域的細胞不可逆的雙鏈DNA斷裂。這種方法導致對癌細胞的細胞毒作用增強,同時限制毒性作用於附近的健康細胞。因此,阿爾法發射體被認爲是用於靶向治療中最強大的載荷。

關於Molecular Partners AG 
Molecular Partners AG是一家臨床階段的生物技術公司,致力於設計和開發DARPin治療藥物,應對醫療挑戰,其他藥物形式無法輕易應對。該公司在各個臨床前和臨床開發階段擁有項目,以腫瘤學爲主要關注領域。分子合作伙伴利用DARPins的優勢,通過自有項目以及與領先藥品公司的合作伙伴關係,爲患者提供獨特解決方案。分子合作伙伴成立於2004年,總部設在瑞士蘇黎世和美國馬薩諸塞州康科德。欲了解更多信息,請訪問www.molecularpartners.com,並在LinkedIn和Twitter/X上查找我們 @MolecularPrtnrs

About Orano Med
Orano Med is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), a rare alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). The company develops several treatments using 212Pb combined with various targeting agents. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently investing to further expand its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe. For more information, please visit: www.oranomed.com.

For further details, please contact:
Molecular Partners:
Seth Lewis, SVP Investor Relations & Strategy
Concord, Massachusetts, U.S.
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Laura Jeanbart, PhD, Head of Portfolio Management & Communications
Zurich-Schlieren, Switzerland
laura.jeanbart@molecularpartners.com
Tel: +41 44 575 19 35

Orano Med :
Sophie Letournel
Strategy, governance, and communication director
sophie.letournel@orano.group
Tel: +33 6 38 44 34 11

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