Awakn Life Sciences Provides Update on Aminoindane New Chemical Entity Patent Portfolio
Awakn Life Sciences Provides Update on Aminoindane New Chemical Entity Patent Portfolio
Toronto, Ontario--(Newsfile Corp. - July 22, 2024) - Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder ("AUD"), is pleased to provide details of the status of the intellectual property ("IP") portfolio for its aminoindane new chemical entity ("NCE") series program (the "Aminoindane NCEs") being developed in commercial collaboration with Graft Polymer (UK) Plc (LSE: GPL) ("Graft"). Details of the commercial collaboration agreement with Graft were announced on July 18, 2024.
多倫多,安大略省—(Newsfile Corp.——2024年7月22日)- Awakn Life Sciences Corp.(CSE:AWKN)(OTCQB:AWKNF)(FSE:954)(“Awakn”或“公司”)是一家臨床階段的生物技術公司,開發用於物質使用和心理健康障礙治療的治療劑,近期重點關注酒精使用障礙(“AUD”),並高興地提供與Graft Polymer(英國)PLC(LSE:GPL)(“Graft”)商業合作中正在開發的氨基碳侖作爲新的化學實體(“NCE”)系列計劃(“氨基碳侖NCEs”)的知識產權(“IP”)組合的狀態細節。Graft的商業合作協議的詳細信息於2024年7月18日宣佈。
The Aminoindane NCEs
氨基焦磷酸酰胺NCE
The Aminoindane NCEs are novel small molecule empathogens that promote the release of serotonin, dopamine, and noradrenaline while blocking their reuptake. These compounds have potential in trauma-related mental health disorders such as post-traumatic stress disorder ("PTSD"), which affects approximately 13 million[1] adults in the U.S. and 20 million[2,3,4] in key international markets.
氨基焦磷酸酰胺NCE是一種新型的小分子共感作用物,能促進血清素、多巴胺和去甲腎上腺素的釋放,同時阻斷它們的再攝取。這些化合物在創傷相關的心理健康障礙中有潛在價值,如創傷後應激障礙(“PTSD”),該病影響着約1300萬成年人[1]和2000萬[2,3,4]國際關鍵市場的成年人。
Patent Status in the U.S. and Key International Markets
在美國和主要國際市場的專利狀態
In 2021 Awakn filed provisional patent applications covering the Aminoindane NCEs, their pharmaceutical compositions, and innovative treatment methods for substance use and mental health disorders. The patent portfolio is now progressing well across multiple jurisdictions:
2021年,Awakn提交了臨時專利申請,涵蓋了氨基化合物NCEs、它們的藥物組成和創新治療物質使用和心理健康障礙的方法。專利組合正在多個司法管轄區發展良好:
United States: The fast-tracked U.S. application, facilitated by the Patent Prosecution Highway ("PPH"), is under examination. Positive evaluations from the International Searching Authority ("ISA") suggest a promising path to a granted U.S. patent.
Europe: The European application is pending, with substantive examination expected to begin soon. European patent counsel is optimistic about securing a granted patent, particularly for claims deemed novel and inventive by the European Patent Office ("EPO") examiner.
Canada: The Canadian application, pending examination, also holds strong prospects for a granted patent. The examination process in Canada can be expedited using the PPH, enhancing IP protection efficiency.
美國:通過專利審查公路("PPH")推進的快速審查正在進行中。國際搜索機構("ISA")的積極評估表明了進入獲得美國專利的良好途徑。
歐洲:歐洲的申請正在等待實質審查,預計很快開始。歐洲專利代理律師對於獲得授予專利,特別是對於歐洲專利局("EPO")檢查員認爲新穎和有創造性的聲明的前景持樂觀態度。
加拿大:加拿大的申請正在等待審查,也擁有獲得專利的強大前景。加拿大的審查程序可以利用PPH進行加速,提高知識產權保護效率。
IP Protection Progress to Date
到目前爲止的知識產權保護進展
In May 2021, Awakn initiated its IP protection strategy for the Aminoindane NCEs by filing two provisional patent applications. These applications cover the Aminoindane NCEs, their pharmaceutical compositions, and innovative methods for treating substance use disorders and mental health disorders. This foundational step laid the groundwork for subsequent advancements in IP protection.
2021年5月,Awakn通過提交兩份臨時專利申請開始了其氨基化合物NCEs的知識產權保護策略。這些申請涵蓋了氨基焦磷酸酰胺NCEs、它們的藥物組成和新穎方法,用於治療藥物使用障礙和心理健康障礙。這項基礎性工作爲後續的知識產權保護進展打下了基礎。
In May 2022, Awakn filed a Patent Cooperation Treaty ("PCT") application, claiming the benefit of priority to both provisional applications.
2022年5月,Awakn提交了專利合作條約("PCT")申請,聲稱對兩項臨時申請的優先權。
In August 2022, an examiner from the EPO, acting as the ISA, issued a search report and written opinion, confirming the pharmaceutical composition and method of use claims for all of Awakn's lead compounds to be both novel and inventive.
2022年8月,歐洲專利局檢查員作爲ISA簽發了一個搜索報告和書面意見,確認所有Awakn主要化合物的藥物組合和使用方法聲明都是新穎且具有創造性的。
In November 2022, the PCT application published as WO2022/238507A1.
2022年11月,PCT申請作爲WO2022/238507A1進行了公佈。
In November 2023, the International Preliminary Report on Patentability was received and Awakn entered the PCT into national phase in the US and Canada, and in December, into European regional phase.
2023年11月,國際初步專利報告書收到,並通過進入美國和加拿大的PCT國家階段,12月進入歐洲地區階段。
In April 2024, a petition to accept the U.S. application onto the PPH was granted based on the novel and inventive claims deemed allowable in the PCT written opinion, indicating a likely U.S. patent grant.
2024年4月,基於PCt書面意見中被允許的新穎和有創造性的聲明,批准了將美國申請納入PPH的請願,顯示了可能獲得美國專利的跡象。
Prof. David Nutt, Awakn's Chief Scientific Officer, commented, "These advancements in our patent portfolio are a testament to the innovative potential of our Aminoindane NCEs. We are committed to progressing these compounds through the development pipeline to address the substantial unmet needs in mental health and addiction treatment."
David Nutt教授,Awakn的首席科學官,評論道:“我們的專利組合的這些進展證明了我們的氨基焦磷酸酰胺NCEs的創新潛力。我們致力於推進這些化合物通過開發流程以滿足心理健康和成癮治療中的巨大未滿足需求。”
About Awakn Life Sciences Corp.
關於Awakn Life Sciences Corp。
Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on Alcohol Use Disorder, a condition affecting approximately 29 million adults in the US and approximately 40 million in the US and key European markets for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercialising our R&D pipeline across multiple channels.
Awakn Life Sciences Corp.是一家臨床階段的生物技術公司,開發治療物質使用和心理健康障礙的治療劑。Awakn近期重點關注酒精使用障礙,這是一種影響着美國約2900萬成年人和美國及歐洲主要市場約4000萬成年人、現有標準治療方法不足的疾病。我們的目標是爲那些急需突破性成癮治療的患者提供治療劑,我們的策略是將我們的研發流水線商業化,覆蓋多個渠道。
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About Graft Polymer (UK) Plc
關於Graft Polymer(UK)Plc
Graft Polymer (UK) Plc (LSE: GPL) is an innovative developer of biopolymer drug delivery systems dedicated to assisting biopharmaceutical companies in enhancing the effectiveness of their therapeutics. Our proprietary patented platform, a bioabsorbable self-nanoemulsifying drug delivery system (SNEDDS), represents a cutting-edge solution in drug delivery technology. By integrating active pharmaceutical ingredients (APIs) into our novel, patented delivery systems, we enable clients to improve the bioavailability, pharmacokinetics, and stability of their therapeutics.
Graft Polymer (UK) Plc(LSE:GPL)是一家專注於協助生物製藥公司提高其治療方案效果的生物高分子藥物輸送系統創新開發公司。我們的自行可吸收納米乳化藥物傳遞系統(SNEDDS)是一種尖端的藥物輸送技術解決方案。通過將活性藥劑成分(API)集成到我們的新穎專利輸送系統中,我們使客戶能夠提高其治療方案的生物利用度,藥物動力學和穩定性。
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Notice Regarding Forward-Looking Information
關於前瞻性信息的通知
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
本新聞稿中含有某些前瞻性信息和前瞻性聲明,如適用證券法所定義的那樣(以下統稱“前瞻性聲明”)。“前瞻性聲明”反映了關於未來事件或公司未來業績的目前期望或信念。除歷史事實之外,所有陳述均爲前瞻性聲明。常常但並非總是能夠通過使用諸如“計劃”、“預計”、“預計”、“預算”、“計劃”、“估計”、“繼續”、“預測”、“項目”、“預測”、“打算”、“ 預售”或這些單詞和短語的變體或這些單詞和短語的否定,或者聲明某些行動,“事件”或“結果”“可能”,“可能”,“將”,“應該”,“可能”或“將要”被採取,發生或實現,包括涉及公司業務的聲明。所有前瞻性聲明,包括此處的所有聲明均受到本警示聲明的約束。
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
儘管公司認爲此類聲明所表達的期望基於合理的假設,但這些聲明並不保證未來業績,實際結果或發展情況可能與陳述不同。存在某些因素可能導致實際結果與前瞻性信息有所不同。這些因素包括但不限於:宏觀經濟環境的波動;公司的業務計劃和戰略;公司能否在高度監管的業務中遵守所有適用政府法規;在某些司法管轄區中目標公司或項目的營運歷史有限或沒有營運歷史,且涉及當前被視爲非法活動的活動;法規變化;運營歷史有限;依賴管理層;需要獲取額外的融資;競爭;證券市場波動性;關於使用致幻藥物用於醫療方面的公衆意見和感知不一致;對戒癮市場規模的預期;以及監管或政治變化。讀者被警告,上述因素清單並非前瞻性聲明影響因素的窮盡清單,請勿過於依賴前瞻性聲明。本新聞稿中的前瞻性聲明僅反映發表日期或在該等聲明中指定的日期或日期。
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at . The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
投資者需注意,此類陳述並不保證未來業績,實際結果或發展情況可能與前瞻性信息所述有所不同。有關公司的更多信息,投資者應鼓勵查閱該公司在SEDAR的公開申報文件。該公司聲明除了法律規定之外,沒有任何意圖或義務更新或修訂任何前瞻性信息。
Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony@awaknlifesciences.com
投資者查詢:
Awakn生命科學首席執行官Anthony Tennyson
anthony@awaknlifesciences.com
Sources
資源
- US VA National Center for PTSD. US Department of Veterans Affairs.
- UK National Health Service (NHS), Adult Psychiatric Morbidity Survey: Survey of Mental Health and Wellbeing, England, 2014.
- Maercker, A., Forstmeier, S., Wagner, B. et al. Posttraumatische Belastungsstörungen in Deutschland. Nervenarzt 79, 577-586 (2008).
- Nemeroff, Charles B., and others, 'Trauma and PTSD in Europe', in Charles B. Nemeroff, and Charles Marmar (eds), Post-Traumatic Stress Disorder (New York, 2018; online edn, Oxford Academic, 1 Sept. 2018)
- 美國退伍軍人事務部(US VA)創傷後應激障礙國家中心。
- 英國國家醫療服務體系(NHS),成年人精神疾病患病率調查:英格蘭,2014。
- Maercker,A.,Forstmeier,S.,Wagner億。等人。2008年德國的創傷後應激障礙。神經病醫師79,577-586(2008年)。
- Nemeroff,Charles b.和其他人,'歐洲的創傷和創傷後應激障礙',見Charles b. Nemeroff和Charles Marmar(eds),後創傷性應激障礙(紐約,2018年;在線版,牛津學術,2018年9月1日)。