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Taysha Gene Therapies Provides Update on Deprioritized Pipeline Programs

Taysha Gene Therapies Provides Update on Deprioritized Pipeline Programs

Taysha 基因療法提供非優先級管道計劃的最新信息
Taysha Gene Therapies ·  02/15 00:00

DALLAS, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) ("Taysha" or "the Company"), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today provided an update on its deprioritized pipeline programs as part of an ongoing effort to help support their further potential development.

達拉斯,2024年2月15日(GLOBE NEWSWIRE)——專注於開發和商業化用於治療中樞神經系統單基因疾病(CNS)的基於AAV的基因療法的臨床階段基因療法公司Taysha Gene Therapies, Inc.(納斯達克股票代碼:TSHA)(“Taysha” 或 “公司”)今天提供了其取消優先順序的研發計劃的最新情況,這是持續支持工作的一部分他們的進一步潛力發展。

Taysha has been working to find ways to advance its deprioritized programs. On November 13, 2023, Taysha terminated its existing loan and security agreement and entered into a new loan and security agreement that provides consent to allow the Company to transfer intellectual property (IP) for several deprioritized programs to third parties in a more efficient manner. The Company's new loan and security agreement also extended its cash runway into 2026.

Taysha一直在努力尋找方法來推進其取消優先順序的計劃。2023年11月13日,Taysha終止了其現有的貸款和擔保協議,並簽訂了一項新的貸款和擔保協議,該協議同意允許公司以更有效的方式將多個非優先項目的知識產權(IP)轉讓給第三方。該公司的新貸款和擔保協議也將其現金流延至2026年。

Recent progress on previously deprioritized pipeline programs includes:

先前已取消優先級的管道計劃的最新進展包括:

  • TSHA-120: The Company initiated the transfer of the United States Food and Drug Administration Investigational New Drug (IND) application and investigational clinical trial material for TSHA-120 in giant axonal neuropathy (GAN) to clinical trial collaborator National Institute of Neurological Disorders and Stroke (NINDS), creating an opportunity for continued clinical evaluation of TSHA-120 in GAN. Additionally, the Company entered discussions with the originating advocacy organization regarding TSHA-120 in an effort to transfer rights back to the advocacy organization to move the program forward.
  • TSHA-101: The Company transferred rights back to Queen's University (Queen's) for TSHA-101 in GM2 gangliosidosis, resulting in Queen's regaining exclusive IP to the program.
  • TSHA-104 and TSHA-112: The Company transferred rights back to the originating institution for select programs, including TSHA-104 in SURF1-associated Leigh syndrome and TSHA-112 in APBD.
  • TSHA-118: The Company provided investigational clinical trial material for TSHA-118 in CLN1 to support an individual-patient investigator-initiated IND request from RUSH University Medical Center for the treatment of a patient with CLN1 disease.
  • TSHA-120:公司開始將美國食品藥品監督管理局針對巨型軸突神經病 (GAN) 的 TSHA-120 的研究性新藥 (IND) 申請和研究性臨床試驗材料移交給臨床試驗合作者美國國家神經系統疾病和中風研究所 (NINDS),這爲繼續對氮化鎵中的 TSHA-120 進行臨床評估創造了機會。此外,該公司與最初的倡導組織就 TSHA-120 進行了討論,以期將權利移交給該倡導組織以推動該計劃向前發展。
  • TSHA-101:公司將 GM2 神經節苷脂症中 TSHA-101 的版權轉讓給了女王大學(女王大學),導致女王大學重新獲得了該項目的專有知識產權。
  • TSHA-104 和 TSHA-112:公司將部分項目的版權移交給了發起機構,包括與SURF1相關的Leigh綜合症中的TSHA-104 和APBD中的TSHA-112。
  • TSHA-118:該公司提供了 CLN1 中 TSHA-118 的研究性臨床試驗材料,以支持拉什大學醫學中心由個體患者研究人員發起的用於治療 CLN1 疾病患者的臨床試驗申請。

"Today's announcement demonstrates meaningful progress to advance important development work for several deprioritized programs. Creating options for these programs has been a focus since the Company completed a management change in December 2022, and the new loan and security agreement afforded the flexibility to implement certain opportunities," said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. "As we continue to focus on advancing our lead TSHA-102 program for the treatment of Rett syndrome, we are pleased that we can ensure these programs are provided to the right advocates, clinicians and scientific experts who can potentially move these programs forward for the benefit of patients."

“今天的公告表明,在推進幾項非優先項目的重要開發工作方面取得了有意義的進展。自公司於2022年12月完成管理層變更以來,爲這些計劃創造選擇一直是重點,新的貸款和擔保協議爲實施某些機會提供了靈活性,” Taysha董事長兼首席執行官肖恩·諾蘭說。“隨着我們繼續專注於推進我們治療雷特綜合徵的主要 TSHA-102 計劃,我們很高興能夠確保將這些計劃提供給合適的倡導者、臨床醫生和科學專家,他們有可能推動這些計劃向前發展,造福患者。”

The Company continues to explore potential partnerships and opportunities for its other deprioritized programs to help support their further potential development.

該公司繼續爲其其他非優先項目探索潛在的合作伙伴關係和機會,以幫助支持其進一步的潛在發展。

About Taysha Gene Therapies
Taysha Gene Therapies (Nasdaq: TSHA) is a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system. Its lead clinical program TSHA-102 is in development for Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies that address the genetic root cause of the disease. With a singular focus on developing transformative medicines, Taysha aims to address severe unmet medical needs and dramatically improve the lives of patients and their caregivers. The Company's management team has proven experience in gene therapy development and commercialization. Taysha leverages this experience, its manufacturing process and a clinically and commercially proven AAV9 capsid in an effort to rapidly translate treatments from bench to bedside. For more information, please visit www.tayshagtx.com.

關於 Taysha 基因療法
Taysha Gene Therapies(納斯達克股票代碼:TSHA)是一家臨床階段的生物技術公司,專注於推進針對中樞神經系統嚴重單基因疾病的基於腺相關病毒(AAV)的基因療法。其主要臨床項目 TSHA-102 正在針對雷特綜合徵開發中,雷特綜合徵是一種罕見的神經發育障礙,尚無經批准的針對該疾病遺傳根源的疾病改善療法。Taysha專注於開發變革性藥物,旨在解決未得到滿足的嚴重醫療需求,顯著改善患者及其護理人員的生活。該公司的管理團隊在基因療法開發和商業化方面擁有豐富的經驗。Taysha利用這種經驗、其製造工藝以及經過臨床和商業驗證的AAV9衣殼,努力將治療從治療臺快速轉化爲牀邊。欲了解更多信息,請訪問 www.tayshagtx.com

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning Taysha's cash runway and potential partnerships and opportunities for Taysha's deprioritized programs. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2022, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, both of which are available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

前瞻性陳述
本新聞稿包含1995年《私人證券訴訟改革法》所指的前瞻性陳述。諸如 “預期”、“相信”、“期望”、“打算”、“項目”、“計劃” 和 “未來” 之類的詞語或類似表述旨在識別前瞻性陳述。前瞻性陳述包括有關Taysha現金流以及Taysha取消優先級計劃的潛在合作伙伴關係和機會的陳述。前瞻性陳述基於管理層當前的預期,受到各種風險和不確定性的影響,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所表達或暗示的結果存在重大和不利的差異。因此,這些前瞻性陳述不構成對未來業績的保證,提醒您不要過分依賴這些前瞻性陳述。我們的證券交易委員會(“SEC”)文件詳細描述了我們的業務風險,包括截至2022年12月31日的全年10-K表年度報告和截至2023年9月30日的季度10-Q表季度報告,兩者均可在美國證券交易委員會的網站上查閱 www.sec.gov。其他信息將在我們不時向美國證券交易委員會提交的其他文件中提供。這些前瞻性陳述僅代表截至本文發佈之日,除非法律要求,否則我們不承擔任何更新這些陳述的義務。

Company Contact:
Hayleigh Collins
Director, Head of Corporate Communications and Investor Relations
Taysha Gene Therapies, Inc.
hcollins@tayshagtx.com

公司聯繫人:
海莉·柯林斯
董事兼企業傳播和投資者關係主管
Taysha 基因療法有限公司
hcollins@tayshagtx.com

Media Contact:
Carolyn Hawley
Inizio Evoke
Carolyn.hawley@inizioevoke.com

媒體聯繫人:
卡羅琳·霍利
Inizio Evoke
Carolyn.hawley@inizioevoke.com

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Source: Taysha Gene Therapies, Inc.

來源:Taysha Gene Therapies, Inc

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