Defence Receives FDA Approval for Phase I Clinical Trial Targeting Solid Cancer Tumors With AccuTOX(R)
Defence Receives FDA Approval for Phase I Clinical Trial Targeting Solid Cancer Tumors With AccuTOX(R)
Vancouver, British Columbia--(Newsfile Corp. - December 11, 2023) - Defence Therapeutics Inc. (CSE: DTC) (OTC Pink: DTCFF) (FSE: DTC) ("Defence" or the "Company"), one of the leading Canadian biotechnology companies working in the field of immune-oncology is pleased to announce that the U.S. FDA has cleared today "Study May Proceed" its Investigational New Drug (IND) application for a Phase I clinical trial of ACCUM-002TM Dimer CDCA-SV40 commonly named "AccuTOX", as an injectable anticancer molecule, for the treatment of solid cancer tumors. The approval granted to AccuTOX, the company's first first-in-class therapy, marks another key advancement for Defence in the immune-oncology field.
不列顛哥倫比亞省溫哥華--（Newsfile Corp.，2023 年 12 月 11 日）-國防治療公司（CSE：DTC）（OTC Pink：DTCFF）（FSE：DTCFF）（FSE：DTC）（”防禦“或者”公司“），加拿大從事免疫腫瘤學領域工作的領先生物技術公司之一很高興地宣佈，美國食品藥品管理局今天 “研究可能繼續” 批准了其 ACCUM-002 I期臨床試驗的在研新藥（IND）申請TM Dimer CDCA-SV40 通常被命名爲 “AccutoX”“，作爲一種可注射的抗癌分子，用於治療實體癌腫瘤。授予 Accutox 的批准是該公司的第一款同類首創療法，標誌着國防在免疫腫瘤學領域的又一重要進展。
The successful filing and safety review by the U.S. FDA of our protocol entitled "Phase 1 trial of ACCUM-002TM administered intratumorally as monotherapy and in combination with Opdualag (fixed IV doses), in patients with unresectable, stage IIIB to IV melanoma refractory to or relapse from standard therapy" marks a significant milestone for the company's strategy featuring diverse pipelines. Alongside its cancer vaccine-related therapies, AccuTOX will become Defence's flagship asset in the anti-cancer therapeutics field. Defence remains committed to its mission of addressing unmet clinical needs and in pursuing its goals to become a global leader in the development of innovation anti-cancer therapies.
美國食品和藥物管理局成功提交了我們的名爲 “ACCUM-002 第一階段試驗” 的協議，並進行了安全審查TM 對於不可切除的、標準療法難治或復發的IIIB期至靜脈黑色素瘤患者，作爲單一療法進行腫瘤內口服，並與Opdualag（固定靜脈注射劑量）聯合使用” 標誌着該公司以多樣化渠道爲特色的戰略的重要里程碑。除了與癌症疫苗相關的療法外，AccutoX 將成爲國防部在抗癌療法領域的旗艦資產。國防部仍然致力於滿足未得到滿足的臨床需求的使命，並追求成爲創新抗癌療法開發領域的全球領導者的目標。
About AccuTOX
關於 AccutoX
AccuTOXis a derivative of the initial Accum backbone molecule. It was initially designed to various cellular processes including endosomal membranes to impair intracellular transport mechanisms, triggering genotoxic effects, blocking DNA repair mechanisms, and eliciting immunogenic cell death to stimulate the immune system. The use of AccuTOX in preclinical animal models with T-cell lymphoma, melanoma or breast cancer, under Dr. Moutih Rafei supervision, Defence's CSO, resulted in impaired tumor growth with 70% of treated animals showing complete responses.
Accutox是初始 Accum 的衍生物 骨幹分子。它最初被設計用於各種細胞過程，包括內體膜，以破壞細胞內轉運機制，觸發遺傳毒性作用，阻斷DNA修復機制，並引發免疫原細胞死亡以刺激免疫系統。AccutoX 的使用 在患有T細胞淋巴瘤、黑色素瘤或乳腺癌的臨床前動物模型中，在國防部首席科學官Moutih Rafei博士的監督下，腫瘤生長受損，70％的接受治療的動物表現出完全的反應。
"We are very proud, thrilled, and we look forward to beginning this Phase I trial as its aim is to test one of our leads and most advanced therapeutic candidate for the treatment of solid tumors for the benefits of the cancer patients. Defence is becoming a clinical stage company," said Sébastien Plouffe, President & CEO of Defence Therapeutics.
“我們感到非常自豪、激動，我們期待着開始這項I期試驗，因爲其目的是測試我們治療實體瘤的領先藥物之一，也是最先進的候選治療藥物，以造福癌症患者。國防公司正在成爲一家處於臨床階段的公司。” Defense Therapeutics總裁兼首席執行官塞巴斯蒂安·普勞夫說。
The primary objective of this upcoming Phase I clinical trial, is to identify the safest dosing range in order to co-administer AccuTOX with Opdulag, a BMS product containing both anti-LAG3 and anti-PD-1. Several other secondary parameters including therapeutic efficacy will be monitored in treated patients in preparation for a Phase II clinical trial on a basket of tumors. More details about the beginning of the Phase I will be announced in the near future.
這項即將到來的I期臨床試驗的主要目標是確定最安全的給藥範圍，以便共同使用AccutoX 和 Opdulag 在一起，一款同時含有抗 LAG3 和抗 PD-1 的 BMS 產品。將在接受治療的患者中監測其他幾個次要參數，包括治療療效，爲針對一籃子腫瘤的II期臨床試驗做準備。有關第一階段開始的更多細節將在不久的將來公佈。
According to Data Bridge Market Research, the solid tumors market was valued at USD 209.61 billion in 2021 and is expected to reach USD 901.27 billion by 2029, registering a CAGR of 20.0% during the forecast period of 2022 to 2029.
根據數據橋市場研究，2021年實體瘤市場的價值爲2,096.1億美元，預計到2029年將達到9012.7億美元，在2022年至2029年的預測期內，複合年增長率爲20.0％。
About Defence:
Defence Therapeutics is a publicly-traded biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.
關於防禦：
Defense Therapeutics是一家上市的生物技術公司，致力於使用其專有平台設計下一代疫苗和ADC產品。Defense Therapeutics 平台的核心是 ACCUM 技術，該技術可以將疫苗抗原或ADC以完整形式精確地輸送到靶細胞。因此，可以提高對抗癌症和傳染病等災難性疾病的療效和效力。
For further information:
Sebastien Plouffe, President, CEO and Director
P: (514) 947-2272
Splouffe@defencetherapeutics.com
欲了解更多信息：
塞巴斯蒂安·普勞夫，總裁、首席執行官兼董事
P: (514) 947-2272
Splouffe@defencetherapeutics.com
Cautionary Statement Regarding "Forward-Looking" Information
關於 “前瞻性” 信息的警示聲明
This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. 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 statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
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