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Immix Biopharma Announces Dosing of First 2 Patients in Its IMX-110 + BeiGene/Novartis Anti-PD-1 Tislelizumab Phase 1b/2a Combination Clinical Trial in Patients With Advanced Cancer

Immix Biopharma Announces Dosing of First 2 Patients in Its IMX-110 + BeiGene/Novartis Anti-PD-1 Tislelizumab Phase 1b/2a Combination Clinical Trial in Patients With Advanced Cancer

Immix 生物製藥宣佈在其 IMX-110 + 貝因/諾華抗 PD-1 替來利珠單抗晚期癌症患者中的首 2 名患者給藥
GlobeNewswire ·  2023/02/07 08:06
  • IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab combination designed to enhance response to solid tumors by turning immunologically "cold" tumors "hot"
  • Initial data anticipated in 1H 2023
  • IMX-110+百濟神州/諾華抗PD-1替斯利珠單抗聯合設計,旨在通過將免疫“冷”腫瘤轉化為“熱”來增強對實體瘤的反應
  • 預計2023年上半年的初始數據

LOS ANGELES, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, today announced dosing of the first 2 patients in its IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab Combination Phase 1b/2a Clinical Trial in patients with advanced solid tumors. Initial clinical data from this combination trial is anticipated to be released on a rolling basis beginning in 1H 2023. IMX-110 + Beigene/Novartis anti-PD-1 tislelizumab combination treatment is designed to enhance response to solid tumors by turning immunologically "cold" tumors "hot". In ImmixBio prior IMX-110 + anti-PD-1 preclinical experiments, a 50% improvement (63-day median survival) was produced by IMX-110 + anti-PD-1 in a genetic (KPC) pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system, compared to a 4-drug combination of 2 chemotherapies and 2 immunotherapies (anti-PD-1/anti-CD40/nab-paclitaxel/gemcitabine) in the same genetic pancreatic cancer mouse model (42-day median survival) according to Winograd et al., 2015.

洛杉磯,2023年2月7日(環球網)--ImMix Biophma,Inc.(納斯達克代碼:IMMX),一家開創組織特異性治療(TSTx)先河的生物製藥公司TM針對腫瘤學和免疫失調疾病的Tislelizumab公司今天宣佈,其IMX-110+百濟神州/諾華抗PD-1聯合臨牀試驗中的前2名患者將在晚期實體腫瘤患者中進行1b/2a期臨牀試驗。這項聯合試驗的初步臨牀數據預計將於2023年上半年開始滾動發佈。IMX-110+百濟神州/諾華抗PD-1替斯利珠單抗聯合治療旨在通過將免疫上的“冷”腫瘤轉變為“熱”來增強對實體腫瘤的應答。根據Winograd等人2015年的研究,在ImMixBio之前的IMX-110+抗PD-1臨牀前實驗中,IMX-110+抗PD-1在遺傳性(Kpc)胰腺癌小鼠模型中產生了50%的改善(63天中位生存期),在該模型中,小鼠自身發展為胰腺癌並具有完整的免疫系統,而在相同的遺傳性胰腺癌小鼠模型中,4種藥物組合的2種化療和2種免疫療法(anti-PD-1/anti-CD40/nab-paclitaxel/gemcitabine)(42天中位生存期)。

"We are thrilled to kick-off this important milestone working with our partner BeiGene," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe the combination of IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab will have a synergistic effect that could bolster responses and expand the population of cancer patients benefiting from these therapies."

ImMixBio公司首席執行官伊利亞·拉赫曼博士説:“我們很高興能與我們的合作伙伴百濟神州一起開啟這一重要的里程碑。我們相信,IMX-110+百濟神州/諾華抗PD-1 Tislelizumab的組合將產生協同效應,可能會增強反應,並擴大從這些療法中受益的癌症患者的人數。“

About IMX-110

關於IMX-110

The U.S. Food and Drug Administration ("FDA") approved orphan drug designation ("ODD") for IMX-110 in soft tissue sarcoma. The FDA also approved Rare Pediatric Disease Designation ("RPDD") for IMX-110 for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children.  RPDD qualifies Immix Biopharma to receive fast track review, and a priority review voucher ("PRV") at the time of marketing approval of IMX-110. PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA.  IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at

美國食品和藥物管理局(FDA)批准了IMX-110治療軟組織肉瘤的孤兒藥物名稱(“ODD”)。FDA還批准了IMX-110用於治療橫紋肌肉瘤的罕見兒科疾病指定(RPDD),橫紋肌肉瘤是一種威脅兒童生命的癌症。RPDD使ImMix Biophma有資格接受快速通道審查,並在IMX-110上市批准時獲得優先審查憑證(PRV)。PRV持有者可以受益於FDA對任何疾病的新藥申請進行為期六個月的快速審查。IMX-110目前正在晚期實體腫瘤患者的1b/2a期臨牀試驗中進行評估。瞭解更多信息

About Immix Biopharma, Inc.

關於ImMix Biophma公司

Immix Biopharma, Inc. (ImmixBio™) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases. Our proprietary SMARxT Tissue-Specific™ Platform produces drug candidates that circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all 3 components of the tumor micro-environment (TME). We believe ImmixBio's TME Normalization™ technology severs the lifelines between the tumor and its metabolic and structural support. Learn more at

混合生物製藥公司(納斯達克代碼:™)是一家臨牀階段的生物製藥公司,開創了一類針對腫瘤和免疫失調疾病的新型組織特異性治療(™)藥物。我們專有的SMARxT組織特異性™平臺生產的候選藥物在血液中循環,通過腫瘤血管退出,並同時攻擊腫瘤微環境的所有三個組成部分。我們相信,ImMixBio的TME標準化™技術切斷了腫瘤與其代謝和結構支持之間的生命線。瞭解更多信息

Forward Looking Statements
This press release contains "forward-looking statements" Forward-looking statements reflect our current view about future events. When used in this press release, the words "anticipate," "believe," "estimate," "expect," "future," "intend," "plan," or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Immix Biopharma's Annual Report on Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Immix Biopharma, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

前瞻性陳述
本新聞稿包含“前瞻性陳述”,這些前瞻性陳述反映了我們對未來事件的當前看法。在本新聞稿中使用的“預期”、“相信”、“估計”、“預期”、“未來”、“打算”、“計劃”或這些術語的否定或類似表述,當它們與我們或我們的管理層有關時,都是前瞻性陳述。這些陳述包括但不限於本新聞稿中包含的與我們的業務戰略、我們未來的經營業績以及流動性和資本資源前景有關的陳述。前瞻性陳述是基於我們目前對我們的業務、經濟和其他未來狀況的預期和假設。由於前瞻性陳述涉及未來,它們受到難以預測的內在不確定性、風險和環境變化的影響。我們的實際結果可能與前瞻性陳述中預期的大不相同。它們既不是對歷史事實的陳述,也不是對未來業績的保證。因此,我們提醒您不要依賴這些前瞻性陳述中的任何一項。可能導致實際結果與前瞻性陳述中的陳述大不相同的重要因素包括但不限於我們籌集資本為持續運營提供資金的能力;我們保護我們知識產權的能力;任何針對我們的侵權訴訟或其他訴訟的影響;來自其他供應商和產品的競爭;我們開發產品和服務並將其商業化的能力;政府法規的變化;我們完成融資交易的能力;以及與我們的行業、我們的運營和運營結果相關的其他因素。實際結果可能與預期的、相信的、估計的、預期的大不相同, 預期或計劃包括:與市場狀況相關的不確定性和在ImMix Biophma截至2021年12月31日的10-K表格年度報告以及提交給美國證券交易委員會的其他定期報告中更全面地描述的其他因素。本新聞稿中包含的任何前瞻性陳述僅代表截至本新聞稿發佈之日的情況,ImMix Biophma,Inc.明確表示不承擔任何因新信息、未來事件或其他原因而更新任何前瞻性陳述的義務。

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements.

可能導致我們實際結果不同的因素或事件可能會不時出現,我們不可能預測所有這些因素或事件。我們不能保證未來的結果、活動水平、業績或成就。

Contacts
Immix Biopharma, Inc.
Gabriel Morris
Chief Financial Officer
ir@immixbio.com 
+1 (888) 958-1084

聯繫人
ImMix Biophma,Inc.
加布裏埃爾·莫里斯
首席財務官
郵箱:ir@imMixBio.com
+1 (888) 958-1084


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