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Coeptis Therapeutics President and CEO Issues Letter to Shareholders Highlighting 2023 Accomplishments and Outlook for 2024

Coeptis Therapeutics President and CEO Issues Letter to Shareholders Highlighting 2023 Accomplishments and Outlook for 2024

Coeptis Therapeutics总裁兼首席执行官致股东的信,重点介绍2023年的成就和2024年的展望
Coeptis Therapeutics ·  01/04 13:00

WEXFORD, Pa., Jan. 4, 2024 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today announced that Dave Mehalick, President and CEO of Coeptis Therapeutics Holdings, has issued a Letter to Shareholders providing a review of its 2023 achievements and anticipated milestones for 2024. The full text of the letter follows.

宾夕法尼亚州韦克斯福德,2024 年 1 月 4 日/PRNewswire/--开发癌症创新细胞疗法平台的生物制药公司Coeptis Therapeutics Holdings, Inc.(纳斯达克股票代码:COEP)(“公司” 或 “Coeptis”)今天宣布,Coeptis Therapeutics Holdings总裁兼首席执行官戴夫·梅哈利克已向股东发出一封信,回顾了其2023年取得的成就和2024年的预期里程碑。这封信的全文如下。

A MESSAGE FROM OUR PRESIDENT AND CHIEF EXECUTIVE OFFICER

来自我们总裁兼首席执行官的一封信

To my fellow shareholders,

致我的股东们,

2023 was nothing short of transformative for Coeptis with the highlight of the year being the exclusive licensing agreement with Deverra Therapeutics Inc. With this single transaction, we gained access to a proprietary allogeneic stem cell expansion and directed differentiation platform, a clinical-stage, unmodified natural killer (NK) cell therapy, DVX201, and a team of visionary scientists led by Colleen Delaney, MD, MSc, who joined Coeptis as our Chief Scientific and Medical Officer.

2023年对Coeptis来说简直是变革性的,今年的亮点是与Deverra Therapeutics Inc.签订的独家许可协议。通过这笔交易,我们获得了专有的异基因干细胞扩张和定向分化平台、临床阶段、未经改良的自然杀伤(NK)细胞疗法(DVX201)以及由科琳·德莱尼领导的富有远见的科学家团队,后者以Coeptis的身份加入 Coeptis 的医学博士、理学硕士我们的首席科学和医学官。

Since completing the agreement in August, we have been working diligently with Dr. Delaney and her team to advance the DVX201 clinical programs, while integrating SNAP-CAR, our universal, multi-antigen CAR technology that we licensed from the University of Pittsburgh into the Deverra allogeneic immune effector cell generation platform. Our strategy is to leverage these innovative and complementary platforms to develop powerful, personalized cell-based treatments to improve outcomes for patients with cancer. Importantly, these cell-based therapies are universal products enabling greater patient access to these medical breakthroughs. It is a bold vision, and I believe we now have under one roof the technological assets and scientific expertise to fully pursue the opportunity. As we look to 2024, we see enormous potential to advance our pipeline and achieve meaningful growth milestones.

自八月份完成协议以来,我们一直在努力与德莱尼博士及其团队合作,推进 DVX201 临床项目,同时将匹兹堡大学许可的通用多抗原 CAR 技术 SNAP-CAR 集成到 Deverra 异基因免疫效应器细胞生成平台中。我们的策略是利用这些创新和互补的平台来开发强大的、个性化的基于细胞的治疗方法,以改善癌症患者的预后。重要的是,这些基于细胞的疗法是通用产品,使患者有更多机会获得这些医学突破。这是一个大胆的愿景,我相信我们现在拥有技术资产和科学专长,可以充分利用这个机会。展望2024年,我们看到了推进产品线和实现有意义的增长里程碑的巨大潜力。

DVX201 – Rapidly Advancing Clinical Programs; Expected, Near-Term Milestones

DVX201 — 快速推进临床项目;预期的近期里程碑

DVX201 is a first-ever allogeneic, cord-blood derived NK cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells. This product is being investigated in two Phase 1 clinical trials for the treatment of relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with COVID-19 infection. Interim data from both trials involving 17 patients and 25 infusions of DVX201 indicated that the NK cell therapy is well-tolerated with no dose limiting toxicities (DLTs), and with no cytokine release syndrome (CRS) or infusion toxicities observed thus far through the highest dose level.

DVX201 是有史以来第一种异体、脐带血衍生的 NK 细胞疗法,由捐赠者 CD34+ 造血干细胞和祖细胞 (HSPC) 细胞合成而成。该产品正在两项用于治疗复发/难治性急性髓系白血病 (AML) 或高风险骨髓增生异常综合征 (MDS) 和因 COVID-19 感染住院的患者的 1 期临床试验中进行研究。这两项试验涉及 17 名患者和 25 次 DVX201 输注的中期数据表明,NK 细胞疗法耐受性良好,没有剂量限制毒性 (DLT),并且迄今为止在最高剂量水平下未观察到细胞因子释放综合征 (CRS) 或输液毒性。

Drilling down further, the Phase 1 clinical trial investigating DVX201 in patients with hospitalized COVID-19 infection completed the three dosing cohorts, enrolling a total of nine patients each receiving a single infusion. DVX201 was tolerated at all dosing levels, an important observation for this first-in-human allogeneic cell therapy derived from pooled donor manufacturing. Based on these favorable results, Coeptis plans to pursue a Phase 2 clinical program investigating DVX201 as an anti-viral therapy in high-risk patients hospitalized with viral respiratory infections, allowing us to expand beyond COVID-19 related infection and into a substantially larger patient population.

进一步深入研究,在住院的 COVID-19 感染患者中调查 DVX201 的 1 期临床试验完成了三个给药队列,共招收了九名患者,每人接受一次输液。DVX201 在所有剂量水平上均可耐受,这是这种首次源自联合供体制造的人体异体细胞疗法的重要观察结果。基于这些良好的结果,Coeptis 计划开展一项二期临床项目,研究 DVX201 作为一种抗病毒疗法,用于治疗因病毒性呼吸道感染住院的高危患者,这使我们能够将业务扩展到与 COVID-19 相关的感染以外,扩大到更大的患者群体。

Meanwhile, the Phase 1 trial investigating DVX201 in relapsed/refractory AML or high-risk MDS has now safely dosed a total of eight subjects each receiving two infusions. The trial is expected to enroll two additional patients who will be infused at the highest dosing level, with completion of dosing expected to occur in Q1 2024. This timeline is also expected to enable us to report topline safety and efficacy data from the full patient population in the first half of 2024.

同时,调查复发/难治性 AML 或高风险 MDS 中的 DVX201 的第 1 期试验现已安全地给药了总共八名受试者,每人接受两次输液。该试验预计将再招收两名患者,他们将以最高剂量进行注射,预计将于2024年第一季度完成给药。预计该时间表还将使我们能够在2024年上半年报告来自全体患者群体的头号安全性和有效性数据。

An Emerging Leader in Natural Killer Cell Therapy

自然杀伤细胞疗法的新兴领导者

Our DVX201 programs represent an important value driver for Coeptis, but we believe they are the tip of the iceberg considering our expectations regarding the greater potential of our assembled technologies. The assets from Deverra along with SNAP-CAR out of the University of Pittsburgh and the GEAR platform developed at the Karolinska Institute provide Coeptis with a foundation for us to pursue one of our primary goals, which is to change the paradigm of how engineered allogeneic NK and other immune effector cell therapies are developed and administered.

我们的 DVX201 计划是 Coeptis 的重要价值驱动力,但考虑到我们对组装技术的更大潜力的期望,我们认为它们只是冰山一角。来自Deverra的资产以及匹兹堡大学的SNAP-CAR以及卡罗林斯卡研究所开发的GEAR平台为我们实现我们的主要目标之一奠定了基础,即改变工程异体NK和其他免疫效应细胞疗法的开发和管理模式。

CAR-T cell therapies have been transformative and curative for some, however challenges with starting material, costs and accessibility continue to persist. NK cell therapies, on the other hand, offer several key advantages compared to CAR-T. For example, NK cells have been shown to be able to target cancer through multiple broadly expressed activating ligands and can be used allogeneically without the risk of graft versus host disease (GVHD) and cytokine release syndrome (CRS) that is associated with T cell therapies.

对于某些人来说,CAR-T细胞疗法具有变革性和治疗作用,但在起始材料、成本和可及性方面的挑战仍然存在。另一方面,与CAR-T相比,NK细胞疗法具有多个关键优势。例如,NK细胞已被证明能够通过多种广泛表达的激活配体靶向癌症,并且可以异基因使用,没有与T细胞疗法相关的移植物抗宿主病(GVHD)和细胞因子释放综合征(CRS)的风险。

Coeptis sees significant potential to integrate our technology platforms to develop next-generation therapies for cancer. The team at Deverra has pioneered advances in donor selection and manufacturing approaches, including pooled donor approaches, that have made it possible to generate significant numbers of unmodified NK cells reproducibly and at scale with minimal lot to lot variability and with low cost of goods, addressing major hurdles in the allogeneic cell therapy development space. These generated unmodified NK cells can also be engineered to vastly enhance the accessibility, versatility and potential enhanced efficacy of NK cell derived therapies for a host of cancers and infectious diseases.

Coeptis看到了整合我们的技术平台以开发下一代癌症疗法的巨大潜力。Deverra的团队在捐赠者选择和制造方法(包括联合供体方法)方面取得了开创性进展,这些方法使批次间差异最小、商品成本低廉的可重复性和大规模生成大量未经修饰的NK细胞成为可能,解决了异体细胞疗法开发领域的主要障碍。这些生成的未经修饰的NK细胞也可以进行改造,以极大地提高NK细胞衍生疗法对许多癌症和传染病的可及性、多功能性和潜在的增强疗效。

Research is underway at Coeptis to bring together Deverra's novel stem cell expansion and differentiation technology, which we have accessed through our exclusive license deal with Deverra, with our existing SNAP-CAR and GEAR technologies. Importantly, in October 2023 and with this strategy in mind, we expanded our licensing agreement with the University of Pittsburgh to include SNAP-CAR NK, adding a third NK-focused technology to Coeptis' development portfolio.

Coeptis正在进行研究,旨在将Deverra的新型干细胞扩张和分化技术(我们通过与Deverra的独家许可协议获得该技术)与我们现有的SNAP-CAR和GEAR技术相结合。重要的是,在2023年10月,考虑到这一战略,我们扩大了与匹兹堡大学的许可协议,将SNAP-CAR NK纳入其中,在Coeptis的开发组合中增加了第三项以NK为重点的技术。

SNAP-CAR, combined with Deverra's proprietary allogeneic stem cell expansion and differentiation platform for the generation of NK cells from pooled donor cord blood CD34+ cells, has us focused on continued development efforts towards a first-in-class fully universal (no HLA matching and antigen agnostic) targeted cell therapy. Our vision is that the combination of technologies offers Coeptis the opportunity to develop cell therapies that can be engineered with off-the-shelf convenience and can target multiple antigens simultaneously while also offering greater control over toxicity.

SNAP-CAR与Deverra专有的异基因干细胞扩增和分化平台相结合,该平台用于从集合的供体脐带血CD34+细胞中生成NK细胞,使我们专注于继续开发同类首创的完全通用(无HLA匹配且与抗原无关)的靶向细胞疗法。我们的愿景是,这些技术的结合为Coeptis提供了开发细胞疗法的机会,这些疗法可以在现成的便利条件下进行设计,可以同时靶向多种抗原,同时还能更好地控制毒性。

In what I believe to be an extremely informative and visionary talk, Dr. Delaney previewed this vision at the 2023 Cell & Gene Meeting on the Mesa, which is one of the most prestigious conferences in cell therapy industry. I encourage all shareholders to view this video. Interest during her presentation and in one-on-one meetings was exceptionally strong, and we are eager to build on the momentum in 2024.

在我认为这是一次内容非常丰富和富有远见的演讲中,德莱尼博士 在 2023 年梅萨细胞与基因会议上预览了这一愿景,这是细胞疗法行业最负盛名的会议之一。我鼓励所有股东观看此视频。在她的演讲和一对一会议期间,人们的兴趣异常强烈,我们渴望在2024年的势头基础上再接再厉。

For our shareholders...
This is a very exciting time in the growth and evolution of Coeptis Therapeutics, and we are working diligently to advance our assets to become a leader in the development of next-generation cell therapy technologies for cancer and infectious diseases. I would like to thank our employees for their dedication and loyalty, and our shareholders for their ongoing support as we pursue our vision to become a leader in the cell therapy industry.

对于我们的股东来说...
这是Coeptis Therapeutics发展和演变中一个非常激动人心的时刻,我们正在努力扩大我们的资产,以成为下一代癌症和传染病细胞疗法技术开发的领导者。我要感谢我们的员工的奉献精神和忠诚度,也感谢我们的股东在我们追求成为细胞疗法行业领导者的愿景时所给予的持续支持。

On behalf of the entire Coeptis team, I wish you all a happy and healthy 2024.

我代表整个Coeptis团队,祝大家2024年快乐、健康。

Best Regards,

最诚挚的问候,

Dave Mehalick
President and CEO
Coeptis Therapeutics Holdings, Inc.

戴夫·梅哈里克
总裁兼首席执行官
Coeptis Therapeutics 控股有限公司

About Coeptis Therapeutics Holdings, Inc.

关于 Coeptis Therapeutics Holdings

Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively "Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer and infectious diseases that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by assets licensed from Deverra Therapeutics, including an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage, unmodified natural killer cell therapy technology. Additionally, Coeptis is developing a universal, multi-antigen CAR T technology licensed from the University of Pittsburgh (SNAP-CAR), and the GEAR cell therapy and companion diagnostic platforms, which Coeptis is developing with VyGen-Bio and leading medical researchers at the Karolinska Institutet. Coeptis' business model is designed around maximizing the value of its current product portfolio and rights through in-license agreements, out-license agreements and co-development relationships, as well as entering into strategic partnerships to expand its product rights and offerings, specifically those targeting cancer. The Company is headquartered in Wexford, PA. For more information on Coeptis visit https://coeptistx.com/.

Coeptis Therapeutics Holdings, Inc. 及其子公司,包括Coeptis Therapeutics, Inc.和Coeptis Pharmicals, Inc.(统称 “Coeptis”),是一家生物制药公司,为癌症和传染病开发创新的细胞治疗平台,这些平台有可能颠覆传统治疗模式并改善患者预后。Coeptis的产品组合和权利以Deverra Therapeutics许可的资产为重点,包括异基因细胞免疫疗法平台和临床阶段、未经修改的自然杀伤细胞疗法技术 DVX201。此外,Coeptis正在开发一种获得匹兹堡大学(SNAP-CAR)许可的通用多抗原CAR T技术,以及GEAR细胞疗法和伴随诊断平台,Coeptis正在与Vygen-bio和卡罗林斯卡研究所的领先医学研究人员共同开发该平台。Coeptis的商业模式旨在通过许可协议、外包许可协议和共同开发关系最大化其当前产品组合和权利的价值,以及建立战略合作伙伴关系以扩大其产品权利和供应,特别是针对癌症的产品权利和供应。该公司总部位于宾夕法尼亚州韦克斯福德。有关 Coeptis 的更多信息,请访问 https://coeptistx.com/

Cautionary Note Regarding Forward-Looking Statements
This press release and statements of our management made in connection therewith contain or may contain "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). Forward-looking statements include statements concerning our plans, objectives, goals, strategies, future events or performance, and underlying assumptions, and other statements that are other than statements of historical facts. When we use words such as "may," "will," "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, we are making forward-looking statements. Forward-looking statements are not a guarantee of future performance and involve significant risks and uncertainties that may cause the actual results to differ materially and perhaps substantially from our expectations discussed in the forward-looking statements. Factors that may cause such differences include but are not limited to: (1) the inability to maintain the listing of the Company's securities on the Nasdaq Capital Market; (2) the risk that the integration of the Deverra licensed assets will disrupt current plans and operations of the Company; (3) the inability to recognize the anticipated benefits of the newly-licensed assets, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth economically and hire and retain key employees; (4) the risks that the Company's products in development or the newly-licensed assets fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable regulatory authorities; (5) costs related to integrating the newly-licensed Deverra assets and pursuing the contemplated asset development paths; (6) changes in applicable laws or regulations; (7) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (8) the impact of the global COVID-19 pandemic on any of the foregoing risks and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission (the "SEC"). The foregoing list of factors is not exclusive. All forward-looking statements are subject to significant uncertainties and risks including, but not limited, to those risks contained or to be contained in reports and other filings filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings made or to be made with the SEC, which are available for review at www.sec.gov. We undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof unless required by applicable laws, regulations, or rules.

关于前瞻性陈述的警示说明
本新闻稿和我们管理层就此发表的声明包含或可能包含 “前瞻性陈述”(定义见经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条)。前瞻性陈述包括有关我们的计划、目标、目标、战略、未来事件或业绩以及基本假设的陈述,以及除历史事实陈述以外的其他陈述。当我们使用诸如 “可能”、“将”、“打算”、“应该”、“相信”、“期望”、“预测”、“项目”、“估计” 等不仅仅与历史问题相关的词语时,我们是在做出前瞻性陈述。前瞻性陈述并不能保证未来的表现,涉及重大的风险和不确定性,可能导致实际业绩与我们在前瞻性陈述中讨论的预期存在重大差异,甚至可能存在实质性差异。可能导致这种差异的因素包括但不限于:(1)无法维持公司证券在纳斯达克资本市场的上市;(2)德维拉持牌资产的整合将扰乱公司当前计划和运营的风险;(3)无法确认新许可资产的预期收益,这些收益可能会受到竞争、公司增长和增长能力等因素的影响经济地管理增长,雇用和留住关键员工;(4)存在的风险公司正在开发的产品或新获得许可的资产未通过临床试验或未获得美国食品药品监督管理局或其他适用监管机构的批准;(5)与整合新获得许可的Deverra资产和走上预期的资产开发道路相关的成本;(6)适用法律或法规的变化;(7)公司可能受到其他经济、商业和/或竞争因素不利影响的可能性;以及(8)的影响由于上述任何风险和其他风险而导致的全球 COVID-19 疫情公司向美国证券交易委员会(“SEC”)提交的文件中确定的风险和不确定性。上述因素清单并不是排他性的。所有前瞻性陈述都存在重大的不确定性和风险,包括但不限于公司向美国证券交易委员会提交的报告和其他文件中包含或将包含的风险。出于这些原因,除其他外,提醒投资者不要过分依赖本新闻稿中的任何前瞻性陈述。公司向美国证券交易委员会提交或将要提交的文件中讨论了其他因素,这些文件可在以下网址进行审查 www.sec.gov。除非适用的法律、法规或规则要求,否则我们没有义务公开修改这些前瞻性陈述以反映本陈述发布之日之后发生的事件或情况。

CONTACTS

联系人

Coeptis Therapeutics, Inc.
Andy Galy, Sr. VP of Communications
andy.galy@coeptistx.com

Coeptis Therapeutics, Inc
Andy Galy,高级传播副总裁
andy.galy@coeptistx.com

Media
David Schemelia
dschemelia@tiberend.com

媒体
大卫·谢梅利亚
dschemelia@tiberend.com

SOURCE Coeptis Therapeutics, Inc.

来源 Coeptis Therapeutics, Inc.

译文内容由第三方软件翻译。


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