SRD-001

Medera is a clinical-stage biotechnology company focused on targeting difficult-to-treat cardiovascular diseases using a range of next-generation gene- and cell-based approaches in combination with bioengineered human mini-heart drug discovery and screening technology platforms Transaction proceeds to accelerate three most advanced clinical programs for the adeno-associated virus (AAV)-based gene therapy candidates The combined company to have an implied initial enterprise value of approximately $622.6 million Medera's founders and key shareholders have committed approximately $22.6 million (via conversion of all shareholders loans) for this merger, with all existing Medera shareholders rolling 100% of their equity As a closing condition to the business combination, Medera shall have at least $40 million in available liquidity Anticipated closing of transaction in fourth quarter of 2024 SUMMIT, N.J. and BOSTON, Sept. 5, 2024 /PRNewswire/ -- Keen Vision Acquisition Corporation ("KVAC") (Nasdaq: KVAC, KVACW) and Medera Inc., ("Medera"), a clinical-stage biotechnology company, announced today that they have entered into a definitive merger agreement. Upon closing of the merger, which is expected to occur in the fourth quarter of 2024, the combined company is to be named Medera Inc. Company Overview Medera Inc. is a clinical-stage biopharmaceutical company, focused on targeting difficult-to-treat and currently incurable diseases by developing next-generation gene- and cell-based approaches in combination with bioengineered human-based (including the exclusively available mini-Heart®) screening technology platform for disease modeling and drug discovery. Medera operates through its two business units, Sardocor and Novoheart. Sardocor executes clinical development of novel next-generation therapies for Medera. Leveraging the Novoheart human-based drug discovery and validation platforms, as described below, Sardocor aims to expedite the drug development and regulatory timelines for its gene therapy and cell therapy pipeline. Sardocor has been granted Investigational New Drug (IND) clearances from the US Food and Drug Administration (FDA) for three ongoing adeno-associated virus (AAV)-based cardiac gene therapy clinical trials for Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) and Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM). In addition, Sardocor's pipeline also includes four preclinical gene therapy and three preclinical small molecule candidates for a range of cardiac, pulmonary and vascular diseases. Sardocor is currently focused on its three most advanced clinical programs, which are AAV-based gene therapy candidates: SRD-001 is intended to treat patients with HFrEF, a prevalent form of heart disease that accounts for half of an estimated 64.3 million heart failure cases worldwide. With an open IND clearance from the FDA, SRD-001 is being evaluated in an ongoing Phase 1/2a clinical trial (called MUSIC-HFrEF; NCT0470384). To date, six patients have been infused with SRD-001 in Cohort A (low-dose 3x1013 vg per patient) and one patient has been infused in Cohort B (high-dose 4.5x1013 vg per patient). A clinical update of this trial was featured in a late-breaking oral presentation at the American Society of Gene & Cell Therapy (ASGCT) in May 2024. Clinically meaningful improvements in multiple metrics of heart function and patient health were observed following delivery of SRD-001 (e.g., NYHA class, 6MW, LVEF and pro-BNP). Sardocor expects to complete the Phase 1/2a portion of the ongoing trial in the fourth quarter and commence an international randomized Phase 2b portion shortly after. SRD-002 is intended to treat patients with HFpEF, another prevalent form of heart failure accounting for the remaining half of all heart failure cases that currently still lack disease-modifying therapeutics. With an open IND and Fast Track Designation from the FDA, SRD-002 is being evaluated in an ongoing First-In-Human Phase 1/2a clinical trial (called MUSIC-HFpEF; NCT06061549). To date, five patients have been infused with SRD-002 in Cohort A (low-dose 3x1013 vg per patient) and Sardocor has been cleared to dose patients in Cohort B (high-dose 4.5x1013 vg per patient). Improvements in cardiovascular performance were observed in the first three patients at six months with additional data being collected. Sardocor expects to complete patient enrolment in both cohorts of the Phase 1/2a clinical trial by the end of 2024 and to provide an interim data readout in the first half of 2025. SRD-003 is intended to treat patients (aged 18 or above) with DMD-CM, for which there is still no cure. Almost all DMD patients eventually die from DMD-CM. With the FDA's IND clearance and Orphan Drug Designation, SRD-003 is currently being evaluated in an ongoing First-In-Human Phase 1/2a clinical trial (called MUSIC-DMD; NCT06224660). Sardocor expects to dose the first patient in the fourth quarter of 2024. Using its proprietary intracoronary infusion methodology, Sardocor delivers its gene therapy candidates directly via blood vessels to the cardiac ventricular muscle cells as an out-patient procedure. This minimally invasive technique allows the delivery of optimal and least amount of drug products to achieve efficient transduction and improved efficacy while avoiding side effects (such as those typically seen with systemic delivery of very large AAV doses). With its proprietary, award-winning human mini-Heart® screening technology platform, Novoheart conducts preclinical disease modelling and drug discovery for Medera, aiming to create, expand, validate, and optimize Medera's therapeutic pipeline (under Sardocor). Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. These are free from species-specific differences and in 3D configurations that accurately reflect the native human heart's physiology or pathophysiology. These properties substantially improve success rates and reduce development cost and time in accordance with the FDA Modernization Act 2.0. Global pharmaceutical and academic leaders are using Novoheart's technology platform their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development and regulatory approvals of Sardocor's lead therapeutic candidates that are currently in clinical trials. Management Comments "Medera is uniquely positioned for sustainable growth with its one-of-a-kind technology platform and a broad portfolio of clinical and preclinical candidates, three of which are leading gene therapy candidates with ongoing FDA clinical trials. In line with FDA's Modernization Act 2.0, Medera's use of its bioengineered human-based technology in drug discovery and development processes promotes more accurate drug testing and fewer animal killings, which are environmentally and socially responsible. Medera's collaboration and licensing arrangements now in place with global pharmaceutical leaders provide validation for its achievements," remarked Kenneth KC Wong, Chairman and Chief Executive Officer of KVAC. "Achieving a Nasdaq listing will allow Medera to be better positioned for advancing our various clinical and preclinical programs, enabling more efficient development aimed at bringing novel therapeutic solutions to patients with unmet needs," stated Ronald Li, PhD, Chief Executive Officer and Founder of Medera. "With this business combination, Sardocor will be well positioned to potentially expediate its three clinical trials for our lead gene therapy candidates in HFrEF, HFpEF and DMD-CM. By utilizing our intra-coronary methodology to directly deliver our gene therapy candidates into the heart, our approach has the potential to significantly lower the dosage compared other therapies that typically utilize systemic delivery. We also plan to accelerate our timetable to apply for an Investigational New Drug (IND) and the start of the Phase 1 trial for our next gene therapy candidate," said Roger Hajjar, MD, President, Chief Medical Officer and co-Founder of Medera. Transaction Overview This merger values Medera at a pre-money valuation of $622.6 million. Cash proceeds from the transactions contemplated by the merger agreement may consist of up to approximately $149.50 million of cash currently held in KVAC's trust account (before any redemptions by KVAC's stockholders). The transaction includes a management incentive plan that the parties intend to tie to the successful commercialization of the three clinical stage assets, reflecting an alignment of interest with shareholders The transaction, which has been unanimously approved by the each of the boards of directors of KVAC and Medera, is subject to, among other customary closing conditions, approval by the shareholders of KVAC and of Medera, with the holders of a majority of the votes of both companies required to approve the transaction having provided commitments to approve the transaction. The transaction is expected to close in the fourth quarter of 2024. A more detailed description of the transaction terms and a copy of the merger agreement will be included in a current report on Form 8-K to be filed by KVAC with the United States Securities and Exchange Commission (the "SEC"). A registration statement (which will contain a proxy statement/ prospectus) will be filed with the SEC in connection with the transaction. About Keen Vision Acquisition Corporation Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance ("ESG") imperatives. EF Hutton LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are serving as Capital Markets Advisors for KVAC. About Medera Inc. Medera is a clinical-stage biopharmaceutical company focused on eradicating difficult-to-treat cardiovascular diseases with significant unmet needs, using a range of next-generation gene- and cell-based approaches in combination with bioengineered human-based technology (including mini-Heart®) platform. Medera operates via two business units Sardocor and Novoheart. Forward-Looking Statements Certain statements included in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward-looking statements. In some cases, you can identify forward-looking statements by words such as "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "strategy," "future," "opportunity," "may," "target," "should," "will," "would," "will be," "will continue," "will likely result," "preliminary," or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements include, without limitation, KVAC's, Medera's, or their respective management teams' expectations concerning the outlook for their or Medera's business, productivity, plans, and goals for future operational improvements and capital investments, operational performance, future market conditions, or economic performance and developments in the capital and credit markets and expected future financial performance, including expected net proceeds, expected additional funding, the percentage of redemptions of KVAC's public shareholders, growth prospects and outlook of Medera' operations, individually or in the aggregate, including the achievement of project milestones, commencement and completion of commercial operations of certain of Medera's projects, as well as any information concerning possible or assumed future results of operations of Medera. Forward-looking statements also include statements regarding the expected benefits of the transactions contemplated by the merger ("Transaction"). The forward-looking statements are based on the current expectations of the respective management teams of Medera and KVAC, as applicable, and are inherently subject to uncertainties and changes in circumstance and their potential effects. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, (i) the risk that the Transaction may not be completed in a timely manner or at all, which may adversely affect the price of KVAC's securities; (ii) the risk that the Transaction may not be completed by KVAC's business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by KVAC; (iii) the failure to satisfy the conditions to the consummation of the Transaction, including the adoption of the Merger Agreement by the shareholders of KVAC and the receipt of certain regulatory approvals; (iv) market risks; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the effect of the announcement or pendency of the Transaction on Medera's business relationships, performance, and business generally; (vii) the outcome of any legal proceedings that may be instituted against Medera or KVAC related to the Merger Agreement or the Transaction; (viii) failure to realize the anticipated benefits of the Transaction; (ix) the inability to maintain the listing of KVAC's securities or to meet listing requirements and maintain the listing of Medera's securities on Nasdaq; (x) the inability to implement business plans, forecasts, and other expectations after the completion of the Transaction, identify and realize additional opportunities, and manage its growth and expanding operations; (xi) risks related to Medera's ability to develop, license or acquire new therapeutics; (xii) the risk that Medera will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xiii) the risk of product liability or regulatory lawsuits or proceedings relating to Medera's business; (xiv) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xv) risks related to regulatory review, and approval and commercial development; (xvi) risks associated with intellectual property protection; (xvii) Medera's limited operating history and risk that it may never successfully commercialise its products; (xviii) Medera expects to continue to incur significant losses and may never achieve or maintain profitability; and (xix) the risk that additional financing in connection with the Transaction may not be raised on favorable terms. The foregoing list is not exhaustive, and there may be additional risks that neither KVAC nor Medera presently knows or that KVAC and Medera currently believe are immaterial. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the "Risk Factors" section of KVAC's Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 29, 2024, the risks to be described in the registration statement, which will include a preliminary proxy statement/prospectus, and those discussed and identified in filings made with the SEC by KVAC from time to time. Medera and KVAC caution you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth in this press release speak only as of the date of this press release. Neither Medera nor KVAC undertakes any obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward-looking statement is updated, no inference should be made that Medera or KVAC will make additional updates with respect to that statement, related matters, or any other forward-looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward-looking statements, including discussions of significant risk factors, may appear, up to the consummation of the Transaction, in KVAC's public filings with the SEC, and which you are advised to review carefully. Important Information for Investors and Shareholders In connection with the Transaction, KVAC and Medera intend to file with the SEC a registration statement, which will include a prospectus with respect to the securities to be issued in connection with the Transaction and a proxy statement to be distributed to holders of KVAC's common shares in connection with KVAC's solicitation of proxies for the vote by KVAC's shareholders with respect to the Transaction and other matters to be described in the Registration Statement (the "Proxy Statement"). After the SEC declares the registration statement effective, KVAC plans to mail copies to shareholders of KVAC as of a record date to be established for voting on the Transaction. This press release does not contain all the information that should be considered concerning the Transaction and is not a substitute for the registration statement, Proxy Statement or for any other document that KVAC may file with the SEC. Before making any investment or voting decision, investors and security holders of KVAC are urged to read the registration statement and the Proxy Statement, and any amendments or supplements thereto, as well as all other relevant materials filed or that will be filed with the SEC in connection with the Transaction as they become available because they will contain important information about, Medera, KVAC and the Transaction. Investors and security holders will be able to obtain free copies of the registration statement, the Proxy Statement and all other relevant documents filed or that will be filed with the SEC by KVAC through the website maintained by the SEC at . In addition, the documents filed by KVAC may be obtained free of charge from KVAC's website at or by directing a request to [email protected]. The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release. Participants in the Solicitation KVAC, Medera and their respective directors, executive officers and other members of management and employees may, under the rules of the SEC, be deemed to be participants in the solicitations of proxies in connection with the Transaction. For more information about the names, affiliations and interests of KVAC's directors and executive officers, please refer to KVAC's annual report on Form 10-K filed with the SEC on March 29, 2024, which can be found at and registration statement, Proxy Statement and other relevant materials filed with the SEC in connection with the Transaction when they become available. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, which may, in some cases, be different than those of KVAC's shareholders generally, will be included in the registration statement and the Proxy Statement and other relevant materials when they are filed with the SEC when they become available. Shareholders, potential investors and other interested persons should read the registration statement and the Proxy Statement and other such documents carefully, when they become available, before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in the Transaction shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. SOURCE Keen Vision Acquisition Corporation; Medera Inc.

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Candel Therapeutics公司公布了两款治疗高级别胶质瘤的病毒免疫疗法积极早期临床数据。2. 癌症疫苗VBI-1901治疗复发性胶质母细胞瘤，患者总生存期（OS）获大幅延长。3. 在研抗体TB006在1个月的治疗后，显著降低阿尔茨海默病患者血浆的Aβ 42水平，且认知能力呈现改善趋势。药明康德内容团队整理CAN-2409：公布1期临床试验数据Candel Therapeutics公司公布了其病毒免疫疗法CAN-2409与抗病毒药物valacyclovir和PD-1抑制剂nivolumab联用，以治疗高级别胶质瘤的1期临床试验数据。CAN-2409是一种复制缺陷的腺病毒，可将单纯疱疹病毒胸苷激酶（HSV-tk）基因递送入癌细胞。HSV-tk可以将口服的valacyclovir转化为有毒的代谢物acyclovir。该候选疗法通过直接注射到肿瘤组织内，可杀死局部的肿瘤细胞，导致微环境中肿瘤特异性新抗原的释放，进而激活全身的抗肿瘤应答。此外，局部注射将免疫应答局部聚焦于肿瘤，能够最大限度地减少与全身静脉给药相关的全身毒性。此次公布的数据显示，在nivolumab治疗前给予CAN-2409+valacyclovir，能够在外周血中观察到全身免疫的激活。在MGMT启动子甲基化的患者中，接受全切除术（GTR）的患者的中位OS为30.6个月，接受次全切除术（STR）的患者的中位OS为12.6个月；在MGMT启动子非甲基化的患者中，中位OS分别为13.2个月和15.9个月。安全性方面，与标准治疗相比，在神经外科手术期间使用该联合疗法的耐受性良好，未显著增加毒性。CAN-3110：公布1期临床试验的新数据Candel Therapeutics公司公布了其工程化单纯疱疹病毒（HSV）CAN-3110在复发性高级别胶质瘤患者中的最新1期试验数据。CAN-3110是一种具有复制能力的病毒免疫治疗候选药物，旨在选择性地在过表达细胞骨架蛋白Nestin的肿瘤细胞中表达负责病毒复制的基因ICP34.5，因此不会影响邻近的正常细胞。Nestin在神经胶质瘤细胞和其他肿瘤组织中高表达，但不在健康成人的大脑中表达。此次公布的数据显示，在41例注射CAN-3110的复发性高级别胶质瘤患者中未观察到剂量限制性毒性，40例接受单次注射患者的中位OS为11.6个月，其中有1例患者实现了持续超过一年的完全缓解（CR）。相关阅读：联手Carl June团队，这家新锐要用病毒帮助CAR-T疗法攻克实体瘤VBI-1901：公布1/2a期临床试验的新数据VBI Vaccines公司公布了其癌症疫苗免疫治疗候选药物VBI-1901治疗复发性胶质母细胞瘤的早期临床数据。研究表明，在多种实体肿瘤中普遍存在CMV感染，包括胶质母细胞瘤。VBI-1901采用了VBI专有的包膜病毒样颗粒（eVLP）技术，靶向两种具有高度免疫原性的CMV抗原gB和pp65。在此次公布的以粒细胞-巨噬细胞集落刺激因子（GM-CSF）为佐剂的高剂量VBI-1901的研究组的数据中，所有7例有响应的患者均至少达到了12个月的生存期，其中2例获得了部分缓解（PR）（其中1例存活了超过32个月，目前仍在接受治疗），5例患者达到持续了一段时间的稳定疾病（SD）。此外，单药标准护理的中位OS为8个月，该疗法的中位OS达到了12.9个月。TB006：公布1b/2期临床试验数据TrueBinding公司公布了其靶向半乳糖凝集素-3（Galectin-3）的研究性单克隆抗体TB006用于治疗轻度至重度AD的早期临床结果。在临床前研究中，Galectin-3被证明可以促进Aβ和pTau蛋白的聚集。在AD体内模型研究中，TB006能够显著减少Aβ/Tau蛋白的聚集和神经炎症的发生，体现了其治疗AD的潜在作用。此次公布的数据显示，与接受安慰剂治疗的患者相比，在接受为期一个月的TB006治疗后，患者的临床痴呆评分总和（CDR-SB）有所改善（p=0.08），血浆Aβ 42的水平显著降低。安全性方面，TB006的耐受性良好，只有轻微不良事件（AE），未发现治疗相关的严重不良事件（SAE）。EDIT-101：公布1/2期临床试验的新数据Editas Medicine公司公布了其体内基因编辑疗法EDIT-101在治疗LCA10的1/2期临床试验中的新数据。先天性黑蒙（LCA）是一类遗传性视网膜退化疾病，它是遗传性儿童失明最常见的原因。LCA10是由CEP290基因突变导致的，也是LCA中最常见的类型，约占20-30%。EDIT-101将编码Cas9核酸酶变体SaCas9的基因和两个指导RNA（gRNA）装进AAV5载体中，通过视网膜下注射将基因编辑系统递送到感光细胞中。gRNA指导的基因编辑可以消除或逆转CEP290基因上的致病突变，从而改善感光细胞功能，为患者带来临床益处。此次公布的数据显示，EDIT-101在所有剂量队列中均显示出良好的安全性，14例接受治疗的受试者中有3例获得了具有临床意义的视力改善。不过，由于符合要求的受试者太少，该公司暂停了该临床试验的招募，并将继续对已接受治疗的所有患者进行长期随访。SRD-001：IND申请获得FDA许可SRD-001是由Sardocor公司开发的一种基于腺相关病毒（AAV）的基因疗法，用于治疗射血分数保留型心力衰竭（HFpEF）。研究表明，肌质网钙ATP酶泵（SERCA2a）是心室舒张过程中，细胞质中钙摄取的重要蛋白泵，其表达下调是HFpEF钙调控缺陷的主要原因。此外，SERCA2a已被证明在所有形式的心力衰竭中普遍下调。SRD-001可通过Sardocor公司专有的冠状动脉内输注系统直接递送至心室肌细胞，增加SERCA2a的蛋白表达和功能活性。在HFpEF人心脏模型中，AAV介导的SERCA2a过表达逆转了疾病表型。EVX-02：公布1/2a期临床试验的中期数据Evaxion Biotech公司公布了其基于DNA的个体化免疫疗法EVX-02联用免疫检查点抑制剂治疗黑色素瘤的早期临床数据。EVX-02的使用首先需要对肿瘤组织进行基因测序，然后利用人工智能（AI）平台筛选出有潜力的癌症靶点，再制造个体化的可递送编码新抗原肽的DNA的药物。此次公布的结果显示，EVX-02诱导的特定T细胞免疫反应强劲且持久，并且所有患者对该治疗的耐受性良好。CB-011：IND申请获得FDA许可CB-011是Caribou Biosciences公司开发的一种靶向B细胞成熟抗原（BCMA）的同种异体CAR-T细胞疗法，用于治疗多发性骨髓瘤。该疗法通过基因编辑敲除内源性B2M蛋白基因，可以消除内源性人源白细胞抗原（HLA）I类分子呈递，并减少T细胞介导的排斥反应，同时插入B2M-HLA-E融合蛋白的基因，该融合蛋白能够抑制NK细胞介导的排斥反应。Caribou表示，通过这种基因编辑方法有望减少患者的T细胞和NK细胞对细胞疗法的排斥，改善CAR-T细胞疗法抗肿瘤反应的持久性。MT-601：IND申请获得FDA许可MT-601是Marker Therapeutics公司开发的一种多肿瘤相关抗原（multiTAA）特异性T细胞产品，靶向在胰腺癌肿瘤细胞中发现的六种抗原。此次IND申请获得FDA批准后，该公司将开展MT-601与一线化疗联合，治疗局部晚期不可切除或转移性胰腺癌患者的1期临床试验。该公司的细胞治疗技术基于非工程化的肿瘤特异性T细胞的选择性扩增，这些T细胞能够识别肿瘤相关抗原，并杀死表达这些靶标的肿瘤细胞。这种T细胞组合在输注到患者体内后可以攻击多个肿瘤靶点，并激活患者的免疫系统以产生广谱抗肿瘤活性。Marker Therapeutics表示，由于这些T细胞没有进行基因工程改造，因此制造起来更容易、成本更低，毒性也更低。CC-42344：公布1期临床试验的初步数据Cocrystal Pharma公司公布了其口服抗病毒药物CC-42344治疗大流行和季节性甲型流感的1期研究的安全数据。CC-42344是一种靶向流感病毒RNA聚合酶的口服碱性蛋白2（PB2）抑制剂。该聚合酶在流感病毒的复制过程中是必需的，具有多种流感病毒株共有的几个高度保守的区域。在该1期研究的单次递增和多次递增剂量部分，所有剂量水平均显示出良好的安全性。SAR-Bombesin：IND申请获得FDA许可SAR-Bombesin是Clarity Pharmaceuticals公司开发的靶向胃泌素释放肽受体（GRPr）的放射性药物。GRPr存在于多种癌症细胞中，包括但不限于前列腺癌、乳腺癌和卵巢癌。研究表明，高达75-100%的前列腺癌中存在着GRPr，包括前列腺特异性膜抗原（PSMA）阴性的前列腺癌。SAR-Bombesin采用Clarity专有的技术，可将铜同位素安全地固定在一种笼状结构中，输送到表达GRPr的肿瘤。新闻稿指出，SAR-Bombesin不仅有为PSMA阴性的前列腺癌患者提供有价值的诊断和治疗选择的潜力，还有望为大量表达GRPr的肿瘤患者提供有价值的诊断和治疗选择。药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Evaxion announces promising results from Phase 1/2a clinical trial of personalized DNA cancer immunotherapy EVX-02. Retrieved November 17, 2022, from https://investors.evaxion-biotech.com/news-and-events/press-releases/news-details/2022/Evaxion-announces-promising-results-from-Phase-12a-clinical-trial-of-personalized-DNA-cancer-immunotherapy-EVX-02/default.aspx[2] Editas Medicine Announces Clinical Data Demonstrating Proof Of Concept Of EDIT-101 From Phase 1/2 BRILLIANCE Trial. Retrieved November 17, 2022, from https://ir.editasmedicine.com/news-releases/news-release-details/editas-medicine-announces-clinical-data-demonstrating-proof[3] VYNE Therapeutics Announces First Subjects Dosed in Phase 1a/b Clinical Trial Evaluating Pan-BET Inhibitor, VYN201, for the Treatment of Vitiligo. Retrieved November 17, 2022, from https://vynetherapeutics.com/press-releases/vyne-therapeutics-announces-first-subjects-dosed-in-phase-1a-b-clinical-trial-evaluating-pan-bet-inhibitor-vyn201-for-the-treatment-of-vitiligo/[4] ImmunoMet Therapeutics Announces First Patient Dosed in a Phase 1b Trial of IM156 in Pancreatic Cancer. Retrieved November 17, 2022, from https://www.businesswire.com/news/home/20221117005817/en/ImmunoMet-Therapeutics-Announces-First-Patient-Dosed-in-a-Phase-1b-Trial-of-IM156-in-Pancreatic-Cancer[5] Skye Bioscience Submits Investigational New Drug Application for SBI-100 Ophthalmic Emulsion to FDA. Retrieved November 17, 2022, from https://ir.skyebioscience.com/news-events/press-releases/detail/147/skye-bioscience-submits-investigational-new-drug[6] Candel Therapeutics Announces Oral Presentation of Updated Data from its Phase 1 Clinical Trial of CAN-3110 in 41 Patients with Recurrent High-Grade Glioma at the Society for Neuro-Oncology 27th Annual Meeting. Retrieved November 18, 2022, from https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-oral-presentation-updated-data-its[7] Candel Therapeutics Announces Late-Breaking Oral Presentation at SITC Annual Meeting with Data on CAN-2409 in Combination with Nivolumab in a Phase 1 Mechanistic Clinical Trial in Patients with High-Grade Glioma. Retrieved November 11, 2022, from https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-late-breaking-oral-presentation[8] Cocrystal Pharma Announces Favorable Safety Data from the Phase 1 Study with Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A. Retrieved November 17, 2022, from https://www.cocrystalpharma.com/news/press-releases/detail/164/cocrystal-pharma-announces-favorable-safety-data-from-the[9] TrueBinding Announces Results of TB006 Phase 1b/2 Placebo Controlled Proof-of-Concept Trial Showing Improvement on the Primary Cognition and Function Endpoint in Patients with Mild to Severe Alzheimer’s Disease. Retrieved November 18, 2022, from https://static1.squarespace.com/static/6118e5173909f118e816918e/t/637871ba8ec03853236e7317/1668842422452/TrueBinding-Topline-Release.pdf[10] Medera receives FDA clearance for a first-in-human gene therapy trial for heart failure with preserved ejection fraction. Retrieved November 21, 2022, from https://pipelinereview.com/index.php/2022112182097/DNA-RNA-and-Cells/Medera-receives-FDA-clearance-for-a-first-in-human-gene-therapy-trial-for-heart-failure-with-preserved-ejection-fraction.html[11] IND approval from the US FDA for theranostic SAR-Bombesin trial in prostate cancer. Retrieved November 21, 2022, from https://www.claritypharmaceuticals.com/news/combat_ind/[12] VBI Vaccines Presents Additional Phase 1/2a Data from VBI-1901 in Recurrent GBM at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting. Retrieved November 22, 2022, from https://www.vbivaccines.com/press-releases/vbi-1901-phase-1-2a-data-sno-2022/[13] MARKER THERAPEUTICS ANNOUNCES FDA CLEARANCE OF IND FOR MT-601, ITS SIX-ANTIGEN T CELL THERAPY FOR THE TREATMENT OF PANCREATIC CANCER. Retrieved November 22, 2022, from https://ir.markertherapeutics.com/news-releases/news-release-details/marker-therapeutics-announces-fda-clearance-ind-mt-601-its-six[14] Caribou Biosciences Announces FDA Clearance of IND Application for CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma. Retrieved November 21, 2022, from https://investor.cariboubio.com/news-releases/news-release-details/caribou-biosciences-announces-fda-clearance-ind-application-cb[15] TRACON Pharmaceuticals Announces Dosing Of First Patient In Phase 1/2 Trial Of YH001 In Combination With Envafolimab And Doxorubicin In Front Line Sarcoma. Retrieved November 21, 2022, from https://traconpharma.gcs-web.com/news-releases/news-release-details/tracon-pharmaceuticals-announces-dosing-first-patient-phase-12免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新