Olafertinib

WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “We’ve made significant recent progress as we seek approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (‘’cSCC’’) who are not candidates for curative surgery or curative radiation. We are pleased to have reached alignment with the U.S. Food and Drug Administration (‘‘FDA’’) on our strategy to potentially address the deficiencies identified in the complete response letter (‘‘CRL’’) received last December. Shortly thereafter, we resubmitted our Biologics License Application (“BLA”), which was accepted by the FDA for review as a complete response to the CRL. We look forward to working with the FDA in advance of the Prescription Drug User Fee Act (‘‘PDUFA’’) goal date of December 28, 2024, to potentially deliver this important therapeutic option to cutaneous squamous cell carcinoma patients and their families.” Recent Corporate Updates: Checkpoint submitted a BLA to the FDA in January 2023 seeking approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or curative radiation. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization (“CMO”) as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. In June 2024, Checkpoint reached alignment with the FDA on its BLA resubmission strategy for cosibelimab and resubmitted the BLA shortly thereafter.In July 2024, Checkpoint announced that the FDA accepted for review the resubmission of its BLA for cosibelimab as a complete response to the CRL issued in December 2023 and set a PDUFA goal date of December 28, 2024.Also in July 2024, Checkpoint announced a collaboration to explore the combined therapeutic potential of cosibelimab, its anti-PD-L1 antibody with dual mechanism of action, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.Also in July 2024, Checkpoint completed a registered direct offering priced At-the-Market under Nasdaq rules and a concurrent private placement of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $12.0 million. Financial Results: Cash Position: As of June 30, 2024, Checkpoint’s cash and cash equivalents totaled $5.0 million, compared to $11.2 million at March 31, 2024 and $4.9 million at December 31, 2023, a decrease of $6.2 million for the quarter and an increase of $0.1 million, year-to-date. After the end of the second quarter, Checkpoint raised gross proceeds of approximately $12.0 million in a registered direct offering completed in July 2024.R&D Expenses: Research and development expenses for the second quarter of 2024 were $4.5 million, compared to $13.9 million for the second quarter of 2023, a decrease of $9.4 million. Research and development expenses for the second quarter of 2024 included $0.6 million of non-cash stock expenses, compared to $0.2 million for the second quarter of 2023.G&A Expenses: General and administrative expenses for the second quarter of 2024 were $2.2 million, compared to $2.3 million for the second quarter of 2023, a decrease of $0.1 million. General and administrative expenses for the second quarter of 2024 included $0.6 million of non-cash stock expenses, compared to $0.8 million for the second quarter of 2023.Net Loss: Net loss attributable to common stockholders for the second quarter of 2024 was $6.7 million, or $0.18 per share, compared to a net loss of $16.5 million, or $1.05 per share, in the second quarter of 2023. Net loss for the second quarter of 2024 included $1.2 million of non-cash stock expenses, compared to $1.0 million for the second quarter of 2023. About Checkpoint TherapeuticsCheckpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential differentiated anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com. Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our resubmission of our BLA for cosibelimab and review thereof, our belief that the BLA resubmission potentially addresses all the issues in the CRL, our belief about the comprehensive nature of our BLA resubmission and reaching alignment with the FDA on our cosibelimab BLA resubmission strategy, our ability to work with our third-party CMO and the FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential marketing approval of cosibelimab, the adequacy of the responses to the inspection issues submitted to FDA by our third-party CMO, our projections of regulatory review timelines, the commercial potential of cosibelimab, if approved, and the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies and the dual mechanism of action of cosibelimab translating into potential enhanced efficacy. Factors that could cause our actual results to differ materially include the following: the risks and uncertainties associated with the regulatory review process; uncertainties regarding the timeline of FDA review of the resubmitted BLA; any inability to successfully work with the FDA to find a satisfactory solution to address any concerns in a timely manner or at all during the review process for the BLA, including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA; our, and our third party CMO’s, ability to adequately address the issues raised in the CRL; issues associated with any facility inspection or re-inspection of our third party CMO or otherwise during the review process for the BLA; the risk that our third-party CMO will not meet deadlines, and/or comply with applicable regulations; whether the FDA accepts the data and results as included in the BLA resubmission at levels consistent with the published results, or at all; our ability to execute a partnering or other relationship to enable the commercialization of cosibelimab, if approved, on acceptable terms, if at all; the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company Contact:Jaclyn JaffeCheckpoint Therapeutics, Inc.(781) 652-4500ir@checkpointtx.com Investor Relations Contact:Ashley R. RobinsonManaging Director, LifeSci Advisors, LLC(617) 430-7577arr@lifesciadvisors.com Media Relations Contact:Katie KennedyGregory FCA610-731-1045checkpoint@gregoryfca.com CHECKPOINT THERAPEUTICS, INC.CONDENSED BALANCE SHEETS(in thousands, except share and per share amounts)(Unaudited) June 30, 2024 December 31, 2023 ASSETS Current Assets: Cash and cash equivalents $4,951 $4,928 Prepaid expenses and other current assets 678 450 Other receivables - related party 41 - Total current assets 5,670 5,378 Total Assets $5,670 $5,378 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable and accrued expenses $18,115 $15,485 Accounts payable and accrued expenses - related party 3,179 2,815 Common stock warrant liabilities 125 125 Total current liabilities 21,419 18,425 Total Liabilities 21,419 18,425 Commitments and Contingencies Stockholders’ Equity (Deficit) Common Stock ($0.0001 par value), 175,000,000 and 80,000,000 shares authorized as of June 30, 2024 and December 31, 2023, respectively Class A common shares, 700,000 shares issued and outstanding as of June 30, 2024 and December 31, 2023 - - Common shares, 41,631,500 and 27,042,035 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 4 3 Common stock issuable, 0 and 1,492,915 shares as of June 30, 2024 and December 31, 2023, respectively - 3,419 Additional paid-in capital 316,195 297,864 Accumulated deficit (331,948) (314,333)Total Stockholders’ Equity (Deficit) (15,749) (13,047)Total Liabilities and Stockholders’ Equity (Deficit) $5,670 $5,378 CHECKPOINT THERAPEUTICS, INC.CONDENSED STATEMENTS OF OPERATIONS(in thousands, except share and per share amounts)(Unaudited) For the three months ended June 30, For the six months ended June 30, 2024 2023 2024 2023Revenue - related party $41 $31 $41 $66 Operating expenses: Research and development 4,480 13,945 12,977 29,771 General and administrative 2,234 2,281 4,685 4,573 Total operating expenses 6,714 16,226 17,662 34,344 Loss from operations (6,673) (16,195) (17,621) (34,278) Other income (expense) Interest income 3 31 7 74 (Loss) gain on common stock warrant liabilities - (357) 7,209 Foreign currency exchange loss - - (1) - Total other income (expense) 3 (326) 6 7,283 Net Loss $(6,670) $(16,521) $(17,615) $(26,995) Loss per Share: Basic and diluted net loss per common share outstanding $(0.18) $(1.05) $(0.51) $(1.97) Basic and diluted weighted average number of common shares outstanding 36,526,268 15,700,324 34,728,623 13,735,646

欢迎关注凯莱英药闻 2024年7月25日，Checkpoint Therapeutics（简称“Checkpoint”）宣布，美国食品药品监督管理局（“FDA”）已受理其为cosibelimab重新递交的生物制品许可申请（“BLA”），作为一种潜在的新疗法，用于治疗不适合进行根治性手术或根治性放疗的转移性或局部晚期皮肤鳞状细胞癌（“cSCC”）成人患者。处方药用户付费法案 (PDUFA) 目标日期为 2024 年 12 月 28 日。 早在2023 年3 月，美国FDA 曾接受过cosibelimab提交的BLA；2023 年12 月，Checkpoint宣布，FDA 已对cosibelimab用于cSCC的BLA发出完整回复函（CRL）；在CRL 中指出，拒批决定主要是因为在检查中发现了第三方合同生产组织的问题，并未对cosibelimab的临床数据包、安全性以及说明书表示任何担忧。 关于Cosibelimab Cosibelimab 是一款高亲和力、IgG1 亚型全人源细胞程序性死亡配体1（PD-L1）单抗，可直接与PD-L1 结合，进而阻断其与PD-1 以及B7.1 受体相互作用，从而消除PD-L1对抗肿瘤CD8+T 细胞的抑制作用，最终恢复细胞毒性T 细胞介导的反应。 相较目前市面上销售的细胞程序性死亡受体1（PD-1）以及PD-L1 单抗，cosibelimab不仅可通过持续的、超过99%的目标肿瘤占位率重新激活抗肿瘤免疫反应，还能通过诱导抗体依赖性细胞介导的细胞毒性作用（ADCC）以加强抗肿瘤活性，具有“同类最佳”的潜力。 该药物的上市申请主要基于一项针对转移性cSCC 患者的注册性临床试验积极数据。该试验由3个阶段组成。在第一个阶段，患者接受了长达28天的筛选。他们在第二个阶段接受治疗，治疗以28天为周期。第三个时期，即随访期，将持续或6个月;在这里，将对选定的队列进行跟踪，以收集生存数据。在试验的剂量递增部分之后，可能会招募更多的患者，以进一步评估cosibelimab在特定剂量或某些亚群中的安全性和有效性。 试验的主要终点是确认的ORR，其他终点包括确认的最佳总反应、反应持续时间(DOR)、总生存期、安全性和药代动力学。截至2023年1月，转移性cSCC的ORR为50% (95% CI: 38.5, 61.5)，局部晚期cSCC为55% (95% CI: 36.0, 72.7)。安全性数据与以前的报告一致，大多数治疗突发的不良反应(AEs)的严重程度为1级或2级。 由于其独特的作用机制和令人信服的安全性，倘若cosibelimab获批，将为目前可用疗法治疗不足的cSCC患者提供新的治疗选择，特别是对于大量患有免疫抑制疾病或自身免疫性疾病的cSCC患者。 关于皮肤鳞状细胞癌 cSCC是非黑素瘤皮肤癌中最常见的肿瘤之一，是美国第二大常见的皮肤癌类型。据皮肤癌基金会估计，每年发病患者达180 万例。大多该疾病患者可通过切除局部肿瘤达到治疗目的，但事实上，约4 万例患者会进展至晚期，预计每年1.5 万例患者因此死亡。 鳞癌的发病主要与长期紫外线累积辐射有关，其他危险因素包括病毒感染、遗传、免疫因素等。除了危及生命，由于cSCC通常发生在头部和颈部，易侵犯血管、神经以及眼睛或耳朵等重要器官，还会导致严重的并发症和外观畸形。 目前，肿瘤生物治疗主要包括靶向治疗与免疫治疗，由于疗效确切、副作用小，适合老年不能手术、转移和晚期患者。由于cSCC 具有高突变负担（Mutational burden），免疫检查点抑制剂非常适合治疗因突变产生新抗原的肿瘤。目前以靶向表皮生长因子受体（EGFR）和针对PD-1/PD-L1的抗体为代表的生物治疗在cSCC 临床应用广泛。 关于PD-1/PD-L1 PD-1/PD-L1抑制剂是免疫检查点抑制剂的代表性药物，当PD-1与PD-L1结合时，通过发生磷脂酰肌醇-3-激酶的磷酸化、蛋白激酶B的进一步激活、刺激性T细胞信号通路的活化、葡萄糖代谢以及干扰素的分泌等，导致T细胞活化的下游信号受阻，进而有效抑制T细胞的转录，最终抑制T细胞的免疫功能，在免疫应答的负性调控方面发挥着重要作用。因此，阻断PD-1/PD-L1信号通路可使T细胞活化上调，激活内源性抗肿瘤免疫反应，从而发挥对肿瘤的治疗作用。 目前，全球范围内PD-1/PD-L1药物约20余种。从销量来看，帕博利珠单抗全年营收250.11亿美元，成为新晋的全球“药王”；百济的替雷利珠单抗2023年销量为5.366亿美元（约38亿元），成为最畅销的国产PD-1；除此以外，销售额超过10亿元的还有信达生物的信迪利单抗28亿元、康方生物的卡度尼利单抗13.58亿元、复宏汉霖的斯鲁利单抗11.2亿元，此外，根据猎药人俱乐部披露，恒瑞的卡瑞利珠单抗2023年院内销售额达13.5亿元。 据弗若斯特沙利文分析，全球PD-1/PD-L1 抑制剂的市场将于2027 年达峰4050 亿元，中国2022年PD-1 总市场规模预计为193亿元，随着适应症持续拓展，PD-1/PD-L1抑制剂市场空间仍有较大的增长潜力，2030年预计将超过500亿元。 全球 PD-1/PD-L1抑制剂的市场预测 中国PD-1/PD-L1 抑制剂的市场预测 关于Checkpoint Checkpoint是一家临床阶段免疫疗法和靶向肿瘤学公司，专注于收购、开发和商业化针对实体瘤癌症患者的新型疗法。 除cosibelimab外，Checkpoint 还在评估其小分子靶向抗癌药物 olafertinib，这是一种第三代表皮生长因子受体（“EGFR”）抑制剂，可作为针对 EGFR 突变阳性非小细胞肺癌患者的潜在新疗法。 参考资料 1、公司官网 2、长城国瑞证券、上海证券 3、药智头条、澎湃新闻、猎药人俱乐部 感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下