Venetoclax

给研发管线做“减法”，正在成为很多药企研发管理中的一个高频动作。近期，又有多家药企宣布终止创新药研发。如百时美施贵宝(BMS) 放弃三年前从Orum Therapeutics收购的一款早期阶段的降解剂-抗体偶联药物(DAC)项目ORM-6151，该交易总额最高 1.8 亿美元。根据Orum在9月17日的一份文件，BMS在审阅了该资产的早期临床数据后，决定终止ORM-6151的开发。ORM-6151是一款抗CD33抗体偶联GSPT1降解剂的降解抗体偶联物(DAC)，设计思路是用 CD33 抗体把 GSPT1 降解剂送进表达 CD33 的肿瘤细胞，靠靶向蛋白降解破坏肿瘤细胞存活所需的蛋白。此前，BMS一直在开展这款药物的1期临床试验，单药或联合阿扎胞苷及维奈托克，用于治疗复发或难治性急性髓系白血病(AML)或骨髓增生异常综合征患者。此外，经诺华近日确认，公司已终止实验性药物VHB937(lifonebart)用于治疗肌萎缩侧索硬化症(ALS)的开发。据悉，诺华早在8月25日就以通报信的形式告知欧洲ALS患者组织EUpALS：该药在Ⅱ期ASTRALS研究中未达到主要终点和次要终点。资料显示，VHB937是一款靶向TREM2的单克隆抗体，机制上不直接作用于运动神经元，而是通过调节脑内小胶质细胞发挥作用。VHB937的设计思路是稳定并激活TREM2，把小胶质细胞推向更具保护性的表型，减轻神经炎症和神经退行性损伤。此前该药的Ⅰ期研究在64名健康受试者中，安全性和耐受性良好，脑脊液中sTREM2水平呈剂量依赖性升高，SPP1、sCSF1R、CCL3等促炎标志物下降。这些靶点作用和生物标志物信号能不能转化成临床获益，要看随机对照研究。ASTRALS两项终点都没达到，TREM2调控在ALS上能否带来疗效，目前没有证据。阿斯利康8月也宣布终止一项评估volrustomig联合化疗治疗转移性非小细胞肺癌的Ⅲ期临床试验。回到国内市场，近期也有多个新药被终止研发。如通化东宝近期决定终止THDBH110/THDBH110胶囊研发项目。这是一款口服小分子GLP-1受体激动剂，拟用于Ⅱ型糖尿病治疗。通化东宝表示，公司基于当前可获得的临床试验数据，并结合同类及相关机制产品研发进展和竞争环境变化，对项目进度、临床价值等进行了评估。最终，公司认为需要合理配置研发资源，聚焦优势项目，因此终止该项目的临床研究开发工作。键凯科技近期决定终止全资子公司天津键凯研发的聚乙二醇伊立替康(JK1201I)治疗广泛期小细胞肺癌的Ⅲ期临床研究开发工作。公司在公告中表示，随着小细胞肺癌领域竞争格局变化，该项目商业价值显著下降。不过公司公告也显示，终止小细胞肺癌适应症Ⅲ期临床研究开发工作后，该项目仍有其他适应症的Ⅱ期临床探索研究在进行。新药研发素有 “九死一生” 的说法，临床失败是行业常态。如今，在行业环境发生改变等背景下，药企不再一味追求管线名单上的项目数量，转而更加看重 “质”。及时终止没有前景的项目，不是研发能力的倒退，反而是成熟的研发管理能力的体现。当然，管线做减法不等于放弃创新。止损省下的资金，会流向更具备差异化、临床需求更迫切的赛道。对于整个行业而言，淘汰平庸项目，减少同质化内卷，才能让真正有价值的候选药物获得更多资源，惠及广大患者。

Newly allowed claims provide LP‑284 patent protection into 2042 for the treatment of mantle cell lymphoma and double-hit lymphoma, two blood cancers with high-unmet-needs The U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/500,032, "Method for Treating Blood Cancers," with claims directed to the use of LP‑284 (hydroxyureamethyl acylfulvene) to treat mantle cell lymphoma (MCL) and double‑hit lymphoma (DHL) Allowed claims include methods of treatment as a monotherapy and in combination with a second anti‑cancer agent — including DNA damage agents, glucocorticoids, immunomodulatory drugs (IMiDs), BCL2 inhibitors, BTK inhibitors, spironolactone, PARP inhibitors, and proteasome inhibitors Once issued, the patent is expected to extend Lantern's LP‑284 patent protection into 2042, complementing the existing composition‑of‑matter estate that provides protection into 2039 across major markets LP‑284 holds three FDA Orphan Drug Designations — in MCL, high‑grade B‑cell lymphoma (HGBL) with MYC and BCL2 rearrangements, and soft tissue sarcomas — and is being evaluated in an ongoing Phase 1 clinical trial (NCT06132503) DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), an AI‑driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/500,032, titled "Method for Treating Blood Cancers," with claims directed to the use of the company's drug candidate LP‑284 to treat patients with mantle cell lymphoma (MCL), double‑hit lymphoma (DHL), and other blood cancers. The allowed claims cover methods of treating a subject diagnosed with blood cancer by administering an effective amount of LP‑284, when the cancer is mantle cell lymphoma or double‑hit lymphoma. Additional allowed claims cover the co‑administration of LP‑284 with a second anti‑cancer agent selected from: DNA damaging agents, glucocorticoids, immunomodulatory drugs (IMiDs), BCL2 inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, spironolactone, PARP inhibitors, and proteasome inhibitors. Additional claims also cover routes of administration including intravenous and intraperitoneal delivery. A Notice of Allowance is issued after the USPTO determines that prosecution on the merits of a patent application has concluded, and the patent grants upon payment of the required issuance fee. "This Notice of Allowance marks an important step in building a durable, layered intellectual-property portfolio around LP‑284,” said Panna Sharma, President and Chief Executive Officer of Lantern Pharma. “The anticipated patent claims cover the use of LP‑284 as a monotherapy and in combination with other therapeutic agent classes for mantle cell lymphoma and double-hit lymphoma, two aggressive B-cell lymphomas with significant unmet needs globally. Together with our composition-of-matter patent estate, this patent is expected to provide LP‑284 protection into 2042 and strengthen the program’s long-term commercial potential. Advancing LP‑284 from AI-generated insights through our RADR® platform to a first-in-human clinical trial in less than three years demonstrates the potential of our precision approach to efficient, data-driven drug development for novel therapies.” Strengthening a Global LP‑284 Patent Estate The newly allowed method‑of‑treatment patent builds on Lantern's existing LP‑284 composition‑of‑matter estate, which provides protection into 2039 across major medicine markets, including the United States, European Union, Japan, China, India, Mexico, Korea, and Australia. Lantern received its first U.S. composition‑of‑matter Notice of Allowance for LP‑284 in April 2023, followed by a Certificate of Patent from the Japan Patent Office in June 2024 and a European Patent Office allowance in July 2025. Once issued, the "Method for Treating Blood Cancers" patent is expected to extend Lantern's LP‑284 protection into 2042, adding a distinct layer of method‑of‑use protection on top of the underlying composition‑of‑matter rights. Lantern intends to continue prosecuting additional patent applications directed to further indications, combination regimens, and formulations of LP‑284 to further strengthen its intellectual property portfolio. LP‑284 — An AI‑Optimized, Next‑Generation Acylfulvene for Aggressive B‑Cell Cancers LP‑284 is an investigational, next‑generation acylfulvene and the stereoisomer (enantiomer) of Lantern's drug candidate LP‑184. It was optimized using Lantern's proprietary RADR® artificial intelligence platform, which identified its synthetically lethal mechanism targeting cancer cells with DNA damage repair (DDR) deficiencies. Unlike LP‑184, whose activity depends on the enzyme PTGR1, LP‑284's cytotoxic activity is independent of PTGR1 expression, making it well suited to hematologic malignancies. LP‑284 induces DNA lesions that are primarily repaired by the transcription‑coupled nucleotide excision repair (TC‑NER) pathway, and its activity is retained in tumors deficient in ATM — a gene inactivated in an estimated 40%–50% of MCL patients — as well as regardless of TP53 mutation status or lymphoma surface antigen expression. In preclinical studies, LP‑284 has demonstrated nanomolar potency across a panel of B‑cell non‑Hodgkin's lymphoma models, with the highest potency observed in MCL cell lines, including lines resistant to standard‑of‑care agents. In data presented at the 2022 Society of Hematologic Oncology (SOHO) Annual Meeting, LP‑284 showed its lowest IC50 of 88 nM in the bortezomib‑resistant MINO MCL cell line and 193 nM in the ibrutinib/venetoclax‑resistant MAVER‑1 line, demonstrating activity even in models resistant to ibrutinib, bortezomib, venetoclax, and zanubrutinib. LP‑284 has also shown preclinical synergy with rituximab in high‑grade B‑cell lymphoma models, and combination with spironolactone enhanced sensitivity to LP‑284 by 2.4‑fold in a multiple myeloma cell line. LP‑284 holds three FDA Orphan Drug Designations: for mantle cell lymphoma (granted January 2023), for high‑grade B‑cell lymphoma with MYC and BCL2 rearrangements (granted November 2023), and for soft tissue sarcomas (granted January 2026). These represent three of the six total Orphan Drug Designations granted across Lantern's clinical pipeline. Clinical Program LP‑284 is currently being evaluated in an ongoing Phase 1a dose‑escalation clinical trial (NCT06132503) in patients with relapsed or refractory B‑cell non‑Hodgkin's lymphomas and solid tumors. In 2025, Lantern reported that a heavily pretreated 41‑year‑old patient with aggressive Grade 3 non‑germinal center B‑cell diffuse large B‑cell lymphoma (DLBCL) — who had failed three prior state‑of‑the‑art treatment regimens, including CAR‑T cell therapy and a CD3xCD20 bispecific antibody — achieved a confirmed complete metabolic response after just two 28‑day cycles of LP‑284. To date, LP‑284 has been well tolerated, with primarily Grade 1–2 adverse events reported. Market Opportunity and Unmet Need MCL and DHL are aggressive B‑cell lymphomas characterized by high relapse rates and poor prognoses. Nearly all MCL patients acquire resistance to and relapse from standard‑of‑care therapies, and patients with double‑hit lymphoma face particularly poor outcomes following relapse. Lantern estimates that LP‑284 targets a global market estimated at $4 billion annually for blood cancers, driven by the rising incidence of non‑Hodgkin's lymphoma globally, and has potential to address an estimated market that could improve outcomes for 40,000 to 80,000 blood cancer patients annually. About LP‑284 LP‑284 is an investigational next‑generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed through Lantern's RADR® AI platform, LP‑284 induces DNA lesions primarily repaired by transcription‑coupled nucleotide excision repair (TC‑NER), creating a distinct anti‑tumor profile. The compound's efficacy remains unaffected by TP53 mutation or lymphoma surface antigen expression, and preclinical studies demonstrate synergistic activity with rituximab and the ability to overcome ibrutinib resistance. LP‑284 is currently in Phase 1 evaluation (NCT06132503) and has received multiple FDA Orphan Drug Designations, including for mantle cell lymphoma, high‑grade B‑cell lymphomas, and soft tissue sarcomas. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI‑driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development. Its proprietary RADR® platform leverages machine learning and large‑scale genomic and clinical data — more than 200 billion oncology‑focused data points and a library of 200+ advanced machine learning algorithms — to identify biomarker signatures and guide the development of targeted therapies for patients with significant unmet need. Lantern's clinical‑stage pipeline includes LP-184 (zirdafulven), LP-300, and LP-284, along with Lantern’s central-nervous-system focused subsidiary, Starlight Therapeutics, and its AI subsidiary, Open Medicine AI. For more information, visit . Forward‑Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; our patents and intellectual property profile; expectations and estimates regarding patent terms and coverage relating to LP-284; our clinical development plans, expectations and estimates regarding clinical trial timing and patient enrollment; estimates regarding patient populations, potential markets and potential market sizes; and our plans to discover and develop drug candidates and to maximize their commercial potential. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “model,” “objective,” “aim,” “upcoming,” “should,” “will,” “would,” or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that a patent may not issue from an allowed application on the expected timeline or with the expected term, (iii) the risk that actual patent terms and coverage may differ from expectations, (iv) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (v) the risk that our research and the research of our collaborators may not be successful, (vi) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (vii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (viii) the risk that no drug product based on our proprietary AI platforms has received FDA marketing approval or otherwise been incorporated into a commercial product, and (ix) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at or on the SEC’s website at . Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Contacts Investor & Media Relations Email: IR@lanternpharma.com Phone: (972) 277‑1136