APG-777

Phase 2 APEX trial of APG777 in atopic dermatitis advancing with interim Part A 16-week data expected in mid-2025 and Part B actively enrolling First patient dosed in Phase 1b trial of APG777 in mild-to-moderate asthma with readout expected in 1H 2026 APG279 on track to initiate Phase 1b head-to-head trial vs DUPIXENT in 2025 with readout expected in 2H 2026 Positive interim Phase 1b readout of APG808 in patients with mild-to-moderate asthma demonstrated rapid, robust and sustained suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma $681.4 million cash, cash equivalents and marketable securities supports runway into Q1 2028 SAN FRANCISCO and WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today provided business updates, pipeline progress and reported first quarter 2025 financial results. “2025 is poised to be a transformational year for Apogee, and we are pleased with the strong execution in the first quarter as we continue to advance therapies with the goal of reshaping the standard of care for patients living with I&I diseases,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We have made significant progress in our Phase 2 APEX trial of APG777, which is actively enrolling Part B and on track for the interim 16-week readout from Part A mid-year. Momentum continues across our programs, driven by the initiation of our Phase 1b trial of APG777 in patients with mild-to-moderate asthma, today’s announcement of positive interim clinical trial results from our Phase 1b trial of APG808 in patients with mild-to-moderate asthma, as well as the positive Phase 1 interim readout for APG990, which exceeded all trial objectives and unlocked the potential for dosing APG279 (APG777 + APG990) two- to four- times per year with a single 2 mL co-formulated injection. Following these encouraging results from APG990, we are advancing our first-in-class combination strategy with plans to initiate a head-to-head Phase 1b study of APG279 versus DUPIXENT in AD later this year. With a very strong cash position and multiple catalysts across our portfolio in the months ahead, we are looking forward to an exciting and productive 2025 and 2026.” New independent market research reinforces APG777's potential to become a market leader in the rapidly expanding AD biologic space:Apogee conducted third-party quantitative market research in April 2025 and asked US patients and physicians the likelihood that they would switch to APG777 from their current or previous biologic assuming APG777 had similar efficacy and overall results to DUPIXENT and an every 3-month, or quarterly, injection maintenance schedule. Responses demonstrated that APG777 was highly preferred over current biologic options by patients and physicians 96% of patients currently on a biologic, both controlled and inadequately controlled, would likely switch to APG777.80% of physicians would likely start their biologic naive patients on APG777, while 83% of physicians would likely switch inadequately controlled biologic patients to APG777.67% of physicians are open to switching their controlled patients to a quarterly dose of APG777. Compared to a hypothetical daily oral with equivalent efficacy and safety, patients and providers prefer APG777’s quarterly dosing profile: Patients prefer the APG777 profile by more than 3 to 1.Providers prefer the APG777 profile by nearly 4 to 1. “Based on the recent market research we commissioned, APG777’s potential quarterly dosing is highly preferred by both physicians and patients to other available options. Physicians expressed strong interest in both initiating new-to-biologic patients to APG777 as well as switching patients already on biologics to APG777, assuming comparable efficacy and safety to current biologics,” said Jeff Hartness, Chief Commercial Officer of Apogee. “The AD biologic market is expanding rapidly—with year-to-date growth of 23% in total prescriptions and 44% in new-to-brand prescriptions—and new entrants are accelerating the shift from topicals to biologics. We believe APG777 is well positioned to transform the AD treatment landscape and significantly improve the quality of life for patients living with moderate-to-severe AD.” Pipeline Highlights and Upcoming Milestones Apogee continues to execute APG777 monotherapy program in AD and expansion indications: APG777 is a novel, subcutaneous (SQ), extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. The Phase 2 APEX clinical trial of APG777 is progressing, with Part A fully enrolled and Part B actively enrolling patients with moderate-to-severe AD. The company expects to report 16-week topline data from Part A of the trial in mid-2025 and from Part B in the second half of 2026.Apogee today announced that the first patient has been dosed in a Phase 1b trial of APG777 in patients with mild-to-moderate asthma. The primary endpoint of the trial is safety and tolerability, with secondary endpoints exploring pharmacokinetics (PK), FeNO suppression of APG777, with readout expected in the first half of 2026.The company also plans to initiate a Phase 2 trial in EoE in 2026. APG279 (APG777 + APG990) Phase 1b head-to-head study against DUPIXENT on track to initiate in 2025: APG990 is a novel, SQ, extended half-life mAb targeting OX40L, and the combination with APG777 offers the potential for improved clinical responses over monotherapy across a variety of I&I diseases while Apogee’s approach of co-formulating two extended half-life mAbs provides the potential for first-in-class and best-in-class dosing. In March 2025, Apogee reported positive APG990 Phase 1 interim results in healthy volunteers, unlocking potential maintenance dosing every three and six months for APG279 (APG777 + APG990)Apogee plans to initiate its first-in-class combination trial, a Phase 1b trial designed to evaluate the safety, PK, pharmacodynamics and efficacy of APG279 against DUPIXENT in patients with moderate-to-severe AD this year, with an interim readout expected in the second half of 2026. Progress continues in our combination approach of APG777 + APG333: APG333 is a novel, SQ, extended half-life mAb targeting thymic stromal lymphopoietin (TSLP), a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the second half of 2025. Positive interim data for APG808 Phase 1b trial in asthma reported: APG808 is a novel, SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. In preclinical studies, APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to DUPIXENT and has demonstrated similar inhibition to DUPIXENT. Today, the company reported positive interim results of the Phase 1b trial of APG808 in patients with mild-to-moderate asthma. The results demonstrated that APG808 was well-tolerated, with multiple doses of APG808 resulting in rapid suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma, with a maximal robust FeNO decrease from baseline of 53% and sustained FeNO decrease from baseline of 50% at 12 weeks.APG808’s optimized PK profile coupled with FeNO suppression out to 12-weeks reinforce the potential for 2-months or longer maintenance dosing, offering a significant advantage compared to the current bi-weekly standard of care. First Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $681.4 million as of March 31, 2025, compared to $731.1 million as of December 31, 2024. Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028.R&D Expenses: Research and development (R&D) expenses were $46.4 million for the quarter ended March 31, 2025, compared to $28.7 million for the quarter ended March 31, 2024. R&D expenses increased primarily due to the advancement of the pipeline and continued development of the company’s programs, and increases in personnel-related expenses and equity-based compensation, associated with the growth in the company's R&D team.G&A Expenses: General and administrative (G&A) expenses were $16.7 million for the quarter ended March 31, 2025, compared to $9.5 million for the quarter ended March 31, 2024. G&A expenses increased primarily due to increases in personnel-related expenses and equity-based compensation, primarily driven by increased headcount and an increase in the fair value of equity awards granted. These increases are the result of the company’s expansion of operations to support the growth in its business.Net Loss: Net loss was $55.3 million for the quarter ended March 31, 2025, compared to a net loss of $32.1 million for the quarter ended March 31, 2024. Net loss increased primarily as a result of higher R&D and G&A expenses as described above, partially offset by higher interest income. About ApogeeApogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; the anticipated timing of the initiation of its clinical trials, including the Phase 1b trial of APG279 (the combination of APG777 and APG990) in AD, the Phase 2 trial of APG777 in EoE, and the Phase 1 trial of APG333 in healthy volunteers; the expected timing of and results from its clinical trials, including data from Part A and Part B of its Phase 2 trial of APG777 in AD, Phase 1b trial of APG279 in AD, Phase 1 trial of APG333 in healthy volunteers, Phase 1b trial of APG777 in asthma; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of APG777, APG279, APG990, APG333, APG808, Apogee’s other product candidates, including combination therapies, and any other potential programs; its planned business strategies; its expected timing for future pipeline updates; and its expectations regarding the time period over which Apogee’s capital resources will be sufficient to funds its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. APOGEE THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)(In thousands, except share data) MARCH 31,2025 DECEMBER 31,2024 Assets Current assets: Cash and cash equivalents $106,916 $141,789 Marketable securities 406,413 378,864 Prepaid expenses and other current assets 8,202 9,060 Total current assets 521,531 529,713 Long-term marketable securities 168,106 210,416 Property and equipment, net 5,679 1,959 Right-of-use asset, net 11,507 11,365 Other non-current assets 7,339 498 Total assets $714,162 $753,951 Liabilities and stockholders' equity Current liabilities: Accounts payable $2,445 $1,071 Lease liability 3,976 3,234 Accrued expenses and other current liabilities 26,539 24,255 Total current liabilities 32,960 28,560 Long-term liabilities: Lease liability, net of current 7,840 8,597 Total liabilities 40,800 37,157 Stockholders' equity: Common Stock; $0.00001 par value, 400,000,000 authorized, 59,526,170 issued and 58,304,801 outstanding as of March 31, 2025; 400,000,000 authorized, 59,478,725 issued and 58,062,898 outstanding as of December 31, 2024 1 1 Additional paid-in capital 1,033,542 1,021,794 Accumulated other comprehensive income 1,074 915 Accumulated deficit (361,255) (305,916)Total stockholders’ equity 673,362 716,794 Total liabilities and stockholders’ equity $714,162 $753,951 APOGEE THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)(In thousands) THREE MONTHS ENDED MARCH 31, 2025 2024 Operating expenses: Research and development $46,387 $28,716 General and administrative 16,709 9,465 Total operating expenses 63,096 38,181 Loss from operations (63,096 ) (38,181)Other income, net: Interest income, net 7,840 6,087 Total other income, net 7,840 6,087 Net loss before taxes (55,256) (32,094)Provision for income taxes (83) — Net loss after taxes $(55,339 ) $(32,094) Investor Contact:Noel KurdiVP, Investor RelationsApogee Therapeutics, Inc.Noel.Kurdi@apogeetherapeutics.com Media Contact:Dan Budwick1AB Mediadan@1abmedia.com

▎药明康德内容团队编辑 本期看点 1. 小分子蛋白降解剂BHV-1300的1期临床试验结果积极，目标IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。 2. 创新生物混合器官Cell Pouch获批一项新的IND申请，它与自体甲状腺细胞疗法相结合，旨在恢复自然的甲状腺功能，使患者无需使用甲状腺激素替代药物或免疫抑制疗法。 3. 巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎，在一项1/2期临床试验中使患者报告的疼痛平均减少47.0%，关节功能改善46%。 药明康德内容团队整理 BHV-1300：公布1期临床试验的新数据 Biohaven公司公布了其皮下给药的在研小分子蛋白降解剂BHV-1300的1期临床试验的新结果。BHV-1300在选择性清除目标IgG（IgG1、IgG2和IgG4）方面具有独特优势，同时保留IgG3水平。IgG3在对抗细菌、寄生虫和病毒中发挥关键作用。BHV-1300的设计目标是避免与其他IgG降低方法相关的广泛免疫抑制，同时在治疗自身免疫性疾病的过程中允许免疫系统对潜在感染做出反应。 在为期四周的1期研究中，每周皮下注射1000 mg剂量的BHV-1300可使总IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。在每次给药后的数小时内，患者的IgG就会逐渐降低，并且与基线值相比，在四周内持续降低。BHV-1300在高达2000 mg的皮下给药剂量下安全性和耐受性良好。大多数不良事件轻微，可自行消退，没有因与研究药物相关的不良事件而停药，也没有严重的不良事件。 ▲BHV-1300的作用方式和1期临床试验结果（图片来源：参考资料[7]） Cell Pouch：IND申请获得FDA许可 Sernova Biotherapeutics公司宣布，美国FDA已批准其IND申请，允许在因结节性甲状腺疾病接受甲状腺手术的患者中评估Cell Pouch与自体移植甲状腺细胞的联合疗法。Sernova公司的Cell Pouch是一种创新的生物混合器官，由非生物材料与活体组织结合而成，旨在恢复或增强受损器官的功能。Cell Pouch与自体甲状腺细胞疗法相结合，旨在通过提供一种稳定、长期的生理解决方案，恢复自然甲状腺功能，而无需使用甲状腺激素替代药物或免疫抑制疗法。 临床前研究表明，在没有免疫抑制的情况下，将甲状腺组织重新植入预先血管化的Cell Pouch中，成功地将两种主要的甲状腺激素——甲状腺素（T4）和三碘甲状腺原氨酸（T3）恢复到甲状腺切除术前水平，而无需激素补充。放射性同位素成像和组织学分析证实，植入后5个月内Cell Pouch内存在健康、功能性的甲状腺组织。 Allocetra：公布1/2期临床试验的中期数据 Enlivex Therapeutics公司公布了其巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎的1/2期临床试验的中期数据。败血症、骨关节炎、银屑病关节炎等疾病会使巨噬细胞失去平衡状态。这些非稳态巨噬细胞在很大程度上导致了相应疾病的严重性。Allocetra是一种通用、现货型细胞疗法，通过对巨噬细胞进行重编程，旨在恢复其稳态（homeostasis），进而治疗疾病。Allocetra提供创新的免疫调节机制，具潜力作为单药或组合疗法治疗这些具未竟医疗需求的疾病。 此次公布的结果显示，治疗后第6个月，患者报告的疼痛平均显著减少了47.0%（P=0.0001），关节功能改善了46%。此外，83%接受治疗的患者在6个月时仍被认为对治疗有应答。这表明Allocetra作为骨关节炎的潜在突破性治疗方法，具有良好的持久性和持续疗效。安全性方面，没有报告严重的不良事件。 PER-001：公布1/2a期临床试验数据 Perfuse Therapeutics公司公布了其玻璃体内植入疗法PER-001在青光眼患者中的首次人体1/2a期试验的24周数据。PER-001是一种新型的小分子长效内皮素受体拮抗剂。内皮素是人体内最强的血管收缩剂，在青光眼中上调，并通过其在视网膜血管和神经视网膜细胞中的受体参与炎症和细胞死亡。PER-001是一种生物可降解的植入疗法，通过一次性25号注射器注入眼球玻璃体腔中。该疗法被设计为每6个月给药一次，能够持续释放药物。 24周的数据表明，PER-001具有良好的耐受性，仅有一例药物相关不良事件（轻微且短暂的玻璃体飞蚊症），没有严重药物相关不良事件或眼内炎症报告。接受PER-001治疗的患者从第1周开始，视神经头血流量较基线平均增加了至少10%，并持续至第24周。第24周时，光学相干断层扫描（OCT）显示，PER-001治疗组患者的视野平均偏差改善了1 dB/年，视网膜神经纤维层厚度平均增加了3微米。相比之下，假手术对照组患者的视野平均偏差下降了0.63 dB/年，OCT视网膜神经纤维层厚度减少了1.3微米。这些结果表明，PER-001在青光眼患者中不仅安全性良好，还显示出显著的功能和结构改善，为其作为青光眼治疗的潜在疗法提供了概念验证。 RPESC-RPE-4W：公布1/2a期临床试验数据 Luxa Biotechnology公司公布了一项1/2a期临床试验的数据，该试验评估了其专有的视网膜色素上皮（RPE）细胞疗法RPESC-RPE-4W在干性年龄相关性黄斑变性（AMD）患者中的应用。RPESC-RPE-4W是一种基于成人RPE干细胞的疗法，旨在通过替换受损的RPE细胞来恢复视力功能。干性AMD是一种导致中心视力模糊或丧失的退行性眼病，目前尚无有效治疗方法。 在1/2a期试验的最低剂量组中，6名干性AMD患者被分为视力较差组和视力较好组。视力较差组的3名患者在12个月的随访中，平均在ETDRS视力表上获得了21.67个字母的改善，视力较好组的3名患者在3个月时，平均改善了3.3个字母。 VXA-G1.1-NN：公布1b期临床试验数据 Vaxart公司宣布，其第一代口服诺如病毒候选疫苗VXA-G1.1-NN在老年人群（55-80岁）中的1b期临床试验完整数据已发表在学术期刊Science Translational Medicine上。VXA-G1.1-NN是一种口服疫苗片剂，将表达诺如病毒GI.1主要衣壳蛋白VP1的非复制性腺病毒载体递送到小肠，旨在预防由诺如病毒引起的急性胃肠炎。 该试验评估了VXA-G1.1-NN在55-65岁和66-80岁两个健康老年人群中的安全性和免疫原性。受试者以2：1的比例随机接受疫苗或安慰剂，并在第28天进行加强接种。63名志愿者完成了研究，安全性及免疫原性评估持续至第390天。免疫原性结果显示，与安慰剂相比，疫苗在所有三个剂量组中均诱导了强效且持久的血清抗体反应，第29天和第57天的血清抗VP1 IgA水平显著增加，且抗VP1 IgG水平也显著高于接种前水平，呈剂量依赖性增加。口服疫苗还刺激了唾液和鼻腔中强烈且持久的IgA反应。安全性方面，疫苗在老年人群中表现出良好的安全性和耐受性，未发生与疫苗相关的3级不良事件。最常见的不良反应为头痛（14%）和不适/疲劳（16%），与安慰剂组的发生率相似。 APG990：公布1期临床试验的中期数据 Apogee Therapeutics公司公布了其新型半衰期延长的OX40L单克隆抗体APG990的首个人体试验的积极中期结果。APG990是一种皮下注射疗法，靶向炎症通路中位于IL-13上游的OX40L，从而对1型、2型和3型炎症通路产生广泛影响。 此次公布的结果显示，APG990的半衰期约为60天，可支持每3个月或6个月一次的维持给药方案。在所有5个剂量组（最高剂量为1200 mg）中，APG990均表现出良好的耐受性。Apogee公司还开发了APG279，即APG777（一种深度抑制2型炎症的药物）与APG990的联合制剂，旨在实现单次注射2 mL联合制剂，每年仅需给药2-4次的治疗方案，为患者提供更有效的治疗选择，同时最大限度地减少其他可用疗法的副作用。 BL-001：公布1期临床试验数据 Bloom Science公司公布了其在研口服疗法BL-001在一项涉及32名健康成年人（体重从正常到超重）的1期试验中的疗效和安全性结果。BL-001是一种潜在“first-in-class”、口服给药的活生物治疗产品（LBP），旨在模拟生酮饮食的治疗效果。临床前数据表明，BL-001在癫痫模型中复制了生酮饮食的治疗效果，并进一步展示了其对γ-氨基丁酸（GABA）和其他关键生物能途径的调节作用，以抑制癫痫发作的关键驱动因素——过度兴奋性。 BL-001在28天的治疗期内在体重减轻方面的整体治疗效果具有统计学显著性（p=0.0424）。超重组（BMI≥25）中接受BL-001治疗的受试者与所有接受安慰剂的受试者相比，体重的百分比变化具有统计学意义（p=0.0007）。此外，BL-001治疗的超重和正常体重个体之间的体重百分比变化也具有统计学意义（p=0.0003），体重减轻最高为4.9%。80%在BL-001治疗期间体重减轻的受试者在最后一次给药两周后仍保持体重减轻，其中接受最高剂量的所有超重受试者的体重继续下降，在两周随访期结束时体重减少了3.4%。 此外，BL-001治疗组观察到了剂量依赖性的变化，包括尿酮、食欲降低和体重减轻，而安慰剂组未观察到这些变化。靶向生物标志物分析显示，与食欲控制、代谢调节和消化相关的关键代谢激素发生了具有统计学意义的变化。更大规模的代谢组学分析还揭示了循环酮体的统计学显著变化，这些发现进一步支持了BL-001的潜在生酮和减肥效果。 ▲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] Perfuse Therapeutics Announces Positive Visual, Structural and Safety Data from a Ph1/2a Trial of PER-001 in Glaucoma Patients at the American Glaucoma Society Meeting. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-visual-structural-and-safety-data-from-a-ph12a-trial-of-per-001-in-glaucoma-patients-at-the-american-glaucoma-society-meeting-302387598.html [2] Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035709/0/en/Sernova-Biotherapeutics-Receives-FDA-Clearance-for-IND-Application-for-its-Cell-Pouch-Bio-hybrid-Organ-with-Autograft-Thyroid-Cells-in-Patients-with-Hypothyroidism.html [3] Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/04/3036995/0/en/Enlivex-Therapeutics-Announces-Investor-Webinar-to-Discuss-Positive-Interim-Data-from-Phase-I-II-Allocetra-Trial-in-Knee-Osteoarthritis.html [4] Bloom Science Reports Positive Data from Phase 1 Trial of BL-001 Demonstrating Statistically Significant, Durable Weight Loss in Overweight Individuals. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bloom-science-reports-positive-data-from-phase-1-trial-of-bl-001-demonstrating-statistically-significant-durable-weight-loss-in-overweight-individuals-302391446.html [5] Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-alllbl-302392846.html [6] Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbi-1140675-a-second-generation-vmat2-inhibitor-in-healthy-adults-302392294.html [7] Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/biohaven-reports-positive-degrader-data-achieving--80-sustained-reductions-in-total-igg-with-potential-first-in-class-bhv-1300-302389515.html [8] Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/adiso-therapeutics-announces-data-publication-of-two-phase-1-studies-of-first-in-class-neutrophil-modulator-ads051-in-the-american-journal-of-gastroenterology-302393958.html [9] Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990). Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035377/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Phase-1-Results-from-the-APG990-Healthy-Volunteer-Trial-Unlocking-Potential-Maintenance-Dosing-Every-Three-and-Six-Months-for-APG279-.html [10] Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study. Retrieved March 7, 2025, from https://acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-and-saniona-announce-initial-positive [11] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-0871, a Novel TRPV4 Inhibitor, for the Treatment of Charcot Marie Tooth Disease 2C. Retrieved March 7, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-0871-a-novel-trpv4-inhibitor-for-the-treatment-of-charcot-marie-tooth-disease-2c/ [12] Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20241216396391/en/Contineum-Therapeutics-Initiates-Patient-Dosing-in-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791 [13] Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study. Retrieved March 7, 2025, from https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-enrollment-in-third-safety-cohort-in-ph-762-phase-1b-dose-escalation-study/ [14] Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-first-subject-dosed-in-phase-1-clinical-trial-of-bbt001-a-novel-multi-targeting-half-life-extended-bispecific-antibody-for-the-treatment-of-atopic-dermatitis-and-other-inflammatory-skin-diseases-302388661.html [15] Luxa Biotechnology Presents Clinical Data from First-in-Human Retinal Pigment Epithelium Cell Therapy Trial for Dry Age-Related Macular Degeneration at the 77th Annual Wills Eye Conference. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20250306998366/en/Luxa-Biotechnology-Presents-Clinical-Data-from-First-in-Human-Retinal-Pigment-Epithelium-Cell-Therapy-Trial-for-Dry-Age-Related-Macular-Degeneration-at-the-77th-Annual-Wills-Eye-Conference [16] ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/immunogenesis-doses-first-patient-in-phase-12-clinical-trial-of-imgs-101-in-combination-with-balstilimab-anti-pd-1-and-zalifrelimab-anti-ctla-4-in-relapsed-or-refractory-advanced-prostate-pancreatic-and-hpv--head--neck-t-302393719.html [17] Vaxart Announces Publication Demonstrating the Immunogenicity and Safety of its First-Generation Oral Pill Norovirus Vaccine Candidate in Elderly Adults. Retrieved March 7, 2025, from https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-publication-demonstrating-immunogenicity-and 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