Allogene Therapeutics, Inc.

- Expanded collaboration agreement with Allogene includes investment for further MRD assay development, clinical sample testing, milestone payments, and international expansion BOULDER, Colo., Feb. 27, 2025 /PRNewswire/ -- Foresight Diagnostics ("the Company"), a leader in ultra-sensitive minimal residual disease detection technology, today announced an expanded strategic collaboration with Allogene Therapeutics, Inc. to include the development of the Company's minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma (LBCL) for the treatment of cemacabtagene ansegedleucel (cema-cel) in Allogene's ALPHA3 clinical trial. Under the strategic collaboration, Allogene and Foresight will work together to support the development of Foresight Diagnostics' MRD assay in the EU, UK, Canada and Australia in support of Allogene's clinical development of cema-cel. Cema-cel is being studied in the groundbreaking randomized controlled pivotal ALPHA3 trial as part of a first-line (1L) treatment to improve the cure rate in patients with LBCL. In the ALPHA3 trial, patients who achieve remission following initial treatment but remain positive for MRD, identified by using Foresight CLARITY™ IUO assay, will have an opportunity to receive cema-cel as a one-time consolidation dose to prevent disease recurrence. "We are excited about our expanded collaboration with Allogene which will enable development of our MRD assay beyond the U.S.," said Sandra Close, PhD, Foresight Diagnostics' Chief Operations and Compliance Officer. "This is an important milestone as we continue to support our biopharma partners implementing MRD-driven clinical trials globally." About Foresight Diagnostics Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-certified laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use. SOURCE Foresight Diagnostics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▎药明康德内容团队编辑 本期看点 1. γδ T细胞疗法INB-100用于造血干细胞移植后的白血病患者的1期临床试验数据亮眼，中位随访时间为20.1个月时，100%的急性髓系白血病（AML）患者仍保持完全缓解（CR）状态，其中有几名患者的缓解时间已超过3年。 2. 同种异体CAR-T疗法cemacabtagene ansegedleucel在一项针对复发/难治性大B细胞淋巴瘤（R/R LBCL）的1期临床试验中，在低疾病负荷患者中的CR率达100%。 3. 自然杀伤（NK）细胞疗法troculeucel用于治疗阿尔茨海默病，在一项1期临床试验中使90%患者的认知功能稳定或有所改善。 药明康德内容团队整理 INB-100：公布1期临床试验的新数据 IN8bio公司公布了其在研现货型γδ T细胞疗法INB-100用于造血干细胞移植后的白血病患者的1期临床试验数据。INB-100是一款来自健康供体的同种异体γδ T细胞，在体外经过扩增和激活后，被输注到白血病患者体内。 截至2025年1月17日的数据，中位随访时间为20.1个月，接受INB-100治疗的原始队列和扩展队列中，所有（100%）AML患者仍保持CR状态，其中有几名患者的缓解时间已超过3年。此外，与真实世界的历史数据相比，接受INB-100治疗的患者相比于接受标准治疗的患者展现出显著更高的一年无进展生存率和总生存率。即使是接受低强度预处理（RIC）的老年高危患者，INB-100也显示出显著的疗效。安全性方面，未报告细胞因子释放综合征（CRS）或神经毒性，移植物抗宿主病（GvHD）可控，感染轻微，对患者的生活质量无明显影响。 Cemacabtagene ansegedleucel（ALLO-501/A）：公布1期临床试验的新数据 Allogene Therapeutics公司宣布，其在研同种异体CAR-T疗法cemacabtagene ansegedleucel（cema-cel，以前称为ALLO-501/A）用于治疗R/R LBCL的1期临床试验数据已发表在Journal of Clinical Oncology期刊上。Cema-cel是一种经基因工程改造、靶向CD19的AlloCAR-T产品。Cema-cel通过TALEN基因编辑技术破坏TRAC与CD52基因，以减少产生GvHD的风险。此前，美国FDA授予cema-cel再生医学先进疗法（RMAT）认定，用于治疗R/R LBCL。 数据显示，cema-cel的疗效与已批准的自体CD19靶向CAR-T细胞疗法相当：该研究中的总缓解率（ORR）和CR率分别为58%和42%，其中所选定用于关键2期试验的方案获得了最高的ORR和CR，分别为67%和58%。在达到CR的患者中，中位缓解持续时间（DOR）为23.1个月，中位总生存期（OS）尚未达到。此外，cema-cel的安全性可控，且与已批准的自体CD19靶向CAR-T细胞疗法一致。值得注意的是，cema-cel治疗在低疾病负荷患者中的CR率达100%。该结果为cema-cel作为LBCL患者的一线巩固治疗提供了支持，相关关键性2期试验ALPHA3已于2024年6月启动。 Troculeucel（SNK01）：公布1期临床试验数据 NKGen Biotech公司公布了其自体增强型自然杀伤（NK）细胞疗法troculeucel（SNK01）用于治疗阿尔茨海默病的1期临床试验数据。Troculeucel是一款自体、非基因工程改造的NK细胞产品，它具有增强的细胞毒性，活化受体表达率超过90%，可从任何供体中稳定生产。该候选疗法能够有效降低AD患者脑脊液（CSF）中的α-突触核蛋白（α-syn）水平，该蛋白的升高被认为与认知能力下降有关。 此次公布的结果显示，10名可评估患者中，90%患者的认知功能稳定或有所改善。此外，troculeucel疗法耐受性良好，并对脑脊液中的蛋白质聚集体水平和神经炎症生物标志物产生了有益影响，其中pTau181和胶质纤维酸性蛋白（GFAP）的减少似乎与剂量相关。 INO-3107：公布1/2期临床试验数据 INOVIO公司宣布，其候选DNA疗法INO-3107的1/2期临床试验数据已发表于学术期刊Nature Communications。INO-3107正在被开发用于治疗成人HPV 6和HPV 11相关的复发性呼吸道乳头状瘤病（RRP），旨在引发针对HPV 6和HPV 11的靶向T细胞反应，以杀死受感染的细胞，使乳头状瘤消退。该疗法还可能清除或降低病毒水平，从而防止或减缓新乳头状瘤的生长。 数据显示，与前一年相比，使用INO-3107治疗的32名受试者中，有26名（81.3%）手术干预次数降低，其中9名（28.1%）受试者在试验期间无需手术干预，ORR为72%。此外，INO-3107具有良好的耐受性和免疫原性，未报告＞2级的治疗相关不良事件。2020年，FDA授予INO-3107孤儿药资格，用于治疗RRP。该公司计划在2025年年中提交INO-3107的生物制品许可申请（BLA）。 Mevrometostat：公布1期联合治疗试验数据 辉瑞（Pfizer）公布了其开发的EZH2抑制剂mevrometostat与雄激素受体抑制剂Xtandi（enzalutamide）联用，治疗转移性去势抵抗性前列腺癌（mCRPC）患者的1期临床试验的首个随机无进展生存期（PFS）结果。Mevrometostat是一款选择性、口服强效EZH2抑制剂。EZH2是基因转录的重要调控因子，在前列腺癌中与癌细胞增殖相关。在临床前模型中，mevrometostat与enzalutamide表现出协同作用，能够进一步抑制前列腺癌细胞系的增殖。 截至2024年9月2日的数据，中位随访时间为9.6个月，mevrometostat加enzalutamide组患者的中位放射学PFS为14.3个月（7.5个月，不可评估），enzalutamide组患者在此数值上为6.2个月（4.1个月，13.9个月）。Mevrometostat/enzalutamide组合与enzalutamide相比，将疾病进展或死亡风险降低49%（HR=0.51，90% CI：0.28，0.95）。此外，在基线时携带可评估病灶的患者中，mevrometostat/enzalutamide组合组的总缓解率为26.7%，enzalutamide单药组这一数值为15.4%。 Tuspetinib：公布1/2期临床试验数据 Aptose Biosciences公司公布了1/2期TUSCANY试验的初步结果，该试验评估了FLT3抑制剂tuspentinib与venetoclax和azacitidine联用治疗新确诊的AML患者的效果。结果显示，3例FLT3野生型患者完成了第1个周期的治疗，无剂量限制性毒性（DLT）且无剂量调整。有两名患者在第1个治疗周期结束时达到CR加部分血液学恢复的完全缓解（CRh）。值得注意的是，其中有1例是具有双等位基因TP53突变和复杂核型的患者。第3名患者在第1个治疗周期内骨髓白血病细胞显著减少，并继续接受第2个周期的治疗。 IVW-1001：公布1/2期临床试验数据 IVIEW Therapeutics公司公布了其创新疗法IVW-1001用于治疗干眼症的1/2期临床试验数据。IVW-1001是一款含有TRPM8激动剂的眼部湿巾。此次公布的结果显示，IVW-1001在第4周时对干眼症患者的体征和症状产生了具有统计学和临床意义的改善，包括角膜荧光素染色的减少和眼干评分的显著降低。此外，泪液分泌量也有积极变化。研究还显示出剂量与效果间的关系，较高剂量（0.2%）在多个疗效终点上表现更优。安全性方面，IVW-1001在所有治疗组中均表现出良好的耐受性，大多数不良事件为轻度或中度。 THB335：公布1期临床试验数据 Third Harmonic Bio公司公布了其强效、选择性口服小分子KIT抑制剂THB335在健康受试者中的1期临床试验结果。结果显示，THB335具有约40小时的半衰期，支持每日一次给药，并在多个剂量水平下显示出剂量依赖性的药物暴露增加。这些数据支持THB335进入针对慢性自发性荨麻疹的2期临床试验。 ▲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] IN8bio Reports Updated Positive Results from Phase 1 Trial of INB-100 in Leukemia Patients. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/11/3024098/0/en/IN8bio-Reports-Updated-Positive-Results-from-Phase-1-Trial-of-INB-100-in-Leukemia-Patients.html [2] Bio-Path Holdings Provides Update from Phase 1/1b Clinical Trial of BP1002 for Treatment of Refractory/Relapsed Acute Myeloid Leukemia. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/12/3025403/0/en/Bio-Path-Holdings-Provides-Update-from-Phase-1-1b-Clinical-Trial-of-BP1002-for-Treatment-of-Refractory-Relapsed-Acute-Myeloid-Leukemia.html [3] Clinical and Immunological Results from Phase 1/2 Study of INO-3107 as a Treatment for Recurrent Respiratory Papillomatosis Published in Nature Communications. Retrieved February 14, 2025, from https://www.prnewswire.com/news-releases/clinical-and-immunological-results-from-phase-12-study-of-ino-3107-as-a-treatment-for-recurrent-respiratory-papillomatosis-published-in-nature-communications-302374685.html [4] Allogene Therapeutics Announces Publication of Durable Response Data from Phase 1 ALPHA/ALPHA2 Trials of the Allogeneic CAR T Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma in the Journal of Clinical Oncology. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/13/3026325/0/en/Allogene-Therapeutics-Announces-Publication-of-Durable-Response-Data-from-Phase-1-ALPHA-ALPHA2-Trials-of-the-Allogeneic-CAR-T-Cemacabtagene-Ansegedleucel-ALLO-501-in-Relapsed-Refra.html [5] NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer’s Disease. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/13/3025843/0/en/NKGen-Biotech-Announces-Publication-of-Phase-1-Troculeucel-Clinical-Trial-Results-for-the-Treatment-of-Alzheimer-s-Disease.html [6] IVIEW Therapeutics Announces Topline Results from Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe for Dry Eye Disease. Retrieved February 14, 2025, from https://www.prnewswire.com/news-releases/iview-therapeutics-announces-topline-results-from-phase-12-trial-of-ivw-1001-ophthalmic-eyelid-wipe-for-dry-eye-disease-302371387.html [7] Aptose’s Frontline Triple Drug Therapy with Tuspetinib Achieves Notable Responses in Newly Diagnosed AML Patients in the Phase 1/2 TUSCANY Trial. Retrieved February 14, 2025, from https://www.aptose.com/news-media/press-releases/detail/308/aptoses-frontline-triple-drug-therapy-with-tuspetinib [8] Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. Retrieved February 11, 2025, from https://meetings.asco.org/abstracts-presentations/243221 [9] Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium. Retrieved February 11, 2025, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-showcase-advancements-across-genitourinary-cancers [10] Oncology Innovation Day. Retrieved February 11, 2025, from https://s28.q4cdn.com/781576035/files/doc_downloads/2024/02/29/Pfizer-Oncology-Innovation-Day-Presentation_FINAL.pdf [11] Third Harmonic Bio Announces Phase 1 Clinical Results for THB335 and Provides Corporate Strategic Update. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/11/3024041/0/en/Third-Harmonic-Bio-Announces-Phase-1-Clinical-Results-for-THB335-and-Provides-Corporate-Strategic-Update.html 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

“We continue to believe cema-cel has the potential to leapfrog other autologous and allogeneic CD19 CAR-T therapies, remain competitive for longer, and expand the total addressable market,” William Blair analysts said.\n Two months after Allogene abandoned plans for its CAR-T in leukemia, analysts have suggested that fresh phase 1 data in lymphoma show the therapy can “leapfrog” the competition.The biotech had been studying the CD19 CAR-T cell therapy, called cemacabtagene ansegedleucel or cema-cel, in the phase 1 ALPHA and ALPHA2 studies of 87 heavily pretreated patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL).The updated data showed a combined overall response rate (ORR) and complete response (CR) rate that was “consistent with those observed with approved autologous CD19 CAR-T cell products for patients with R/R LBCL after two or more lines of systemic therapy,” Allogene said in a Feb. 13 post-market release.The treatment regimen that Allogene has already taken into the ALPHA3 phase 2 study of cema-cel showed the highest ORR and CR rates, of 67% and 58%, respectively, the company said.But it was the durability data that caught analysts’ attention. Patients who achieved a CR had “excellent outcomes,” according to Allogene, with a progression-free survival of 24 months and a median overall survival (OS) not reached. The median durability of response among patients receiving the phase 2 regimen was 23.1 months and the median OS for this cohort was not reached, the biotech said.“We continue to believe cema-cel has the potential to leapfrog other autologous and allogeneic CD19 CAR-T therapies, remain competitive for longer and expand the total addressable market,” William Blair analysts said in a Feb. 14 note.They also highlighted that all of the six patients with a low tumor burden had achieved a complete response. “Although we think this data point supports cema-cel’s potential as a therapeutic option in patients with minimum residual disease and its ongoing development in a frontline remission consolidation setting, we highlight the publication does not specify if any of the six patients were treated with the selected phase 2 regimen,” the analysts added.Allogene noted in its release that today’s results “represent the largest dataset of LBCL patients treated with an allogeneic CAR-T product and, with a minimum of two years of follow-up, the longest follow-up to date.”“With multiple patients in ongoing complete remissions beyond four years, the lingering question of whether an allogeneic CAR-T could deliver durable responses has now been answered,” Allogene Chief Medical Officer Zachary Roberts, M.D., Ph.D., said in the release.“Furthermore, these results provide potent evidence supporting the use of CAR-T in patients with low disease burden and the unique opportunity for the ALPHA3 trial to achieve something novel in this disease—predict and intervene before relapse,” Roberts added. “Opportunities to redefine the standard of care in oncology are rare, but if successful, ALPHA3 has the potential to achieve precisely that.”Last November, Allogene ended work on cema-cel in leukemia in the face of competition from the likes of Bristol Myers Squibb’s Breyanzi.Allogene’s pipeline also includes a CD70-targeting CAR-T called ALLO-316 that recently showed success in a phase 1 renal cell carcinoma trial as well as a CD19/CD70 dual CAR-T called ALLO-329 in preclinical development for autoimmune disease.