North Bergen, New Jersey--(Newsfile Corp. - January 7, 2026) - Apollo Biowellness, Inc. (OTCID: KOAN) (the "Company"), announces that the Letter of Intent between the Company and Revive Regenerative, Inc., dated September 12, 2025, (the "LOI") has expired and it no longer in effect.To view an enhanced version of this graphic, please visit:https://reportify-1252068037.cos.ap-beijing.myqcloud.com/media/production/n_image_a4b47bafbc19ca58a81daa5f3a4e1fb8.jpgThe LOI contained a proposed closing date of October ...

公司信息 * 公司为BridgeBio Oncology Therapeutics (BBOT)，专注于开发针对RAS通路的小分子疗法，旨在治疗最具致命性的癌症[3] * 公司拥有强大的财务状况，资金足以支持运营至2028年[4] * 公司拥有多个临床阶段资产，预计在2026年将迎来多个重要的价值拐点[3] 核心产品管线与数据要点 **BBO-8520 (KRAS G12C on/off抑制剂)** * **作用机制**：设计用于直接结合KRAS G12C的激活态（on-state）和非激活态（off-state），通过直接阻断效应物结合，可能有助于防止适应性耐药机制[12] * **单药疗效数据**：在未接受过G12C抑制剂治疗的KRAS G12C非小细胞肺癌患者中，客观缓解率为65%（17例患者中有11例），疾病控制率为100%[13] * **缓解持久性**：在符合6个月随访条件的患者中，83%（12例中的10例）仍在接受治疗超过6个月，6个月无进展生存率为66%[13] * **安全性优势**：显示出良好的安全性，特别是与off-stage抑制剂相比，肝酶升高频率低、级别低且短暂无症状[14] 至今未出现剂量限制性毒性、4级或以上治疗相关不良事件或治疗相关严重不良事件[14] * **与帕博利珠单抗联合疗效**：在初治和经G12C抑制剂治疗过的患者中显示出早期疗效信号，分别有3/3和2/5例患者达到部分缓解[14] * **联合用药安全性**：与帕博利珠单抗联合显示出可耐受的安全性，未观察到肝酶升高增加[15] 唯一一例3级AST/ALT升高被认为主要与合并用药有关[15] * **暴露量优势**：BBO-8520的on-stage抑制使其在低系统暴露量下实现疗效，其暴露量远低于其他off-stage抑制剂（相比adagrasib和sotorasib低700倍以上，相比MK-1084和D3S-001低150倍以上，相比olomorasib和divarasib低10倍以上）[16] * **特殊人群疗效**：在STK11/KEAP1共突变肿瘤患者中观察到早期疗效信号，5例初始患者均显示部分缓解[17] **BBO-11818 (可逆性泛KRAS抑制剂)** * **作用机制**：是BBO-8520的近亲，是一种口服生物可利用的可逆性泛KRAS抑制剂，针对KRAS的激活态和非激活态，对KRAS具有高选择性[18] * **早期疗效**：在剂量递增中显示出抗肿瘤活性，包括一例经治胰腺导管腺癌患者达到部分缓解，据公司所知，这是首次公开披露的PDAC患者单药泛KRAS缓解[6][7] * **安全性**：在13例患者中治疗总体可耐受且可管理，无剂量限制性毒性，治疗相关不良事件主要为胃肠道相关[19] * **药代动力学**：暴露量大致与剂量成正比，600毫克每日两次的剂量可覆盖G12D和G12V突变等位基因[19] **BBO-10203 (RAS/PI3Kα通路“破坏剂”)** * **作用机制**：采用新颖机制，旨在抑制RAS与PI3Kα之间的物理相互作用，从而破坏RAS驱动的PI3Kα-AKT信号传导，而不抑制PI3Kα的激酶活性，且对任一伙伴的突变状态不敏感[20] * **安全性优势**：单药治疗显示出高度差异化的安全性，无剂量限制性毒性、无治疗相关严重不良事件，且未观察到高血糖，即使在研究入组时未对HbA1c和血糖水平设限的情况下也是如此[22] * **剂量选择**：基于安全性、药代动力学和靶点结合数据，选择500毫克每日一次作为扩展研究的推荐剂量[21] * **早期疗效信号**：在结直肠癌（其中超过80%为三线或以后治疗）和HR阳性乳腺癌患者中观察到临床获益，部分患者出现肿瘤缩小[22] * **临床开发计划**：将专注于联合策略，已启动与标准疗法的三个联合队列，并计划在今年晚些时候与BBO-8520和BBO-11818开展内部联合研究[10][21] 开发策略与未来展望 * **组合策略**：公司的产品组合旨在实现协同作用，支持靶向KRAS组合策略，包括与标准疗法以及公司内部管线药物的联合[3] 公司相信其产品组合使其能够首次通过内部组合安全地实现对PI3Kα和MAPK的高水平同时抑制[10] * **目标患者群体**：公司估计在美国每年约有250,000名患者可能从其疗法中受益[11] * **未来数据披露**：公司预计在2026年下半年公布所有项目的最新数据，包括BBO-8520与帕博利珠单抗联合的更多疗效和安全性数据、BBO-11818的单药和联合数据，以及BBO-10203在多种肿瘤类型中的联合数据[24] 专家观点与竞争格局 * **挑战与机遇**：专家指出，当前G12C off抑制剂的主要挑战是自身免疫性肝炎，且其发生率似乎与活性相关，这不利于未来的联合治疗[32] 专家担心在更大规模的随机研究中，由于缺乏经验丰富的研究者进行精细管理，毒性可能会被放大[33] * **BBO-8520的差异化优势**：专家认为BBO-8520在单药治疗中显示出同类最佳的约65%缓解率，且未出现自身免疫性肝炎信号，在联合治疗中也未出现，实现了高效力与低毒性的结合[34] 即使在olomorasib等强效药物进展后的患者中观察到缓解，也进一步支持了该分子的潜力[35] * **竞争前景**：专家推测，最终胜出的将是像BBO-8520这样强效且无毒的药物[35] 其他重要细节 * **临床试验设计**：BBO-8520的OncRAS 101是一项开放标签、多中心全球1期研究[12] BBO-11818的CONCUR 101研究正在评估其在局部晚期或转移性KRAS突变实体瘤患者中的安全性和初步抗肿瘤活性[18] BBO-10203的BRINCL-101研究是一项多中心开放标签1期研究[21] * **STK11/KEAP1患者背景**：早期显示疗效的5例STK11/KEAP1突变患者均未接受过KRAS G12C抑制剂治疗[38] * **开发路径考量**：对于一线G12C突变非小细胞肺癌，公司认为如果拥有非常好的G12C抑制剂，在早期治疗环境中可能不需要化疗，但将继续根据2026年产生的更多数据进行评估[28] * **TPS评分活动**：早期数据显示，BBO-8520在非常低的TPS评分患者中也有活性和缓解[31]

Company to host analyst call at 5:00pm ET today to discuss progress to date and expansion of clinical trial SOUTH SAN FRANCISCO, Calif, Jan. 07, 2026 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTCQB: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces a key clinical update from the Company’s ongoing CertainT-1 trial focused on patients with acute myeloid leukemia (AML). Following completion of the dose-lim ...

Within the first week of 2026, the S&P 500 leaderboard has already delivered a surprise. Moderna Inc (NASDAQ:MRNA) has quietly muscled its way into the top year-to-date performers, up more than 20% in just three trading days, and the technicals suggest the move may not be a fluke.Track MRNA stock here. Zoom out, and you’ll see that MRNA stock has been declining for the past four years. A golden cross on the chart suggests it has finally broken the curse.Chart created using Benzinga ProModerna's rally has be ...

SAN DIEGO, CA / ACCESS Newswire / January 7, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing inflammation, today announced the start of GMP manufacturing of GEMINI and placebo. This manufacturing run will provide the Company with clinical drug supply for later stage clinical studies. "We are delighted to be working with a leading global contract manufacturing organization," said James Rolke, Chief Execut ...

LEXINGTON, Mass., Jan. 7, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today announced that it has entered into a securities purchase agreement with new and existing healthcare-focused, high-quality institutional investors and certain insiders of the Company for a private placement (the "PIPE financing") for gross proceeds of up to $80.8 million to the Company, incl ...

Trading under DCOY to commence on January 8, 2026Company's proprietary peptide-conjugate platform leverages AI-enabled computational infrastructure to accelerate candidate selectionCapital-efficient 2026 plan features advancing lead antiviral into the clinic while expanding pipeline and partnership opportunitiesCAMBRIDGE, Mass., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX) (Salarius) announces it will change its corporate name to Decoy Therapeutics Inc. (Decoy) and its comm ...

Trading under DCOY to commence on January 8, 2026 Company’s proprietary peptide-conjugate platform leverages AI-enabled computational infrastructure to accelerate candidate selection Capital-efficient 2026 plan features advancing lead antiviral into the clinic while expanding pipeline and partnership opportunities CAMBRIDGE, Mass., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) (Salarius) announces it will change its corporate name to Decoy Therapeutics Inc. (Decoy) and its ...

临床试验结果 - BBO-8520在临床试验中显示出65%的客观缓解率(ORR)，100%的疾病控制率(DCR)[21] - 在6个月的随访中，83%的患者仍在接受治疗，66%的患者达到6个月无进展生存期(PFS)[27] - BBO-8520的安全性资料显示，84%的患者报告了任何治疗相关不良事件(TRAE)，其中62%为恶心，51%为腹泻[28] - BBO-8520的剂量暴露与剂量成比例，200mg及以上剂量可达到预期的有效水平[37] - STK11/KEAP1共突变患者在治疗中显示出早期疗效信号，所有五名初始患者均有反应[45] - KRASG12C OFF抑制剂在STK11/KEAP1共突变患者中的客观缓解率(ORR)为25%-33%，而野生型患者约为60%[45] - BBO-11818在600mg BID剂量下对重度预处理的胰腺癌患者显示出1例部分缓解[56] - BBO-11818的单药治疗显示出62%的疾病控制率(DCR)，包括完全缓解(CR)、部分缓解(PR)和稳定病(SD)[76] - BBO-10203在500mg QD剂量下实现了预期的有效暴露，且在所有剂量水平下观察到完全的靶点结合[74] - BBO-10203在与标准治疗组合时显示出强大的肿瘤回归能力，特别是在乳腺癌和KRAS突变的CRC、NSCLC和PDAC模型中[78] - BBO-11818的安全性数据表明，治疗相关不良事件(TRAEs)主要为胃肠道相关，且无剂量限制毒性(DLTs)[58] - BBO-10203在剂量递增试验中未观察到高血糖现象，且无3级以上的TRAEs[77] 财务状况与市场机会 - 公司预计财务状况能够支持运营至2028年[5] - 公司预计现金流将持续到2028年，财务状况良好[80] - BBO-8520的临床资产预计在2026年将有多个价值拐点[5] - 公司在美国多个适应症中每年有超过25万例新发患者的市场机会[10] 新产品与技术研发 - BBO-8520与pembrolizumab联合使用时，47%的患者报告了任何治疗相关不良事件，13%为3级或以上不良事件[33] - BBO-8520的治疗指数优于OFF抑制剂，可能使其在早期治疗中与pembrolizumab联合使用时具有差异化优势[35] - BBO-8520的独特设计使其能够同时抑制KRASG12C的ON和OFF状态，提升了药物的效能[14] - BBO-8520在与pembrolizumab联合使用时的安全性优于其他OFF抑制剂，可能实现最佳同类药物地位[40]

HOUSTON, Jan. 07, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today issued the following letter to shareholders. Fellow Shareholders, Looking back on 2025, I'm reminded of something I've always believed: the best way to predict the future is to invent it. At ...