Daraxonrasib

2026 年，是生物技术行业复苏的一年。一方面，追踪美国生物科技板块的交易所交易基金（ETF）XBI 表现强劲。另一方面，众多初创企业接连上市，打破了 IPO 市场的沉寂，其中 Kailera 和 Parabilis 的发行规模更是创下纪录。 研发和监管层面，同样传出积极信号。Revolution Medicines 的胰腺癌新药 Rasonque 斩获批准，FDA 也释放出对行业更加友好的信号。这些变化，让药物研发领域的前景显得颇为乐观。 不过饶是如此，2026 年，生物医药行业依旧有一批 Biotech 公司或破产清算，或结束独立运营。据外媒统计，今年已有 10 家 Biotech 倒闭，包括专注于癌症疫苗开发的 IO Biotech、专注于开发分子胶药物的 f5 Therapeutics 等。 对于早期 Biotech 来说，每一轮融资都生死攸关。它们往往需要先花掉大量资金，才能拿出足以说服下一轮投资人的数据，但投资人又更青睐那些拥有成熟资产和临床数据支持的公司。 Adecto 的遭遇，就是这种困境的缩影。 这家源自塔夫茨大学研究团队的公司成立于 2014 年，旨在开发针对 ADAM8 阳性癌症的疗法。2026 年成立十余年后，其核心候选药物 AD100 仍处于临床前开发阶段。Adecto 长期依靠美国国家癌症研究所的小企业创新研究资助推进项目，从未进行过传统的融资。 2026 年 10 月，Adecto 宣布关闭。管理层公开表示，投资环境对缺少临床数据的新靶点愈发谨慎，最终公司耗尽了现金。 分子胶公司 f5 Therapeutics 也在 3 月宣布关闭，其研发尚未进入临床。创始人在告别时，同样谈到了近年来早期平台型企业艰难的融资环境。 相比融资受阻，另一些企业的退场与项目本身的结果直接相关。 Nido Biosciences 开局强劲，2023 年公开亮相时，就已经获得了 1.09 亿美元资金，支持者包括礼来。其核心小分子药物 NIDO-361 进入了针对肯尼迪病的全球 Ⅱ 期试验，但结果未达到预期。公司随后决定停止该候选药物的临床开发，并于 2026 年初收尾。 Arpeggio Biosciences 则停在了临床之前。公司曾围绕转录组学开展药物发现，并推进治疗非小细胞肺癌的 Nrf2 小分子降解剂。管理层披露，团队始终无法将分子的疗效与脱靶问题分离，最终决定结束运营。 IO Biotech 走得更远，却没有跨过最后几道关口。其癌症疫苗 Cylembio 联合 Keytruda 的 Ⅲ 期黑色素瘤研究，未能显著优于 Keytruda 单药。FDA 随后建议公司不要基于该组数据提交上市申请。经历裁员和战略选择评估后，公司于 2026 年 3 月进入破产程序并停止运营。 不过，即使有产品上市，商业化也是一大考验。 Iterum 的抗菌药 Orlynvah 于 2025 年 8 月正式推出，但上市当季销售额仅有 40 万美元，同期费用却达到 650 万美元，公司将其中很大一部分归因于产品上市投入。到 2026 年 3 月，现金压力仍未得到解决，与潜在买方的交易也未能及时完成，Iterum 最终启动清盘。 这份名单里，Rome Therapeutics 的结局有所不同。 2026 年 1 月，Rome 披露原有运营的收尾工作已经完成，同时宣布成为 Pretzel 的全资子公司。其科学联合创始人将继续参与相关工作，研究得以在新的组织安排下延续。 更多公司详细信息，可以前往丁香园 Insight 数据库查看。 编辑：月牙 封面来源：站酷海洛 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，不构成任何投资建议，也不作治疗方案推荐和介绍。如有就医需求，请咨询和联系正规医疗机构

iStock, wildpixel Early-stage clinical data from our company and others point to the Wnt/β-catenin pathway as a new avenue for targeting multiple cancer types. For more than four decades, the “big four” oncology targets—KRAS, MYC, TP53, and Wnt/β-catenin —have represented a holy grail for cancer drug development. Each plays a critical role in tumor biology and is implicated across a broad range of cancers, yet all four were long considered out of reach for different reasons. At the ASCO 2026 annual meeting earlier this year, KRAS was emphatically crossed off that list when Revolution Medicines presented Phase 3 data showing that daraxonrasib, now on the market as Rasonque, nearly doubled survival compared with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. A target once dismissed as impossible to drug now has approved medicines, late-stage clinical programs and billions of dollars in investment behind it. The KRAS story is a reminder that progress begins with deeper understanding of target biology and the perseverance to translate that understanding into therapeutic reality. The next target to be removed from this “out of reach” list may well be Wnt/β-catenin, which is dysregulated in roughly a third of all cancers. While no drugs targeting this pathway have yet reached the approval stage, promising early- and mid-stage clinical results from Iterion Therapeutics, where I serve as CEO, as well as from Parabilis Medicines and Sapience Therapeutics, point to a new way of throwing a wrench in the gears of certain cancers. How Wnt/β-catenin became druggable As a founder, scientist and executive in multiple venture-backed companies that have pursued previously undrugged targets, I was drawn to Wnt/β-catenin as one of oncology’s most important and challenging pathways. In healthy tissues, it helps coordinate tissue maintenance, stem cell renewal and repair. When activated in tumors, however, the pathway can promote growth, stemness, immune evasion and therapeutic resistance. Wnt/β-catenin is implicated in colorectal, hepatocellular, gastric and endometrial cancers, and is often associated with more aggressive tumor behavior. One challenge is that β-catenin is not a typical enzyme with well-defined, druggable pockets. Its oncogenic activity depends on large, flat protein-protein interfaces and transcriptional complexes that are inherently difficult to target. β-catenin also has essential roles in normal tissue homeostasis and cell-cell adhesion, meaning that broad pathway inhibition can cause unacceptable toxicities. Indeed, this was a major limitation in early Wnt/β-catenin programs, which underestimated the complexity of Wnt biology. Then the industry realized that drugging the undruggable requires a different approach. KRAS became druggable when researchers identified vulnerabilities created by specific cancer-causing mutations, enabling the development of drugs that selectively target mutant KRAS proteins and better identification of the patients most likely to benefit. First-generation inhibitors of the cancer-associated KRAS G12C mutation proved the target could be reached. More recent RAS programs have expanded the field from this single allele toward broader therapeutic applications. A recent analysis of the Rasonque Phase 3 data show that certain mutational subgroups fared better than others, suggesting there is still significant opportunity to improve outcomes for patients with KRAS-mutated tumors. Cancer RevMed’s Rasonque gets a subtype data asterisk, but analysts remain bullish Data released by the FDA show that Revolution Medicine’s newly approved pancreatic cancer drug underperformed in a large subgroup of patients, but analysts say the biotech still has a clear winner. October 12, 2026 · 3 min read · Michael Gibney Read more A similar evolution is now underway for Wnt/β-catenin. A small group of companies is targeting Wnt’s activation of transcriptional machinery in cancer cells, while aiming to avoid the toxicities historically associated with broader upstream Wnt inhibition. At Iterion, we are pursuing this strategy by targeting TBL1, a nuclear regulator of β-catenin–mediated transcription with a defined binding pocket that is not involved in essential β-catenin functions in healthy cells. Our small molecule asset tegavivint is designed to disrupt the TBL1:β-catenin interaction, resulting in degradation of nuclear β-catenin and the inhibition of oncogenic gene expression. Other companies are pursuing complementary approaches. Parabilis Medicines’ zolucatetide targets the β-catenin:TCF interaction using its Helicon peptide platform, while Sapience Therapeutics is developing ST316, a peptide directed at the β-catenin:BCL9 interface. Early clinical data support the concept that Wnt/β-catenin transcriptional activity can be targeted in humans without eliciting toxicity. At ASCO 2026, Iterion reported encouraging Phase 1 data with tegavivint in heavily pre-treated patients with hepatocellular carcinoma (HCC) that contains Wnt-pathway activating mutations, including excellent tolerability, monotherapy clinical responses and evidence of pathway inhibition. While still early, these data provide the first clinical evidence that a Wnt/β-catenin–directed therapy can deliver meaningful benefit in a biomarker-selected HCC population . Parabilis , meanwhile, reported early monotherapy activity with zolucatetide in desmoid tumors, a rare Wnt/β-catenin–driven sarcoma, including compelling responses and disease control. And Sapience recently presented encouraging early Phase 2 data with ST316 in second-line colorectal cancer in combination with standard therapy. Together, these data are promoting Wnt/β-catenin from a theoretical pathway of interest to a clinically relevant cancer target. The future of Wnt/β-catenin It is becoming clear that Wnt/β-catenin is no longer undruggable. A deeper understanding of biology has opened a new door, and we think the next several years will determine just how many new cancer treatments we can find as we walk through it. Science alone is not sufficient for successful drug development. It must be matched by capital, conviction and a willingness to test difficult hypotheses in patients. Parabilis’ recent record-breaking IPO , supported in part by enthusiasm around zolucatetide clinical data, shows that investors are willing to commit meaningful capital to companies pursuing historically difficult intracellular oncology targets. IPO Sky-high Parabilis, Kailera IPOs spur optimism—but only for derisked biotechs Biotechs are benefitting from the AI tech frenzy and inflation, but validated pipelines and careful planning are still key to the recent record-setting IPOs, experts say. June 11, 2026 · 5 min read · Annalee Armstrong Read more At Iterion, we are now evaluating tegavivint as a monotherapy and in combination with Exelixis’ next-generation multi-kinase inhibitor zanzalintinib in second- and third-line Wnt-mutated HCC. Additional clinical programs in colorectal cancer and pediatric osteosarcoma are also actively enrolling. Wnt-directed agents may ultimately be most powerful as part of rational combinations matched to tumor biology. As evidence, Iterion recently announced encouraging Phase 1b clinical data evaluating the combination of osimertinib and tegavivint in patients with first-line EGFR-mutated NSCLC. If the tolerability is maintained in larger studies, it could lead to further exploration of Wnt-directed therapies across a broader range of cancers and combinations, both to enhance established treatment modalities and reduce or eliminate therapeutic resistance. The field must still identify which tumors are truly Wnt-dependent, which mechanisms produce the best therapeutic window and which combinations generate the most meaningful benefit for patients. From that vantage point, Wnt/β-catenin looks less like an impossible target and more like the next major test of whether oncology can again make the undruggable druggable.