Terrestrial Bio, Inc.

Gilgamesh Pharma 获得 6000 万美元 A 轮融资，用于推进其神经精神药物研发管线和发现平台。其治疗抑郁症的药物 Blixeprodil 在 II 期临床试验中取得了显著成果，即将进入后期临床试验阶段。Blixeprodil是一种在研的、口服生物利用度高、非解离性、速效的N-甲基-D-天冬氨酸（NMDA）受体拮抗剂。与此同时，公司正在启动 GM-3009 的 I 期临床试验，并推进与艾伯维的神经可塑性原合作项目。 数字健康平台Triangle Health成功完成400万美元融资，旨在帮助用户更清晰地认识自身健康状况，并探索个性化的治疗方案。用户只需上传或输入自身健康数据，Triangle Health平台便会利用先进的人工智能算法进行深度分析，提供详细的疾病风险评估和潜在的治疗建议。这项技术不仅提升了用户对健康的理解，也为医生的临床决策提供了有力支持。本轮融资资金将主要用于加快产品研发和市场推广，推动人工智能技术在医疗健康领域的广泛应用。 英国剑桥生物科技公司Immutrin成功完成8600万美元A轮融资，计划加速推进其针对遗传性进行性心脏病——转甲状腺素淀粉样变性心肌病（ATTR-CM）的新药研发。ATTR-CM作为一种因转甲状腺素（TTR）异常沉积导致的致命性心脏疾病，正成为辉瑞、Alnylam和BridgeBio等生物医药巨头激烈争夺的市场热点。ATTR-CM是转甲状腺素淀粉样变性（ATTR）的一种心脏表现形式。该病因TTR蛋白异常折叠并沉积，形成毒性淀粉样物质，逐渐损害心脏功能，最终可能导致心力衰竭甚至死亡。患者常见症状包括呼吸困难、下肢水肿和心律失常。ATTR不仅影响心脏，还可能累及神经系统及其他器官。此次融资所得将主要用于支持抗体药物的临床前研究及后续的临床试验阶段，加速其临床开发进程。 Terrestrial Bio（前身为Vaxess Technologies）融资5000万美元，支持其在GLP-1递送领域的研发和临床推进。其开发的微针贴片技术，利用微米级针头实现无痛且高效的疫苗注射，改善了传统注射的痛感和患者依从性问题。本轮融资将主要用于优化微针贴片的药物负载和释放特性、推进临床试验以及扩大生产能力。公司计划在未来数年内推动其GLP-1微针贴片产品上市，力争成为慢性代谢疾病治疗领域的创新领导者。 盐野义制药宣布将以1亿美元收购合作伙伴Apnimed在其睡眠障碍领域合资企业中的全部股份。此次交易完成后，盐野义将全面掌控该合资企业，从而能够更灵活、高效地推进相关候选药物的临床开发和商业化进程。Apnimed的主要产品是AD109，是一种在研的每日一次口服药片，旨在通过靶向导致上呼吸道塌陷的神经肌肉根源来治疗阻塞性睡眠呼吸暂停（OSA）。目前该产品正处于3期临床试验阶段，目标是成为首个用于治疗OSA的药物。Apnimed作为睡眠障碍领域的专业生物技术公司，早期与盐野义携手合作，共同推动治疗产品的研发。盐野义方面表示，未来将持续加大对睡眠障碍相关研发的投入，力争在该领域实现突破，推动更多创新疗法尽早惠及患者。此次收购预计将在近期完成，双方将密切配合，确保平稳过渡和业务整合。 比利时制药巨头UCB宣布，将在美国乔治亚州投资20亿美元建设其首个生物制药生产基地，并计划招聘约330名员工。该工厂将引入人工智能（AI）、机器人和自动化等先进技术，以满足旗下关键产品日益增长的市场需求。这不仅是UCB在美国的首个生物制药生产设施，也标志着公司全球制造战略迈出重要一步。去年，UCB首次披露了在美国建设生物制药工厂的计划，并展开了选址调研，重点考察人才储备丰富的地区。最终，乔治亚州亚特兰大郊区的Gwinnett县脱颖而出。该县将成为UCB新工厂的所在地，工厂面积达46万平方英尺。乔治亚州州长Brian Kemp宣布，Gwinnett县将为该项目提供超过1.74亿美元的激励支持，包括物业税减免和基础设施投资。州政府团队今年早些时候还专程赴比利时推介乔治亚的优势，促成了这笔Gwinnett历史上最大规模的资本投资。新工厂预计将创造约330个永久制造岗位和超过1000个建筑施工岗位，成为Rowen开发区2000英亩园区中的首个全球租户。该园区的设计与建设周期预计为六至七年，得益于多年来公共基础设施的完善，包括水务和污水处理能力的提升。 吉利德科学将以近17亿美元收购成立于去年、专注自身免疫疾病的初创公司Ouro Medicines，获得其开发的一款针对免疫细胞表面两大热门靶点BCMA和CD3的双特异性抗体及相关T细胞连接剂。BCMA和CD3因在免疫治疗中的独特作用，长期受到制药企业的高度关注。吉利德不仅获得了Ouro这家年轻生物技术公司的全部资产，还接手了其从中国生物技术企业许可引进的T细胞连接剂。Ouro成立于2025年初，背后投资方包括GSK和Monograph Capital。其主打产品OM336（商品名gamgertamig）是一种能同时结合BCMA和CD3的双特异性抗体，具备清除异常B细胞和激活T细胞的双重功能。OM336的工作机制类似细胞疗法，能够有效清除异常B细胞，但相比细胞疗法，制造成本更低，无需复杂的化疗预处理，且支持多次给药，大大提升了治疗的灵活性和患者依从性。目前，OM336正处于临床试验阶段，针对多种罕见且难治的自身免疫疾病开展研究，涵盖自身免疫性细胞减少症、水疱性疾病、特发性炎症性肌病以及干燥综合征等。 总部位于马萨诸塞州的Pulmatrix宣布，将与私有生物科技公司Eos SENOLYTIX进行反向合并。后者专注于线粒体靶向药物的研发，其主打候选药物PTC-2105目前处于临床评估阶段，主要针对与年龄相关的肌肉质量和力量流失问题。合并完成后，新公司将以Eos SENOLYTIX的名义继续运营，并更换纳斯达克股票代码为“EOSX”，重点聚焦PTC-2105的开发。根据协议，Pulmatrix现有股东将持有合并后公司约6%的股份，其余94%由Eos SENOLYTIX投资者持有。双方董事会已批准该交易，预计将在2026年年中完成。Eos SENOLYTIX总部位于德克萨斯州休斯顿，专注于衰老的生物学机制。不同于多数抗衰老初创企业单纯依赖知名投资者，Eos SENOLYTIX将抗衰老研究与肥胖症这一生物制药热门领域相结合。该公司开发的MitoXcel衰老肽，旨在提升老化细胞中线粒体的功能，同时清除停止分裂但未凋亡的衰老细胞。基于此，Eos SENOLYTIX表示，PTC-2105有望实现“减少脂肪量超过目前司美格鲁肽（GLP-1受体激动剂）所能达到的水平，增加瘦体重，同时在不减少食物摄入且无体重反弹的情况下改善身体功能。”根据合并协议，双方已获得1900万美元的私募融资，主要用于推进PTC-2105治疗肌少症，即与年龄相关的肌肉质量和力量流失，以及其他相关疾病的临床开发。 生物医药公司Endogenex完成了一笔5000万美元融资，旨在加速其针对2型糖尿病的微创治疗技术开发，并推动该技术进入美国FDA的审批流程。这笔资金的到位，正值公司发布初步临床数据之后，显示其脉冲电场（PEF）治疗系统不仅达到了安全性指标，还在糖化血红蛋白（HbA1c）、空腹血糖和体重等关键代谢指标上取得了显著改善。Endogenex由美国著名的梅奥诊所（Mayo Clinic）合作创立，治疗的靶点是小肠上段的十二指肠。该技术旨在通过重置与2型糖尿病相关的炎症和功能障碍组织，恢复肠道对血糖、食欲和消化的调节能力。治疗过程中，内窥镜导入的电极阵列向十二指肠黏膜层施加脉冲电场，选择性消除功能低下的细胞，促进组织再生。这种方法避免了传统热能消融可能带来的热损伤，安全性更高。此前，该技术已获得FDA突破性疗法认定。本月早些时候，Endogenex公布了其在美国和澳大利亚展开的概念验证研究的48周数据。研究中，超过70名血糖控制不佳的2型糖尿病患者接受了该治疗，技术成功率达到100%。其中一组31名患者使用第二代高能量设备进行了两次治疗，48周后平均HbA1c下降1.5个百分点，体重平均减轻约5.4公斤，占体重的5%至6%。连续血糖监测显示，患者血糖维持在健康范围内的时间从治疗前的55.8%提升至82.1%。这笔5000万美元的融资由新投资者Arboretum Ventures领投，作为2024年C轮融资（当时筹集了8800万美元）的追加资金，将主要用于支持Endogenex关键性临床试验ReCET的开展，目前该试验正处于患者招募阶段。 武田宣布将开展一项全面重组计划，旨在精简运营结构，提升效率，以支持即将上市的新药和后续研发项目的发展。该计划于3月25日对外公布，目标是在2028财年实现超过2000亿日元（约12.6亿美元）的年度成本节约。公告中未透露此次重组将对员工人数产生何种具体影响，但公司强调，将通过优化企业职能、缩短领导层与团队间的距离，更贴近患者和客户需求，同时借助先进技术简化流程，提升整体运营效率。武田预计，2026财年将为此计提约1500亿日元（约9.4亿美元）的重组费用，未来两年还将产生一定的离职相关支出，但规模相对较小。 默沙东以67亿美元全现金收购纳斯达克上市公司拓臻生物。核心资产为白血病药物TERN-701。TERN-701是一款口服别构性BCR-ABL酪氨酸激酶抑制剂（TKI），专门针对慢性髓性白血病（CML）患者，尤其是那些对现有TKI治疗反应不佳的费城染色体阳性（Ph+）慢性期患者。CML是一种由基因突变引起的罕见血液恶性肿瘤，患者长期依赖靶向治疗维持病情。根据最新临床数据显示，TERN-701不仅显著降低了患者血液中异常白细胞的数量，而且安全性良好，严重不良反应少，且未见明显的血压异常或脂肪酶升高。这些积极信号在2025年3月获得了FDA孤儿药资格认定，彰显了其临床潜力。拓臻生物计划于今年年底或明年初启动更大规模的晚期临床试验。默沙东此次收购以每股53美元的价格完成，较拓臻生物最新收盘价溢价6%。扣除约10亿美元现金后，拓臻生物整体估值约为57亿美元。Scemblix最初获批用于多线治疗，现已扩展至新诊断Ph+ CML患者，全球峰值销售预期被诺华上调至40亿美元。市场研究机构BMO资本市场预测，TERN-701的未经调整峰值销售额同样有望超过40亿美元，显示出巨大的商业潜力。

Reflecting its new focus on the intradermal delivery of GLP-1 receptor agonists, Vaxess Technologies rebranded as Terrestrial Bio on Thursday. Alongside a pivot to use its patch technology for obesity treatments, the biotech also raised a $50-million series C led by RA Capital, with participation from Engine Ventures, GHIC and SiteGround.Terrestrial's microarray patch (MAP), which looks like an adhesive bandage, is applied to the skin with a preloaded applicator and removed after a few minutes. The patch has bioactive tips that, after being inserted into the skin, quickly dissolve and release their therapeutic payload. The MAP is temperature-stable and able to to be self-administered. Originally, the company's goal was to use its patches to deliver vaccines, including for influenza and COVID-19. But last year, Terrestrial shared early data suggesting its technology could also be used to deliver, via patch, a formulation of injectable GLP-1 drugs, like Novo Nordisk's Wegovy/Ozempic (semaglutide).At the 2025 American Diabetes Association (ADA) meeting, Terrestrial presented data on two different semaglutide patch designs tested on Gottingen minipigs. Each design delivered a clinically-relevant 2 nmol/kg dose, and demonstrated bioavailability comparable to subcutaneous injection, along with similar half-life profiles and modestly higher maximum plasma concentration.The company said Thursday that it signed a lease in Boston to expand its manufacturing capabilities as it readies for clinical trials of its lead GLP-1 programme.

Fourteen years ago, a group of Harvard Business School students launched a startup called Vaxess Technologies with a goal to disrupt the vaccine industry by replacing needles with a simple skin patch. Getting the technology to work was never easy. And just as the startup was beginning to make progress, times got tough for vaccine developers. AstraZeneca, which was evaluating how mRNA vaccines worked in the startup’s skin patches, quietly terminated its partnership last year. But Vaxess had another trick up its sleeve. The Boston-based company began work to see if it could use the patches — based on dissolving microneedles that slip beneath the surface of the skin — to deliver semaglutide, the GLP-1 agonist in Ozempic and Wegovy. On Wednesday, that pivot to GLP-1s became official. Vaxess has rebranded as Terrestrial Bio, and raised $50 million in Series C funding — its largest round yet — led by RA Capital and supported by Engine Ventures, GHIC and Siteground, its leaders told Endpoints News in an exclusive interview. “The explosive growth of the GLP-1 market really created a lot of interest and enthusiasm on our side, and an opportunity to actually impact patient health, population health, in a different way, arguably perhaps even in a bigger way, than vaccines,” CEO Rachel Sha said in an interview. The money brings the startup’s total funding from venture capital and grants to more than $150 million. Sha said the 60-person company could potentially double in size by the end of the year. The new funds will also go toward a Phase 1 trial of a semaglutide skin patch, which will start soon, and help the company scale up manufacturing of the patches. A patch for vaccines and complex drugs is an idea that scientists have kicked around for decades, but it’s never gained much traction. While transdermal patches allow the skin to absorb simple molecules like nicotine, the key ingredients of vaccines and drugs like semaglutide are too big to pass through the skin’s tough outer layer. Online supplement retailers already sell products marketed as GLP-1 skin patches. Many of them don’t list GLP-1 agonists in their ingredients, but if they do, Sha doubts that they work. “We’re guessing very, very little is actually being absorbed by the body,” she said. Terrestrial uses an array of dozens of microneedles that barely penetrate the skin. They plunge just far enough for the dissolvable tips, made from silk proteins, to fall off and lodge themselves in the body, but not so deep that they hurt nerves. Sha compared the sensation to snapping a rubber band on your wrist and said the patch can be removed after just five minutes. Excitement for novel vaccine approaches during the Covid-19 pandemic helped the company raise its first big round of funding and start its first clinical trial, for a flu vaccine, in 2022. Lynda Tussey, the company’s chief development officer, said the protection spurred by the vaccine was “consistent with the criteria for licensure.” But the startup pivoted from an older vaccine component to chase growing excitement over mRNA vaccines. Then, as the pandemic waned, so did interest in vaccine startups. The second Trump administration’s attacks on mRNA vaccines further eroded investment — and helped push away AstraZeneca. “We had a good relationship with AstraZeneca, but that program did pause with the administration change, so I would say it played a role,” Sha said. By the time Sha became CEO of Vaxess in 2024 — replacing the longtime CEO and founder Michael Schrader — the company had already explored loading its microneedles with drugs like semaglutide. Promising lab studies in animals prompted her to fully pivot to GLP-1s. Terrestrial’s upcoming Phase 1 trial, which could start as soon as this spring and yield data by the end of the year, aims to prove that a comparable amount of semaglutide gets into the bloodstream from its patches compared to subcutaneous injections. “We think it’s a fairly streamlined path to approval,” Sha said. It will face challenges. A pill version of semaglutide, which is selling rapidly, is already approved. In five years, when Terrestrial believes its patches could be done with testing and up for approval, the weight loss market will likely look very different, with some drugs off patent and combination therapies more common. Despite that, Sha thinks there will still be a market for Terrestrial. “We feel pretty bullish,” she said. Since semaglutide is sold at five dose levels, Terrestrial will need to make five different-sized patches with different numbers of needles — the largest just slightly bigger than the size of a US quarter. The company is opening a new 40,000-square-foot manufacturing facility close to Harvard to begin ramping production up to millions of patches a year, a small but important step toward the ultimate goal of producing “hundreds of millions at time of launch,” Sha said.