Unity Biotechnology, Inc.

COLUMBUS, Ohio--(BUSINESS WIRE)--Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an AAV development and manufacturing agreement to help advance Fractyl Health’s Rejuva* pancreatic gene therapy platform for the treatment of patients with obesity and type 2 diabetes (T2D). "We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,” said John Maslowski, President and CEO of Forge. "We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,” said John Maslowski, President and CEO of Forge. “We are proud to support Fractyl in advancing a new class of metabolic disease therapies. Their mission to break the cycle of chronic disease management for patients is one we are honored and excited to help enable.” “We are excited to collaborate with Forge in advancing our Rejuva pancreatic gene therapy platform. Forge’s expertise in large-scale, efficient AAV manufacturing is invaluable as we move forward in our mission to develop scalable treatments that aim to prevent and reverse obesity and metabolic disease,” said Harith Rajagopalan M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. Through this relationship, Forge will provide Fractyl process development, cGMP manufacturing and analytical development services. Fractyl will also leverage Forge’s FUEL™ platform, including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio. *The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. About Forge Biologics Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.

在现今生物技术领域融资困难的背景下，一家抗衰老生物技术公司完成了一笔高额的B轮融资，进入大众视野。近日，NewLimit宣布完成了1.3亿美元的B轮融资，该轮融资由Kleiner Perkins领头，包括新投资者Nat Friedman/Daniel Gross、Khosla Ventures、Human Capital和Valor Equity Partners，以及现有投资者Dimension。新的资金主要用于推进一种恢复衰老肝脏细胞功能的mRNA药物的临床开发。逆转细胞衰老NewLimit成立于2022年，是一家主要开发抗衰老药物的生物技术公司。NewLimit认为，衰老是人类几乎所有主要疾病的元驱动力。衰老被认为是不可逆的，但是新兴的表观遗传编程科学表明，衰老是可塑的，这为人类疾病提供了更大的治疗机会。NewLimit的科学就建立在表观遗传重编程的发现上，即调整基因表达从而改变细胞的行为，乃至完全改变细胞类型。基于该策略，NewLimit目标旨在开发一定的药物分子，来对人体内的衰老细胞进行重编程，使其具有年轻细胞的功能，以延长患者的健康寿命。此外，NewLimit还利用了AI技术进行药物开发工作。NewLimit表示，将利用实验室的结果数据来训练前沿的AI模型，AI与规模化基因组学的结合，能够确保筛查最有前途的潜在药物。首个管线—酒精性肝病根据报道，NewLimit首个药物管线，是一款针对酒精相关肝病的mRNA分子。其编码表达的转录因子能够使得肝脏细胞更年轻化，并利用脂质纳米颗粒进行mRNA的封装递送。该管线被设计为静脉注射，目标是最短每三周给药一次，类似Alnylam的RNAi药物，该给药方式和方案已经经过商业验证，被证明是安全有效的。NewLimit的联合创始人兼总裁Jacob Kimmel表示，“衰老细胞与年轻细胞使用不同的基因。更重要的是，衰老细胞的功能会丧失，例如在肝脏中，衰老细胞就不像年轻细胞那样删除处理酒精和咖啡因。”NewLimit计划将在未来几年将该核心资产酒精性肝病mRNA推进临床，并在未来的开发当中，将其应用扩展至更广泛的患者群体。小结实际上，抗衰老一直是非常热门的研究方向。近年涌现了不少与抗衰老相关的药物开发公司，例如上个月Flagship Pioneering也推出了Etiome，旨在延长健康寿命，而非仅仅是寿命。但，抗衰老也非常的难做，其需要庞大的科学知识理论支撑和资金支持。前几天，刚有一家抗衰老药物研发企业Unity Biotechnology失败了，裁撤了全部的员工，并正在进行战略审查。参考资料：1.https://www.fiercebiotech.com/biotech/anti-aging-biotech-newlimit-raises-130m-push-liver-reprogramming-med-clinic2.https://blog.newlimit.com/p/newlimit-raises-130-million-series?utm_campaign=post&utm_medium=web本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处········

UBX1325 demonstrated vision gains that were comparable and statistically non-inferior to aflibercept at week 36 in a difficult-to-treat DME patient population UBX1325 generally outperformed aflibercept in a pre-specified subgroup of patients entering the study with CST Company to explore strategic alternatives to advance UBX1325, Tie2/anti-VEGF bispecific, and Tie2 agonistic antibody assets and reduce operational cash burn May 05, 2025 -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced complete 36-week results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment. The Company previously disclosed 24-week and interim 36-week results from its ASPIRE trial, demonstrating that UBX1325 was non-inferior to aflibercept at most time points through 36 weeks, except for the average of weeks 20 and 24, the primary endpoint. Non-inferior visual gains in Best-Corrected Visual Acuity (BCVA) compared to leading anti-VEGF product UBX1325 was statistically non-inferior to aflibercept at week 36 UBX1325 generally outperformed aflibercept in subjects who had moderately aggressive disease (central subfield thickness (CST) Favorable safety and tolerability profile UBX1325 continues to demonstrate a favorable safety and tolerability profile across multiple clinical studies to date There have been no cases of intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis across multiple studies “UBX1325 has demonstrated the potential to provide a much-needed alternative treatment to anti-VEGF therapy through a completely novel mechanism of action,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “UBX1325’s demonstration of non-inferiority to aflibercept at 36 weeks and superior vision gains in the subgroup of patients with CST under 400 microns underscores its potential to provide a valuable treatment option to patients. We believe that further development of UBX1325 would benefit from the capabilities of a company with an existing ophthalmic franchise, and we are exploring partnerships so that this program can continue to be advanced as a potential new treatment. I am proud of the valuable contributions our team has made in advancing a new therapeutic concept for DME, as featured in our recently published article in NEJM Evidence.” The Company will present full 36-week results from the ASPIRE study at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting on Wednesday, May 7, 2025. Corporate Update: In conjunction with the full 36-week results, the Board of Directors has also approved a revised operating plan focused on evaluating strategic alternatives while reducing operational cash burn. As part of the operating plan, the Company will be implementing a reduction in force affecting all of its workforce, with certain consulting arrangements in place to close down the ASPIRE study. The Company intends to explore a full range of strategic alternatives, which may include, but are not limited to, the sale, license, monetization and/or divestiture of one or more of the Company’s assets and technologies (including UBX1325, the Tie2/aVEGF bispecific, and the Tie2 agonistic antibody), a strategic transaction, collaboration, partnership, merger, sale, or a winddown or dissolution of the Company. The Company’s Chief Executive Officer, Chief Financial Officer, and Chief Legal Officer will transition into consulting roles with the Company to support in evaluation of strategic alternatives and orderly transition of management roles. The Company may engage external advisors to support the evaluation of strategic alternatives. The Company's exploration of strategic alternatives may not result in the consummation of any transaction or the realization of any value for the Company or its shareholders. UBX 1325 (BCL-xL inhibitor) Clinical data from the Phase 2 BEHOLD Study and the Phase 2B ASPIRE study in patients with DME demonstrate improvement in visual acuity with UBX1325 treatment. UBB 2048 (Tie2/aVEGF Bispecific) Preclinical data indicate strong Tie2 pathway activation and inhibition of VEGF pathways, as well as efficacy in models of retinal disease, with clinical candidate molecule. The molecule targets a validated pathway for treating DME and wet age-related macular degeneration (AMD), with best-in-class potential. UBX2050 (Tie2 agonistic antibody) Preclinical data indicates strong Tie2 pathway activation with clinical candidate molecule with therapeutic rationale for diseases of vascular permeability, including chronic kidney disease, diabetic nephropathy, and vascular dementia. Alpha-Klotho (biologic) Global license agreement with Jocasta Neuroscience, Inc. for development and commercialization in neurological indications, with development milestones, approval milestones, and sales-based royalties. Senescence and Aging biology IP portfolio: Broad and foundational patent portfolio in senescence and other age-related biology for multiple indications including ophthalmology, neurological diseases, pulmonary diseases, kidney-related diseases, cardiac and vascular diseases. ASPIRE is a multi-center, randomized, double-masked, active-controlled Phase 2b study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active DME who are not achieving optimal benefit from standard of care. The study enrolled 52 subjects who were randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months after randomization. The primary efficacy endpoint is non-inferiority to aflibercept as assessed by mean change from baseline in Best Corrected Visual Acuity (BCVA) to the average of weeks 20 and 24. Additional information about ASPIRE (NCT06011798) can be found here. UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of BCL-xL, a member of the BCL-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean BCVA through 48 weeks compared to sham treatment. In preclinical studies, UNITY has demonstrated that targeting BCL-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease. UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. The content above comes from the network. if any infringement, please contact us to modify.