A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:
* Does AP301 lower blood phosphate levels?
* Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?
* What discomfort or medical problem do the patients have when taking AP301?
* Does AP301 improve quality of life in Chinese patients?
The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.
In the study, the patients will experience the following stages in a chronicle order:
* Stop all using blood phosphate-lowering drugs,
* Take AP301 or the comparator three times a day for 8 weeks,
* Take AP301 three times a day for 24 weeks, and
* Take AP301 or the comparator three times a day for 3 weeks.
In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.
If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.

Start Date13 Jun 2025

Sponsor / Collaborator

Shanghai Alebund Pharmaceuticals Co., Ltd.

[+1]

CTR20250674

/ CompletedPhase 1

一项在中国健康受试者中评估AP301与西那卡塞的药物-药物相互作用的研究

[Translation] A study evaluating drug-drug interactions between AP301 and cinacalcet in healthy Chinese subjects

主要目的：在健康男性和女性受试者中评估AP301（2.1g/次，每日3次）连续2日口服给药对西那卡塞（75 mg）单次口服给药的PK影响。次要目的：在健康男性和女性受试者中评估AP301和西那卡塞联合给药的安全性和耐受性。

[Translation]

Primary objective: To evaluate the PK effect of AP301 (2.1 g/time, 3 times daily) administered orally for 2 consecutive days on a single oral administration of cinacalcet (75 mg) in healthy male and female subjects. Secondary objective: To evaluate the safety and tolerability of AP301 and cinacalcet co-administered in healthy male and female subjects.

Start Date09 Apr 2025

Sponsor / Collaborator

Shanghai Alebund Pharmaceuticals Co., Ltd.

[+1]

CTR20250363

/ CompletedPhase 1

一项在中国健康参与者中评估AP301与罗沙司他的药物-药物相互作用的研究

[Translation] A study evaluating drug-drug interactions between AP301 and roxadustat in healthy Chinese participants

主要目的：在健康男性和女性参与者中评估AP301（2.1 g/次，每日3次）连续2日口服给药对罗沙司他（150 mg）单次口服给药的PK影响。次要目的：在健康男性和女性参与者中评估AP301和罗沙司他同时口服给药的安全性和耐受性。

[Translation]

Primary objective: To evaluate the PK effect of AP301 (2.1 g/time, 3 times daily) administered orally for 2 consecutive days on a single oral administration of roxadustat (150 mg) in healthy male and female participants. Secondary objective: To evaluate the safety and tolerability of AP301 and roxadustat administered orally simultaneously in healthy male and female participants.

Start Date03 Mar 2025

Sponsor / Collaborator

Shanghai Alebund Pharmaceuticals Co., Ltd.

[+1]

100 Clinical Results associated with VS-505

100 Translational Medicine associated with VS-505

100 Patents (Medical) associated with VS-505

Literatures (Medical) associated with VS-505

27 Sep 2024·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis

Article

Author: Li, Kanghui ; Yuan, Weijie ; Liu, Bin ; Li, Yiwen ; Ye, Hong ; Peng, Ai ; Shi, Ming ; Zhang, Zhizheng ; Lin, Hongli ; Chen, Xiaolan ; Zheng, Huixiao ; Zhang, Weifeng ; Lu, Wei ; Zheng, Feng ; Gao, Qing ; Wang, Song ; Zuo, Li ; He, Qiang ; Liu, Yingxue Cathy ; Wang, Baoxing ; Long, Gang ; Luo, Yuan ; Wang, Lihua ; Luo, Ping ; Yang, Junwei ; Zhang, Shiying ; Liu, Tongqiang ; Liu, Changhua ; Zhuang, Bing ; Li, Xiaoling ; Gan, Liangying

ABSTRACT:

Background:

VS-505 (AP301), an acacia and ferric oxyhydroxide polymer, is a novel fiber-iron-based phosphate binder. This two-part Phase 2 study evaluated the tolerability, safety and efficacy of oral VS-505 administered three times daily with meals in treating hyperphosphatemia in chronic kidney disease (CKD) patients receiving maintenance hemodialysis (MHD).

Methods:

In Part 1, patients received dose-escalated treatment with VS-505 2.25, 4.50 and 9.00 g/day for 2 weeks each, guided by serum phosphorus levels. In Part 2, patients received randomized, open-label, fixed-dosage treatment with VS-505 (1.50, 2.25, 4.50 or 6.75 g/day) or sevelamer carbonate 4.80 g/day for 6 weeks. The primary efficacy endpoint was the change in serum phosphorus.

Results:

The study enrolled 158 patients (Part 1: 25; Part 2: 133), with 130 exposed to VS-505 in total. VS-505 was well tolerated. The most common adverse events were gastrointestinal disorders, mainly feces discolored (56%) and diarrhea (15%; generally during Weeks 1–2 of treatment). Most gastrointestinal disorders resolved without intervention, and none was serious. In Part 1, serum phosphorus significantly improved (mean change −2.0 mg/dL; 95% confidence interval −2.7, −1.4) after VS-505 dose escalation. In Part 2, serum phosphorus significantly and dose-dependently improved in all VS-505 arms, with clinically meaningful reductions with VS-505 4.50 and 6.75 g/day, and sevelamer carbonate 4.80 g/day [mean change −1.6 (−2.2, −1.0), −1.8 (−2.4, −1.2) and −1.4 (−2.2, −0.5) mg/dL, respectively]. In both parts, serum phosphorus reductions occurred within 1 week of VS-505 initiation, returning to baseline within 2 weeks of VS-505 discontinuation.

Conclusion:

VS-505, a novel phosphate binder, was well tolerated with a manageable safety profile, and effectively and dose-dependently reduced serum phosphorus in CKD patients with hyperphosphatemia receiving MHD.

Clinical Trial registration number:

NCT04551300

01 Jan 2022·Computational and structural biotechnology journal

Conformational ensemble of the TNF-derived peptide solnatide in solution

Article

Author: Martin-Malpartida, Pau ; Fischer, Bernhard ; Arrastia-Casado, Silvia ; Tzotzos, Susan ; Farrera-Sinfreu, Josep ; Lucas, Rudolf ; Macias, Maria J ; Fischer, Hendrik ; Eaton, Douglas C

Tumor necrosis factor (TNF) is a homotrimer that has two spatially distinct binding regions, three lectin-like domains (LLD) at the TIP of the protein and three basolaterally located receptor-binding sites, the latter of which are responsible for the inflammatory and cell death-inducing properties of the cytokine. Solnatide (a.k.a. TIP peptide, AP301) is a 17-mer cyclic peptide that mimics the LLD of human TNF which activates the amiloride-sensitive epithelial sodium channel (ENaC) and, as such, recapitulates the capacity of TNF to enhance alveolar fluid clearance, as demonstrated in numerous preclinical studies. TNF and solnatide interact with glycoproteins and these interactions are necessary for their trypanolytic and ENaC-activating activities. In view of the crucial role of ENaC in lung liquid clearance, solnatide is currently being evaluated as a novel therapeutic agent to treat pulmonary edema in patients with moderate-to-severe acute respiratory distress syndrome (ARDS), as well as severe COVID-19 patients with ARDS. To facilitate the description of the functional properties of solnatide in detail, as well as to further target-docking studies, we have analyzed its folding properties by NMR. In solution, solnatide populates a set of conformations characterized by a small hydrophobic core and two electrostatically charged poles. Using the structural information determined here and also that available for the ENaC protein, we propose a model to describe solnatide interaction with the C-terminal domain of the ENaCα subunit. This model may serve to guide future experiments to validate specific interactions with ENaCα and the design of new solnatide analogs with unexplored functionalities.

01 Dec 2021·TrialsQ4 · MEDICINE

Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial

Q4 · MEDICINE

ArticleOA

Author: Zwißler, Bernhard ; Markstaller, Klaus ; Frank, Sandra ; Kranke, Peter ; Meybohm, Patrick ; Schmid, Benedikt ; Fischer, Bernhard ; Krenn, Katharina ; Kredel, Markus ; Lucas, Rudolf ; Ullrich, Roman

Abstract:

Background:

Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a Phase I clinical trial. Here, we present the protocol for a Phase IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients.

Methods:

This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of 7 days, ensued by a follow-up period of another 21 days.

Discussion:

The patients to be included in this trial will be severely sick and in need of mechanical ventilation. The amount of data to be collected upon screening and during the course of the intervention phase is substantial and the potential timeframe for inclusion of any given patient is short. However, when prepared properly, adherence to this protocol will make for the acquisition of reliable data. Particular diligence needs to be exercised with respect to informed consent, because eligible patients will most likely be comatose and/or deeply sedated at the time of inclusion.

Trial registration:

This trial was prospectively registered with the EU Clinical trials register (clinicaltrialsregister.eu). EudraCT Number: 2017-003855-47.

News (Medical) associated with VS-505

26 Jun 2025

·www.prnewswire.com

Alebund Announces Positive Topline Results from Pivotal Phase 3 Study of AP301 for Serum Phosphorus Control in Dialysis Patients with Hyperphosphatemia

SHANGHAI, June 26, 2025 /PRNewswire/ -- Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for renal diseases and related chronic conditions, announced the database lock was achieved on June 16, 2025 for the pivotal phase 3 study of its investigational drug AP301, a new generation of oral iron-based phosphate binder, in dialysis patients with hyperphosphatemia. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in serum phosphorus control with AP301. The safety profile of AP301 is favorable and consistent with previous studies. As a novel fiber-iron-based phosphate binder, AP301 provides high phosphate-binding capability, no need to chew before swallow, no volume expansion when exposed to gastric fluid, and no systemic absorption. These properties contribute to a reduced pill burden, good tolerability and improved patient compliance. The pivotal study (NCT07030595, CTR20231624) is a randomized, open-label, active-controlled, multi-center phase 3 study designed to evaluate the efficacy and safety of AP301 in controlling serum phosphorus levels in dialysis patients with hyperphosphatemia. The 52-week study contains an active control phase, an AP301 low-dose control phase and an extended treatment phase. Sevelamer carbonate served as the active comparator throughout the whole study period. A total of 474 participants were randomized across 50 investigational sites in China; the study was led by Professor Li ZUO, Director of the Department of Nephrology at Peking University People's Hospital. "We are deeply grateful to all the participants, investigators, and study personnel for their strong commitment and dedication to this phase 3 study over the past 2 years." Dr. Jin Tian, Co-founder and CMO of Alebund commented, "In the completed phase 2 study, AP301 was shown to be safe, well tolerated, and can effectively lower serum phosphorus in a dose-dependent manner [1]. This pivotal trial further demonstrates the clinical value of AP301, which has the potential to advance the treatment option for millions of patients with hyperphosphatemia through further increasing their adherence." Alebund plans to engage with China National Medical Products Administration (NMPA) regarding its new drug application plan in the third quarter of 2025. Detailed results from this phase 3 study will be presented at an upcoming medical conference. Reference [1] Bing Zhuang, Liangying Gan, Bin Liu, Weijie Yuan, Ming Shi, Ai Peng, Lihua Wang, Xiaolan Chen, Tongqiang Liu, Shiying Zhang, Song Wang, Qing Gao, Baoxing Wang, Huixiao Zheng, Changhua Liu, Yuan Luo, Hong Ye, Hongli Lin, Yiwen Li, Qiang He, Feng Zheng, Ping Luo, Gang Long, Wei Lu, Kanghui Li, Junwei Yang, Yingxue Cathy Liu, Zhizheng Zhang, Xiaoling Li, Weifeng Zhang, Li Zuo, Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis, Nephrology Dialysis Transplantation, Volume 39, Issue 10, October 2024, Pages 1649–1661, About Hyperphosphatemia Hyperphosphatemia is one of the most common complications in CKD patients. The long-term elevated serum phosphorus level could cause multiple complications such as secondary hyperparathyroidism, renal osteodystrophy and vascular calcification. It is an independent risk factor of cardiovascular events and all-cause mortalities. A good control of serum phosphorus level could effectively improve the patients' outcome. For CKD patients undergoing dialysis treatment, the regular dialysis is not sufficient to remove the overload of serum phosphate in the body. Considering the limitations of low-phosphate diet which might cause dystrophia, oral use of phosphate binders is the prevailing treatment for hyperphosphatemia. However, there is low compliance for patients (less than 50% reaching good phosphate control) to use PBs due to gastrointestinal side effects, high pill burden etc. According to Global and Chinese Hyperphosphatemia Drug Industry Blue Book by China Insights Consultancy in 2023, the out of target rate of serum phosphorus level in dialysis patients in Chinese mainland was significantly higher than other countries and regions. There is still room for improvement in terms of the proportion and duration of phosphorus binders usage. The market size of serum phosphorus lowering products in China is expected to reach 10 billion RMB by 2035. About Alebund Pharmaceuticals Alebund was incubated in Shanghai in 2018. It focuses on the discovery, development, production and commercialization of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions, to bring greater therapeutic options to patients in China and globally. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal indications, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis (FSGS) and autosomal dominant polycystic kidney disease (ADPKD). Alebund has completed the construction of its manufacturing site for small molecules in Yangzhou that will supply bulk of Alebund's pipeline drugs, including AP301, upon commercial launch. Alebund has also established a dedicated commercialization team in China, responsible for the commercial promotion of renal products. SOURCE Alebund Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Phase 2

24 Feb 2025

·synapse.patsnap.com

Major Funding Rounds Drive Next-Gen Therapies in January 2025

With the thriving development of the biopharmaceutical industry, January 2025 witnessed several significant financing events exceeding $100 million, infusing fresh resources into pioneering companies dedicated to addressing unmet medical needs. For many startups focused on developing next-generation therapies and technologies, this period of fundraising activities represents a crucial milestone in achieving scientific breakthroughs and advancing commercialization of their products. Whether concentrating on gene editing technologies for personalized treatment plans or exploring new paths for vaccine development with biotechnological platforms, each successful financing case underpins the crystallization of scientists' wisdom and a hopeful vision for future health. Additionally, the active response from the capital market provides a solid foundation and support for companies seeking to expand production scales, accelerate clinical trial processes, or broaden international markets. 1.Alebund Pharmaceuticals completes a 550 million yuan Series C financing to accelerate the R&D and commercialization process of innovative therapies for kidney diseases On January 7, 2025, Alebund Pharmaceuticals announced the successful completion of its Series C financing, raising a total of 550 million yuan (approximately $75.046 million). Founded in 2018 and headquartered in Shanghai, Alebund Pharmaceuticals is a comprehensive biopharmaceutical company specializing in the development of innovative drugs for kidney diseases and related chronic conditions. The company aims to provide better clinical treatments for patients worldwide with chronic kidney disease (CKD) and related disorders and has established a rich and balanced product pipeline covering various kidney disease areas including CKD, IgA nephropathy, diabetic nephropathy, focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). The funds raised will primarily be used to accelerate the R&D process of its core products. Part of the funds will be used to advance the New Drug Application (NDA) and pivotal Phase III global clinical trials for AP301, a novel iron-based phosphate binder designed to treat hyperphosphatemia in patients with chronic renal failure. AP301 works by effectively binding to dietary phosphates in the gastrointestinal tract, reducing phosphate absorption, thus lowering serum phosphate levels and improving long-term clinical outcomes. The key Phase III clinical trial of AP301 has already witnessed the enrollment of its first patient in China and conducted an investigator meeting, marking an important step towards marketization. Additionally, funds will also support the Phase II clinical trials in the U.S. and China for AP306, a small molecule pan-phosphate transporter inhibitor. This represents the first globally to enter clinical development, holding a pioneering significance. 2.Kardigan Secures $300 Million in Series A Funding to Accelerate Development of Precision Therapies for Cardiovascular Diseases On January 10, 2025, Kardigan announced the completion of a $300 million Series A funding round led by Perceptive Advisors, ARCH Venture Partners, and Sequoia Heritage. The funds will be used to advance research in areas of unmet need within cardiology, specifically focusing on the development of treatment protocols for heart failure caused by primary and secondary cardiomyopathies. Kardigan utilizes a proprietary set of cardiac-specific tools that enable deep insights into the mechanisms of action of its therapeutic candidates and the personalized responses of patients to treatments. This approach allows the company to optimize clinical trial processes, ensuring that new therapies are provided to those most likely to benefit while seeking alternative treatments for those less likely to benefit. Additionally, Kardigan’s R&D platform not only focuses on discovery and translational research but also integrates strategic licensing and acquisitions, forming a comprehensively integrated biopharmaceutical company. In terms of R&D pipeline, Kardigan concentrates on concurrently developing multiple targeted therapeutic approaches to offer more effective treatment options for patients with cardiovascular diseases. For example, the company is exploring a range of disease-modifying drugs that shift the therapeutic paradigm from symptom management to functional cure. Kardigan’s projects encompass several key areas of cardiovascular disease, including but not limited to primary and secondary cardiomyopathies leading to heart failure. Notably, Kardigan’s R&D strategy also includes establishing a cardiac intelligence model that enables the team to generate and share data across various projects, further enhancing research efficiency and success rates. 3.Neko Health Raises $260 Million in Series B Funding to Accelerate Innovation in Preventive Medical Technology and Global Market Expansion On January 22, 2025, Neko Health completed a $260 million Series B funding round led by Lightspeed Venture Partners, with additional support from General Catalyst, O.G. Venture Partners, Rosello, Lakestar, and Atomico among other prominent investment firms. The funding will be used to expedite Neko Health's rapid expansion in the European and US markets and continue investing in the development of its innovative non-invasive health diagnostic technology. This funding round not only signifies investor confidence in Neko Health’s technology and services but also reflects a growing market trend towards preventive medical services. Neko Health aims to address the global rise in chronic disease burden by providing efficient, convenient, and comprehensive health management solutions. Neko Health's core technology is a non-invasive full-body scanner that can map millions of health data points within minutes, helping to identify multiple health risk factors. This technology incorporates high-resolution 2D and 3D imaging, thermal imaging, cardiovascular measurements, grip strength tests, intraocular pressure assessments, and blood tests with AI analysis to rapidly provide personalized health insights to clients. Neko Health's scans can detect risks for skin cancer, metabolic syndrome symptoms, stroke and heart disease, prediabetes signs, and blood abnormalities. Since its first service launch in London and Stockholm in 2023, the company has completed over 10,000 scans and amassed a global waiting list exceeding 100,000 people. 4.Aviceda Therapeutics Secures $207.5 Million in Series C Funding to Advance Ophthalmic Innovations to New Milestones On January 7, 2025, Aviceda Therapeutics completed a $207.5 million Series C financing round, co-led by Omega Funds and TCGX, with support from Enavate Sciences, Jeito Capital, Blue Owl Healthcare Opportunities, and other investment institutions. This capital will primarily fund the clinical development of their lead project, AVD-104, especially the critical Phase 3 clinical trial targeting Geographic Atrophy (GA), a vision-threatening condition commonly secondary to late-stage Age-Related Macular Degeneration (AMD). Based in Cambridge, Massachusetts, Aviceda Therapeutics is a biotechnology firm focused on developing the next generation of immunomodulators. Utilizing its proprietary high-affinity Siglecs ligand (HALOS™) nanotechnology platform, the company aims to tackle chronic unresolved inflammation. Its primary candidate, AVD-104, is a vitreous-injectable nanoparticle that works via a dual mechanism on inflammatory cells and the complement pathway to slow the progression of GA lesions and improve visual function in patients. Currently, AVD-104 is undergoing a Phase 2b/3 clinical trial, with key data expected to be released in the second half of 2025. 5.Colossal Biosciences Raises $200 Million in Series C Funding to Accelerate Genetic Engineering Breakthroughs and Vision for De-extincting Species On January 15, 2025, Colossal Biosciences completed a $200 million Series C funding round co-led by TWG Global, Mark Walter, and Thomas Tull. This funding round brought the company's total funding to $435 million and increased its valuation to $10.2 billion. The capital will be used to further advance genetic engineering technologies and develop new software, hardware, and wetware solutions to support its core projects of resurrecting extinct species, such as the woolly mammoth, thylacine, and dodo bird, and exploring applications in species conservation and human healthcare. Colossal Biosciences is a company dedicated to de-extincting species using cutting-edge technologies like CRISPR gene editing, along with innovative approaches like artificial wombs to restore extinct species and increase Earth's biodiversity. Beyond bringing extinct species back to life, Colossal is also exploring how its technologies can be applied in broader ecological conservation, agricultural technologies, and human medical fields. The company plans to spin off several enterprises in the next two years, including one focused on artificial womb technology, which may offer new possibilities for human reproductive treatments. 6.Windward Bio Secures $200 Million in Series A Funding to Accelerate Long-Acting TSLP Antibody and Immunotherapy Pipeline On January 10, 2025, Windward Bio announced the completion of a $200 million Series A financing round co-led by OrbiMed, Novo Holdings, and Blue Owl Healthcare Opportunities, with participation from other prominent investment firms including SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners. This capital will primarily fund the Phase 2 clinical trials of WIN378 and support Windward Bio in developing a pipeline of long-acting bispecific antibodies for immune diseases. Based in Switzerland, Windward Bio is a clinical-stage pharmaceutical company whose main project, WIN378 (also known as HBM9378/SKB378), is a fully human monoclonal antibody targeting the thymic stromal lymphopoietin (TSLP) ligand. WIN378 works by blocking the interaction between TSLP and its receptor, inhibiting the associated signaling pathway, playing a significant role in treating severe respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). The antibody is designed with an extended half-life, potentially allowing for bi-annual dosing, which could significantly reduce treatment burden and improve quality of life for patients. Besides WIN378, Windward Bio plans to expand its R&D pipeline focused on developing long-acting bispecific antibodies utilizing validated targets and principles of synergistic biology to achieve optimal therapeutic effects. The company is building an early discovery pipeline that includes several projects focused on the development of long-acting bispecific antibodies for immune diseases. With the latest $200 million in Series A funding, these funds will support advancing two undisclosed projects through the preclinical stages required for new drug research applications (INDs). Additionally, the company is preparing to initiate a Phase II clinical trial for severe asthma, with initial clinical data expected in 2026. For COPD treatment, Windward Bio has clear development aims and plans to conduct additional clinical trials in regions such as the US, Europe, and Japan to meet the needs of an estimated 5 million patients with late-stage, poorly controlled conditions. 7.Timberlyne Therapeutics Closes $180 Million Series A Funding to Accelerate Clinical Studies of CD38 Antibody CM313 On January 9, 2025, Timberlyne Therapeutics completed a $180 million Series A funding round led by renowned investment firms Abingworth, Bain Capital Life Sciences, and Venrock Healthcare Capital Partners, with additional participation from Boyu Capital, Lilly Asia Ventures, Braidwell LP, and 3H Health Investment. These funds will primarily be used to advance the clinical development of their flagship project CM313, a monoclonal antibody targeting CD38 for treating various autoimmune diseases and cancers. Timberlyne Therapeutics, a clinical-stage biopharmaceutical company, focuses on developing innovative therapies for autoimmune diseases and cancer. Their flagship product, CM313, is a potentially best-in-class anti-CD38 monoclonal antibody that has demonstrated positive clinical outcomes in conditions including immune thrombocytopenic purpura (ITP), systemic lupus erythematosus (SLE), and relapsed/refractory multiple myeloma (RRMM). By targeting CD38, CM313 modulates various immune cell types, aiming for a rapid and sustained therapeutic response. 8.Ouro Medicines has completed a Series A funding round of $120 million On January 10, 2025, to speed up the global development of its immunotherapy, OM336. The financing was led by TPG Life Sciences Innovations, NEA, and Norwest Venture Partners, with additional support from Monograph Capital, GSK, UPMC Enterprises, Boyu/Zoo Capital, LongRiver Investments, and other prominent investment firms. This capital will primarily facilitate the global development of the company's flagship product OM336 (CM336), focusing on clinical studies for multiple myeloma and exploring its potential applications in autoimmune diseases. Ouro Medicines is a biotechnology company dedicated to developing immune reset therapies, aiming to provide innovative treatment options for patients with chronic immune-mediated diseases. The company's core product, OM336, is a BCMA-targeted bispecific T cell engager (TCE) antibody that enables sustained disease remission by precisely targeting and depleting pathogenic cell populations without relying on long-term immunosuppression. OM336 is currently undergoing a Phase 2 clinical trial for multiple myeloma and is planned to enter Phase 1 trials in 2025 to evaluate its efficacy in B cell-mediated diseases like systemic lupus erythematosus, scleroderma, and rheumatoid arthritis. 9.Aspect Biosystems has announced the completion of a $115 million Series B funding round On January 8, 2025, to accelerate the clinical development of its bioprinted tissue therapies. Led by Dimension, a multi-stage investment firm focused on the intersection of technology and life sciences, the round also saw participation from Novo Nordisk, Radical Ventures, InBC, Pallasite Ventures, Pangaea Ventures, Rhino Ventures, and T1D Fund. The funds will be used to accelerate the clinical development of bioprinted tissue therapies and expand its full-stack tissue therapy platform. Aspect Biosystems is a leading biotechnology company revolutionizing regenerative medicine through bioprinting technology. The company has developed an AI-driven full-stack tissue therapy platform, integrating proprietary bioprinting technology, computational design tools, and advanced biomaterials and therapeutic cells. The core products are focused on developing novel cell therapies for severe metabolic and endocrine disorders, providing patients with functional treatment options. 10.Geneoscopy raised $105 million in Series C funding to advance the commercialization of its non-invasive colorectal cancer screening tool, ColoSense® On January 8, 2025, Geneoscopy announced the completion of a Series C funding round totaling $105 million, led by Bio-Rad Laboratories and supported by several investment institutions including Petrichor, Labcorp, Morningside Ventures, Lightchain Capital, NT Investments, Granger Management, Mercy Health, and Tri Locum Partners. This funding will primarily support the commercialization of ColoSense®, a home-based fecal colorectal cancer screening test, and further the development of the company's pipeline for diagnosing inflammatory bowel disease (IBD). Geneoscopy is a life sciences company focused on developing diagnostic tests for gastrointestinal health, with a core technology that isolates human RNA from patients’ stool samples, enabling effective screening for colorectal cancer. By integrating Bio-Rad's Droplet Digital PCR (ddPCR) technology, Geneoscopy offers a non-invasive screening approach that yields higher patient compliance compared to traditional colonoscopy. Additionally, the company plans to collaborate with Labcorp to expand the market coverage of the ColoSense® test, integrating it into comprehensive screening programs offered by healthcare providers. Summary The dynamics in the capital markets of the biopharmaceutical sector in 2025 reveal several important trends in industry development. On one hand, personalized medicine, preventive medicine, and regenerative medicine have become investment hotspots, reflecting the market’s high expectations for innovative therapies that can meet unmet medical needs. Alebund Pharmaceuticals, which focuses on treating chronic kidney disease, Kardigan, which is dedicated to developing precision therapies for cardiology, and Neko Health, which advances early disease detection through non-invasive health diagnostic technologies, illustrate successful financing not only showcases their technological strength but also represents the shift towards more personalized and preventive medical models. With advancements in artificial intelligence and big data analytics, these companies are offering more precise and effective treatment options to patients. On the other hand, despite significant progress, the biopharmaceutical industry's research and development process remains challenging. From laboratory research to clinical trials, and onto product commercialization, each stage requires substantial resource investment and prolonged effort. Companies that have secured funding need to effectively manage and utilize these resources to ensure that R&D investments translate into tangible treatment outcomes. Additionally, given the increasingly competitive market, maintaining a technological edge and avoiding redundant development are strategic imperatives for these companies. Furthermore, transnational collaboration and mergers and acquisitions are accelerating, which aids in resource integration and technology exchange, promoting the development of the global biopharmaceutical industry. How to get the latest progress on drug deals? If you would like to access the latest transaction event information, you can click on the 'Deal' module from the homepage of the Synapse database. Within the Deal module, you can search for global pharmaceutical transaction information using labels such as Drugs, Organization, Target, Drug Type, Deal Date. Furthermore, you can obtain the original link to the transaction coverage by clicking on the "Deal Name." In the analysis view, you can see the most active assignors, assignees, popular targets, and other dimensions of analysis, as well as the distribution of research and development statuses at the time of the transaction, to help you better understand the search results. The Synapse database also supports the ability to view current transactions from the dimension of "drugs" (by selecting "drugs" from the "Adjust Dimension" dropdown menu above). Targeting transactions involving renowned pharmaceutical companies that are of interest to the industry, such as Merck, Roche, etc., Synapse has identified a group of "leading companies" through drugs that have achieved global sales exceeding 1 billion US dollars in 2022. Transactions involving drugs from these leading companies can be filtered by clicking on the "Leading Company" tag on the left-hand side. In addition to the drug transaction module, you can also view related transaction history on the drug detail page and the institution detail page. Click on the image below to explore new pharmaceutical funding transactions!

07 Jan 2025

·www.fiercebiotech.com

Fierce Biotech Fundraising Tracker \'25: Alebund adds $75M; XyloCor raises $67M

Our fundraising tracker includes venture capital rounds of $50 million or more secured by biotechs. \n A new year means a new Fierce Biotech Fundraising Tracker to record the significant amounts of venture capital being funneled into the industry.We\'re maintaining the criteria we used for last year\'s tracker, which means including financing rounds north of $50 million. Of course, we\'ll still profile innovative new companies and larger rounds in-depth, while we focus more coverage on clinical trial results, M&A and special reports. JanuaryJan. 7—Aviceda TherapeuticsSeries: CAmount: $207.5 millionInvestors: Co-led by Omega Funds and TCGX, with participation from Enavate Sciences, Jeito Capital, Blue Owl Healthcare Opportunities, Longitude Capital, OrbiMed, Logos Capital, Marshall Wace, Catalio Capital Management, funds managed by abrdn Inc., and Digitalis Ventures.Aviceda will use the proceeds to advance AVD-104, the firm’s intravitreal glycan-coated nanoparticle currently undergoing a phase 2b/3 trial comparing the candidate to Astellas’ approved eye drug Izervay for geographic atrophy, a degenerative eye condition. Twelve-month data from the study are due in the second half of 2025, while a phase 2 trial in diabetic macular edema kicked off in September. Story Jan. 7—Alebund PharmaceuticalSeries: CAmount: RMB 550 million (about $75 million) Investors: Unnamed healthcare fund, Yangzhou Guojin Investment Group and Kingray Capital.The China-based biotech\'s new funds will support development and potential commercial activities of its renal disease pipeline. The raise will support the firm\'s Chinese new drug application and global pivotal study for its iron-based phosphate binder AP301, as well as a phase 2 study for other asset AP306 and further commercial expansion of Roche\'s Mircera in China, which Alebund is heading up. Release Jan. 7—XyloCor TherapeuticsSeries: BAmount: $67.5 millionInvestors: New investor Jeito Capital and existing institutional investors EQT, Fountain Healthcare Partners and Lumira Ventures. XyloCor has closed a series B financing that will go toward the biotech\'s mission of developing gene therapies for cardiovascular disease. Specifically, the new funds will be used to support a phase 2b clinical trial assessing XC001 (encoberminogene rezmadenovec), in refractory angina, as well as a second mid-stage study of the candidate as an adjunctive treatment for coronary artery bypass graft surgery. Release Jan. 6—Orbis MedicinesSeries: AAmount: €90 million (About $93.4 million)Investors: NEA (New Enterprise Associates), Eli Lilly, Cormorant, the Export and Investment Fund of Denmark, and founding investors Novo Holdings and Forbion.Danish biotech Orbis has closed its first series financing, money that will be used for oral macrocycle drug discovery. The biotech has also tapped Morten Graugaard to lead as CEO after three years of serving as executive chair of Orbis\' board of directors. Graugaard is a Novo Holdings partner with more than 20 years of experience in the life sciences. Under his leadership, the biotech will work to develop oral macrocycles—a drug class that has historically been difficult to create oral versions of—as alternatives to blockbuster drugs. Release

$Fierce Biotech Fundraising Tracker \'25: Alebund adds $75M; XyloCor raises $67M$

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	Phase 3	China	Libang Biomedical (Jiangsu) Co., Ltd.	12 Jun 2023
Kidney Failure, Chronic	Phase 3	China	Shanghai Alebund Pharmaceuticals Co., Ltd.	12 Jun 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07030595 \| CTR20231624 (PRNewswire) Manual	Phase 3	Hyperphosphatemia	474	AP301	jurgmgnzaj(vajscvzfxc) = The trial met its primary endpoint zqaxtrzczf (elbuiubzcn ) Met	Positive	26 Jun 2025
				sevelamer carbonate active contro
NCT04551300 (Pubmed) Manual	Phase 2	Hyperphosphatemia Maintenance	130	VS-505 2.25 g/day	qyatecqwqg(hbxtitooik) = ndvkkpdftq ebpelglcpi (ljxaeteaqg, -2.7 to -1.4)	Positive	07 Mar 2024
				VS-505 4.50 g/day	qyatecqwqg(hbxtitooik) = hwcwhbzkxo ebpelglcpi (ljxaeteaqg )
NCT02469467 (VS-505, ASN2018)	Phase 1/2	-	-	VS-505	kisxdbvfhn(ypowqajruk) = no change of Ca levels xecfnemnoc (vqnroxoghl ) View more	Positive	23 Oct 2018
				Sevelamer

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