相关临床试验
29
15 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2004
进行中（未招募）
14
48.3%
已完成
7
24.1%
尚未招募
1
3.5%
终止
3
10.3%
Unknown
2
6.9%
撤回
2
6.9%
暂无批准数据
- Akari Therapeutics' AKTX-101 combined with Adagrasib showed synergistic cell-killing in KRAS-mutant pancreatic cancer models, while older TROP2 ADCs demonstrated antagonism. - AKTX-101 is a TROP2-targeting ADC powered by the company's proprietary PH1 RNA spliceosome-modulating payload, with IND-enabling studies underway. - Initiation of a Phase 1 first-in-human clinical trial for AKTX-101 is expected by mid-2027. - The company implemented a 1-for-40 reverse stock split on March 31, 2026, to maintain its Nasdaq listing.
- Akari Therapeutics announced preclinical data showing AKTX-101, a Trop2-targeting ADC with novel spliceosome-modulating payload PH1, demonstrated single-digit nanomolar cytotoxic potency against K-Ras G12V mutated pancreatic cancer cell lines. - The K-Ras G12V mutation drives one-third of all pancreatic ductal adenocarcinoma cases, representing a significant unmet medical need with median overall survival of only 1.4 years. - AKTX-101 outperformed daraxonrasib, an investigational K-Ras inhibitor from Revolution Medicines, in multiple pancreatic cancer cell lines during preclinical testing. - The company plans to initiate first-in-human trials in late 2026, with preliminary safety and efficacy data expected in 2027.
- Akari Therapeutics has initiated GMP manufacturing for AKTX-101, its lead antibody drug conjugate featuring a novel PH1 payload that targets RNA splicing modulation in cancer cells. - The company partnered with WuXi XDC, a leading ADC contract development and manufacturing organization, to support IND-enabling activities for clinical trial initiation. - AKTX-101 targets the Trop2 receptor and has demonstrated significant activity and prolonged survival in preclinical studies compared to traditional ADC payloads. - The Phase 1 first-in-human clinical trial is planned for late 2026 or early 2027, marking approximately 12 months from the current manufacturing milestone.
- Akari Therapeutics raised $5 million through a registered direct offering and private placement, with significant participation from company leadership and institutional investors. - The financing supports development of the company's innovative ADC platform featuring PH1, a novel spliceosome modulator payload that disrupts RNA splicing in cancer cells. - Lead candidate AKTX-101 targets Trop2 receptor and has demonstrated superior activity and prolonged survival compared to traditional ADCs in preclinical studies. - The transaction also includes conversion of approximately $2.5 million in existing debt to equity, improving the company's capital structure.
- Akari Therapeutics received Patent No. 562,919 from India's Intellectual Property Office for its novel PH1 payload, a spliceosome inhibitor that disrupts RNA splicing to kill cancer cells and activate immune responses. - The patent covers the company's immuno-oncology PH1 payload, proprietary linkers, and ADC technology with applications across various cancer targets, strengthening global IP protection. - India represents a strategic market with cancer cases projected to reach 2.08 million by 2040, highlighting the growing need for innovative cancer therapies. - The company's lead candidate AKTX-101 targets Trop2 receptors and has demonstrated significant tumor-killing activity and prolonged survival in preclinical studies compared to traditional ADC payloads.
- Akari Therapeutics has appointed Mark F. Kubik as Head of Business Development - Oncology, bringing over 25 years of experience in transformative deal creation across oncology therapeutics. - Kubik will lead business development activities for Akari's novel antibody-drug conjugate (ADC) platform and its lead asset AKTX-101, which utilizes a first-in-class spliceosome inhibitor payload. - The strategic hire aims to position Akari as a key player in the growing ADC market, capitalizing on increasing Big Pharma interest in early-stage ADC technologies with novel mechanisms of action.
- Akari Therapeutics (NASDAQ: AKTX) has successfully priced a $7.6 million private placement financing round, with funds directed toward its spliceosome inhibitor payload ADC technology platform. - The offering includes issuance of 6,637,626 unregistered American Depository Shares priced at $0.87 per ADS, along with Series A and Series B warrants, with company Chairman Dr. Huh converting a $1 million note as part of the transaction. - This financing follows recent leadership changes at Akari, including the appointment of biotechnology industry veteran Abizer Gaslightwala as President and CEO, bringing extensive oncology commercialization experience from Jazz Pharmaceuticals, Amgen, and Pfizer.
- NorthSea Therapeutics appoints Melissa Bradford-Klug as CFO/CBO, bringing over 20 years of experience and $6 billion in financing track record to advance metabolic disease therapies. - Dr. Sophie Jeannin joins as CMO, contributing extensive expertise in orphan and metabolic diseases from leadership roles at Summit Clinical Research and GENFIT. - The company anticipates key clinical milestones with SEFA-1024 Phase 2a SHTG trial data in Q3 2025 and Orziloben Phase 2a IFALD interim results in H1 2026.
• Bullous pemphigoid (BP), a subepidermal autoimmune blistering disease primarily affecting the elderly, currently lacks approved therapies in the United States, creating a significant unmet need. • The BP treatment landscape is dominated by off-label corticosteroids and immunosuppressants, highlighting the urgent need for targeted and approved therapies to improve patient outcomes. • Several therapies are in advanced Phase III clinical development, including AstraZeneca's Fasenra, Sanofi/Regeneron's Dupixent, and Akari Therapeutics' nomacopan, signaling potential paradigm shift. • The influx of pipeline therapies aims to address unmet needs, such as diagnostic biomarkers and vulnerable patient population, and could reshape the market dynamics in bullous pemphigoid.
