Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of novel targeted therapies. It also develops and markets medicines for relapsed or refractory cancer patients. The company was founded in 2000 and is headquartered in New York, NY.
相关临床试验
6
2 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
2000
进行中（未招募）
1
16.7%
已完成
1
16.7%
尚未招募
1
16.7%
招募中
1
16.7%
终止
1
16.7%
撤回
1
16.7%
暂无批准数据
- The radioligand therapy market was valued at USD 2.98 billion in 2025 and is forecast to reach USD 15.85 billion by 2035, an 18.2% CAGR. - Novartis received expanded FDA approval in 2026 for Pluvicto in earlier-line metastatic castration-resistant prostate cancer, moving PSMA therapy ahead of chemotherapy. - Eli Lilly advanced 177Lu-PNT2002 into a pivotal Phase 3 trial in biochemically recurrent prostate cancer, while Convergent Therapeutics began Phase III testing of CONV01-alpha. - Alpha-emitter pipeline agents using actinium-225 and lead-212 are the fastest-growing product segment, projected at a 24.6% CAGR through 2035.
- Orano Med is advancing a pipeline of lead-212-based targeted alpha therapies, with its lead asset AlphaMedix showing positive phase 2 results in neuroendocrine tumors in collaboration with Sanofi and RadioMedix. - The company holds a unique competitive advantage through parent company Orano's ownership of what may be the world's largest stock of pure thorium, enabling unlimited access to the rare lead-212 isotope. - Orano Med has built a complete value chain spanning isotope extraction, drug manufacturing, and R&D, with recent expansions including new headquarters in France and an industrial-scale production facility. - Big Pharma interest in targeted alpha therapies is intensifying, with AstraZeneca and Bristol Myers Squibb making significant investments in actinium-225-based platforms, while Orano Med also partners with Roche on a metastatic colorectal cancer program.
- Actinium Pharmaceuticals has appointed Steffen Heeger, MD, MSc, as Chief Medical Officer, bringing extensive radiotherapy expertise and a track record of developing multiple oncology programs from preclinical through global approvals. - Dr. Heeger previously led clinical development of blockbuster drug Erbitux at Merck KGaA and served as CMO at NBE Therapeutics, which was acquired by Boehringer Ingelheim for $1.4 billion. - The appointment comes as Actinium prepares to advance its targeted radiotherapy pipeline, including Actimab-A, ATNM-400, and Iomab-ACT, toward key data readouts and expanded clinical trials in the second half of 2026. - Dr. Heeger's experience with anti-PSMA programs directly aligns with Actinium's ATNM-400 asset, which targets a novel antigen and has shown preclinical activity across multiple solid tumor indications.
- Actinium Pharmaceuticals received Canadian patent allowances for its Actimab-A combination therapy in acute myeloid leukemia and Iomab-ACT conditioning program for gene-edited cell therapies. - The Canadian allowances expand protection across hematologic malignancies and next-generation conditioning approaches, building on existing patents in Japan and the United States. - These patents strengthen Actinium's global intellectual property estate of approximately 250 issued and pending patents, with the Canadian patents extending into 2038-2039.
• Actinium Pharmaceuticals has enrolled the first patient in a pioneering trial evaluating Iomab-ACT as a targeted radiotherapy conditioning agent with commercial CAR-T therapy, with initial data expected in late 2025. • Iomab-ACT targets CD45 on immune cells and has shown promise in reducing serious CAR-T toxicities including ICANS and CRS, potentially addressing major barriers to CAR-T therapy access and efficacy. • The therapy could significantly expand the $4 billion CAR-T market by replacing conventional chemotherapy conditioning regimens, potentially benefiting approximately 150,000 patients diagnosed annually with eligible conditions.
- Actinium Pharmaceuticals has developed ATNM-400, a novel non-PSMA targeting radiotherapy for prostate cancer using Actinium-225, achieving 99.8% tumor growth inhibition in preclinical models. - The new therapy demonstrates selective tumor accumulation for up to 144 hours with minimal uptake in healthy tissues, potentially reducing off-target effects compared to existing treatments. - ATNM-400 aims to address unmet needs for patients who don't respond to or progress after Pluvicto therapy, with initial data to be presented at the upcoming AACR Annual Meeting in April 2025.
- Actinium Pharmaceuticals has launched a first-of-its-kind clinical trial evaluating Actimab-A in combination with venetoclax and ASTX-727 for newly diagnosed acute myeloid leukemia patients unsuitable for intensive chemotherapy. - The phase 1 trial (NCT06802523) represents the first triplet combination using targeted radiotherapy as a backbone in AML treatment, with Actimab-A's alpha-particle payload causing lethal DNA breaks with no known resistance mechanisms. - Initial data from the 48-patient study is expected in the second half of 2025, with researchers hoping the mutation-agnostic approach will overcome high-risk features like TP53 mutations and improve outcomes for patients who typically respond poorly to standard venetoclax-HMA therapy.
- The FDA approved obecabtagene autoleucel (Aucatzyl) for adults with relapsed or refractory B-cell precursor ALL, marking a significant advancement in CAR T-cell therapy. - A pivotal clinical trial revealed transformative findings poised to change the standard of care for children with acute lymphoblastic leukemia (ALL), marking a milestone in pediatric oncology. - Pfizer's BESPONSA received FDA approval for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell ALL, expanding treatment options for this population.
- Actinium Pharmaceuticals is set to release topline data from its pivotal Phase III SIERRA trial of Iomab-B for relapsed/refractory acute myeloid leukemia (AML) in Q4 2022. - Iomab-B is designed to deliver iodine-131 directly to the bone marrow, potentially reducing side effects compared to traditional chemotherapy. - Actinium is also advancing Iomab-ACT in a Phase I/II study for lymphoma and B-ALL and Actimab-A in Phase I/II trials for relapsed/refractory AML. - The company's cash reserves stood at approximately $115 million as of June 30, 2022, supporting ongoing clinical development programs.
- Targeted alpha therapy (TAT) is emerging as a promising cancer treatment, delivering localized radiation to tumor cells while minimizing harm to healthy tissues. - The FDA approval of Xofigo in 2013 for advanced prostate cancer marked a pivotal moment, spurring research into TAT for various solid tumors and hematological malignancies. - Clinical trials are evaluating TAT candidates like RayzeBio's RYZ101 for neuroendocrine tumors and Actinium Pharmaceuticals’ Actimab-A for leukemia, showing potential in addressing unmet medical needs. - TAT's precision and efficacy are attracting significant investments and regulatory support, positioning it as an integral component of precision medicine in oncology and beyond.
