AB001 / ARTBIO, AlphaGen Therapeutics - LARVOL DELTA

Phase I/II dose escalation and expansion of AB001 in patients with metastatic castration-resistant prostate cancer (mCRPC): The ARTISAN trial (ESMO 2025) - "Background Treatment options for patients with mCRPC have been improved by radioligand therapies such as beta-emitting 177 Lu-PSMA-617...Legal entity responsible for the study ARTBIO. Funding ARTBIO."

Clinical • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARTISAN: Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: ARTBIO Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARTISAN: Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: ARTBIO Inc.

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARTBIO Announces FDA Clearance of IND Application for Lead Alpha Radioligand Therapy AB001 (PRNewswire) - "ARTBIO plans to initiate the Phase 1 clinical trial for AB001 across multiple sites in the U.S. by leveraging its distributed manufacturing network of production hubs, including leading radiopharmaceutical CDMOs like SpectronRx, PharmaLogic, and Nucleus Radiopharma....The company plans to enroll patients outside of the U.S. once additional regulatory approvals are secured."

IND • New P1 trial • Castration-Resistant Prostate Cancer

ARTBIO Announces $132 Million Series B Financing to Advance Pipeline of Alpha Radioligand Therapies and Expand Manufacturing and Supply Chain Infrastructure (ARTBIO Press Release) - "ARTBIO, Inc...announced the closing of a $132 million Series B financing co-led by new investors Sofinnova Investments and B Capital along with a life sciences dedicated investment fund that invested previously. Further support came from existing investors F-Prime, Omega Funds, and Third Rock Ventures, and new investors Qatar Investment Authority and Alexandria Venture Investments. These proceeds will be used to advance the company’s development of ARTs....This latest round of funding will support the advancement of ARTBIO’s pipeline, including its lead program, AB001, for metastatic castration-resistant prostate cancer, through Phase II clinical trials, and enable continued expansion of the company’s supply chain."

Financing • Castration-Resistant Prostate Cancer

ARTBIO to Enter into Licensing and Research Partnership with 3B Pharmaceuticals to Advance a First-in-Class Alpha Radioligand Therapy for Solid Tumors (PRNewswire) - "ARTBIO, Inc...and 3B Pharmaceuticals GmbH...today announced a worldwide, exclusive license and research agreement to develop an advanced preclinical stage first-in-class peptide ART for the treatment of solid tumors. This partnership extends ARTBIO's pipeline with the addition of a highly differentiated program focused on a novel, first-in-class target that is optimal for 212Pb-based alpha radioligand therapy. 212Pb has an ideal clinical profile well suited to this program due to a short half-life and single alpha emission that delivers maximal energy into tumors."

Licensing / partnership • Oncology • Solid Tumor

First-in-human study of Phase 0 experience (EMUC 2024) - "A theragnostic microdose phase 0 clinical trial of AB001 (formerly 212 Pb-NG001), a PSMA targeting small molecule labeled with the in vivo generating alpha-emitter 212 Pb, was conducted at Oslo University Hospital. Conclusions The 212 Pb alpha radioligand AB001 was safely administered to mCRPC patients in this microdose study. Gamma camera imaging was shown to be feasible, and provided proof of metastatic targeting for AB001, which combined with promising biodistribution and clearance warrant further clinical investigation."

P1 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • FOLH1

ARTBIO and Nucleus RadioPharma Announce Collaboration to Manufacture GMP-Grade Therapeutic Products Containing Radioisotope Pb-212 to Support Emerging Clinical Trials (Businesswire) - "ARTBIO, Inc...and Nucleus RadioPharma Inc...announced a strategic manufacturing and supply agreement to support ARTBIO’s therapeutic product manufacturing. Under the terms of the agreement, Nucleus will manufacture ARTBIO’s 212Pb-radiolabeled therapies for its planned Phase I and II clinical trials of its lead program in prostate cancer, AB001, using ARTBIO’s proprietary AlphaDirectTM 212Pb isolation technology. This agreement will enable the supply and manufacturing of ARTs from Nucleus’ facility in Rochester, Minn., for patients living in the Northern and Midwest U.S."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

AlphaGen Therapeutics and ARTBIO Announce Exclusive Strategic Collaboration for the Development and Commercialization of AB001 in Greater China and on ARTBIO’s 212Pb AlphaDirect Technology (ARTBIO Press Release) - "AlphaGen Therapeutics...and ARTBIO, Inc...jointly announced an exclusive strategic collaboration agreement....The exclusive agreement enables AlphaGen to use ARTBIO’s AlphaDirect™ isotope isolation technology to generate ²¹²Pb, a unique isotope without a global supply. AlphaGen will also receive rights to develop and commercialize AB001, a clinical-stage alpha RLT targeting prostate-specific membrane..."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARTBIO and PharmaLogic Announce Supply Agreement for Lead-212 based Therapeutic Candidate AB001 for New York and Surrounding States (PRNewswire) - "PharmaLogic Holdings Corp...and ARTBIO...announce a manufacturing and supply agreement for ARTBIO's lead-212 (212Pb) based radiopharmaceutical candidate, AB001, for the treatment of prostate cancer. Under the terms of the agreement, PharmaLogic will assist ARTBIO with radiochemistry and supply of the finished radiopharmaceutical product for future Phase I and II clinical trials of AB001 from their facility in New York, using ARTBIO's proprietary AlphaDirect™ 212Pb isolation technology."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Eckert & Ziegler and ARTBIO Announce Manufacturing and Supply Partnership for Lead-212 Conjugates (PharmiWeb) - "Eckert & Ziegler...and ARTBIO, Inc...have entered into a strategic manufacturing and supply agreement. Under the collaboration Eckert & Ziegler will support ARTBIO to establish manufacturing and delivery of its pipeline therapies using its proprietary AlphaDirect^TM Lead-212 (Pb-212) isolation technology. The collaboration aims to expedite the development of Lead-212 based alpha radioligand therapies, starting with the clinical development of ARTBIO’s lead asset of AB001 in prostate cancer. Initially focussing on the US market and utilizing Eckert & Ziegler’s facilities in Boston, both companies plan to evaluate a global operations expansion at a later stage. Besides the US, Eckert & Ziegler’s global CMO service network includes manufacturing sites in Berlin, Germany and Jintan, China."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SpectronRx and ARTBIO Join Forces to Develop and Manufacture Clinical Supply of Novel Alpha Radioligand Therapy AB001 for Indiana and Surrounding States (BioSpace) - "SpectronRx...has entered into a new partnership agreement with ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), to produce a novel prostate cancer therapy known as AB001. SpectronRx will utilize its expertise and state-of-the-art facilities in Indiana to be a contract developer and manufacturer for the groundbreaking treatment currently undergoing first-in-human trials. The manufacturing processes will start with ARTBIO’s proprietary AlphaDirect^TM technology for isolation of Pb212."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 0/1 Study of 212Pb-NG001 in mCRPC (clinicaltrials.gov) - P1 | N=3 | Completed | Sponsor: ARTBIO Inc. | Recruiting ➔ Completed | N=23 ➔ 3

Enrollment change • Metastases • Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 0/1 Study of 212Pb-NG001 in mCRPC (clinicaltrials.gov) - P1 | N=23 | Recruiting | Sponsor: ARTBIO Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 0/1 Study of 212Pb-NG001 in mCRPC (clinicaltrials.gov) - P1 | N=23 | Not yet recruiting | Sponsor: ARTBIO Inc.

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor