PBA-0405 / Pure Biologics - LARVOL DELTA

A First in Human Phase 0 microdose study with the novel anti-ROR1 antibody (PBA-0405) in patients with solid tumors of Soft Tissue Sarcoma and Head and Neck Cancer (SITC 2025) - "Based on the findings from this early phase CIVO microdose study, further clinical development of PBA-0405 for the treatment of ROR1 expressing solid tumors is warranted.Ethics Approval This study was approved by the Institutional Review Boards of the University of Pennsylvania (approval #855699), and WCG (approval #20240440). All patients gave informed consent before taking part."

Clinical • First-in-human • P1 data • Head and Neck Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CASP3 • CXCL10

PBL-0405-01: A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Pure Biologics S.A. | Recruiting ➔ Completed

Trial completion • Breast Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

PUR Conclusion of an annex to the term sheet regarding the sale transaction of projects PBA-0405 and PBA-0111 [Google translation] (Money.Pl) - "The Management Board of Pure Biologics S.A. with its registered office in Wrocław...with reference to current report no. 44/2024 dated September 16, 2024 on the signing of a term sheet document regarding the sale transaction of the PBA-0405 and PBA-0111 projects ['Term Sheet'], taking into account that work on concluding an agreement for the sale of rights to the above projects ['Transaction'] is highly advanced and in connection with the Extraordinary General Meeting of the Company convened for December 27, 2024, the agenda of which includes the adoption of a resolution on giving consent to the sale by the Company of rights to the PBA-0405 and PBA-0111 projects, informs that today an annex was concluded between the parties to the Term Sheet, in which the parties agree to extend the Transaction deadline until December 30, 2024."

Commercial • Hematological Malignancies • Solid Tumor

PUR Conclusion of a term sheet regarding the sale transaction of projects PBA-0405 and PBA-0111 [Google translation] (Money.Pl) - "The Management Board of Pure Biologics S.A...hereby announces that on September 16, 2024, the Company signed a term sheet document regarding the sale of the PBA-0405 [PB004] and PBA-0111 [PB003G] projects to a company incorporated under American law ['Buyer'], which intends to continue the development of PBA-0405 and PBA-0111...According to the Term Sheet, the parties expect to conclude an agreement for the sale of rights to the projects within 90 days from the date of the Term Sheet. The Transaction Assumptions provide that for the sale of all rights to the PBA-0405 and PBA-0111 projects, the Company will be entitled to an initial fee ['Upfront'] in the amount of USD 4,000,000 to 4,500,000 for each project, i.e. in the total amount of USD 8,000,000 to 9,000,000....If the Transaction is concluded, the Company will present detailed plans for further development."

Licensing / partnership • Hematological Malignancies • Oncology • Solid Tumor

PUR FIRST RESULTS OF PHASE 0 IN PROJECT PB004 (PBA-0405) [Google translation] (Money.Pl) - P=Early Phase 1 | N=15 | NCT06273852 | Sponsor: Pure Biologics S.A. | "The study is being conducted to determine the ability to kill cancer cells in patients with certain solid tumors, including head and neck cancer, soft tissue sarcoma and triple-negative breast cancer....As part of the cooperation with Presage Biosciences Inc. (Seattle, United States), the Company received Phase 0 study results from the first three patients enrolled in the study who received direct injections of PBA-0405 into their tumors, which were then surgically removed 24-48 hours later. There were no drug-related adverse events, and all three patients demonstrated transcriptional expression of the candidate's molecular target, ROR1. At the same time, immune cells essential for the mode of action of PBA-0405 were identified in each patient....The Company expects further results in a few to a dozen weeks."

Clinical data • Breast Cancer • Head and Neck Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer

Presage Biosciences Announces First Patient Dosing of Pure Biologics' ROR1 Targeting Antibody For Treatment of Cancer (PRNewswire) - "Presage Biosciences...announced the Phase 0 dosing of the first cancer patient with Pure Biologics' PBA-0405, an antibody that targets ROR1. PBA-0405 has been engineered to induce tumor cell killing by cytotoxic immune cells. This exploratory study is designed to study the biological effects of PBA-0405 within the human tumor microenvironment."

Trial status • Solid Tumor

Twist Bioscience Announces Clinical Progression of Pure Biologics’ Antibody Candidate Discovered Using Twist’s Antibody Libraries (Businesswire) - "Twist Bioscience Corporation...today announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405...This exploratory study is designed to provide early insights into the biological effects of PBA-0405 within the tumor environment...The study will evaluate the pharmacodynamic activity of PBA-0405 in solid tumors including head and neck squamous cell carcinoma, certain subtypes of soft-tissue sarcomas and triple-negative breast cancer."

Trial status • Breast Cancer • Oncology • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

PBL-0405-01: A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Pure Biologics S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Head and Neck Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CASP3 • CD86 • GZMB • ROR1 • TNFA

A Phase 0 Multicenter Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Pure Biologics S.A.

New P1 trial • Breast Cancer • Head and Neck Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CASP3 • CD86 • GZMB • ROR1 • TNFA

Presage Announces FDA Study May Proceed to Evaluate Pre-GMP Drug Candidate in CIVO Phase 0 Clinical Trial (PRNewswire) - "Presage Biosciences...announced that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed notification for testing a pre-GMP drug candidate with the CIVO^® platform. The drug candidate, PBA-0405, is owned by Poland-based biopharmaceutical company, Pure Biologics, and represents the earliest stage material to date that will be evaluated in patients in a CIVO Phase 0 clinical trial. PBA-0405 is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells."

FDA event • Oncology • Solid Tumor