alpha lactalbumin oleic acid (Alpha1H) / Linnane Pharma - LARVOL DELTA

A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=194 | Recruiting | Sponsor: Hamlet Pharma AB | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=194 | Not yet recruiting | Sponsor: Hamlet Pharma AB

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Meeting with FDA paves way for phase 3 trial of Alpha1H in NMIBC (Urology Times) - "Hamlet BioPharma recently announced the successful completion of an in-person meeting with the FDA, paving the way for initiation of the company’s pivotal phase 3 trial of Alpha1H in patients with non–muscle invasive bladder cancer (NMIBC). The company said that they remain on track to initiate the study, subject to final protocol agreement from the FDA."

FDA event • New P3 trial • Bladder Cancer

Strong Alpha1H treatment effects confirmed in patients with bladder cancer, in final analysis. Clinical study report is being completed for submission to the FDA. (Hamlet BioPharma Press Release) - P1/2 | N=52 | NCT03560479 | Sponsor: Hamlet Pharma AB | "Hamlet BioPharma...announces that Hamlet BioPharma’s drug candidate Alpha1H has shown potent treatment effects in patients with cancer of the urinary bladder....A complete or partial tumor response was detected in >80% of the tumors in patients treated with 8.5 mM of Alpha1H. Intravesical Alpha1H administrations triggered rapid, dose-dependent tumor cell shedding and tumor fragmentation, consistent with the reduction in tumor size. Alpha1H was taken up by tumor tissue and treatment triggered rapid tumor cell apoptosis, during both treatment rounds."

P1/2 data • Bladder Cancer

New scientific advances for Alpha1H highlight the unique discovery pipeline and drug development potential for the treatment of bladder cancer (Hamlet BioPharma Press Release) - "Hamlet BioPharma...announces the publication of new scientific advances important for the mechanism of action of Alpha1H in the treatment of bladder cancer, in collaboration with scientists at Lund University....The study shows that Alpha1H targets a major membrane system (ER) in tumor cells that stretches from the cell border all the way to the nuclei....The scientists discovered that Alpha1H changes the structure of the network and triggers a process similar to the tightening of fishing nets around their content of fish. The paper proposes that this process allows dying cells to contain toxic components and avoid leakage to the surrounding tissue during the cell death process. This mechanism could be an essential explanation for the low toxicity of the Alpha1H complex, which has been seen in cells, animal models and patients."

Clinical • Bladder Cancer

Hamlet BioPharma secures large scale Alpha1 peptide production in an agreement with Polypeptide Group (Hamlet BioPharma Press Release) - "Hamlet BioPharma...has secured continued production of Alpha1-peptide with the Swiss public company Polypeptide Group. The new production, at a larger scale, will be essential for the clinical trial program in bladder cancer, currently advancing towards Phase III....Through a cooperative effort with the Polypeptide Group's facilities in Strasbourg and Malmö over the years, Hamlet BioPharma has developed large-scale synthesis methods with Good Manufacturing Practice (GMP) quality. The recent agreement will secure supply of the Alpha1 peptide for use in the formulation of Hamlet BioPharmas lead drug candidate Alpha1H."

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

Alpha1H to be the first asset for the commercial collaboration (Hamlet BioPharma Press Release) - "Hamlet BioPharma...announces today that the commercial collaborations with Top International Advisory Firms will start with the Alpha 1H Investigational new drug....Hamlet Biopharma entered commercial collaborations with top international advisory firms to enhance partnering and strategic alliances. The collaboration has been initiated with the clinical stage oncology partnering asset with fast-track designation, Alpha 1H."

Licensing / partnership • Oncology • Solid Tumor

Hamlet BioPharma AB announces that the company will receive a total of approximately SEK 46.7 million through a rights issue before deductions for issue costs (Hamlet BioPharma Press Release) - "Hamlet BioPharma AB...announces the final outcome of the new issue with preferential rights for the Company's existing shareholders that was decided by the extraordinary general meeting on 14 December 2023 and for which the subscription period ended on 7 February 2024 (the 'Rights Issue'). The rights issue provides the Company with approximately SEK 46.7 million before deductions for issue costs, which exceeds the target of securing at least SEK 40 million....'The proceeds of approximately SEK 46.7 million before issue costs will be used, among other things, for preparations for a phase III clinical trial of Alpha1H in bladder cancer...'"

Financing • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

New analyzes of clinical data from Alpha1H-treated bladder cancer patients demonstrate a strong immune response with anti-tumor effects [Google translation] (Hamlet BioPharma Press Release) - P1/2 | N=52 | NCT03560479 | Sponsor: Hamlet Pharma AB | "Hamlet BioPharma's drug candidate Alpha1H has been shown to affect the majority of tumors in treated patients with bladder cancer. A new analysis now provides another explanation for the strong effect, based on an immune response in the treated patients. In addition to killing tumor cells and inducing tumor cell shedding, Alpha1H activates a broad immune response, providing a strong protective potential against cancer. The manuscript describing this study has been submitted for publication...the complex has shown therapeutic effects in a placebo-controlled study of patients with bladder cancer, with increased efficacy in patients treated with higher doses...A new analysis now shows unexpectedly strong effects on the immune response in the bladder of those in the patients treated with Alpha1H...The new analysis further shows that the immune response profile in Alpha1H-treated patients with early tumors is rapid..."

P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Hamlet BioPharma receives U.S. FDA Fast Track designation for Alpha 1H for the treatment of non-muscle invasive bladder cancer (Cision) - "Hamlet BioPharma AB...announces today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its drug candidate Alpha1H for the treatment of non-muscle invasive bladder cancer. The U.S. FDA Fast Track Designation accelerates the approval process for Alpha 1H and potential for reaching the US market."

Fast track designation • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

"Manufacturing of Alpha1H for clinical trials is secured https://t.co/VLtgyadgbA" (,@CisionNews)

Clinical

"Alpha1H Patent granted in Europe https://t.co/RMrXLG7qTj" (,@CisionNews)

A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1/2; N=52; Recruiting; Sponsor: Hamlet Pharma AB; Trial completion date: Mar 2022 ➔ Dec 2023; Trial primary completion date: Mar 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer