ALG.APV-527 / Alligator Biosci, Aptevo Therap - LARVOL DELTA

Preliminary results from a phase I dose escalation study of ALG.APV-527, a 5T4 x 4–1BB bispecific antibody, in patients with advanced solid tumors demonstrate favorable safety and biological activity (SITC 2024) - "APV-527 treatment demonstrates good tolerability, safety, biological activity, and prolonged SD in some patients suggesting clinical benefit of treatment. Upon determining the optimized dose, subsequent development will likely take place as a combination treatment."

Clinical • IO biomarker • Metastases • P1 data • Breast Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD8 • TNFRSF9

First-in-Class Bispecific Antibody, ALG.APV-527, Meets Important Trial Endpoints in Phase 1 Solid Tumor Trial (Alligator Bioscience Press Release) - P1 | N=56 | NCT05934539 | Sponsor: Aptevo Therapeutics | "Alligator Bioscience AB...and Aptevo Therapeutics...announced preliminary data from the companies’ Phase 1 trial evaluating the first-in-class bispecific antibody, ALG.APV-527, as monotherapy for the treatment of multiple solid tumor types....Outcomes were presented at a poster session on Friday, November 8, 2024, at the Society for Immunotherapy of Cancer Conference....Nine of 16 efficacy evaluable patients (56%) achieved stable disease (SD). One colon cancer patient achieved SD for more than six months. The longest SD duration was in a breast cancer patient who entered the study with progressive disease, achieved stable disease and remained on study for >11 months. This patient successfully transitioned to a higher dose level twice...Analysis of biomarkers in the serum of treated patients including soluble 4-1BB (surface protein found on certain immune cells) confirm biological activity of ALG.APV-527."

Biomarker • P1 data • Colon Cancer • Solid Tumor

Alligator Bioscience and Aptevo Therapeutics to Present Additional Positive Interim Phase 1 Data Evaluating ALG.APV-527 Monotherapy in Multiple Solid Tumor Types, at SITC 2024 (ACCESSWIRE) - "Alligator Bioscience AB...and Aptevo Therapeutics...announced that new, positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 will be presented in a poster session on Friday, November 8, 2024, at the Society for Immunotherapy of Cancer 2024 (SITC)..."

P1 data • Solid Tumor

First-in-human phase I dose escalation study of ALG.APV-527, a 5T4 tumor antigen-conditional 4-1BB bispecific antibody, in patients with advanced solid tumors, demonstrates positive safety, signals of biological activity and patients with lasting stable disease (ESMO 2024) - P1/2 | "ALG.APV-527 demonstrates good tolerability, safety, biological activity, and prolonged SD among two heavily pretreated breast cancer patients. Dose escalation is ongoing to identify MTD and recommended Phase 2 dose."

Clinical • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor

Aptevo Therapeutics and Alligator Bioscience to Present Positive Interim Phase 1 Data Evaluating ALG.APV-527 Monotherapy in Multiple Solid Tumor Types, at ESMO Congress 2024 (ACCESSWIRE) - "Aptevo Therapeutics...and Alligator Bioscience AB...announced that positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 will be presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress 2024....The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that will include administration of ALG.APV-527 up to sixescalating dose levels in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. and will enroll adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks."

P1 data • Solid Tumor

Aptevo Therapeutics Reports 2Q 2024 Financial Results and Provides a Business Update (Aptevo Therapeutics Press Release)

P1 data • Solid Tumor

Alligator Bioscience AB reports financial results for Q1 2024 and provides a business update (Alligator Bioscience Press Release) - "'This quarter has been an excellent demonstration of how we are effectively and efficiently progressing our diversified pipeline of immuno-oncology assets through their various stages of development.'...Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors....data readout is expected in H2 2024."

P1 data • Oncology • Solid Tumor

Aptevo Therapeutics Reports 1Q 2024 Financial Results and Provides a Business Update (ACCESSWIRE) - "Aptevo Therapeutics Inc...reported financial results for the quarter ended March 31, 2024 and provided a business update...A heavily pretreated breast cancer patient, enrolled in the ALG.APV-527 Phase 1 open-label, multi-center, multi-cohort trial for the treatment of multiple solid tumor types, entered the trial with progressive disease and improved to long-lasting stable disease (SD) while on therapy. The patient has remained on study for more than eleven months, having been successfully transitioned to a higher dose level and has experienced no new adverse events since the transition. The higher dose may allow for increased clinical benefit. The trial is more than 50% enrolled and we are dosing cohort 5."

Trial status • Breast Cancer • Oncology • Solid Tumor

Aptevo Therapeutics Reports 2023 Financial Results and Provides a Business Update (Aptevo Therapeutics Press Release) - "ALG.APV-527 Phase 1 Trial for the Treatment of Multiple Solid Tumors Continues Enrollment, Interim Results Expected 1H24."

Enrollment status • P1 data • Oncology • Solid Tumor

Alligator Bioscience and Aptevo Therapeutics Announce Positive Interim Data of Dose Escalation Phase of ALG.APV-527 Phase 1 Study in Solid Tumor Cancers Expressing Tumor Antigen 5T4 (Alligator Bioscience Press Release) - P1 | N=56 | NCT05934539 | Sponsor: Aptevo Therapeutics | "Alligator Bioscience AB...and Aptevo Therapeutics...announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4...Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing; ALG.APV-527 could be measured in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose; Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527...'I am pleased to share that we are now dosing cohort four, heading into higher dose ranges where we believe there is potential for increased signs of clinical activity based on preclinical models.'....'We look forward to announcing additional data later in the year.'"

P1 data • PK/PD data • Trial status • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Alligator carries out a rights issue of units of approximately SEK 150.9 million with an over-allotment issue of up to an additional approximately SEK 100.0 million and raises bridge loans (Alligator Bioscience Press Release) - "The Board of Directors of Alligator Bioscience AB...has today, subject to approval by the Extraordinary General Meeting on March 14, 2024, resolved to carry out an issue of shares and warrants...with preferential rights for the Company’s existing shareholders of initially approximately SEK 150.9 million (the 'Rights Issue')...Alligator intends to use the proceeds from the Rights Issue, after set-off of bridge loans, for preparations and continued studies of the drug candidates mitazalimab, ATOR-4066 and ALG. APV-527, and design and development of new Neo-X-Prime candidates and other general corporate purposes...In December 2024, the Company may receive additional proceeds if the warrants series TO 9 issued in the Rights Issue....The issue proceeds from the exercise of warrants series TO 9 are intended to be used for clinical development of ALG-APV 527, preclinical development of ATOR-4066 and discovery of new Neo-X-Prime candidates, and other general corporate purposes."

Financing • Oncology • Solid Tumor

Alligator Bioscience AB reports full year financial results for 2023 and for Q4 2023 and provides a business update (Alligator Bioscience Press Release) - "Alligator is also expecting the preliminary Phase 1 readout for ALG.APV-527, a bispecific antibody with a tumor-directed 4-1BB agonistic effect being co-developed with Aptevo Therapeutics, in the first half of 2024."

P1 data • Solid Tumor

ALG.APV-527 First-in-human Study (clinicaltrials.gov) - P1/2 | N=56 | Recruiting | Sponsor: Aptevo Therapeutics

Metastases • New P1/2 trial • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Aptevo Therapeutics Reports 1Q23 Financial Results and Provides Business Update (Issuer Direct) - "...'We continue to advance our ALG.APV-527 Phase 1 trial for the treatment of multiple solid tumor types after dosing the first patient in early February. This trial is ongoing, and we expect preliminary results in the second half of this year'."

P1 data • Trial status • Oncology • Solid Tumor

Alligator Bioscience & Aptevo Therapeutics Announce Dosing of First Patient with ALG.APV-527 in Phase 1 Clinical Trial (Yahoo Finance) - "Alligator Bioscience AB...and Aptevo Therapeutics...announced the dosing of the first patient in the companies' Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors expressing the tumor-associated antigen 5T4. ALG.APV-527 is a bispecific antibody with a tumor-directed 4-1BB agonistic effect and the ability to specifically stimulate antitumor-specific T cells and NK cells involved in tumor control....The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S."

Trial status • Oncology • Solid Tumor

Alligator Bioscience & Aptevo Therapeutics Announce Publication Highlighting ALG.APV-527 Preclinical Data in Peer-Reviewed Journal Molecular Cancer Therapeutics (Issuer Direct) - "Alligator Bioscience AB...and Aptevo Therapeutics...announced the publication of a peer-reviewed article highlighting preclinical data that demonstrates a positive safety and anti-tumor activity profile in both in vitro and in vivo studies for ALG.APV-527....The publication in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR), includes data provided in the companies' investigational new drug (IND) application....The preclinical functional data presented demonstrate that ALG.APV-527 has the potential to activate key immune cell populations such as T cells and NK cells within the tumor microenvironment."

Preclinical • Oncology

The bispecific tumor antigen-conditional 4-1BB x 5T4 agonist, ALG.APV-527, mediates strong T cell activation and potent anti-tumor activity in preclinical studies. (PubMed, Mol Cancer Ther) - "ALG.APV-527 is uniquely designed for 5T4-conditional 4-1BB-mediated anti-tumor activity with potential to minimize systemic immune activation and hepatotoxicity while providing efficacious tumor-specific responses in a range of 5T4-expressing tumor indications as demonstrated by robust activity in preclinical in vitro and in vivo models. Based on the combined preclinical dataset, ALG.APV-527 has potential as a promising anti-cancer therapeutic for the treatment of 5T4-expressing tumors."

Journal • Preclinical • Hepatology • Immune Modulation • Inflammation • Oncology • CD8 • TNFRSF9 • TPBG

Alligator Bioscience and Aptevo Therapeutics Announce that FDA has Issued a "May Proceed" Notification for the ALG.APV-527 IND (Issuer Direct) - "Alligator Bioscience AB...and Aptevo Therapeutics...announced that the US Food and Drug Administration (FDA) has issued a 'may proceed' notification for the ALG.APV-527 investigational new drug application (IND), allowing the companies to initiate clinical trials evaluating the compound for the treatment of 5T4-expressing tumor antigens in multiple solid tumor types. The companies are moving rapidly to initiate a multi-center Phase 1 trial in the US....'ALG.APV-527 is specifically designed to trigger 4-1BB-mediated antitumor activity in 5T4-expressing tumor indications, meaning it has potential across a range of solid tumors with high unmet medical need'."

IND • New P1 trial • Oncology • Solid Tumor

"$APVO Alligator Bioscience and Aptevo Therapeutics Announce that FDA has Issued a "May Proceed" Notification for the ALG.APV-527 IND https://t.co/LSZajdYddX" (@stock_titan)

Aptevo Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights (BioSpace) - "ALG.APV-527 remains on track for IND submission in the second half of 2022, following a pre-IND meeting with the FDA held during the second quarter."

IND • Oncology

Aptevo Therapeutics Reports 2021 Financial Results and Provides Business Update (Yahoo Finance) - "2021 Highlights: Solidified plans with Alligator Bioscience to submit an IND for ALG.APV-527 in the second half of 2022 to evaluate the compound for the treatment of multiple solid tumor types."

IND • Oncology • Solid Tumor

Alligator Bioscience & Aptevo Therapeutics Announce Co-Publication in Peer-Reviewed Journal Nature Communication (PRNewswire) - "Professor Melero's data supports the bispecific antibodies, such as ALG.APV-527, targeting 4-1BB, and link 4-1BB signaling in cis (directly to tumor targets, such as 5T4), are more efficient at stimulating the anti-tumor response than bispecific agents that link 4-1BB signaling in trans to adjacent non-tumor cell targets such as the stroma."

Preclinical • Oncology • Solid Tumor

ALG.APV-527: A 5T4 tumor directed bispecific approach utilizing ADAPTIRTM technology designed for conditional 4-1BB T cell/NK agonism against solid tumors (SITC 2021) - "The unique design of the molecule minimizes systemic immune activation and hepatotoxicity, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in in vitro models. Based on these preclinical data, ALG.APV-527 is a promising anti-cancer therapeutic for the treatment of a variety of 5T4-expressing solid tumors and is progressing towards a phase I clinical trial in 2021."

IO biomarker • Oncology • Solid Tumor • CD8 • TNFRSF9 • TPBG

Alligator Bioscience and Aptevo Therapeutics Announce a Poster Presentation of ALG.APV-527 at SITC Annual Meeting 2021 (Yahoo Finance) - "Alligator Bioscience AB...and Aptevo Therapeutics...announce preclinical data on ALG.APV-527, a potentially first-in-class bispecific targeting both 4-1BB and tumor antigen 5T4 will be presented in a poster at the Society of Immunotherapy Cancer's (SITC) 36th Annual Meeting, taking place virtually and in-person November 12- 14, 2021 in Washington D.C....To complement the in vivo anti-tumor data previously shown, the poster shows in vitro, that combining ALG.APV-527 and a bispecific T-cell engager promotes enhanced immune cell-mediated tumor cell killing better than the T-cell engager alone."

Preclinical • Oncology

Aptevo Therapeutics and Alligator Bioscience advancing the bispecific 4-1BBx5T4 antibody ALG.APV-527 into Phase I clinical development (PRNewswire) - "Alligator Bioscience...and Aptevo Therapeutics Inc...provided an update on ALG.APV-527, a novel immunotherapeutic bispecific candidate intended for the treatment of multiple solid tumors expressing 5T4, a tumor-restricted antigen...The companies anticipate filing a Clinical Trial Authorization during the first half of 2021 to initiate Phase I clinical development in multiple sites in the European Union."

European regulatory • Oncology • Solid Tumor