evunzekibart (ATOR-1017) / Alligator Biosci - LARVOL DELTA

Alligator Bioscience Announces Publication of Clinical Data for ATOR-1017 (evunzekibart) in the Journal for ImmunoTherapy of Cancer (Alligator Bioscience Press Release) - "Alligator Bioscience...announces that clinical data for its 4-1BB agonist, ATOR-1017, has been published in the Journal for ImmunoTherapy of Cancer (JITC). This publication validates ATOR-1017’s safety and tolerability in patients with advanced cancers and highlights early signs of clinical efficacy. Additionally, pharmacokinetic and pharmacodynamic analyses demonstrate proof of mechanism, further supporting the therapeutic potential of ATOR-1017....These findings strengthen the clinical package for ATOR-1017 and support its potential for future development, particularly in combination with other anticancer agents."

P1 data • Solid Tumor

First-in-human, multicenter, open-label, phase I study of ATOR-1017 (evunzekibart), a 4-1BB antibody, in patients with advanced solid malignancies. (PubMed, J Immunother Cancer) - "Treatment with ATOR-1017 was safe and well tolerated at all dose levels and demonstrated biological activity. Furthermore, almost one-third of patients experienced long-lasting stable disease in this heavily pretreated population. The encouraging safety and preliminary efficacy data warrant further clinical development of ATOR-1017, possibly in combination with other anticancer agents."

IO biomarker • Journal • P1 data • Fatigue • Febrile Neutropenia • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Pain • Solid Tumor • Thrombocytopenia • TNFRSF9

First-in-human, multicenter, open-label, phase I study of ATOR-1017 (evunzekibart), a 4-1BB antibody, in patients with advanced solid malignancies (J Immunother Cancer) - P1 | N=27 | NCT04144842 | Sponsor: Alligator Bioscience AB | 'Of the 27 patients screened, 25 received treatment with ATOR-1017. The median time on study was 13.1 weeks (range 4.3–92.3). The MTD of ATOR-1017 was not reached. Treatment-related adverse events (TRAEs) were reported in 13 (52%) of 25 patients; most common (≥10%) were fatigue (n=4 (16.0%) patients) and neutropenia (n=3 (12.0%) patients). Five patients experienced a severe (≥ grade 3) TRAE; neutropenia (n=2), febrile neutropenia (n=1), chest pain (n=1), increased liver enzymes (n=1), and leukopenia and thrombocytopenia (n=1)."

P1 data • Solid Tumor

ATOR-1017 (evunzekibart), an Fc-gamma receptor conditional 4-1BB agonist designed for optimal safety and efficacy, activates exhausted T cells in combination with anti-PD-1. (PubMed, Cancer Immunol Immunother) - "These preclinical data demonstrate a strong safety profile of ATOR-1017, together with its potent therapeutic effect as monotherapy and in combination with anti-PD1, supporting further clinical development of ATOR-1017."

Combination therapy • Journal • Oncology • TNFRSF9

Alligator Bioscience Announces Capital Markets Day 2023 (Alligator Bioscience Press Release) - "Alligator Bioscience...today announces it will hold a Capital Markets Day on December 1, 2023...Capital Markets Day Agenda...Dr. Sumeet Ambarkhane will provide an update on the clinical data generated so far by mitazalimab along with a broader view of the Company's CD40 program...Dr. Gregory Beatty...will explain the current treatment landscape for pancreatic cancer and the potential of mitazalimab to change the treatment paradigm...Laura von Schantz will discuss Alligator's proprietary technology platforms Neo-X-Prime™ and Ruby™, including the pivotal role Ruby™ is playing in Alligator's research collaboration and license agreement with Orion Corporation...Peter Ellmark will look at the progress Alligator is making with ATOR-4066, a third generation bispecific antibody targeting CD40 and CEACAM5, developed by the Company's Neo-X-Prime™ platform...Dr. Sumeet Ambarkhane will provide the latest updates on ATOR-1017."

Clinical • Clinical data • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017 (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Alligator Bioscience AB | Active, not recruiting ➔ Completed | N=50 ➔ 27 | Trial completion date: Aug 2023 ➔ Mar 2023 | Trial primary completion date: Aug 2023 ➔ Mar 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

ATOR-1017, a 4-1BB antibody, demonstrates promising safety and proof of mechanism in a first-in-human study in patients with advanced solid malignancies. (SITC 2022) - "Conclusions ATOR-1017 demonstrated excellent safety at doses up to 900 mg, together with a favorable PK profile, confirmation of biologic activity and signs of clinical benefit. These data warrant further development of ATOR-1017, a 4-1BB agonistic antibody, in combination with other therapeutic approaches in solid tumors."

Clinical • IO biomarker • P1 data • Oncology • Ovarian Cancer • Solid Tumor • CD8 • TNFRSF9

Initial findings from a first-in-human, multicenter, open-label study of ATOR-1017, a 4-1BB antibody, in patients with advanced solid malignancies. (ASCO 2022) - P1 | "ATOR-1017 is safe and well-tolerated at doses up to 600 mg and has shown biologic activity. No DLTs have been reported so far and dose escalation continues."

Clinical • IO biomarker • P1 data • Fatigue • Febrile Neutropenia • Hematological Disorders • Immune Modulation • Inflammation • Leukopenia • Neutropenia • Oncology • Pain • Solid Tumor • Thrombocytopenia • TNFRSF9

Alligator Bioscience announces positive safety data from ATOR-1017 study (PharmaTimes) - P1 | N=50 | NCT04144842 | Sponsor: Alligator Bioscience AB | "Alligator Bioscience has announced positive safety data from the 900mg dose cohort in its phase 1, first-in-human clinical trial with its drug candidate, ATOR-1017....The data also demonstrates that, for doses up to 900mg, there were no significant safety concerns with the therapy, confirming previously announced signs of clinical benefit. Furthermore, no dose-limiting toxicity was observed and the maximum tolerated dose of ATOR-1017 has not been reached."

P1 data • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Solid Tumor

Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017 (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Alligator Bioscience AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

Alligator Bioscience Announces Completion of 600 mg Dose Cohort for ATOR-1017, Dose-escalation and Enrollment for 900 mg dose Cohort Commences (PRNewswire) - "Alligator Bioscience...today announced the completion of the patient enrollment for the 600 mg dose cohort from Alligator's Phase I, first-in-human clinical trial with the 4-1BB (CD137) targeting drug candidate, ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic cancer....The data indicate that for doses up to 600 mg, there were no significant safety concerns with stable disease as the best tumor response. Patient enrollment and treatment for the highest planned dose cohort, 900 mg, has commenced."

Enrollment status • Oncology • Solid Tumor

Alligator Bioscience Announces Trial Update and Early Readout for ATOR-1017 Confirming Biomarker, Safety & Tolerability Data (PRNewswire) - P1, N=50; NCT04144842; Sponsor: Alligator Bioscience AB; “The results from the current evaluation shows that ATOR-1017 has an encouraging safety profile. Again, there was no dose-limiting toxicity or severe immune-related adverse events. The results support data from earlier read-outs that ATOR-1017 exhibits a favorable pharmacokinetic profile. Additionally, it confirms and extends previous biomarker data demonstrating proof of mechanism of ATOR-1017, including increased proliferation of circulating T-cells and dose-dependent increases in soluble 4-1BB, both biomarkers of T-cell activation. A full data read-out is expected in Q1 2022.”

P1 data • Oncology

ATOR-1017, a second generation 4-1BB antibody with potential to enhance efficacy of PD-1 therapies (SITC 2021) - "Conclusions In summary, these results support further clinical development of ATOR-1017 in combination with PD-1 antibodies. By combining ATOR-1017 with anti-PD-1, tumor infiltrating T cells can be more effectively activated and potentially increase the response rate in multiple indications."

Clinical • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG

Alligator Announces Poster Presentation on ATOR-1017 at SITC Virtual Annual Meeting 2021 (Cision) - “Alligator Bioscience AB…announced new preclinical data highlighting the 4-1BB (CD137) antibody ATOR-1017 including an update on the ongoing phase 1 study. ATOR-1017, a promising candidate for immunotherapy with enormous potential for combination with other immunomodulatory antibodies, will be presented at the Society for Immunotherapy Cancer’s (SITC) 36th Annual Meeting & Pre-Conference Programs virtually on November 10th – 14th, 2021.”

Preclinical • Oncology

[VIRTUAL] A first-in-human, multicenter, open-label, phase 1 study of ATOR-1017, a 4-1BB antibody, in patients with advanced solid malignancies. (ASCO 2021) - P1 | "ATOR-1017 is safe and well-tolerated up to 100 mg . Dose escalation continues and the current dose level is 200 mg."

Clinical • P1 data • Adenoid Cystic Carcinoma • Anal Carcinoma • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Choroidal Melanomas • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Hematological Disorders • Hepatology • Immune Modulation • Inflammation • Leukopenia • Melanoma • Musculoskeletal Pain • Neutropenia • Ocular Melanoma • Oncology • Ovarian Cancer • Pain • Pancreatic Cancer • Sarcoma • Solid Tumor • TNFRSF9

"Alligator is exploring financing alternatives to support phase II studies for Mitazalimab, phase II preparations for ATOR-1017 as well as the development of other pipeline https://t.co/ENrvgB2Uqn" (@CisionNews)

Alligator is exploring financing alternatives to support phase II studies for Mitazalimab, phase II preparations for ATOR-1017 as well as the development of other pipeline (PRNewswire) - “Alligator Bioscience…announces that the Company, in order to enable further progress, will begin evaluating potential financing alternatives, which may include issuance of equity...the right opportunities to develop the Company, the Board's current assessment is that working capital will need to be strengthened in order to enable phase II studies for Mitazalimab, phase II preparations for ATOR-1017 as well as the development of other pipeline candidates…”

Financing • Oncology

Alligator Bioscience presents positive Phase I data at ASCO for its 4-1BB agonist drug candidate ATOR-1017 (PRNewswire) - P1, N=120; NCT04144842; Sponsor: Alligator Bioscience AB; "Alligator Bioscience...today presents novel supportive data from the ongoing Phase I clinical trial with the 4-1BB (CD137) drug candidate ATOR-1017 developed as tumor-directed therapy for metastatic cancer...validate the therapeutic potential of ATOR-1017 demonstrating a very favorable safety profile combined with clear signs of proof of mechanism...As of data cut-off March 31, 2021, a total of 13 patients with varying advanced solid malignancies had been included. 4 patients (31%) remained on treatment, 3 (23%) of whom had confirmed stable disease for a period of 3.5-12.5 months...The results further demonstrate that ATOR-1017 exhibits a favorable pharmacokinetic profile with linear elimination and no accumulation."

P1 data • Oncology • Solid Tumor

Alligator Bioscience AB: Year-end Report January-December 2020 (PRNewswire) - P1, N=50; NCT04144842; Sponsor: Alligator Bioscience AB; "'Safety data has been presented from the ongoing Phase I study with ATOR-1017 in patients with metastatic cancer. The results show a promising safety profile with only minor drug-related side effects.'"

P1 data • Oncology • Solid Tumor

Alligator Bioscience's rights issue oversubscribed (PRNewswire) - “Alligator Bioscience…has completed the share issue with pre-emption rights for the Company's shareholders, which was resolved upon by the Board of Directors on December 15, 2020 pursuant to the authorization from the annual general meeting on May 5, 2020 (the 'Rights Issue')…Alligator has carried out the Rights Issue to initiate and conduct Phase II studies for mitazalimab and to complete Phase I study and initiate preparatory work on Phase II study for ATOR-1017.”

Financing • Trial status • Gastric Cancer • Gastrointestinal Cancer • Oncology

Predicted therapeutic range dose levels reached in ATOR-1017 Phase I (PRNewswire) - P1, N=50; NCT04144842; Sponsor: Alligator Bioscience AB; "Alligator Bioscience...announced additional positive interim safety data from its ongoing clinical Phase I study of the drug candidate ATOR-1017...The Data Review Committee that monitors the safety of the patients in the Phase I study, has cleared a 100 mg dose and approved to start dosing at 200 mg, corresponding to approximately 3.2 mg/kg. The majority of the observed drug related adverse events have been mild or moderate (grade 1 or 2) and there are indications that ATOR-1017 activates the immune system of patients....The Phase I study is planned to read out in H1 2021, with a Phase Ib/II efficacy study starting in H2 2021."

DSMB • New P1/2 trial • P1 data • Oncology • Solid Tumor

"Predicted therapeutic range dose levels reached in ATOR-1017 Phase I https://t.co/FjddKUW8cN" (@CisionNews)

Alligator Bioscience focuses on ATOR-1017 and mitazalimab (PRNewswire) - "Alligator...today announced the decision to focus its resources on the two proprietary candidate drugs, ATOR-1017 and mitazalimab. Positive safety and strong Proof of Mechanism data support moving both into clinical efficacy (Phase Ib/II) studies in 2021. Due to this prioritization, Alligator will complete the ongoing dose-escalation study with the bispecific ATOR-1015 as planned during Q4 2020, after which it will be partnered for further development."

New P1/2 trial • Trial status • Oncology

Alligator Bioscience AB (publ): Interim report January-September 2020 (PRNewswire) - "The Phase I study with ATOR-1017 has progressed exceptionally well...we expect to present safety and potentially efficacy data from the entire study in the spring of 2021. At the same time, we have shown strong Proof of Mechanism data for mitazalimab, while the ATOR-1015 program reported side effects at high dose levels....We will now focus our clinical investments to ATOR-1017 and mitazalimab. Both programs have first-in-class potential, and will move into clinical Phase II during 2021', commented CEO Per Norlén....The CTA for the upcoming Phase II study in pancreatic cancer is scheduled to be submitted in December 2020....Revised plan due to further evaluation of doses and adverse reactions, leading to delay of Phase Ib....Encouraging emerging safety data at clinically relevant dose levels in the ongoing Phase I study."

Clinical • New P2 trial • P1 data • Regulatory • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

"Alligator Bioscience fokuserar på ATOR-1017 och mitazalimab https://t.co/94puflRfGT" (@CisionNews)