ATOR-1015 / Alligator Biosci, BioInvent - LARVOL DELTA

[VIRTUAL] Safety and pharmacodynamic activity of ATOR-1015, a CTLA-4 x OX40 bispecific antibody, in a phase 1 dose escalation study of patients with advanced solid malignancies (SITC 2020) - P1 | "Following the dose escalation phase, an expansion cohort for patients with advanced malignant melanoma will be initiated. Ethics Approval The study is approved by the Ethic Boards in Sweden and Denmark."

Clinical • IO Biomarker • P1 data • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • CTLA4

[VIRTUAL] Safety and pharmacodynamic activity of ATOR-1015, a CTLA-4 x OX40 bispecific antibody, in a phase 1 dose escalation study of patients with advanced solid malignancies (SITC 2020) - P1 | "Following the dose escalation phase, an expansion cohort for patients with advanced malignant melanoma will be initiated. Ethics Approval The study is approved by the Ethic Boards in Sweden and Denmark."

Clinical • IO Biomarker • P1 data • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • CTLA4

[VIRTUAL] A first-in-human phase 1 study in patients with advanced and/or refractory solid malignancies to evaluate the safety of ATOR-1015, a CTLA-4 x OX40 bispecific antibody (AACR-I 2020) - P1 | "The dosing of ATOR-1015 has been safe and well-tolerated up to 100 mg. Dose escalation continues and the current dose level is 200 mg."

Clinical • P1 data • TNFRSF4

[VIRTUAL] A first-in-human phase I study in patients with advanced and/or refractory solid malignancies to evaluate the safety of ATOR-1015, a CTLA-4 x OX40 bispecific antibody. (ASCO 2020) - P1 | "The dosing of ATOR-1015 has been safe and well-tolerated up to 200 mg. Dose escalation continues and the current dose level under evaluation is 400 mg. Research Funding: Alligator Bioscience AB"

Clinical • P1 data • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Dermatology • Dermatopathology • Gastrointestinal Cancer • Gynecologic Cancers • Ocular Melanoma • Ovarian Cancer • Pain • Pancreatic Cancer • Solid Tumor • Vitiligo • CTLA4 • TNFRSF4

A first-in-human, multicenter, open label, phase I study in patients with advanced and/or refractory solid malignancies to evaluate the safety of intravenously administered ATOR-1015. (ASCO 2019) - P1; "Abstract P683. Clinical trial information: NCT03782467"

Clinical • P1 data

ATOR-1015 First-in-human Study (clinicaltrials.gov) - P1; N=33; Completed; Sponsor: Alligator Bioscience AB; Active, not recruiting ➔ Completed; Trial completion date: Nov 2022 ➔ Mar 2021; Trial primary completion date: Nov 2022 ➔ Mar 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

ATOR-1015 First-in-human Study (clinicaltrials.gov) - P1; N=33; Active, not recruiting; Sponsor: Alligator Bioscience AB; Recruiting ➔ Active, not recruiting; N=53 ➔ 33; Trial completion date: Feb 2023 ➔ Nov 2022; Trial primary completion date: Feb 2023 ➔ Nov 2022

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

The CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects through tumor-directed immune activation (AACR 2018) - "In conclusion, ATOR-1015 is a next generation CTLA-4 antibody with tumor directed activity with augmented T-reg depletion. It is currently in GLP manufacturing of clinical material and will start clinical trials in the second half of 2018."

Oncology

Alligator Bioscience presents at the SITC 35th Annual Meeting (PRNewswire) - "Alligator Bioscience...announced that it will present data from three immuno-oncology projects at the Society for Immunotherapy of Cancer's (SITC) 35th Virtual Annual Meeting, November 9-14, 2020. The presentations will include the Phase I study of ATOR-1015, the Phase I-ready ALG.APV-527 developed in partnership with Aptevo Therapeutics, as well as the novel bispecific concept Neo-X-Prime."

P1 data • Preclinical • Oncology • Solid Tumor

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 presents an update regarding the Phase I study with the drug candidate ATOR-1015 (PRNewswire) - "Alligator Bioscience...announced today updated timelines indicating 3-6 months delay for the planned Phase Ib study with ATOR-1015, its tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer…The ongoing Phase I dose escalation will be completed during the fourth quarter 2020 as previously communicated. The start of the Phase Ib expansion in malignant melanoma will be pushed into 2021 due to study amendments to adjust for the observed reactions. Recruitment will start as soon as regulatory approval has been obtained."

Enrollment status • P1 data • Trial status • Melanoma • Oncology

"#AlligatorBioscience receives patent approval for the drug candidate #ATOR1015 $ATORX https://t.co/d8ycKsgyp5" (@1stOncology)

Alligator Bioscience receives patent approval for the drug candidate ATOR-1015 (PRNewswire) - "Alligator Bioscience...announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,774,150 which covers compositions of matter directed to Alligator's bispecific drug candidate ATOR-1015. The granted patent's earliest expiry year is 2036....ATOR-1015 is developed for the treatment of metastatic cancer."

Patent • Oncology

The CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects through tumor-directed immune activation. (PubMed, J Immunother Cancer) - P1 | "By targeting CTLA-4 and OX40 simultaneously, ATOR-1015 is directed to the tumor area where it induces enhanced immune activation, and thus has the potential to be a next generation CTLA-4 targeting therapy with improved clinical efficacy and reduced toxicity. ATOR-1015 is also expected to act synergistically with anti-PD-1/PD-L1 therapy. The pre-clinical data support clinical development of ATOR-1015, and a first-in-human trial has started (NCT03782467)."

IO Biomarker • Journal • Bladder Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor

Alligator Bioscience presents novel supportive phase I data at ASCO for its CTLA-4 x ox40 bispecific drug candidate ATOR-1015 (PRNewswire) - P1, N=53; NCT03782467; Sponsor: Alligator Bioscience; AB; "The results from the evaluation of doses up and including 600 mg (about 10 mg/kg) show that ATOR-1015 is well tolerated, and dose-escalation has continued to 750 mg (12.5 mg/kg). In this presentation, 21 patients with varying cancer types (colon cancer, eye melanoma, pancreatic cancer, ovarian cancer, gallbladder cancer, gastric cancer, and melanoma) are included and evaluated in terms of safety. The drug related adverse events in the study have generally been mild and transient. No dose-limiting toxicity or severe immune-related adverse events have been reported…Due to the positive tolerability profile of ATOR-1015, dose escalation will continue at even higher doses than expected but still allows for a preliminary efficacy readout in melanoma patients already towards the end of 2021."

P1 data • Melanoma • Oncology • Solid Tumor

Alligator Bioscience AB interim report January-March 2018 (PRNewswire) - "Theradex Oncology contracted as clinical CRO (Clinical Research Organization) for the upcoming clinical study with ATOR-1015...Positive preclinical data presented that confirm the intended ATOR-1015 mechanism of action."

Licensing / partnership • New trial • Preclinical • Oncology

Alligator Bioscience AB (publ) interim report January-March 2020 (PRNewswire) - "The COVID-19 pandemic impacts the recruitment of new patients to the company's ongoing Phase clinical I studies with the ATOR-1015 and ATOR-1017 drug candidates...The Phase I clinical study [of ATOR-1015] progressed well with ten dose levels evaluated for initial safety. Currently, evaluation is in progress of doses of 600 mg, approximately 10 mg/kg, administered every two weeks."

Enrollment status • Trial status • Oncology

Alligator Bioscience presents promising interim phase I data for its bispecific drug candidate ATOR-1015 at AACR (PRNewswire) - P1, N=53; NCT03782467; Sponsor: Alligator Bioscience AB; "Alligator Bioscience...announces that the company today presents the status of the ongoing Phase I clinical trial with the bispecific drug candidate ATOR-1015 developed as tumor-directed therapy for metastatic cancer. The presentation will take place at the AACR (American Association for Cancer Research) Annual Meeting, which this year is being held digital for the first time...The adverse events in the study were generally mild and transient, all of grade 1 or 2 (on a scale of 1-5). The most common adverse events were infusion-related reactions (five patients)."

P1 data • Oncology • Solid Tumor

Alligator Bioscience increases focus on clinical development (PRNewswire) - "The ongoing covid-19 pandemic has imposed a major burden on our health care sector and as a consequence the ability to run clinical studies is temporarily limited. The clinical studies for ATOR-1015 and ATOR-1017 continue even if patient recruitment is expected to be temporarily affected. It is currently too early to estimate how it affects our study completion timelines."

Enrollment status

Alligator Bioscience informs about temporary halt of recruitment of new patients due to the COVID-19 pandemic (PRNewswire) - "Alligator Bioscience...announced....a temporary halt in the recruitment of new patients to the company's ongoing Phase I clinical trials with the drug candidates ATOR-1015 and ATOR-1017. Patients currently enrolled in clinical studies are expected to continue with their scheduled visits as planned. The company intends to, in consultation with clinical sites and authorities, resume the recruitment of patients as soon as possible."

Enrollment status

Alligator Bioscience AB appoints Chief Operating Officer (PRNewswire.co.uk) - "In Alligator's management team, Malin Carlsson will have overall responsibility for the company's clinical projects, with emphasis on the development plans for the candidate drugs mitazalimab (ADC-1013) and ATOR-1015, both of which are planned to start phase II clinical studies in 2020."

New P2 trial

Alligator Bioscience to present the ATOR-1015 phase I study outline at ASCO (PRNewswire) - “Alligator Bioscience…announces that the outline of the ongoing Phase I study with the bispecific drug candidate ATOR-1015 will be showcased at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago on May 31- June 4, 2019….the study results are expected to read out in the second half of 2020.”

P1 data

Alligator Bioscience to present new preclinical data on ATOR-1015 at PEGS Boston (PRNewswire) - "Alligator Bioscience...announces that Chief Medical Officer Charlotte Russell, MD, PhD, will give an oral presentation on its bispecific CTLA-4 x OX40 antibody ATOR-1015 at PEGS, the Essential Protein Engineering Summit, in Boston, US on April 10 2019. The presentation will showcase new preclinical tumor-localization data for ATOR-1015 demonstrating that ATOR-1015 physically localizes to the tumor in an experimental tumor model using a live imaging computerized technique."

Preclinical

Alligator Bioscience: first patient dosed in phase I study of ATOR-1015 (PRNewswire) - “Alligator Bioscience…announces that the first patient has successfully been dosed in its phase I study of ATOR-1015, its drug candidate in development for tumor-directed immunotherapy….The study, being initiated in five different clinics across Sweden and Denmark, is a first-in-human dose-escalation study in up to 53 patients with advanced solid tumor disease….The results of the study are expected to read out in the second half of 2020.”

Enrollment open • P1 data