On November 12, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported new preclinical data highlighting the 4-1BB (CD137) antibody ATOR-1017 including an update on the ongoing phase 1 study (Press release, Alligator Bioscience, NOV 12, 2021, View Source [SID1234595323]). 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) (Free SITC Whitepaper) 36th Annual Meeting & Pre-Conference Programs virtually on November 10th – 14th, 2021.

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"By combining ATOR-1017 with antibodies blocking PD-1, tumor infiltrating T cells, in particular exhausted tumor specific T cells, can be more effectively activated and potentially increase the response rate in multiple types of cancer," stated Karin Enell Smith, PhD, MS, Principal Scientist at Alligator Bioscience. "The functional activation profile of ATOR-1017 is expected to minimize the risk of systemic immune activation and toxicity, by directing a potent immune response to immune cells in tumor tissue and tumor draining lymph nodes. This is supported by early data from the ongoing first-in human phase I study where ATOR-1017 has been shown to be safe and tolerable. These results support further clinical development of ATOR-1017 in combination with PD-1 blocking antibodies"

In addition, the poster includes data from the 360 mg cohort of the ongoing ATOR-1017 phase 1 study.

Title: ATOR-1017, a second generation 4-1BB antibody with potential to

enhance efficacy of PD-1 therapies

Presenter: Karin Enell Smith, PhD, MS

Virtual Meeting: E-Posters Session: Poster

The above poster presentations will be available online at www. View Source on Saturday, November 13, 2021.

On November 12, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported that data highlighting the efficacy and safety of Neo-X-Prime bsAbs and how Alligator’s lead compound targeting CD40 and CEA meets key needs in Immuno-oncology, will be presented at the Society for Immunotherapy Cancer’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-Conference Programs virtually on November 10th – 14th, 2021 (Press release, Alligator Bioscience, NOV 12, 2021, View Source [SID1234595322]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are very excited by this data as it reinforces the robust potential of our proprietary Neo-X-Prime platform. The data shows that simultaneous CD40 engagement and delivery of neoantigen-containing tumor exosomes to antigen-presenting cells mediates an expansion of the tumor-specific T cell repertoire, resulting in potent anti-tumor effects," stated Karin Hagerbrand, PhD., Senior Scientist at Alligator Bioscience. "This is another step forward in the development of our platform technology and we are enthusiastic over the data presented on our lead Neo-X- Prime compound, targeting CD40 and CEA."

Session: Poster Hall

Title: Neo-X-Prime bispecific antibodies targeting CD40 and tumor antigens promote cross-presentation of tumor exosome-derived neoantigen and induce superior anti-tumor responses compared to CD40 mAb

Presenter: Karin Hagerbrand, PhD.

The above poster presentation will be available online at www. View Source on Saturday, November 13, 2021.

On November 12, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported that the design and scientific rationale of OPTIMIZE-1, Alligator´s phase 2 study (NCT02829099) in 1st line metastatic pancreatic cancer in combination with mFOLFIRINOX, will be presented at the Society for Immunotherapy Cancer’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-Conference Programs virtually on November 10th – 14th, 2021 (Press release, Alligator Bioscience, NOV 12, 2021, View Source [SID1234595321]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Mitazalimab, a best-in-class second generation CD40 agonist, reported positive clinical data from Phase I studies, displaying a manageable safety profile, proof-of-mechanism as well as early signs of efficacy. OPTIMIZE-1 reinforces our commitment to developing mitazalimab in combination with standard of care therapies," stated Yago Pico de Coaña, PhD., Medical Science Director at Alligator Bioscience. "Targeting CD40 with mitazalimab in pancreatic ductal adenocarcinoma (PDAC), has the potential to augment responses to chemotherapy, initiating an effective anti-tumor immune response and potentially better tumor control."

Title: OPTIMIZE-1, an open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

Presenter: Yago Pico de Coaña, PhD.

Virtual Meeting II: E-Posters Session: Poster

The above poster presentation will be available online at www. View Source on Saturday, November 13, 2021.

On November 12, 2021 Alligator Bioscience AB ("Alligator") and Aptevo Therapeutics ("Aptevo") reported that 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 for Immunotherapy Cancer’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place virtually and in-person on November 12th – 14th, 2021 in Washington D.C (Press release, Alligator Bioscience, NOV 12, 2021, View Source [SID1234595320]). The poster highlights preclinical datasets as an overview of the potential indication landscape, mechanism of action and the efficacy profile of ALG.APV-527, which support the molecule’s progression into the clinic.

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Poster # 796 entitled, "ALG.APV-527: A tumor directed bispecific approach utilizing ADAPTIR technology designed for conditional 4-1BB T cell/NK agonism against solid tumors," will be available on-demand starting today or displayed on-site on Saturday, November 13th. The poster describes the dual expression of CD8 and 5T4 in several tumor indications that will support the clinical development. 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.

"ALG.APV-527 is designed to elicit safe and efficacious 4-1BB-mediated antitumor activity in a range of 5T4-expressing tumor indications. The differentiated design of the molecule minimizes systemic immune activation and risk of hepatotoxicity, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in in vitro models," stated Michelle H. Nelson, PhD., Principal Scientist at Aptevo. "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 the programme is progressing towards a phase I clinical trial."

Title: ALG.APV-527: A 5T4 tumor directed bispecific approach utilizing ADAPTIRTM technology designed for conditional 4-1BB T cell/NK agonism against solid tumors

Presenter: Michelle H. Nelson, PhD (Aptevo Therapeutics)

Date/Time: Saturday, November 13th

On November 12, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that interim data from the ongoing Phase 1/2 GLORIA trial in brain cancer will be presented by Dr. Frank Giordano in an oral presentation at the Society for Neuro-Oncology (SNO) Annual Meeting (Press release, NOXXON, NOV 12, 2021, View Source [SID1234595294]). The meeting will take place in Boston, Massachusetts, USA from November 18 to 21, 2021.

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Dr. Frank Giordano, lead investigator of the GLORIA study, commented: "For many years, I have been focused on optimizing radiation therapy of brain cancers to offer patients more effective treatments that do not come at the costs of higher toxicity. The clinical data obtained to date from the combination of NOX-A12 with radiotherapy, that I will be presenting at the SNO, show a mild toxicity profile and at the same time encouraging efficacy. I am very much looking forward to seeing the results of six months of therapy of patients in the high-dose cohort in Q1 2022. To gather further data, we have also expanded the study to evaluate additional treatment combinations of NOX-A12 and radiotherapy."

The oral presentation entitled "CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial" will present and discuss the results of the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of brain cancer. Patients enrolled are all newly diagnosed with MGMT promoter unmethylated glioblastoma (GBM), that do not respond to standard of care chemotherapy (temozolomide). Advanced MRI and multiplexed immunofluorescence of treated patient samples suggest efficacy of combined radiotherapy and CXCL12 inhibition in unmethylated GBM. In addition, outcomes of patients treated with NOX-A12 and radiotherapy will be compared to a matched historical cohort of patients who received standard of care. More information about the GLORIA study (NCT04121455) can be found at ClinicalTrials.gov.

Details of the oral presentation are as follows:

Title: CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial (NCT04121455)
Abstract: download
Session Title: Abstract Session: Clinical Trials I
Session Date: Friday, November 19, 2021
Presentation Time: 05:00 p.m. EST // 11:00 p.m. CET
Presenter: Dr. Frank Giordano, Director and Chairman of the Department of Radiation Oncology at the University Hospital Bonn, Germany
Registration: To register to the event, please click here.

The NOXXON team will attend the conference in person. A copy of the presentation will be made available on the NOXXON website at the time of Dr. Giordano’s presentation.