ATOR-4066 / Alligator Biosci - LARVOL DELTA

ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces myeloid and T-cell dependent anti-tumor activity and synergizes with PD-1 inhibition (SITC 2024) - "The strong in-vivo anti-tumor activity indicates the potential of ATOR-4066; either as a monotherapy or in combination with other anticancer agents, in particular immune checkpoint inhibitors (ICI) to overcome ICI resistance in CEACAM5 expressing tumors. Ethics Approval All animal experiments were conducted in accordance with national Swedish guidelines and approved by Malmö-Lund djurförsökssetiska nämnd with approval nr 18602-23."

IO biomarker • Gastric Cancer • Oncology • Solid Tumor • CD40 • CEACAM5

Alligator Bioscience Presents…at SITC 2024 (ACCESSWIRE) - "Alligator also had a poster presentation on ATOR-4066, its next-generation bispecific CD40 antibody candidate that targets CD40 and CEACAM5. The results showed that ATOR-4066 induces both myeloid cell-dependent and T-cell dependent anti-tumor activity in preclinical models. The strong in-vivo anti-tumor activity indicates the potential of ATOR-4066 as a monotherapy or in combination with other anticancer agents, in particular immune checkpoint inhibitors (ICI), to overcome ICI resistance in CEACAM5-expressing tumors."

Preclinical • Solid Tumor

Alligator Bioscience to Participate in Upcoming Scientific and Investor Conferences in Q4 2024 (Alligator Bioscience Press Release) - "Alligator Bioscience...today announces participation in the following conferences during Q4 2024...Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, November 6-10, Houston."

P2 data • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor

Alligator Bioscience Announces Publication Highlighting Potential of Next-Generation CD40 Agonists in Peer-Reviewed Medical Journal “Expert Opinion on Biological Therapy” (Alligator Bioscience Press Release) - "Alligator Bioscience...announces the publication of a scientific article detailing the potential of next-generation CD40-targeting therapies in immuno-oncology in the peer-reviewed medical journal 'Expert Opinion on Biological Therapy'. The article...highlights how: Bispecific CD40-targeting antibodies, as those developed using Alligators Neo-X-Prime platform, that maximize the ability of CD40 to both remodel the tumor microenvironment and boost the anti-tumor T cell response have the potential to meet key needs in immuno-oncology; Enhancing efficacy is the most important driver for developing new CD40-targeting therapies while ensuring safety is also critical to allow effective dosing in combination with other treatment modalities....CD40 targeting bispecific antibodies, such as ATOR-4066 developed by Alligator, can take CD40 agonists to the next level in terms of efficacy and safety."

Review • Solid Tumor

Modulation of the Tumour Microenvironment Using CD40 Targeting Neo-X-Prime bsAbs Developed Using the RUBY Format (IO-SUMMIT EUROPE 2024) - "The platform is built on bispecific antibodies targeting CD40 and highly expressed tumour-associated antigens (TAA). The lead candidate, ATOR-4066, targets CD40 and CEACAM5 and induces superior anti-tumour activity by myeloid cell-mediated and T cell-dependent mechanisms."

Tumor microenvironment • Oncology • CD40 • CEACAM5

ATOR-4066, a Neo-X-Prime™ bispecific antibody targeting CD40 and CEACAM5, induces tumor localized immune cell activation in preclinical in vivo tumor model (AACR 2024) - "In contrast, RNA-sequencing of peripheral blood in ATOR-4066 treated mice showed only small transcriptomic differences compared to the vehicle treated group, but distinct from mice treated with a CD40 mAb, further demonstrating the CEACAM5 dependent response of ATOR-4066. In summary, these preclinical data demonstrate that ATOR-4066 activates infiltrating myeloid cells resulting in increases in activated tumor infiltrating T cells, thus creating a pro-inflammatory tumor microenvironment, which strongly supports further development and clinical testing of ATOR-4066."

Immune cell • Preclinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40 • CD86 • CEACAM5

Alligator Bioscience Announces Two Presentations on Mitazalimab and ATOR-4066 at the AACR Annual Meeting 2024 (Alligator Bioscience Press Release) - "The second presentation, entitled 'ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces tumor localized immune cell activation in preclinical in vivo tumor model', demonstrates that ATOR-4066 activates tumor infiltrating dendritic cells and macrophages resulting in increases in activated tumor infiltrating T cells, thus creating a pro-inflammatory tumor microenvironment leading to single-agent complete responses in translational tumor models. These data strongly support further development and clinical testing of ATOR-4066."

Preclinical • Solid Tumor

Modulation of the Tumour Microenvironment Using CD40 Targeting Neo-X-Prime bsAbs Developed Using the RUBY Format (IO-SUMMIT EUROPE 2024) - "The platform is built on bispecific antibodies targeting CD40 and highly expressed tumour-associated antigens (TAA). The lead candidate, ATOR-4066, targets CD40 and CEACAM5 and induces superior anti-tumour activity by myeloid cell-mediated and T cell-dependent mechanisms."

Tumor microenvironment • Oncology • CD40 • CEACAM5

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 Granted First U.S. Patent for Neo-X-Prime Bispecific Antibody ATOR-4066 for Cancer Treatment (Alligator Bioscience Press Release) - "Alligator Bioscience...announces that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. US 11,873,348 covering ATOR-4066, a Neo-X-Prime™ next generation bispecific antibody targeting CD40 and CEACAM5, in the treatment of cancer. The patent, titled 'Novel peptides', provides ATOR-4066 with protection regarding methods of treating cancer and/or a tumor using a bispecific antibody comprising the complementarity-determining regions (CDRs) of the ATOR-4066 molecule."

Patent • Oncology

Combination treatment with ATOR-4066, a Neo-X-Prime™ bispecific antibody targeting CD40 and CEACAM5, and anti-PD-1 reverses T cell exhaustion in vitro (SITC 2023) - "Furthermore, using DTCs from gastric cancer patients, ATOR-4066 induced activation of multiple immune cell populations. Conclusions Overall, these data emphasize the potential of ATOR-4066 as monotherapy and as a checkpoint inhibitor combination partner to further enhance the immune response in tumors, demonstrating the promise of this new candidate drug for further clinical development."

IO biomarker • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40 • CEACAM5 • IFNG

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

Alligator Bioscience Announces Poster Presentation on Neo-X-Prime Bispecific Antibody ATOR-4066 at SITC Annual Meeting 2023 (Alligator Bioscience Press Release) - "Alligator Bioscience...announces a poster presentation on ATOR-4066, a Neo-X-Prime™ bispecific antibody targeting CD40 and CEACAM5, at the 2023 SITC (Society for Immunotherapy of Cancer) Annual Meeting, being held in San Diego November 1-5, 2023....ATOR-4066 has a superior anti-tumor effect compared to a CD40 monospecific antibody; ATOR-4066 activation of CD40 expressing cells is CEACAM5-conditional with no activation in absence of CEACAM5 indicating a potential for a wide therapeutic window; ATOR-4066 is well positioned, with distinct advantages compared to other CD40 or CEACAM5 targeting therapies, such as strong anti-tumor effect in vivo also in larger tumors with heterogenous CEACAM5 expression; ATOR-4066 induces immunological memory in vivo and were able to clear homologous tumors upon re-challenge."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Neo-X-Prime: Bispecific Tumor Antigen Conditional CD40 Agonistic Antibodies (IO-SUMMIT EUROPE 2023) - "Neo-X-Prime is a platform based on bispecific conditional CD40 agonistic antibodies that target TAAs expressed at high densities, where the lead program, ATOR-4066, targets CD40 and CEA. We have demonstrated that Neo-X-Prime bsAbs enable a novel mode of action involving delivery of tumor antigens to DCs and increased priming of tumor-specific T cells, which results in increased anti-tumor efficacy compared to monoclonal antibodies."

Oncology • CD40

ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEA, activates myeloid cells in primary human tumors in vitro and induces anti-tumor immunity in vivo (AACR 2023) - "In vivo studies using human CD40 transgenic mice bearing CEA-transfected MC38 tumors showed superior anti-tumor effects of ATOR-4066 compared to a CD40 mAb, demonstrating the ability of ATOR-4066 to efficiently induce a tumor-targeting immune response. Overall, these data show the ability of ATOR-4066 to remodel the immune microenvironment and activate tumor-infiltrating immune cells in primary human tumors expressing CEA, demonstrating the promise of this new candidate drug for further clinical development."

Preclinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40 • CEACAM5

Alligator Bioscience Announces Poster Presentation on ATOR-4066 at the AACR Annual Meeting 2023 (Market Screener) - "Alligator Bioscience...announces the company presented a poster on ATOR-4066, a Neo-X-Prime™ bispecific antibody (bsAb), at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 14-19, 2023, in Orlando, Florida....CEACAM5-conditional CD40-activation of tumor-infiltrating immune cells in patient-derived dissociated tumor samples from indications with high CEACAM5 expression, including colorectal and gastric cancer; co-localization of CEACAM5-expressing tumor debris and CD40-expressing antigen presenting cells; strong in vivo anti-tumor efficacy and induction of immunological memory."

Preclinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Bispecific antibodies targeting CD40 and tumor-associated antigens promote cross-priming of T cells resulting in an antitumor response superior to monospecific antibodies. (PubMed, J Immunother Cancer) - "The data presented herein support the hypothesis that CD40×TAA bispecific antibodies can engage tumor-derived vesicles containing tumor neoantigens to myeloid cells such as DCs resulting in an improved DC-mediated cross-priming of tumor-specific CD8 T cells. Thus, this principle may offer therapeutics strategies to enhance tumor-specific T-cell immunity and associated clinical benefit in indications characterized by poor T-cell infiltration or deficiencies in T-cell priming."

Journal • Immune Modulation • Inflammation • Oncology • CD40 • CD8 • CEACAM5

Alligator Bioscience Announces Publication Highlighting Bispecific Antibodies Targeting CD40 and Tumor Antigens in Peer-Reviewed Journal for ImmunoTherapy of Cancer (Market Screener) - "Alligator Bioscience...announced the publication of a peer-reviewed article highlighting how bispecific Neo-X-Prime antibodies targeting CD40 and tumor-associated antigens (TAA) represent a promising novel treatment modality with the potential to meet key needs in immuno-oncology....The results of the study also demonstrated in vitro that the antibodies induced clustering of tumor debris and CD40-expressing cells in a dose-dependent manner and superior T cell priming when added to dendritic cells, and antigen-containing tumor debris or exosomes. Further, the data show that the CD40 x TAA bispecific antibodies induced TAA-conditional CD40 activation both in vitro and in vivo, which shows the potential for a wide therapeutic window for Neo-X-Prime bispecific antibodies."

Preclinical • Oncology

Alligator Bioscience to Present at 10th Annual Immuno-Oncology Summit, October 12 -14, 2022 (Market Screener) - "Alligator Bioscience AB...announced that Mattias Levin, PhD, Sr Team Manager Antibody Engineering at Alligator Bioscience, will present at the 10th Annual Immuno-Oncology Summit being held in Boston and virtually, October 12-14....The presentation will focus on Alligator's Neo-X-Prime™, a CD40-based bispecific platform with a dual mechanism of action that, in addition to CD40, targets tumor associated antigens (TAA) expressed at high densities....The presentation will highlight preclinical data and the medical opportunities in multiple cancer indications of ATOR-4066, Alligator's preclinical first-in-class bispecific CD40 agonist."

Preclinical • Oncology