Aulos Bioscience Announces Presentation of Updated Safety and Efficacy Data From First-in-Human Phase 1/2 Clinical Trial of AU-007 at 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting

On September 27, 2023 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that new safety and efficacy data from the Phase 1 dose escalation portion of its Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting (Press release, Aulos Bioscience, SEP 27, 2023, View Source [SID1234635444]). AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors. The SITC (Free SITC Whitepaper) meeting is being held virtually and in San Diego, California, from November 1-5, 2023.

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"Using artificial intelligence, AU-007 is designed to bind to IL-2 precisely instead of the IL-2 receptor. The result is a novel mechanism of action showing early promise in overcoming long-standing challenges for IL-2 therapies," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "As patient enrollment continues at multiple study locations in the United States and Australia, we look forward to presenting updated safety and efficacy data from the Phase 1 portion of the study at the SITC (Free SITC Whitepaper) Annual Meeting."

Details of the poster presentation are as follows:

Poster Title: A phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors: Interim results from dose escalation

Abstract: 717

Date and Time: Friday, November 3, 2023, 9:00 a.m.-7:00 p.m. PDT

The poster will be presented in the Poster Hall, Exhibit Halls A and B1 at the San Diego Convention Center. It will also be available as an ePoster on display on the SITC (Free SITC Whitepaper) 2023 virtual meeting platform.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

Allogene Therapeutics Announces Three Poster Presentations from its Next Generation AlloCAR T™ Platform at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

On September 27, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported three preclinical poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting November 1-5, 2023, in San Diego, CA (Press release, Allogene, SEP 27, 2023, View Source [SID1234635443]). These presentations will focus on the Company’s next generation AlloCAR T platform technologies and the foundation for an early-stage solid tumor product candidate, ALLO-182.

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"We are excited to share some of the groundbreaking work from our research team as we define next generation platform technologies that are designed to enhance engraftment and expansion of our AlloCAR TTM product candidates," said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research & Development and Chief Medical Officer. "We believe this important and foundational work could expand the potential of off-the-shelf CAR T products by improving their persistence and anti-tumor activity across multiple targets while also creating a path to reducing the intensity of conditioning therapy."

Allogene Abstracts:

DAGGER PLATFORM TECHNOLOGY
Preclinical Evaluation of Allogeneic CD19 CAR T Cells Expressing an Anti-Rejection CD70 CAR
Presenter: Elvin Lauron, Ph.D.
Abstract: 279
Poster Session Display Date and Time: Friday, Nov. 3, 2023, 9:00 a.m. – 7:00 p.m. PT
Location: Exhibit Halls A and B1

CLOAK PLATFORM TECHNOLOGY
Generation of Immune-Evasive Allogeneic CAR T Cells by Inactivation of the HLA Transcriptional Regulator RFX5 and Disruption of the Immune Synapse
Presenter: Hsin-Yuan Cheng, Ph.D.
Abstract: 302
Poster Session Display Date and Time: Saturday, Nov. 4, 2023, 9:00 a.m. – 8:30 p.m. PT
Location: Exhibit Halls A and B1

SOLID TUMOR TARGET (ALLO-182)
Preclinical Development and Characterization of Allogeneic CAR T Cells Targeting Claudin18.2 Positive Tumors
Presenter: Joanne Li, Ph.D.
Abstract: 283
Poster Session Display Date and Time: Friday, Nov. 3, 2023, 9:00 a.m. – 7:00 p.m. PT
Location: Exhibit Halls A and B1

Alligator Bioscience Announces Publication Highlighting Pharmacodynamic Data from Mitazalimab Phase 1 Study in Scientific Journal "Cells"

On September 27, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of a scientific article highlighting pharmacodynamic data from a Phase 1 dose escalation study of its lead asset mitazalimab, a best-in-class CD40 mAb agonist, in patients with advanced solid stage tumors (NCT02829099) (Press release, Alligator Bioscience, SEP 27, 2023, View Source [SID1234635442]).

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The publication in the journal Cells highlights how RNA sequencing was used to assess peripheral pharmacodynamic activity in patients from the Phase 1 study. The analysis revealed that at the current Phase 2 dose 900 μg/kg mitazalimab induced peripheral transcriptomic alterations consistent with immune activation expected from a strong CD40 agonist.

In particular, the transcriptomic alterations are in line with migration of effector cells (e.g. CD8+ T cells and natural killer cells) and B cells to tissues such as the tumor, while dendritic cells, monocytes, B cells and natural killer cells show transcription profiles consistent with increased immune activation. This activation of the immune system support the potential of mitazalimab to activate myeloid cells and overcome the immune suppressive mechanisms in the tumor microenvironment, which can induce anti-tumor responses and make the tumor more sensitive to other therapies, such as mFOLFIRINOX, in pancreatic cancer patients. The pharmacodynamic activity seen in this study is also in line with the immune phenotypic changes seen in the OPTIMIZE-1 study, with further details to be presented at AACR (Free AACR Whitepaper) Pancreatic on Thursday 28th September 2023.

The full article, entitled "Early pharmacodynamic changes measured by RNA sequencing in peripheral blood from patients in a phase 1 study with mitazalimab, a potent CD40 agonistic monoclonal antibody", is available online via this link.

"The publication of this article in the renowned, peer-reviewed journal Cells further underlines the importance of the CD40 research being carried out by our dedicated scientific team," said Søren Bregenholt, CEO of Alligator Bioscience. "The data presented here reinforce mitazalimab’s mode of action, validate the design of our ongoing OPTIMIZE-1 study and provide yet more clear evidence to support mitazalimab’s continued clinical development. We are now looking forward mitazalimab’s next major milestone, the topline readout from its evaluation in pancreatic cancer due early next year."

Mitazalimab is currently being evaluated in OPTIMIZE-1, a Phase 2 open-label, multi-center study to assess its safety and efficacy in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (NCT04888312). The study is on track for top-line readout in early Q1 2024.

Akari Therapeutics to Present at Emerging Growth Conference

On September 27, 2023 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that the company will participate in the Emerging Growth Conference being held October 4 and 5, 2023 (Press release, Akari Therapeutics, SEP 27, 2023, View Source [SID1234635441]). President and CEO Rachelle Jacques will present an overview of the company and its lead asset nomacopan, a bispecific inhibitor of complement C5 and leukotriene B4 (LTB4), on October 4, 2023 from 11:25 am to 11:55 am ET.

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Register for the presentation here.

Questions may be submitted in advance at [email protected].

Adcentrx Therapeutics Announces First Patient Dosed in the Phase 1a/b Study of ADRX-0706, a Novel ADC Targeting Nectin-4 for the Treatment of Advanced Solid Tumors

On September 27, 2023 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company dedicated to revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported the first patient dosed in the Phase 1a/b study of ADRX-0706 for the treatment of advanced solid tumors (Press release, Adcentrx Therapeutics, SEP 27, 2023, View Source [SID1234635440]).

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"We are pleased to announce this important milestone for Adcentrx that marks our transition from the discovery stage into a clinical stage company," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We are enthusiastic about the potential of ADRX-0706 to address the unmet needs of patients with Nectin-4 expressing cancers."

The first-in-human Phase 1a/b clinical trial of ADRX-0706 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects an initial data readout in the middle of 2024.

About ADRX-0706

ADRX-0706 is an ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. The ADC is produced using Adcentrx’s proprietary i-Conjugation technology and novel tubulin inhibitor payload, AP052, to generate an ADC with a drug-antibody ratio of eight (DAR 8). ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models, and has demonstrated significant efficacy across a variety of tumor indications.