On September 27, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, reported that its study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway" has been accepted for a poster presentation at the AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer, held from September 27-30, 2023, in Boston, Massachusetts (Press release, Can-Fite BioPharma, SEP 27, 2023, View Source [SID1234635446]).

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The pre-clinical studies presented in the poster used advanced pancreatic carcinoma patient cells that were treated with Namodenoson both in tissue cultures and in in vivo studies. Namodenoson treatment resulted in a significant growth inhibition and de-regulation of two signal transduction pathways, the Wnt and the KRAS, both of which are responsible for the etiology and pathology of this devastating disease.

Can-Fite completed the development of an exploratory Phase II protocol in patients with pancreatic carcinoma who have failed first line treatment and plans to shortly submit it for approval to medical sites in Israel and the U.S. Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored.

"The robust inhibition of pancreatic carcinoma growth both in vitro and in vivo, together with the definitive mechanism of action is a strong basis for evaluating Namodenoson in patients with pancreatic carcinoma where chemotherapeutic drugs have a very limited effect. We are very happy that the AACR (Free AACR Whitepaper) granted us the opportunity to present these encouraging data and to discuss the very important results with the leading global experts in this field," stated Prof. Pnina Fishman, CSO & Executive Chairman of Can-Fite.

About Pancreatic Cancer

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson

Namodenoson was evaluated in Phase 2 trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase 2b trial for steatotic liver disease and a pivotal Phase 3 for HCC. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On September 27, 2023 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company focused on using a groundbreaking technology platform for drug discovery and developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs, reported the presentation of a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting, taking place on November 3 through 5 in San Diego, CA (Press release, BeyondSpring Pharmaceuticals, SEP 27, 2023, View Source;utm_medium=rss&utm_campaign=beyondspring-and-leading-cancer-center-to-present-poster-at-sitcs-38th-annual-meeting [SID1234635445]).

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The poster, titled, "​​Immune Activation with Plinabulin Enhances Anti-tumor Response Combining Radiation with Immune Checkpoint Blockade," will be presented by Dr. Steven H. Lin, MD., Ph.D., physician-scientist, radiation oncologist and professor who specializes in thoracic malignancies at The University of Texas MD Anderson Cancer Center.

Additional presentation details are as follows:

Poster Session Date / Time: Saturday, November 4th, 2023, at 9 a.m. to 8:30 p.m. PDT
Location: San Diego Convention Center, Exhibit Halls A and B1
Type of Presentation: Poster Presentation
Abstract No.: 732

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).

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

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.