On November 6, 2023 Galvanize Therapeutics, Inc., a leader in developing pulsed electric field therapies, reported compelling data from the INCITE-ES clinical study at the recent Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) conference (Press release, Galvanize Therapeutics, NOV 6, 2023, View Source [SID1234637074]). The study evaluated the ability of the Aliya Pulsed Electric Field (PEF) system to induce adaptive anti-tumor immunity in patients with Non-Small Cell Lung Cancer (NSCLC).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The Aliya PEF System delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of a cell, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and extracellular matrix. In addition to focal ablation, preclinical studies suggest this process may release damage associated molecular patterns (DAMPs) and antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation.

The INCITE-ES clinical study is a treat and resect study conducted outside of the U.S., designed to assess safety and examine immune activation in patients with early stage IA2‐IB NSCLC (NCT04732520). The two-arm study enrolled 34 patients in the PEF treatment group and 8 in the control group. Blood, bronchoalveolar lavage, and tumor tissue samples were collected from treated and untreated patients. Single‐cell RNA sequencing (scRNA‐Seq) from pre‐PEF and post‐PEF tumor samples was performed to examine PEF‐induced changes in the cell frequency and gene expression of tumor immune cells. Flow cytometry and serum cytokine profiling were used to evaluate systemic changes in the immune cell populations and cytokines after PEF treatment. Data presented previously demonstrated safety and feasibility to deliver PEF with no device or procedure-related adverse events, a significant reduction in malignant tissue, and an increase in formation of tertiary lymphoid structures (TLS) in PEF-treated patients.

Initial results from the INCITE-ES study highlight the potential for the Aliya PEF system to enhance the body’s natural defenses against tumors. The data suggest that Aliya PEF may facilitate and stimulate the migration of immune cells into the tumor, as well as the activity of the immune cells against tumor cells. This could lead to a stronger immune response, allowing the body to better target and fight the tumors.

Single-cell RNA sequencing in PEF-treated samples revealed a shift in gene expression in cell types that are instrumental in supporting a local inflammatory response.
Single-cell RNA sequencing showed that PEF‐treated tumors had a significant increase in plasma B cells and cytotoxic CD8 T cells (p < 0.05), which are key cells that target cancer cells.
Ingenuity Pathway Analysis (IPA) of serum cytokines in PEF-treated samples demonstrated that PEF induces immunogenic cell death, a type of cell death that triggers the stimulation of the immune system.
Flow cytometry showed higher levels of circulating B cells and effector memory T cells, and lower Tregs in PEF-treated samples, further suggesting activation of multiple aspects of the patients’ immune system.
Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics, commented on the significance of the findings, stating, "The data from the INCITE-ES study underscores the potential of Aliya PEF as a transformative approach in the fight against cancer. By harnessing the body’s own immune system, we are moving closer to offering patients a personalized and potentially more effective treatment option. Our team has been dedicated to investigating the biologic mechanism of action and the data presented at SITC (Free SITC Whitepaper) reflects our ongoing efforts to establish Aliya in the treatment of solid tumors."

The Aliya System is 510(k) cleared in the United States for the surgical ablation of soft tissue. It is not currently commercially available in any other geography.

On November 6, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported its participation in the Jefferies London Healthcare Conference, taking place November 14-16, 2023, in London (Press release, Aadi Bioscience, NOV 6, 2023, View Source [SID1234637073]). Dave Lennon, Ph.D., President and CEO, will participate in a fireside chat on Tuesday, November 14, 2023, at 8:30 am GMT.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The fireside chat will be webcast live on the IR pages of the Aadi Bioscience website and will be available for replay for approximately 30 days following each investor event.

On November 6, 2023 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeted therapies based on its proprietary Alluminox platform reported the presentation of two posters of AI-based analyses at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held November 3-5, 2023, in San Diego, CA (SITC 2023) (Press release, Rakuten Medical, NOV 6, 2023, View Source [SID1234637072]). The posters present data that may be relevant to improved clinical outcomes with treatment based on Rakuten Medical’s Alluminox platform (photoimmunotherapy).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The samples analyzed for these posters are from patients enrolled in an open-label Phase 1b/2 clinical trial (ASP-1929-181 study/ClinicalTrials.gov Identifier: NCT04305795) of ASP-1929 photoimmunotherapy in combination with anti-PD-1 for recurrent or metastatic head and neck squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma. Promising early evaluation data from the ASP-1929-181 study* was presented at the American Head and Neck Society (AHNS) in July 2023 (Abstract #: S252). The studies presented at SITC (Free SITC Whitepaper) 2023 utilized AI technology developed by Rakuten Institute of Technology Bengaluru, a part of Rakuten India Enterprise Private Limited and a branch of the global R&D organization of Rakuten Group, Inc., to further interpret the response data presented at AHNS. Rakuten Medical and Rakuten Institute of Technology Bengaluru have collaborated on AI-based analyses of patient samples since 2020.

* These preliminary findings may change upon completion of follow up and final data analysis.

Key findings presented at SITC (Free SITC Whitepaper) 2023

Title: Development of an image-based tumor microenvironment analysis coupled with peripheral flow cytometry reveals a distinct immune cell phenotype in responder patients in the Phase 1b/2 study ASP-1929-181

Abstract #: 83

The first poster addresses immune characteristics between responders and non-responders who received ASP-1929 photoimmunotherapy. Potentially predictive immune biomarkers were identified using a combination of multiplex immunofluorescent imaging methods with AI-based quantification and flow cytometry analyses of peripheral blood. The study results suggest that lower frequencies of CD8+ T cells in the blood at screening correlate with treatment response. Interestingly, of CD8+ T cells in the blood, an increased frequency of PD-1 co-expression also correlates with treatment outcome. At the tumor, an increase in cytotoxic CD8+ T cells in all 22 analyzed patients was observed over the course of treatment, suggesting the induction of the immune response following photoimmunotherapy.

Title: Development of a novel, cellular-level drug uptake quantification pipeline for accurate quantification of fluorescence-conjugated therapeutics: Data from the Phase 1b/2 open-label study ASP-1929-181

Abstract #: 1307

The second poster describes the quantification of drug binding to target cells for ASP-1929 photoimmunotherapy. The preliminary data suggested that a modified drug quantification method using AI-based tumor detection and cell segmentation has the potential to accurately measure drug uptake in tumors at the cellular level. Using this method, high drug uptake (>50-100%) in tumors prior to light treatment was observed for the first time in the clinical samples. Understanding drug uptake levels could help support dose response analyses in future preclinical studies and clinical trials.

On November 6, 2023 XNK Therapeutics AB ("XNK") reported that it will participate in the SITC (Free SITC Whitepaper) meeting, which takes place in San Diego, USA, and present the latest research relating to the company’s leading natural killer (NK) cell therapies (Press release, XNK Therapeutics, NOV 6, 2023, View Source [SID1234637071]). Two abstracts have been accepted for presentation at the meeting.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The first poster, titled Harnessing the Potential of Autologous NK Cells for Immune Therapy of Patients with Advanced Bladder Cancer, describes the successful expansion of autologous NK cells from peripheral blood mononuclear cells (PBMCs) from bladder cancer patients. Results demonstrate that NK cells from patients before and after first line platinum-based chemotherapy can be expanded and activated ex vivo to become cytotoxic against tumor cells.

The second poster, titled Feeder-free Expansion of Autologous Cytotoxic NK Cells for Acute Myeloid Leukemia Treatment, describes the successful expansion and activation of autologous NK cells from PBMCs of diverse cohorts of patients with Acute Myeloid Leukemia (AML).

XNK will be represented at the meeting by Chief Scientific Officer Dr. Anna-Karin Maltais.

The data have been generated in collaboration with XNK’s external partners, Dr. Anders Ullén and Dr. Fernanda Costa Svedman at the Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden, for the bladder cancer study, and Dr. Abhishek Maiti and Dr. Naval Daver at The University of Texas MD Anderson Cancer Center in Houston, Texas, USA, for the AML abstract.

On November 6, 2023 Biotheus Inc. ("Biotheus"), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, reported that the company has entered into an exclusive global license and collaboration agreement under which BioNTech will be developing, manufacturing and commercializing PM8002 globally ex-Greater China, whereas Biotheus retains the rights to exploit PM8002 in Greater China (Press release, Biotheus, NOV 6, 2023, View Source [SID1234637070]). PM8002 is currently being tested in Phase 2 studies in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Biotheus will receive an upfront payment of $55 million, and is eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1 billion as well as tiered royalties on potential future product sales. The transaction is expected to close in Q4 2023, subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ("HSR") Antitrust Improvements Act, and regulatory clearances.

PM8002 is a bispecific antibody candidate with humanized anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations. PM8002 has demonstrated a positive safety profile and encouraging antitumor activity presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumor microenvironment at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting and ESMO (Free ESMO Whitepaper) Congress 2023.

"Biotheus’ innovative platform has the capability to expedite preclinical research, bolstering our impressive innovative pipeline of products with encouraging efficacy and safety including PM8002. Collaborating with industry trailblazer BioNTech, we hope to advance PM8002 through multi-regional clinical trials with the aim to be able to provide it to patients worldwide," stated Xiaolin Liu, Co-founder, Chairman, and CEO of Biotheus.