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Innate Pharma Highlights Data From Its Innovative Oncology Portfolio Selected for the SITC Annual Meeting 2024

On November 8, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that new preclinical data supporting the clinical development of its proprietary next generation antibody-drug conjugate (ADC) and innovative tetra-specific ANKET will be presented at the SITC (Free SITC Whitepaper) Annual Meeting 2024 (Press release, Innate Pharma, NOV 8, 2024, View Source [SID1234648054]).

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"We are thrilled to share our latest preclinical data at the SITC (Free SITC Whitepaper) Annual Meeting, highlighting the potential of IPH6501, our tetra-specific NK cell engager and IPH4502, our innovative ADC targeting Nectin-4. These findings underscore our commitment to advancing next-generation immunotherapies and reflect significant progress in the development of our drug candidates. We look forward to engaging with the scientific community as we continue to push the boundaries of next generation immunotherapies," commented Pr. Eric Vivier, Chief Scientific Officer of Innate Pharma.

Details of the presentations

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting | 6-10 November, Houston, Texas and Virtual

Harnessing NK Cells in Cancer Therapies
Session 107d: NK Cells and Innate Immunity
Presentation Type: Oral Presentation
Session Date and Time: Friday, Nov. 8, 2024, 3:50-5:25pm CST
Presentation Time: 4:35pm CST
Speaker: Eric Vivier, Chief Scientific Officer, Innate Pharma (co-chair of the session)
Preclinical Characterization of IPH6501: A Novel IL2v-Armed Tetraspecific NK Cell Engager Targeting CD20 in Relapsed or Refractory B cell Non-Hodgkin Lymphoma Subtypes and Post-CAR-T Therapy.
Abstract Number: 1083
Presentation Type: Poster Presentation
Primary Category: Immuno-Conjugates and Chimeric Molecules
Poster Presentation Day: Friday, Nov. 8, 2024
IPH45, a next-generation antibody-drug conjugate (ADC) targeting Nectin-4
Abstract Number: 1056
Presentation Type: Poster Presentation
Primary Category: Immuno-Conjugates and Chimeric Molecules
Poster Presentation Day: Saturday, Nov. 9, 2024
More information can be found on the JITC website.

Protein & Antibody Engineering Summit (PEGS) Europe | November 5-7, Barcelona, Spain and virtual

In addition, the presentation entitled « A Next-Generation ADC for Nectin-4 Expressing Tumours: Preclinical Characterisation of IPH45, a Novel and Differentiated Exatecan-Based ADC Targeting Nectin-4 » was presented at the PEGS Europe Summit. The presentation is available on the Company website, in the publications section.

About IPH4502

IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues.

In non-clinical models, IPH4502 is well tolerated and shows anti-tumor efficacy in vitro and in vivo.

In September 2024, the U.S Food and Drug Administration cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications.

About IPH6501

IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not a subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells.

IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA (Free EHA Whitepaper) 2023).

IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma.

Synthekine Announces Presentation of New Translational Data from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting

On November 9, 2024 Synthekine Inc., an engineered cytokine therapeutics company, reported positive translational results from the Phase 1a dose escalation portion of a Phase 1a/1b clinical trial of its first-in-class α/β-IL-2R biased partial agonist, STK-012, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting in Houston (Press release, Synthekine, NOV 8, 2024, View Source [SID1234648053]). STK-012 is engineered to selectively stimulate CD25+ antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity. The Phase 1b dose expansion portion of the study in adults with advanced solid tumors remains ongoing (NCT05098132) and will include treating patients with STK-012 in combination with standard of care therapy in first line PD-L1 negative non-small cell lung cancer (NSCLC).

Initial clinical findings for STK-012 monotherapy from the Phase 1a dose escalation portion of the study were presented at AACR (Free AACR Whitepaper) earlier this year, showing a favorable safety profile without Capillary Leak Syndrome (CLS) and with single agent efficacy, including multiple objective responses, in IO-refractory solid tumors. The findings shared at SITC (Free SITC Whitepaper) build on these monotherapy results from the same study population, further demonstrating the mechanism of action of STK-012 and its ability to selectively induce T cell activation and expansion.

Results presented in the STK-012 poster at SITC (Free SITC Whitepaper) include an analysis of key biomarkers, such as cytokine induction and memory CD8 T cell activation and expansion, both of which were found to correlate with best overall response (BOR). The poster also includes analysis of the TCR clonal expansion observed upon treatment with STK-012 monotherapy, which led to an 80-fold median increase in expanding TCR clones. TCR clonal expansion was found to correlate with both progression-free survival (PFS) and BOR in these patients.

"We are very encouraged by the translational data for STK-012 monotherapy as it represents a powerful advancement in cancer therapy, designed to realize the full efficacy potential of IL-2 while eliminating severe toxicities typically associated with IL-2 treatment," said Martin Oft, M.D., chief scientific officer of Synthekine. "Our data reinforces STK-012’s unique mechanism of action, as demonstrated by selective expansion of antigen activated T cells without broad expansion of other lymphocytes including NK cells. In addition, we see strong and sustained induction of interferon gamma (IFNγ) coupled with minimal increase of interleukin-6 (IL-6), supporting the efficacy and tolerability profile of STK-012. We look forward to advancing this promising candidate to the next stage of clinical development."

The company will also present two posters for STK-026, a biased IL-12 cytokine partial agonist. The preclinical data to be presented demonstrates STK-026 is engineered to retain the potent antitumor activity of IL-12 while avoiding its systemic toxicities. In addition, results of a GLP toxicology study in cynomolgus monkeys showed excellent tolerability of STK-026 and confirmed its preferential activity toward CD8 T cells. Relative to therapies based on unmodified IL-12, STK-026 is tuned to bias immune activation toward the adaptive and away from the innate immune systems, thus avoiding NK cell mediated dose-limiting toxicities that are the hallmark of IL-12 therapy, including cytokine release syndrome (CRS), hepatoxicity, and lymphopenia.

Details are as follows and available on the SITC (Free SITC Whitepaper) website:

Title: T cell and Immune Activation from a Phase 1 Study of STK -012, a First-in-class IL-2R α/ß Selective Partial Agonist in Advanced Solid Tumors
Session Name: Novel Single-Agent Immunotherapies
Session Date & Time: Friday, November 8, 2024, 9:00 AM – 7:00 PM CT
Format: Poster Presentation
Abstract Number: 1325

Title: STK -026, a detoxified IL-12 partial agonist is well-tolerated and sustains CD8+ T cell activity with repeat doses in cynomolgus macaques
Session Name: Immune-Stimulants and Immune Modulators
Session Date & Time: Friday, November 8, 2024, 9:00 AM – 7:00 PM CT
Format: Poster Presentation
Abstract Number: 941

Title: Gradual lymphocyte activation with IL-12 partial agonist STK-026 maintains anti-tumor efficacy but escapes acute NK-mediated cytokine release and toxicities associated with WT IL-12
Session Name: Immune-Stimulants and Immune Modulators
Session Date & Time: Saturday, November 9, 2024, 9:00 AM – 8:30 PM CT
Format: Poster Presentation
Abstract Number: 964

Copies of the posters will be available on Synthekine’s website following presentation at the meeting.

Tempus Announces Nine Abstracts Accepted for Presentation at the 2024 Society for Immunotherapy of Cancer Annual Meeting

On November 8, 2024 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported nine abstracts were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th Annual Meeting, which convenes in Houston, Texas, from November 6-10, 2024 (Press release, Tempus, NOV 8, 2024, View Source [SID1234648052]).

"Presenting our latest research is a vital opportunity to showcase the advancements Tempus is making in harnessing the power of data and AI to drive immunotherapy innovation," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "We are committed to working with the oncology community to share insights that can accelerate the development of more effective, personalized therapies and contribute to the improvement of outcomes for patients."

This year, highlights of Tempus’ poster presentations include:

Poster Presentation (#188): Clinical validation of a novel multi-omic algorithm for stratifying outcomes in a real-world cohort of metastatic solid cancer patients treated with immune checkpoint inhibitors
Session Date & Time: Saturday, November 9, 2024; 9:00 a.m. – 8:30 p.m. CT
Location: George R. Brown Convention Center; Exhibit Halls AB

Overview: This study aimed to predict patient outcomes to immune checkpoint inhibitors (ICI) by developing an integrated DNA/RNA ICI biomarker. A de-identified pan-cancer cohort from the Tempus multimodal real-world database was utilized to develop and validate the Immune Profile Score (IPS) algorithm that leverages Tempus xT (DNA sequencing) and xR (RNA sequencing). The researchers found that IPS status can be used to stratify patient cohorts and prognosticate ICI-treatment response.

Poster Presentation (#1352): Impact of timing of real-world CT imaging on cost-effectiveness of a molecular biomarker for treatment response monitoring of immunotherapy
Session Date & Time: Saturday, November 9, 2024; 9:00 a.m. – 8:30 p.m. CT
Location: George R. Brown Convention Center; Exhibit Halls AB

Overview: The research team sought to model the impact of Computed Tomography (CT) imaging patterns on the clinical utility and cost-effectiveness of a molecular biomarker for treatment response monitoring (TRM) compared to imaging. The team analyzed real-world imaging patterns from a cohort of 4,147 advanced cancer patients treated with immune checkpoint inhibitors (ICI) across five solid tumor types. The study found significant variability in CT scan intervals between cancer types and treatments. Incorporating these patterns into a microsimulation model, the team demonstrated that using the molecular biomarker in conjunction with CT imaging provided substantial cost savings and reduced inappropriate therapy compared to imaging alone, with the most benefit observed in small cell lung cancer (SCLC) treated with ICI-chemotherapy.

Palleon Pharmaceuticals Presents Results from the Phase 1/2 GLIMMER-01 Trial of E-602 in Combination with Cemiplimab in Patients with Solid Tumors at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 8, 2024 Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat autoimmune diseases and cancer, reported results from the Phase 1/2 GLIMMER-01 trial of E-602, its first-in-class human sialidase enzyme therapeutic, in combination with PD-1 inhibitor cemiplimab (Libtayo) in patients with PD-(L)1-resistant solid tumors (Press release, Palleon Pharmaceuticals, NOV 8, 2024, View Source [SID1234648051]). The results will be shared in both rapid oral and poster presentations on Saturday, November 9 at the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Houston, Texas.

In the Phase 1/2 study, 21 patients with anti-PD(L)-1-resistant melanoma, non-small cell lung cancer and esophagogastric junction cancer, defined according to the SITC (Free SITC Whitepaper) consensus definition for resistance to immunotherapy, were treated with E-602 in combination with cemiplimab. All patients were assessed for tumor sialoglycan levels and characterized as having hypersialylation or not. The combination was generally well-tolerated, with no dose-limiting toxicities observed. Patients with tumor hypersialylation trended toward better clinical outcomes compared to those lacking hypersialylation, including a confirmed partial response achieved in one anti-PD-1 resistant melanoma patient, and disease stabilization achieved in another six patients. All patients lacking hypersialylation showed disease progression. In addition, paired tumor biopsies from patients with hypersialylation showed tumor desialylation and immune modulation in tumors, however, tumor desialylation only lasted 2-3 days with weekly dosing. These findings provide the first proof of mechanism for glycan editing as a novel therapeutic approach to modulating the immune system.

"The proof of mechanism and antitumor responses observed with E-602 as a combination therapy for patients with solid tumors further validate the therapeutic potential of targeting glyco-immunology to regulate the immune response in treating cancer and autoimmune diseases," said Li Peng, Ph.D., Chief Scientific Officer of Palleon Pharmaceuticals. "We look forward to applying E-602 to treat diseases that align with its pharmacological characteristics, and advancing our next-generation EAGLE molecules that have a longer half-life sialidase and a tumor-targeting moiety to address the unmet needs of cancer patients."

"E602 is the first candidate in a brand new class of therapeutics designed to modulate the immune system by targeting glyco-immunology. Palleon is building a rich pipeline of first-in-class drug candidates with the potential to improve and extend the lives of patients with diseases characterized by immune dysfunction, including cancer and autoimmunity," added Jim Broderick, M.D., CEO and Founder of Palleon.

The study results will be available for viewing on the Palleon Publications section of the Education Hub page of Palleon’s website following the official presentation on November 9.

SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M17D1 in Advanced Solid Tumors

On November 8, 2024 SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology (Press release, SystImmune, NOV 8, 2024, View Source [SID1234648050]). The IND supports the initiation of a Phase 1 clinical trial, BL‑M17D1-ST-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 for the treatment of patients with advanced or metastatic solid tumors in the United States.

‍The clearance of this IND application marks an important milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Jie D’Elia, Chief Executive Officer of SystImmune, commented, "Our mission at SystImmune is to bring therapies that can provide transformative clinical benefit to patients. As BL-M17D1 is developed using our next generation linker and payload technology, the initiation of clinical development for BL-M17D1 demonstrates our ability to continue to innovate in the ADC space and bring potentially best-in-class products to patients."