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]).

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"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.

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.

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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.

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.

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‍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."

On November 8, 2024 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported an oral presentation at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 2024 annual meeting, occurring November 6 – 10, 2024, in Houston, Texas (Press release, Myeloid Therapeutics, NOV 8, 2024, View Source [SID1234648049]). Dr. Matthew Maurer, Myeloid’s Chief Medical Officer, will present on Myeloid’s discovery and development of MT-303. MT-303 is the Company’s second in vivo mRNA CAR program to enter the clinic from its pipeline of in vivo immune cell programming therapies.

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MT-303 is a first-in-class Glypican-3 (GPC3) targeting CAR encoded from mRNA and encapsulated in lipid nanoparticles. It is currently in a first-in-human Phase 1 clinical trial of advanced hepatocellular carcinoma (HCC). There are limited treatment options to combat HCC.

GPC3 is a target of growing therapeutic interest given its overexpression in many cancers, including the majority of hepatocellular carcinomas, coupled with limited expression in normal tissues. GPC3 expression has been linked to aggressive tumor behavior and poor prognosis.

Myeloid’s treatment approach focuses on selective in vivo programming of immune cell subsets with innovative off-the-shelf mRNA-encoded CAR technologies. These candidates are administered without the need for preconditioning. MT-303 arms myeloid cells with a proprietary chimeric antigen receptor that expresses specifically within myeloid cells. This approach directs and enables myeloid cells to kill GPC3 expressing cancers while orchestrating a coordinated adaptive immune anti-tumor response marked by expansion of new T cell clones.

"Myeloid has rapidly advanced MT-303 into first-in-human testing as our second in vivo CAR clinical program. Dose escalation of MT-303 and MT-302 continues, and we are encouraged by the ongoing biologic indications of proof-of-mechanism, as well as the early observed safety and efficacy experience," said Dr. Matthew Maurer, Chief Medical Officer of Myeloid. "The clinical observations extend the earlier preclinical results, that also demonstrated selective activation of CAR myeloid cells and robust anti-tumor activity in mouse hepatocellular tumor models."

Oral presentation details are as follows:

Abstract #: 1125
Title: "Preclinical Development of MT-303, a Novel LNP-Formulated GPC3-Specific CAR mRNA, for in vivo Programming of Monocytes to Treat Hepatocellular Carcinoma"
Session Title: Protein and Cellular Engineering Strategies
Session Date and Time: Friday, November 8, 2024, 5:10 pm
Presenting Author: Matthew Maurer – Myeloid Therapeutics

For more information, please visit the SITC (Free SITC Whitepaper) 2024 website.

Myeloid’s in vivo programming candidates are designed with proprietary insights to deliver personalized therapy, providing benefits to patients while reducing time and costs through the elimination of ex vivo handling of patient cells and complex neoantigen sequencing. The Myeloid platform integrates validated antibody/antigen binding with novel combinations of myeloid signaling domains, coded within a simple mRNA that can be delivered repeatedly using lipid nanoparticles (LNPs). The platform’s versatility provides a range of signaling domains and immune cell types useful for combination approaches.

About Liver Cancer

With limited treatment options, and over 850,000 new cases diagnosed globally each year, liver cancer has become the third leading cause of cancer death. After initial treatment success with small molecule therapies, the development of new treatment approaches in the field of liver cancer has been limited. Today, patients with liver cancer who are refractory to first line treatment are left with few treatment options, creating a substantial unmet medical need. Myeloid sees an opportunity to make a significant contribution to address this need, by providing a new CAR for these patients who are living with liver cancer. The CARs are capable of providing a coordinated and durable immune response to counter advanced disease. The CARs are combinable and will expand the treatment options for physicians.

About the Phase 1 Study of MT-303

The MT-303 Phase 1 study (NCT06478693) is an open-label dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-303 in adults with advanced or metastatic hepatocellular carcinoma that overexpresses GPC3. This study will also define the recommended Phase 2 dose (RP2D) of MT-303.

About MT-303

MT-303 represents the first candidate in a new therapeutic modality targeting hepatocellular carcinoma (HCC). This clinical candidate is a first-in-class, GPC3-FcA-LNP, with a strong preclinical profile supporting its advance into this first-in-human trial. GPC3 is overexpressed in most human hepatocellular carcinomas, with limited expression in corresponding normal tissues. Increased GPC3 expression has been linked to tumor growth.

Treatment with MT-303 as a monotherapy demonstrates activity in a GPC3/HCC preclinical model, confirming the tumor-fighting potency of programmed myeloid cells even in the model’s absence of T cells. MT-303 has demonstrated strong expression in myeloid cells and a favorable safety profile in rodents and non-human primates. Unlike other therapies, MT-303 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells.

MT-303 represents Myeloid’s second in vivo CAR clinical program, building on the company’s innovative approach to cancer treatment through immune cell programming.

On November 8, 2024 Infinitopes, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, reported that it will be presenting three posters on its pioneering cancer vaccine discovery and development, including one that has been recognised as a ‘top 100’ poster presentation, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024, held in Houston, US, from 6-10th November (Press release, Infinitopes, NOV 8, 2024, View Source [SID1234648048]).

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A spinout from Oxford University, supported by Cancer Research UK (CRUK), Infinitopes announced its oversubscribed £12.8 million seed financing in April 2024, to advance its AI/ML Precision ImmunomicsTM antigen discovery platform. The Company exploits this technology to accurately design ‘best-in-class’ therapeutics for multiple cancer indications. Led by an exceptional Scientific Advisory Board (SAB) and world-class team of clinicians, scientists, and regulatory leaders, Infinitopes is poised to commence its lead vaccine candidate ITOP1 in a highly anticipated, double-blind, randomised, placebo-controlled phase I/IIa clinical trial, starting H1’25 at four UK NHS university cancer centres, to treat patients with oesophageal cancer (OC).

Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, said: "Using our integrated ‘right targets, right vectors, right patients, right time’ approach, we aim to address the unmet clinical need for durably effective, accessible therapies, to save lives by preventing or significantly delaying disease recurrence for cancer patients. We combine our deep knowledge of the field of immunology with our uniquely sensitive AI/ML Precision ImmunomicsTM platform to identify and select optimal synergistic tumour targets, alongside engineering safe and effective proprietary vector delivery systems, designed to reliably stimulate lasting T-cell protection. With our expert capabilities and highly experienced team, our strategy to win an Innovation & Licensing Access Pathway (ILAP) innovation passport from the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has unlocked rapid entry into an ambitious clinical development programme for our lead vaccine candidate, ITOP1. The VISTA study, commencing H1’25, will open to oesophageal cancer patients most likely to positively respond, at the moment of their cancer journey where long-term protection is anticipated to be most likely."

Abstract One, number 635 is titled ‘A randomised, placebo-controlled, multi-centre Phase I/IIa study evaluating the safety and clinical activity of a novel viral vector cancer vaccine (ITOP1) in patients with resectable oesophageal adenocarcinoma (VISTA study)’. It details the overall design and purpose of the Oxford University-led VISTA study, to test Infinitopes’ ITOP1 vaccine in HLA-matched patients undergoing surgery to remove their oesophageal cancers (OC). ITOP1 is an "off-the-shelf" vaccine administered as a prime-boost regimen before and after surgery, to prevent recurrence for patients with OC. OC is the 12th most common type of cancer in the UK, with about 10,000 cases a year. Due to its poor prognosis OC is the UK’s sixth most common cause of cancer deaths, claiming around 8,500 lives annually. Surgical resection plus neoadjuvant/adjuvant chemotherapy is the current best standard of care. Nearly half of those patients undergoing this ‘curative’ surgery suffer recurrence even after best standard of care; with a median disease-free survival of 11 months.

Abstract Two, number 1039 recognised as a ‘top 100’ SITC (Free SITC Whitepaper) poster, is titled ‘Vaccination with a single dose of a novel delivery platform confers durable >8 month immune responses, with lasting protection against tumour and metastases in preclinical models’. It details how Infinitopes has developed a foundational, proprietary vector delivery system and confirmed the success of this approach in industry-standard preclinical models. Immunisation with a single priming dose reliably generated durable, antigen-specific immune T-cell protection, capable of halting or significantly delaying tumour progression, without checkpoint inhibitor co-treatment. Up to 80% of mice survived tumour challenge, versus control animals dying within three weeks. Metastases were completely suppressed in multiple models.

Abstract Three, number 1427 is titled ‘Precision ImmunomicsTM: Identification of hundreds of novel cancer antigens using a sensitive immunopeptidomics-led platform’. It details how Infinitopes has used its unique AI/ML Precision ImmunomicsTM antigen discovery platform to identify hundreds of novel cancer-specific antigens from primary tumour samples. The abstract explains how this best-in-class pool of therapeutic combination targets could be used to accurately treat tumours, forming the basis for a suite of "off-the-shelf" therapies for many different cancer types. Infinitopes has begun discussions with potential Big Pharma collaboration partners to licence these for use in T-cell, TCR and other modalities, and is excited to progress its own vaccine programme.

Prof. David Curiel, Professor of Radiation Oncology and Director of the Biologic Therapeutic Centre at Washington University St Louis., commented: "Infinitopes’ systematic approach to cancer vaccine development is making rapid and substantive progress. This week’s findings support acceleration towards clinical development. Infinitopes’ lead candidate ITOP1 represents a significant milestone for the Company, and is a potential treatment paradigm change for the early and effective treatment of future patients with cancerous tumours, beginning with oesophageal cancer."

Details of the poster presentations are as follows:

Poster Title: A randomised, placebo-controlled, multi-centre Phase I/IIa study evaluating the safety and clinical activity of a novel viral vector cancer vaccine (ITOP1) in patients with resectable oesophageal adenocarcinoma (VISTA study)
Abstract Number: 635
Primary Category: Clinical Trials in Progress
Presenting Author: Michael Grant, Executive Medical Director at Infinitopes
Date & Time: Friday 8 November 2024, 9am – 7pm CDT
Abstract Authors: Michael Grant¹, Jonathan Kwok¹, Paul Smith¹, Lian Ni Lee¹, Senthil Chinnakannan¹, Orion Tong¹, David Thompson², Paul Klenerman², Nicola Ternette² and Mark Middleton²

¹ Infinitopes, Oxford, UK, ² University of Oxford, Oxford, UK

Poster Title: Vaccination with a single dose of a novel delivery platform confers durable >8 month immune responses, with lasting protection against tumour and metastases in preclinical models
Abstract Number: 1039
Primary Category: Immune-Stimulants and Immune Modulators
Presenting Author: Lian Lee, VP Preclinical & Co-Founder at Infinitopes
Date & Time: Friday 8 November 2024, 9am – 7pm CDT
Abstract Authors: Lian Ni Lee1, Jonathan Kwok1, Anna Maria Theresa Kroon2, Senthil Chinnakannan1, Spyridoula Marinou1, Annemieke Kok1, Callum Beach1, Steve John1, Tim Davies1, Andrew Highton2, Catherine de Lara2, Claire Hutchings2, Robert Parker1, Silvia Salatino2, Orion Tong1, Nicola Ternette2, Uzi Gileadi2, Paul Klenerman2

¹ Infinitopes, Oxford, UK, ² University of Oxford, Oxford, UK

Poster Title: Precision ImmunomicsTM: Identification of hundreds of novel cancer antigens using a sensitive immunopeptidomics-led platform
Abstract Number: 1427
Primary Category: Antigen Presentation
Presenting Author: Georges Bedran, Senior Scientist & Computational Immunomics Lead at Infinitopes
Date & Time: Friday 8 November 2024, 9am – 7pm CDT
Abstract Authors: Yuxin Sun¹, Nil Adell Mill¹, Tiffany Ma¹, Yves du Toit¹, Ava Van Ess¹, Chloe Hyun-Jung Lee¹, Spyridoula Marinou¹, Annemieke ten Bokum¹, May Ke¹, Oliver Turnbull¹, Luke Heirene¹, Lian Ni Lee¹, Alexey I. Nesvizhskii², Pouya Faridi³, Paul Klenerman⁴, Jonathan Kwok¹, Orion Tong¹, Robert Parker¹ and Georges Bedran