On April 17, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported a poster presentation providing additional mechanistic insights into its Goldspire platform based on preclinical studies of its lead product candidate, IGV-001, for the treatment of glioblastoma (GBM) (Press release, Imvax, APR 17, 2023, View Source;utm_medium=rss&utm_campaign=imvax-presents-new-data-at-aacr-2023-supporting-the-mechanism-of-action-of-its-lead-program-igv-001-for-glioblastoma [SID1234630158]). These data are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, FL, running from April 14-19, 2023.

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"These new data provide us with deeper insights into the unique mechanism of our personalized immunotherapy platform, Goldspire, that combines whole-tumor derived cells with an antisense nucleotide in proprietary implanted chambers," said Mark A. Exley, Ph.D., Chief Scientific Officer. "The Goldspire platform is designed to induce a durable, broad-spectrum immune response against tumors, and additional studies like this one are key to furthering our understanding of both IGV-001 and our platform."

The data published in the AACR (Free AACR Whitepaper) poster presentation examined the effect on tumor cells of the Goldspire process, the release of subcellular immunogenic particles, their transit across the diffusible membrane of the implanted chambers and related immunological changes. IGV-001 was found to impose oxidative and endoplasmic reticulum stress onto GBM cells. Particle analysis confirmed that a human variant of IGV-001 prepared with human GBM cells produced particles that can efficiently diffuse through the membrane of the implanted chambers. Finally, the results indicated that lymph nodes through which IGV-001 drains are enriched in mature antigen-presenting cells and lymphoid effector cells.

The poster can be found on the Imvax website and the details for the presentation are below:

Title: ROS-dependent activation of immunogenic glioblastoma cell death & release of immunogenic particles by an autologous cell-based immunotherapeutic platform
Number: 1812
Timing: Monday, April 17, 2023, 9:00 AM – 12:30 PM
Presenter: Jenny Zilberberg, Ph.D.

About IGV-001
IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b study in newly diagnosed GBM (ndGBM) patients also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC. In March 2023, Imvax initiated a Phase 2b clinical trial of IGV-001 in ndGBM patients (NCT04485949).

On April 17, 2023 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena"), a targeted oncology company forging new territory in patient-directed cancer treatment, reported that it will present preclinical data in two poster presentations highlighting the Company’s novel Hippo pathway inhibitor, IK-930, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Orlando, FL from April 14-19, 2023 (Press release, Ikena Oncology, APR 17, 2023, View Source [SID1234630157]).

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Data being shared today reveals that IK-930 selectively binds and inhibits TEAD1 and further describes the mechanism for its antitumor activity. Key advantages demonstrated in the nonclinical studies include IK-930’s superior tolerability and comparable antitumor activity compared to panTEAD inhibition, resulting in a significantly improved projected therapeutic window in cancer patients. IK-930 was designed as a TEAD1-selective inhibitor to avoid on-target renal toxicity expected from panTEAD inhibition. TEAD1 is the most highly expressed TEAD paralog in mesothelioma and epithelioid hemangioendothelioma (EHE). The data being presented support the ongoing IK-930 Phase 1 program in patients with Hippo mutated cancers and the planned expansion into combinations of IK-930 with other targeted therapies in multiple cancer types, including across EGFR and RAS mutated cancers, to potentially delay or even reverse therapeutic resistance.

"IK-930’s selectivity profile is the ultimate example of what we are aiming to do at Ikena – creating effective and safe targeted oncology treatments that have the potential to benefit both patients with primary-defined cancers and prevent resistance to other targeted therapies. Targeted oncology came to fruition as a way to develop highly specific therapies that can benefit patients — to spare healthy tissue instead of causing widespread toxicity — it is crucial to take into account a target’s function outside of a patient’s cancer," said Mark Manfredi, Ph.D., Chief Executive Officer of Ikena Oncology. "Tolerability across multiple nonclinical species, including non-human primates, was central to our design of IK-930 and our enthusiasm about its potential in the clinic."

Highlights from the data in today’s poster include:

In nonclinical models and species, IK-930 demonstrated selective inhibition of TEAD1 with equivalent activity to broad TEAD inhibitors and a significantly improved tolerability profile

IK-930 promotes repressive TEAD1 activity by driving interactions with VGLL4, a signaling partner that reduces expression of pro-growth and anti-apoptotic genes

Through its binding with TEAD1 and VGLL4, IK-930 potentially blocks chromatin binding of other TEAD paralogs

In assessing the potential on-target renal toxicity of targeting TEAD, average urinary protein-to-creatinine ratios and histopathology in non-human primates predicted a therapeutic index of less than one for panTEAD inhibitions and a broad therapeutic window for IK-930

In addition, tomorrow the Company will present a poster that highlights IK-930’s ability to reduce and reverse resistance to other targeted therapies in preclinical models. Highlights include:

Treatment with IK-930 in combination with multiple targeted agents, such as EGFR, KRAS G12C, and MEK inhibitors, demonstrated a reduction in emergence of drug resistant "persister" cells

"IK-930 was designed by leveraging TEAD biology to rebalance the oncogenic activity of the Hippo pathway, providing a potentially differentiated and tolerable therapeutic option for patients," added Jeff Ecsedy, Ph.D., Ikena Chief Development Officer. "The data presented at AACR (Free AACR Whitepaper) today demonstrate the beauty of IK-930’s ability to preferentially keep TEAD1 in a transcriptionally repressive state, and to likely block other TEAD paralogs from activating oncogenic transcription. We are thrilled to be able to share this essential differentiation today and look forward to sharing more later this year from our progress with IK-930 in the clinic."

Presentation Details:

Poster Title: IK-930 A TEAD Paralog Selective Inhibitor for Treating YAP/TAZ-TEAD Dependent Cancers

Session: Novel Antitumor Agents 4

Presenter: Nathan Young, Ph.D., Associate Director of Molecular and Cellular Oncology at Ikena Oncology

Date: Monday, April 17, 2023

Time: 9:00 AM – 12:30 PM ET

Poster Title: IK-930, A Paralog Selective Novel TEAD-Inhibitor, Effectively Attenuates Drug-Tolerant Persister Cell Proliferation

Session: Drug Resistance in Molecular Targeted Therapies 3

Presenter: Daniel Hidalgo, Ph.D., Scientist I, Translational Science at Ikena Oncology

Date: Tuesday, April 18, 2023

Time: 9:00 AM – 12:30 PM ET

Both posters will be available on Ikena’s Resources Page on their website following the conference.

About IK-930

IK-930 is an oral, paralog-selective TEAD inhibitor targeting the Hippo signaling pathway. IK-930 selectively binds to TEAD1 and prevents transcription of multiple genes that drive cancer progression. By targeting the Hippo pathway, a key driver of cancer pathogenesis that is genetically altered in approximately 10% of all cancer types, IK-930 could have a differentiating impact across many cancers with high unmet need. Ikena is advancing IK-930 both as a monotherapy in patients with Hippo pathway mutated cancers and in combination with other approved targeted therapies to combat therapeutic resistance. IK-930 is currently being studied in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors with or without gene alterations in the Hippo pathway, including NF2-deficient malignant mesothelioma, Epithelioid Hemangioendothelioma (EHE) with documented TAZ/CAMTA1 fusion genes as well as other solid tumors with either NF2 deficiency or with YAP/TAZ genetic fusions (NCT05228015).

On April 17, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Craig Collard, Chief Executive Officer of Heron, will participate in a fireside chat on Thursday, April 20, 2023, at 11:45 AM ET at the 22nd Annual Needham Virtual Healthcare Conference (Press release, Heron Therapeutics, APR 17, 2023, View Source [SID1234630156]). The conference is being held in a virtual format, April 17-20, 2023.

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section.

On April 17, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of fibrotic diseases, including non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that an abstract highlighting its lead drug candidate, rencofilstat, will be presented by its Chief Scientific Officer, Daren Ure, PhD, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held April 15-19, 2023, in Orlando, Florida (Press release, Hepion Pharmaceuticals, APR 17, 2023, View Source [SID1234630155]).

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Poster Presentation Details

Title: Rencofilstat Exerts a Dominant Role in Synergistic Anti-PD1-Combination Effects in a Fatty Liver Model of Hepatocellular Carcinoma

Authors: Ure D, Leslie J, Haddon L, Variya B, Fu C, Mann J, Mann D

Date: Tuesday, April 18, 2023

Time: 9:00 AM – 12:30 PM ET

A copy of the presentation materials will be accessible on the Company’s website at www.hepionpharma.com under "Publications" in the Pipeline section.

On April 17, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported three presentations related to the company’s neoantigen vaccine programs and capabilities at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, Florida (Press release, Gritstone Bio, APR 17, 2023, View Source [SID1234630154]). An oral presentation (minisymposium) on April 16 highlighted data from the Phase 1/2 study of GRANITE, the company’s personalized (also referred to as "individualized") neoantigen vaccine program which is now in a randomized Phase 2/3 study for first-line microsatellite-stable colorectal cancer (MSS-CRC). The poster presentations, occurring April 17 and 18, will address the company’s proprietary neoantigen prediction capabilities (EDGE) and "off-the-shelf" neoantigen vaccine program, SLATE.

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"Gritstone was originally founded to create best-in-class personalized and ‘off-the-shelf’ cancer vaccines through deep learning-enabled neoantigen prediction and deployment of potent vaccine platforms that drive robust T cell responses against delivered neoantigens. These presentations at AACR (Free AACR Whitepaper) highlight our continued progress in this endeavor," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "Our antigen prediction platform, EDGE, which we believe leads the field in neoantigen prediction, is being enhanced to identify class II HLA-presented neoantigens. Within the SLATE program, we have identified a novel KRAS class II epitope that may carry additional clinical utility beyond CD8+ T cell responses. And continued evaluation of GRANITE, our personalized vaccine candidate for which we expect preliminary Phase 2/3 data in the fourth quarter of 2023, reinforces the potential of our personalized approach to unlock MSS-CRC and other cold tumors."

"These presentations demonstrate our commitment to understanding and leveraging foundational immunology and biology aspects to enhance our development of best-in-class vaccines for solid tumors," said Karin Jooss, Ph.D., Executive Vice President, and Head of R&D. "Optimizing the ability of EDGE to better predict HLA class II restricted neoantigens can help drive more comprehensive T cell responses. The importance of broad T cell immunity is reinforced by vaccine induction of both cytolytic CD8+ and CD4+ T cells following treatment with SLATE, offering the potential to expand patient eligibility irrespective of HLA alleles. We believe longitudinal ctDNA monitoring can offer effective real-time assessment of clinical response and monitor for acquired resistance, as evident by the ongoing survival benefit seen in GRANITE to date that correlates with expansion of T cells in the periphery and tumor."

GRANITE Phase 1/2 Presentation (Minisymposium): Disease monitoring with comprehensive genomics provides evidence of mechanism of action and immune evasion in patients receiving an individualized neoantigen cancer vaccine
Presenter: Matthew Davis, PhD
Key Highlights:

Comprehensive ctDNA longitudinal monitoring enables real-time assessment of clinical response and acquired resistance
Paired pre- and post-vaccine biopsy analyses show upregulation of gene signatures associated with immune infiltration, supporting T cell expansion and induction of dynamic T cell receptor (TCR) repertoire changes in the tumor and periphery
Majority of neoantigens are retained in tumor even after patient receives treatment prior to GRANITE administration
Neoantigen-directed immunotherapy drives durable immune pressure on the tumor of patients with advanced disease where checkpoint inhibitors alone have provided minimal benefit
EDGE (Epitope Discovery for Genomes Platform) Presentation (Poster Presentation): Language modeling of peptide-HLA interactions achieves state-of-the-art performance on prediction of peptide presentation by HLA Class II
Presenter: Ankur Dhanik, PhD
Key Highlights:

While cytotoxic CD8+ T cells are critical to tumor control and clearance, CD4+ T cells can play a key role for the induction component of durable anti-tumor responses
Accurate prediction of immunogenic HLA Class II restricted neoantigens, which drive CD4+ T cell response, can further vaccine immunogenicity and durability
Gritstone’s EDGE platform capabilities have been enhanced to include state-of-the-art immunogenicity prediction of peptide presentation by HLA Class II with significant performance improvements over current approaches
Expanding the prediction capabilities of EDGE to include both HLA Class I and II neoantigens can help identify neoantigens with potential to mount broader and more robust overall immune responses
SLATE Phase 1/2 Presentation (Poster Presentation): HLA-DR-restricted CD4+ T cell responses to KRAS G12C in healthy donors linked to bacterial mimotope: lessons for KRAS neoantigen vaccines in cancer patients
Presenter: Christine Palmer, PhD
Key Highlights:

Vaccines targeting KRAS mutations may overcome the challenges of acquired resistance encountered with small molecule-based approaches targeting KRAS mutations
Study links CD4+ T cell responses to KRAS G12C in healthy donors to a bacterial mimotope
Data from healthy donors and from a SLATE patient show responses to KRAS G12C are driven by CD4+ T cells with cytotoxic capabilities likely driven by TCRs with cross-reactivity to a bacterial mimotope
SLATE induction of both CD8+ (Class I driven) and CD4+ (Class II driven) T cell responses may expand patient eligibility to potentially include subjects harboring a KRAS G12C mutation irrespective of HLA alleles
*Both the GRANITE and SLATE-KRAS studies administered Gritstone’s cancer vaccine in combination with nivolumab and subcutaneous anti-CTLA-4 antibody ipilimumab.

Copies of these presentations will be available on the Gritstone bio website following the conclusion of each presentation. To view Gritstone’s AACR (Free AACR Whitepaper) presentations, visit ir.gritstonebio.com/investors/events.