On May 31, 2024 Artera, the developer of multimodal artificial intelligence-based prognostic and predictive cancer tests, reported that it will present three abstracts at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrating that its multimodal artificial intelligence (MMAI) platform provides significant prognostic value across various stages of prostate cancer and for early stage breast cancer (Press release, Artera, MAY 31, 2024, View Source [SID1234643917]). These studies build upon the first AI-enabled test that delivers prognostic and predictive insights for localized prostate cancer patients: ArteraAI Prostate Test.

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"Medicine is filled with instances where the seed of an idea took years to grow into an innovative tool that changes the standard way of practice," said Andre Esteva, CEO of Artera. "Currently, cancer care strongly emphasizes biochemistry and molecular biology, and advancements can take decades to develop and adopt. Artera’s model offers a novel way of thinking, utilizing AI and image analysis to significantly fast-track innovation and advancements in cancer care, demonstrating performance across diverse patient cohorts. We are proud to be working on this new way forward."

The MMAI platform can provide results to support personalized therapy by combining a patient’s unique clinical data with their pathology slides. Artera is taking a unique approach to this by applying AI to images of hematoxylin and eosin (H&E)-stained pathology slides to provide prognostic and predictive results.

Traditionally, after a cancer diagnosis, additional insights to support a more personalized treatment plan can require multiple tests – an approach that can be expensive and hard to scale due to the complicated process of identifying and quantifying the correct genomic biomarkers across different disease states and patient populations. Artera created AI-enabled algorithms that use digitized whole slide images of the H&E slides to be able to provide personalized results in a way that can potentially boost confidence for patients and their clinicians that they are making the optimal treatment choices throughout their journey.

"Using the MMAI platform on these different groups of patients, with different types and stages of cancer, and getting clinically actionable results demonstrates just how reliable analyzing H&E slides, which are already created during the routine course of care, can be for predicting risk to personalize treatment," said Trevor Royce, MD MPH, Senior Medical Director at Artera. "This approach to cancer research has the potential to transform the future of cancer care."

This announcement follows Artera’s recent presentation at the 2024 AUA Annual Meeting, which validated the first AI-based biomarker to stratify the risk of metastasis in patients with biochemical recurrence after radical prostatectomy, showing the company’s continued commitment to extending its platform to patients at various stages of prostate cancer.

As more treatment options become available to patients, being able to personalize their treatment plan can aid in mitigating negative side effects from unnecessary treatment and increase confidence in decision-making. Artera is focused on continuing to train and validate other biomarkers using this platform, so more patients with prostate cancer at different stages, as well as other disease states such as breast cancer, will be able to use this tool that can one day personalize their treatment plans.

The three presentations include:

Oral Presentation: Multimodal artificial intelligence models from baseline histopathology to predict prognosis in HR+ HER2- early breast cancer: Subgroup analysis
Abstract Number: 101
Session Type and Title: Clinical Science Symposium – Using "Artificial" Intelligence to Achieve "Real" Improvements in Cancer Care
Date and Time: June 1, 2024 at 8:00 AM-9:30 AM CDT

Poster Presentation: Validation of a digital pathology-based multimodal artificial intelligence model in oligometastatic castration-sensitive prostate cancer, including in patients from the STOMP and ORIOLE phase II randomized clinical trials.
Abstract Number: 5080
Session Type and Title: Poster Session – Genitourinary Cancer—Prostate, Testicular, and Penile
Date and Time: June 2, 2024 at 9:00 AM-12:00 PM CDT

Poster Presentation: Prognostic validation of a digital pathology-based multi-modal artificial intelligence (MMAI) biomarker in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the CHAARTED trial (ECOG-ACRIN EA3805).
Abstract Number: 5077
Session Type and Title: Poster Session – Genitourinary Cancer—Prostate, Testicular, and Penile
Date and Time: June 2, 2024 at 9:00 AM-12:00 PM CDT

For more information on Artera, visit Artera.ai.

On May 31, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer will present at the following investor conferences (Press release, Bio-Techne, MAY 31, 2024, View Source [SID1234643902]):

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William Blair 44th Annual Growth Conference
June 4, 2024
9:20 AM CDT

Jefferies Global Healthcare Conference
June 6, 2024
9:30 AM EDT

Goldman Sachs 45th Annual Global Healthcare Conference
June 11, 2024
9:20 AM EDT

A live webcast of the presentations can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

On May 31, 2024 Agendia, Inc. reported that it will present new data characterizing the immune biology of MammaPrint High Risk tumors in an oral session at the 2024 Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, taking place in Chicago, IL. on June 3rd, 2024 (Press release, Agendia, MAY 31, 2024, View Source;Early-Stage-Breast-Cancer-at-2024-ASCO [SID1234643918]).

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The study presented by Erin Cobain MD, Associate Professor in the Division of Hematology/Oncology at the University of Michigan Medical School, Ann Arbor and co-Principal Investigator of the SWOG S2206 Trial, titled Elucidating the immune active state of HR+HER2- MammaPrint High 2 early breast cancer [Cobain, E., et al.] characterizes the underlying immune biology that mediates immune therapy response in early stage hormone receptor-positive (HR+), Human Epidermal Growth Factor Receptor negative (HER2-) breast cancer, categorized as MammaPrint High Risk 2 (MP H2) in patients enrolled in the prospective, observational FLEX Study (NCT03053193). This study builds upon the findings from the I-SPY 2 Trial, which showed that patients with MP High-2, HR+HER2- tumors have improved response rates when immunotherapy is added to standard neoadjuvant chemotherapy.

Using whole transcriptome analysis, researchers evaluated relative frequency of immune cell types, expression level of genes involved in antigen processing and presentation, and expression of immune checkpoint genes PD-1 and PD-L1. Results of the analysis showed that MP High-2 tumors had a significantly higher frequency of antigen presenting cells (APCs) (including activated dendritic cells and macrophages, CD4+ memory T cells, CD8+ T cells, memory B cells and antibody producing plasma cells) relative to High-1 tumors, highlighting an increased immune active state in High-2 tumors. The increased antigen presentation and presence of APCs, which are critical in activating T- and B-cells, may explain why High-2 tumors display improved response rates to immunotherapy. The data from this study suggests that early stage HR+HER2- High-2 tumors might benefit from the addition of immunotherapy to their chemotherapy treatment regimens. These findings support the rationale for the ongoing SWOG S2206 (NCT06058377) Trial, which is utilizing MP High-2 as a biomarker to select patients for neoadjuvant chemo-immunotherapy treatment.

"There is a great need for biomarkers beyond PD-L1 and tumor mutational burden that may predict clinical benefit from immunotherapy-based treatments. The recent CheckMate 7FL and KEYNOTE-756 studies demonstrated that there is a subset of patients with HR+HER2- early breast cancer that will benefit from immunotherapy, as both trials demonstrated an improvement in likelihood of pathologic complete response rates for those patients receiving neoadjuvant chemo-immunotherapy compared to chemotherapy alone," said Dr. Cobain. "However, we are aiming to take this a step further and refine the biomarkers that will allow for us to identify those patients most likely to benefit from this approach and avoid overtreatment. This is particularly important given the potential serious toxicities that can result from immunotherapy treatment."

"This study highlights the importance of understanding how the classification of tumors may determine different response rates to treatment and how this will inform breast cancer care going forward. With the FLEX Study, we are now able to not only look at clinical outcomes but also analyze whole transcriptome data to better understand how women with breast cancer respond to different treatment regimens and use this information to customize breast cancer treatment," said William Audeh, MD, MS, Chief Medical Officer of Agendia. "The data we’re sharing at 2024 ASCO (Free ASCO Whitepaper) further validates MammaPrint utility in identifying not only the question of chemo vs. no chemo, but also illustrates the ability of MammaPrint to identify tumors with increased immune activation, supporting the rationale for using MammaPrint High 2 as a selective biomarker for immunotherapy in SWOG S2206."

On May 31, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported Phase 1 data with the first off-the-shelf ImmTAC targeting PRAME, brenetafusp (IMC-F106C), in patients with late-line, post-checkpoint cutaneous melanoma (Press release, Immunocore, MAY 31, 2024, View Source [SID1234643903]). Brenetafusp was shown to be well tolerated, in monotherapy and in combination with anti-PD1, and demonstrated durable clinical benefit.

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"Brenetafusp continues to demonstrate promising monotherapy clinical activity in late-line cutaneous melanoma patients who were previously treated with checkpoint therapies," said Dr. Omid Hamid, Chief, Translational Research and Immunotherapy, Co-Director, Melanoma Therapeutics at Cedars-Sinai Cancer at the Angeles Clinic and Research Institute. "The disease control and PFS benefit for these brenetafusp-treated melanoma patients compares favorably to data with other immunotherapies."

"The best measure of brenetafusp monotherapy activity is disease control, which is observed in 56% of checkpoint pre-treated melanoma patients," said David Berman, Head of Research and Development. "We expect brenetafusp PFS to be even higher in first-line based on our analysis of blood T cell fitness. These data points, in conjunction with the significant molecular response and the expected additive benefit of combining with an active anti-PD1, provide confidence for PFS as an endpoint in our ongoing Phase 3 first-line trial."

Phase 1 data in post-checkpoint cutaneous melanoma

As of 18 March 2024, 47 patients have received brenetafusp (IMC-F106C) monotherapy at clinically active target dose levels. All monotherapy treated patients had received prior immune checkpoint inhibitors (100% anti-PD1, 81% anti-CTLA4). PRAME expression was high amongst evaluable patients (median H score of 215). Only 11% of patients had PRAME negative tumors, as measured by immunohistochemistry.

Brenetafusp was well-tolerated, with treatment-related adverse events (TRAEs) that were manageable and consistent with the mechanism of action. The most frequent TRAE reported was Grade 1 or 2 cytokine release syndrome (CRS) and rash; these events occurred predominantly following the initial three doses. There were no Grade 3 or higher CRS TRAEs.

Of the 47 monotherapy patients, 36 had a RECIST evaluable tumor assessment. The disease control rate (DCR), consisting of partial response (PR) and stable disease (SD), was 56% including 4 PR (ORR 11%) and 16 SD (44%). Durable tumor reduction, confirmed by at least one subsequent scan, was observed in 28% of patients and is an attribute of the ImmTAC platform1. Clinical benefit was enriched in the 31 evaluable PRAME positive patients. The DCR in this group was 58% and included all 10 patients (32%) with confirmed tumor reduction.

Both median progression free survival (mPFS) and 6-month overall survival (OS) rates were greater in PRAME positive than in PRAME negative monotherapy patients: 4.2 vs 2.1 months and 95% vs 40%, respectively.

42% of ctDNA-evaluable, PRAME positive monotherapy patients had a molecular response (10/24) and there was a trend for longer PFS and OS in molecular responders. No ctDNA-evaluable PRAME negative patients had ctDNA reduction.

In addition to the monotherapy patients treated with brenetafusp, there were 9 cutaneous melanoma patients who received brenetafusp in combination with an anti-PD1 (pembrolizumab), all of whom had received prior checkpoint inhibitors (100% prior anti-PD1, 89% prior CTLA4). Overall, patients were more heavily pre-treated in the combination cohort compared to monotherapy (median prior lines: 4 vs 2; PD-1 refractory: 67% vs 30%). Brenetafusp in combination with pembrolizumab was well tolerated, with TRAEs that were manageable and consistent with the mechanism of action of both agents. There was one dose-limiting toxicity (transaminitis) reported in one patient with prior history of checkpoint inhibitor induced autoimmune hepatitis.

Of the 7 patients evaluable for efficacy in combination, 4 achieved disease control including 1 ongoing PR (confirmed after the data cut off for the presentation), and 3 of the 4 ctDNA evaluable patients having molecular response.

In 41 gene-expression evaluable monotherapy patients, a gene signature was identified from baseline peripheral blood that was a measure of systemic T cell fitness. Patients with gene signature expression levels greater than or equal to the median had higher clinical benefit including a median PFS of 6 months and DCR of 69%, compared to those with less than the median gene expression levels (2 months and 42%, respectively). Patients with only 1-2 prior lines of therapy had higher T cell fitness gene signature, on average, than those with 3 or more prior lines of therapy.

The advanced cutaneous melanoma data from the ongoing Phase 1/2 trial of brenetafusp will be presented today at 2:45 PM CT / 3:45 PM ET, in the Melanoma/Skin Cancers oral abstract session at the 2024 American Society of Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentation will be accessible in the ‘Events & Presentations’ section of the Investor Relations section of the Company’s website.

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Company is enrolling patients in a registrational Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma (CM) with a primary endpoint of progression-free survival (PFS) (NCT06112314). The trial will randomize HLA-A*02:01-positive, first-line advanced CM patients to brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled.

Under the terms of a clinical trial collaboration and supply agreement, Immunocore will sponsor and fund this registrational Phase 3 clinical trial, and Bristol Myers Squibb will provide nivolumab.

Audio Webcast

Immunocore will host a conference call today, May 31, 2024 at 7:15 PM ET / 6:15 PM CT, to discuss the Phase 1 PRAME expansion data and Phase 3 registrational trial in cutaneous melanoma. The call will also be available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 30 days.

Conference Call Details:
U.S. (toll-free): 877-405-1239
International (toll): +1 201-389-0851

On May 31, 2024 MBrace Therapeutics, Inc. ("MBrace"), a clinical-stage oncology company developing novel antibody-drug conjugates (ADCs) against solid tumor targets, reported that the Company will be presenting a Trial in Progress (TIP) poster at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held from May 31-June 4, 2024, in Chicago, Illinois (Press release, MBrace Therapeutics, MAY 31, 2024, View Source [SID1234643904]).

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The poster will highlight the trial design, dosing regimen and study protocol for the Company’s ongoing Phase 1/1b clinical trial of MBRC-101. This first-in-human, multicenter, open-label study (NCT06014658) is examining the safety and efficacy of MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. The Company expects to report initial clinical data from this trial in the first half of 2025.

MBRC-101 selectively targets the EphA5 receptor tyrosine kinase, a cell surface receptor highly expressed in many commonly occurring cancers. Through its precision targeting of EphA5, a novel mechanism for solid tumor-directed therapy, MBRC-101 offers a potential new treatment modality, particularly for patients with advanced tumors that are non-responsive to prior cancer therapy.

"ADCs are an incredibly promising class of therapeutics with the potential to offer improved efficacy and greater tolerability," said Shiraj Sen, M.D., Ph.D., medical oncologist and director of clinical research at NEXT Oncology – Dallas, and an investigator in the Phase 1/1b study of MBRC-101. "I look forward to seeing the clinical progress for MBRC-101 and the potential impact that this investigational therapy could have for patients with a cancer that isn’t responding to current treatments."

Details of the ASCO (Free ASCO Whitepaper) 2024 presentation are as follows:
Abstract Title: A multi-center, open-label phase 1/1b dose finding, safety, and pharmacokinetic study of MBRC-101, an Anth-EphA5 monomethyl auristatin (MMAE) antibody drug conjugate, in advanced refractory solid tumors
Presenter: Shiraj Sen, M.D., Ph.D., Medical Oncologist and Director of Clinical Research, NEXT Oncology – Dallas
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Saturday, June 1, 2024, 9:00 AM-12:00 PM CDT
Poster Bd #: 305b
Abstract Number: TPS3161

About MBRC-101
MBRC-101 is an investigational antibody-drug conjugate (ADC) that uniquely targets the EphA5 receptor tyrosine kinase, which is present in multiple cancers including, but not limited to, breast, non-small cell lung (NSCLC), colorectal, gastric, and pancreatic cancers. MBRC-101 is currently being evaluated in the MBRC-101-001 Phase 1/1b clinical trial, a first-in-human, open-label, multicenter, dose escalation and dose expansion study enrolling patients with advanced metastatic solid tumors refractory to standard-of-care treatment. For more information about the MBRC-101-001 clinical trial and to review patient eligibility criteria visit clinicaltrials.gov (NCT06014658).