On April 8, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that management will be participating in the following investor and scientific conferences (Press release, Gritstone Bio, APR 8, 2024, View Source [SID1234641869]). Select events (marked by *) will be webcasted live and webcast details will be available on the ‘Events’ page of Gritstone bio’s website: View Source Archived replays will be accessible for 30 days following each event.

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23rd Annual Needham Virtual Healthcare Conference (Presentation*)
Date and Time: Tuesday, April 9, 2024 at 11:00am ET
Location: Virtual

Canaccord Genuity Horizons in Oncology Virtual Conference (Panel)
Panel Title: Cancer Vaccines – Building on Recent Learnings
Date and Time: Monday, April 15, 2024 at 11:00am ET
Location: Virtual

Cambridge Healthtech Institute’s Immuno-Oncology Summit Europe (Presentation)
Presentation Title: Clinical Trial Results with a Personalised Neoantigen Vaccine in a Cold Tumour—Can We Bring the Heat?
Date and Time: Wednesday, April 24, 2024 at 9:05am BST
Location: London, UK

7th International Neoantigen Summit (Presentation)
Panel Title: Clinical Trial Data with a Personalised Neoantigen Cancer Vaccine in Metastatic
Colorectal Cancer
Panel Date and Time: Tuesday, April 30, 2024 at 12:30pm CEST
Location: Amsterdam, Netherlands

PEGS BOSTON (Panel)
Panel Title: Personalized Cancer Vaccines – Where are They Going Now?
Date and Time: Monday, May 13, 2024 at 9:00am ET
Location: Boston, MA

Citizens JMP Life Sciences Conference (Fireside Chat*)
Date and Time: Tuesday, May 14, 2024 at 10:30am ET
Location: New York, NY

On April 8, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported an update on its T cell epitope discovery platform, EDGE, at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, CA (Press release, Gritstone Bio, APR 8, 2024, View Source [SID1234641868]). The presentation details improvements Gritstone has made in prediction of peptide presentation by HLA Class I, associated with CD8+ T cells, since the publication of the initial results in 2018 (Nature Biotechnology). It also reviews how Gritstone has expanded EDGE’s application to predict peptide presentation by HLA Class II.

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"Identifying which of the hundreds of tumor mutations are most likely to serve as neoantigens, key targets of tumor-specific T cells, is critical to the development of effective neoantigen-directed vaccines," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "Since our Nature Biotechnology publication in 2018, we have further enhanced and expanded the application of EDGE in support of our cancer and infectious disease vaccines by improving our already-robust prediction of HLA Class I epitopes, associated with CD8+ T cell induction, and incorporating HLA Class II epitope prediction to enable CD4+ T cells to join the fight. Gritstone remains at the forefront of driving robust and broad T cell induction post-vaccination, and EDGE is an important asset and differentiator in that effort."

"Today, EDGE is able to predict HLA Class I presentation of epitopes with >80% accuracy, a significant increase since 2018 when we initially published the model," said Karin Jooss, Ph.D., Executive Vice President, and Head of R&D of Gritstone bio. "EDGE also now includes a comprehensive state-of-the-art model for predicting peptide presentation by HLA Class II in the context of active vaccination, which could serve to effectively broaden T cell response to our novel vaccines. The improvements we are making to EDGE, leveraging advances in protein large language models and in-house immunopeptidomics, have positioned EDGE as a leading HLA/peptide predictive platform in the neoantigen cancer vaccine field. The superior performance and association with cellular immunity seen across all our models compared to currently publicly available models support Gritstone’s potential to develop highly potent vaccines for both oncology and infectious disease."

Abstract 904: EDGE enables state-of-the-art identification of peptide-HLAs for the development of T cell inducing vaccines in oncology and infectious diseases

EDGE for Oncology:

Class I antigens – predicted using allele-specific and pan-specific models
Allele-specific model is an improved version of published 2018 EDGE model that predicts for 116 HLA alleles and achieves an Average Precision (AP) of 0.63 and Positive Predictive Value at 40% Recall (PPV40) of 0.79
Pan-specific model trains using the HLA allele sequence and is applicable to any Class I allele with known sequence, achieving an AP of 0.65 and PPV40 of 0.81
2-fold better performance vs MHCFlurry 2.0 when ranking mutations from 80 cancer patients based on immunogenicity
Detectable CD8 responses to over half of the 20 administered candidate neoantigens per patient (n = 5) after treatment with Gritstone’s personalized cancer vaccines
Class II antigens – predicted using EDGE-II model
Uses a pretrained protein language model, a novel learned HLA allele-deconvolution strategy, and in-house immunopeptidomics training data
Achieves a test set AP of 0.92 and outperforms NetMHCIIpan and BERTMHC on an externally curated validation set with an AP = 0.71
CD4 immunogenicity in a personalized cancer vaccine context is better predicted by EDGE-II than NetMHCIIpan and MARIA
EDGE for Infectious Disease:

Class I antigens – predicted using EDGE-ID model
Optimizing EDGE for use on infectious diseases results in improved performance
Trained using both human immunopeptidomics and infectious disease binding affinity datasets and tested on publicly available infectious disease datasets (HIV, Influenza A, and SARS-CoV-2)
Better performance on HIV and Influenza A datasets vs. MHCFlurry 2.0; comparable SARS-CoV-2 performance
The poster has been added to the ‘Scientific Publications’ page of the Gritstone bio website.

About EDGE (Epitope Discovery for GEnomes)
Gritstone bio believes effective identification of the mutations that are most likely to serve as neoantigens is critical to developing effective neoantigen-directed vaccines. For this reason, we developed EDGE, a proprietary platform technology that leverages artificial intelligence to identify which of the hundreds of mutations within a tumor are most likely to serve as targets for a patients’ immune system. A key strategic asset, Gritstone leverages EDGE’s capabilities to identify T cell targets for oncology and infectious disease.

On April 8, 2024 Glycotope GmbH, a biotechnology company utilizing a proprietary platform technology to developing antibodies against proteins carrying tumor-specific carbohydrate structures, reported that it will present its platform approach and GlycoTarget database in a poster presentation at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting, being held in San Diego, California, United States, between 05-10 April 2024 (Press release, Glycotope, APR 8, 2024, View Source [SID1234641867]).

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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

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Patrik Kehler, Chief Scientific Officer of Glycotope GmbH commented: "At Glycotope, we have established a standardized process for the data collection and prioritization of potential protein/carbohydrate combined glycoepitopes (GlycoTargets). We look forward to attending AACR (Free AACR Whitepaper) to present our workflow and corresponding database to leading cancer research experts, illustrating how this information is subsequently used for the targeted discovery of antibodies that bind to our GlycoTargets, offering increased tumor-specificity compared to simple protein targets."

Poster details are as follows:

Abstract: Download here

Title: Platform approach to develop antibodies specifically recognizing cancer-associated glycoforms

Abstract Number: 5896 Link

Session Date and Time: Tuesday Apr 09, 2023 1:30 PM – 05:00 PM PDT

Location: Poster Section 25, Poster Board Number 10

Contact Information:

Glycotope GmbH

Dr. Patrik Kehler (CSO)

Phone: +49 30 9489 2600

Email: [email protected]

On April 8, 2024 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present late-breaking data from the first analysis of the ASCEND-2 study demonstrating the compelling performance of its investigational multi-biomarker class, multi-cancer early detection (MCED) blood test (Press release, Exact Sciences, APR 8, 2024, View Source [SID1234641865]). These results validate the sensitivity and specificity of the company’s multi-biomarker class approach across a broad range of cancer types, including the most aggressive cancers and cancers with no current standard of care for screening. ASCEND-2 is a large, multi-center, prospective, case-control study of over 11,000 clinically characterized participants from a racially, ethnically, and geographically diverse cohort representative of the U.S. population. These data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, April 5-10 in San Diego, California.1

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"Cancer is the second-leading cause of death in the U.S., and while early detection is associated with longer survival, two-thirds of deaths are caused by cancers that lack standard screening tests. MCED tests have the potential to revolutionize cancer screening by enabling us to spot more cancers and intervene earlier," said Tom Beer, MD, Chief Medical Officer, Multi-Cancer Early Detection, Exact Sciences.2-4 "This analysis from ASCEND-2 confirms that our multi-biomarker class approach to MCED test design may deliver benefits beyond what is currently achievable. The sensitivity and specificity achieved in the detection of the most aggressive cancers and those cancers with no current standard of care provide the confidence to move forward to a real-world evidence study."

Exact Sciences will also present new outcomes data from DETECT-A, the first large prospective study of an earlier multi-biomarker class MCED test that enrolled more than 10,000 participants with more than four years of follow-up.5

The abstracts featured at AACR (Free AACR Whitepaper) 2024 are as follows:

Title: Performance of a multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively collected cohort
Presenter: Diehl, F
Session: Monday, April 8, 9:00 a.m. – 12:30 p.m. PDT (Session LBPO.CL01)
Poster number: LB100/11
Location: Section 51
Key findings: First analysis of the refined multi-biomarker class MCED test achieved an overall sensitivity of 50.9% with 98.5% specificity and 56.8% sensitivity when breast and prostate cancer were excluded from the analysis. Sensitivity was 54.8% for cancers without standard-of-care screening for average-risk populations and 63.7% in the most aggressive cancers with the shortest 5-year survival rate (pancreas, esophagus, liver, lung and bronchus, stomach, and ovary).

Title: Case report: DETECT-A participants with pre-malignant conditions
Presenter: Rego, SP
Session: Monday, April 8, 9:00 a.m. – 12:30 p.m. PDT (Session PO.CL01.16)
Poster number: 2449/14
Location: Section 41
Key findings: Results showed that in the rare instance when MCED testing detected pre-cancerous conditions in the DETECT-A study, surgical interventions prevented cancer development, and all patients were cancer-free at follow-up.

About the ASCEND-2 study

The ASCEND-2 (Ascertaining Serial Cancer patients to Enable New Diagnostic 2) study is a large, multi-center, prospective, case-control study of clinically characterized participants. Key goals of the study are to develop the algorithm and identify the biomarkers to inform the final design of the Cancerguard test, Exact Sciences’ investigational, multi-biomarker class blood-based MCED test. ASCEND-2 has enrolled over 11,000 participants across 151 sites within the U.S. and Europe. The study population includes male and female subjects 50 years and over with known cancer, suspicion of cancer, and controls without cancer. ASCEND-2 selected cancer types in an incidence-targeted manner, including rare and common cancers and evenly distributed stages. By enrolling racially, ethnically, and geographically diverse participants, the study enables MCED test development with a widely representative cohort.

About the DETECT-A study

The DETECT-A (Detecting cancers Early Through Elective mutation-based blood Collection and Testing) study was the first-ever large, prospective, interventional study to use a blood test to detect multiple types of cancer in a real-world setting. The DETECT-A study enrolled more than 10,000 women with no history of cancer to determine if a blood test in combination with standard-of-care screenings could detect cancers before signs and symptoms appeared. The CancerSEEK test, the MCED test studied in DETECT-A, was the forerunner to the Cancerguard test, the MCED test currently in development at Exact Sciences.

About the Cancerguard test

The Cancerguard test, currently in development, is designed to detect multiple cancers in their earliest stages from a single blood draw. Building upon decades of research, Exact Sciences intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages. The Cancerguard test will utilize a streamlined and standardized imaging-based diagnostic pathway, which may result in fewer follow-up procedures. The test is being developed to provide high specificity to help minimize false positives while detecting multiple cancers, including those with the biggest toll on human health. The Cancerguard test is currently under development. These features describe current development goals. The Cancerguard test has not been cleared or approved by the U.S. Food and Drug Administration or any other national regulatory authority. To learn more, visit View Source

On April 8, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported new preclinical data demonstrating proof-of-concept for its differentiated HER3-ADC program (Press release, Elevation Oncology, APR 8, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-presents-preclinical-proof-of-concept-data-for-her3-adc-program-at-aacr-annual-meeting-2024 [SID1234641864]). The data will be presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, being held April 5-10 in San Diego, California.

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"We are pleased to share the first preclinical proof-of-concept data for our HER3-ADC program, reinforcing our commitment to advancing a portfolio of differentiated ADC-based therapies that may deliver better outcomes for patients," said David Dornan, Ph.D., Chief Scientific Officer of Elevation Oncology. "With our HER3-ADC program, we set out to design a differentiated ADC which selectively binds to HER3 and is internalized to potentially attack HER3-expressing cancerous cells while minimizing systemic exposure. Preclinical data with our proof-of-concept HER3-ADC shows HER3-dependent cell killing and robust anti-tumor activity in vivo where HER3 is expressed at high levels. We look forward to nominating a development candidate from our HER3 program later this year and, subsequently, advancing our program closer to the clinic."

HER3 is a clinically validated oncology and antibody-drug conjugate (ADC) target, which is overexpressed in a range of solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer, and is often associated with poor clinical outcomes. Elevation Oncology’s HER3-ADC program conjugated seribantumab, its anti-HER3 monoclonal antibody, with a cleavable valine-citrulline linker and monomethyl auristatin E (MMAE) payload to yield HER3-ADC1, a proof-of-concept molecule with an average drug-antibody ratio (DAR) of 4.

In a poster titled, "Therapeutic potential of a HER3 antibody-drug conjugate for the treatment of HER3-expressing cancers," Elevation Oncology scientists presented in vitro and in vivo data of a seribantumab-based ADC for patients with HER3-expressing cancers. The data showed:

HER3-ADC1 binding to cancer cells, endocytosis, MMAE release and inhibition of proliferation were dependent on HER3 expression.
In cytotoxicity assays, HER3-ADC1 displayed HER3-dependent cell killing and outperformed a benchmark HER3-ADC with a deruxtecan payload, which is currently in clinical development.
In a patient derived xenograft (PDX) model of pancreatic cancer with high HER3 expression, HER3-ADC1 induced tumor regression, whereas an isotype-MMAE control and a benchmark HER3-ADC with a deruxtecan payload had only a modest effect.
The poster presentation is now available in the "Publications" section of Elevation Oncology’s website: View Source