On June 1, 2023 BostonGene reported that four abstracts have been accepted for poster presentations and two abstracts have been accepted for online publication for the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), which will be held June 2 – 6, 2023, at McCormick Place Convention Center in Chicago, IL (Press release, BostonGene, JUN 1, 2023, View Source [SID1234632374]). BostonGene will also exhibit at booth 28155.

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"We look forward to sharing results from our research analyzing genomic and transcriptomic classifications and our analysis demonstrating the added benefit of comprehensive genomic profiling in a thousand diverse cancer patients at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. These presentations reflect our scientific expertise and commitment to bringing innovative solutions into clinical practice," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details about the abstracts selected for presentation can be found below:

Abstract Number: 3076
Title: Aggregated analysis of 1,000 patients with cancer to assess the benefits of integrated whole exome and whole transcriptome sequencing
Date and Time: Saturday, June 3 | 8:00 AM – 11:00 AM CT
Location: McCormick Place Convention Center
Poster Number: 274
Speaker: Anna Ogloblina, PhD, BostonGene

The deep interrogation of BostonGene’s comprehensive approach to molecular profiling demonstrates the advantages of integrated RNA sequencing (RNA-seq) and whole exome sequencing (WES) analysis, including an increase in clinically significant biomarkers and matched clinical trials, which can ultimately lead to more effective personalized treatments for cancer patients.

Abstract Number: 11547
Title: Novel genomic alterations and transcriptomic-based tumor microenvironment classification of sarcoma and their impact on treatment decision-making
Date and Time: Saturday, June 3 | 1:15 PM – 4:15 PM CT
Location: McCormick Place Convention Center
Poster Number: 481
Speaker: Krystle Nomie, PhD, BostonGene

This presentation demonstrates the ability of the BostonGene’s Tumor PortraitTM test to identify genomic alterations and classify tumor microenvironment (TME) subtypes of sarcomas that ultimately provide insights on potential immunotherapy and specific gene-related treatment strategies.

Research conducted in collaboration with The University of Texas MD Anderson Cancer Center

Abstract Number: 579
Title: Differential genomic and transcriptomic analysis of invasive lobular and ductal carcinomas
Date and Time: Sunday, June 4 | 8:00 AM – 11:00 AM
Location: McCormick Place Convention Center
Poster Number: 409
Speaker: Jason Mouabbi, MD, MD Anderson

In this study, the use of BostonGene’s integrated analysis platform provided an in-depth understanding of the molecular differences between two breast cancer subtypes, invasive lobular carcinoma (ILC) and invasive ductal carcinoma (IDC), revealing mechanistic insights for both subtypes that can be used to tailor ILC-specific interventional clinical trials.

Abstract Number: 1039
Title: Genomic characterization of the GATA3 mutational landscape in breast cancer
Date and Time: Sunday, June 4 | 8:00 AM – 11:00 AM
Location: McCormick Place Convention Center
Poster Number: 260
Speaker: Jason Mouabbi, MD, MD Anderson

This presentation highlights the use of integrated genomic and transcriptomic analysis to understand further the mutational landscape of GATA3, a broadly used biomarker in breast cancer, to guide future prospective clinical studies.

Online publication abstracts:

Abstract Number: e15058
Title: RNA sequencing as a confirmatory assay and its impact on patient care in multiple cancer types

This presentation describes the advantage of RNA sequencing (RNA-seq) to confirm the pathological detection of biomarkers, demonstrating the utility of RNA-seq analysis to drive treatment decisions in 4 cancer types.

Research conducted in collaboration with Weill Cornell Medicine, Englander Institute of Precision Medicine, MD Anderson, Oncology Consultants, and Cancer Centers of South Florida

Abstract Number: e14691
Title: Tumor immunity portrait: An AI-driven molecular predictor combining tumor microenvironment and tumor mutational burden for immune checkpoint inhibitor response prediction

This study highlights the ability of BostonGene’s Tumor Immunity PortraitTM, an integrated approach combining the tumor’s characteristics and TME, to provide an accurate prediction of ICI non-response in 3 cancer types for personalized treatment decision-making.

For more information, please visit the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting website. The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

On June 1, 2023 Shasqi, Inc. ("Shasqi"), a clinical-stage biotech company, whose mission is to revolutionize cancer treatment with click chemistry, reported that it has entered into a research collaboration with Johnson & Johnson Enterprise Innovation Inc (Press release, Shasqi, JUN 1, 2023, View Source [SID1234632373]). Through the collaboration, Shasqi will apply its novel tumor-targeted Click Activated Protodrugs Against Cancer (CAPAC) platform to the development of new cancer therapies.

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Shasqi’s CAPAC platform relies on chemistry, not biology, for activation of drugs at the tumor. The platform is made up of two separate components: a tumor-targeting agent and a cancer therapeutic. These come together at the site of the tumor, and the cancer therapeutic is activated via click chemistry, a Nobel Prize winning technology. Using this platform, Shasqi is targeting high doses of cancer drugs directly to the site of the tumor, while minimizing toxicity to healthy cells. Shasqi is the first company to use click chemistry in humans.

"This is a compelling opportunity to expand our platform," said José M. Mejía Oneto, MD, PhD, founder and chief executive officer of Shasqi. "We are excited to collaborate and apply click chemistry for potential new therapies in areas of significant unmet medical need."

The use of click chemistry to activate cancer drugs at the tumor has been clinically validated. In a phase 1 study, click chemistry was used to activate a dose of doxorubicin that is 12-times a conventional dose, with a favorable toxicity profile. Tumor localization of click chemistry was achieved through an intratumorally injected biopolymer. A phase 2a study is currently enrolling patients with soft tissue sarcoma and head and neck cancer.[1]

The collaboration will focus on Shasqi’s intratumorally injected biopolymer (SQL70) and a co-development committee has been formed with the aim of identifying the next clinical candidate.

"This marks the start of Shasqi’s ambition to advance our platform and collaboratively develop the next generation of tumor-targeted therapies, expanding on the foundation built by antibody drug conjugates," said Mukul Agarwal, chief business officer at Shasqi. "The reliance on chemistry, not biology for drug activation, allows for the use of small molecules, peptides, and antibody fragments to target tumor antigens, creating unprecedented flexibility."

On June 1, 2023 Sengenics Corporation LLC, driving the discovery of next-gen biomarkers through its immunoproteomics platform, reported that Dr. Iman Osman, Director of the Interdisciplinary Melanoma Program at New York University Grossman School of Medicine, will be presenting groundbreaking findings at the American Association of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 2nd – 6th, 2023 (Press release, Sengenics, JUN 1, 2023, View Source [SID1234632372]). Her poster, titled "Determinants of racial disparities in immune-related adverse events (irAE) with checkpoint inhibition (ICI) in melanoma" (Abstract #9549, Poster Board # 312), sheds light on the prediction of irAEs in patients treated with checkpoint inhibitors. The predictive antibody data were generated with the Sengenics immunoprofiling platform.

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The emergence of immune checkpoint inhibitors has revolutionized cancer treatment by effectively countering cancer cells’ suppression of the cytotoxic T-cell response. They have revolutionized the field and brought hope to many patients. However, these inhibitors often give rise to immune-related adverse events (irAEs). The ability to predict the occurrence of irAEs would significantly enhance clinicians’ decision-making in treatment protocols.

Dr. Osman’s research investigates the hypothesis that patients susceptible to irAEs may exhibit baseline antibody profiles that hold predictive value for their response. Notably, she is extending her investigation to identify predictive signatures within underrepresented minority populations.

"I believe it is of utmost importance to develop predictive models that can be universally applicable, encompassing all patients and not solely the majority population," stated Dr. Osman. "Recognizing the diversity in immune responses and avoiding the oversimplification of assuming what works for one group will work for another is crucial."

Jerry Williamson, President, and CEO of Sengenics, expressed enthusiasm for promoting Dr. Osman’s critical work, stating, "We are thrilled to support Dr. Osman’s groundbreaking research, as it contributes to the growing body of evidence supporting the value of antibody biomarkers."

Dr. Osman currently serves as the Associate Dean for Clinical Research Strategy and Director of the Interdisciplinary Melanoma Program at New York University Grossman School of Medicine. Her primary focus revolves around conducting translational research in melanoma where she spearheads the Melanoma Research Enterprise at NYU.

On June 1, 2023 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and the University of Oxford reported results from the prospective SYMPLIFY study will be presented during an oral session on Saturday, June 3, at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Grail, JUN 1, 2023, View Source [SID1234632371]). SYMPLIFY is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented to primary care and were referred for diagnostic follow-up for suspicion of cancer. The analysis showed strong performance of GRAIL’s MCED methylation-based platform in the symptomatic population of more than 6,000 patients and demonstrated the feasibility of using an MCED test to assist clinicians with decisions around the route of referral from primary care. These results are in press for publication in The Lancet Oncology.

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"Earlier cancer detection and subsequent intervention has the potential to greatly improve patient outcomes. Most patients diagnosed with cancer first see a primary care physician for the investigation of symptoms suggestive of cancer, like weight loss, anemia, or abdominal pain, which can be complex as there are multiple potential causes. New tools that can both expedite cancer diagnosis and potentially avoid invasive and costly investigations are needed to more accurately triage patients who present with non-specific cancer symptoms," said Brian D. Nicholson, MRCGP, DPhil, Associate Professor at the Nuffield Department of Primary Care Health Sciences, University of Oxford, United Kingdom and co-lead investigator of the study. "The high overall specificity, positive predictive value, and accuracy of the cancer signal detected and cancer signal origin prediction that was reported across cancer types in the SYMPLIFY study indicate that a positive MCED test could be used to confirm that symptomatic patients should be evaluated for cancer before pursuing other diagnoses."

The SYMPLIFY study enrolled 6,238 patients, aged 18 and older, in England and Wales who were referred for urgent imaging, endoscopy or other diagnostic modalities to investigate symptoms suspicious for possible gynecological, lung, lower GI or upper GI cancer, or who had presented with non-specific symptoms. Participants provided a blood sample, from which cell-free DNA was isolated and stored until GRAIL’s MCED test was performed in batches, blinded to clinical outcome. GRAIL’s MCED test’s predictions (cancer signal detected, and if so, cancer signal origin [CSO]) were compared with the diagnosis obtained by standard of care to assess the test’s performance. The most commonly reported symptoms leading to referral were unexpected weight loss (24.1%), change in bowel habit (22.0%), post-menopausal bleeding (16.0%), rectal bleeding (15.7%), abdominal pain (14.5%), pain (10.6%), difficulty swallowing (8.8%) and anemia (7.1%).

Within the study, 368 (6.7%) of the 5,461 evaluable patients were diagnosed with cancer through standard of care. The most common cancer diagnoses were colorectal (37.2%), lung (22.0%), uterine (8.2%), oesophago-gastric (6.0%) and ovarian (3.8%).

GRAIL’s MCED test detected a cancer signal in 323 people, 244 in whom cancer was diagnosed, resulting in a positive predictive value (PPV) of 75.5%, negative predictive value (NPV) of 97.6%, and specificity of 98.4%. The overall sensitivity of the MCED test was 66.3%, ranging from 24.2% in stage I cancers to 95.3% in stage IV, and increased with age and later cancer stage. The overall accuracy of the top CSO prediction after a positive MCED test was 85.2%. The mean age of patients in the study was 62.1 years old.

"GRAIL’s earlier PATHFINDER study previously demonstrated that adding GRAIL’s MCED testing to standard of care screening more than doubled the number of cancers detected compared with standard screening alone in adults with no symptoms or suspicion of cancer. Now, the SYMPLIFY data confirm the potential benefit of methylation-based MCED blood tests as a diagnostic aid for use in the symptomatic patient population," said Sir Harpal Kumar, President of GRAIL Europe. "These exciting results will inform our development of an optimized classifier for use in symptomatic patients with a suspicion of cancer."

The University of Oxford sponsored the SYMPLIFY study and was responsible for data collection, analysis and interpretation. The study was funded by GRAIL with support from National Health Service (NHS) England, NHS Wales, the National Institute for Health and Care Research (NIHR) and NIHR Oxford Biomedical Research Centre.

"This is a fantastic example of how academia and industry can work together for patient benefit, recruiting over 6,000 patients to SYMPLIFY in under six months and within less than a year of launching the project," said Professor Helen McShane, Director of the NIHR Oxford Biomedical Research Centre. "We are committed to diagnosing cancers earlier, when they can be cured, and this study is an important step on that journey. SYMPLIFY also shows that we can run trials at scale using digital systems to deliver research quickly and cost effectively, with the help of the NIHR’s Clinical Research Network."

On June 1, 2023 iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways, reported that it will be presenting at leading scientific conferences throughout June 2023 (Press release, iOnctura, JUN 1, 2023, View Source [SID1234632370]).

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The iOnctura team will present the Company’s research on its first-in-class, non-ATP-competitive, allosteric modulator of PI3Kδ, roginolisib.

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Chicago, USA
2-6 June 2023
Poster title: ‘First-in-human (FIH) phase I dose escalation study (Part A) of the first oral allosteric modulator of phosphoinositide 3-kinase inhibitor delta (PI3Kδ) roginolisib in patients with advanced cancer and dose confirmation in Uveal Melanoma (Part B)’
Presentation Time: 3 June 2023 at 08:00-11:00 CDT

European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress, Frankfurt, Germany
8-16 June 2023
Poster title: ‘Highly selective allosteric modulator of the phosphoinositide 3-kinase data (PI3Kδ) roginolisib (IOA-244) in a dose escalation study of patients with refractory/relapsed follicular lymphoma (FL)’
Presentation Time: 10 June 2023 at 16:30-17:45 CEST

European Association for Cancer Research (EACR) Congress 2023, Torino, Italy
12-15 June 2023
Poster title: ‘Patient derived tumor cells identify mechanistically rational combinations for the PI3Kδ inhibitor roginolisib in solid and hematologic malignancies’
Presentation Time: 14 June 2023 at 11:00-18:00 CEST.

International Conference on Malignant Lymphoma, Lugano, Switzerland
13-17 June 2023
Poster title: ‘Highly Selective Allosteric Modulator of the Phosphoinositide 3-Kinase Delta (PI3Kδ)
Roginolisib In Patients With Refractory/Relapsed Follicular Lymphoma’
Presentation Time: 15 June 2023 at 12:30-13:00 CEST

Michael Lahn, Chief Medical Officer of iOnctura, said: "As our lead therapeutic candidates advance through the clinic, we are excited to be sharing our research developments with the scientific community. We are excited about the recent clinical observations for roginolisib as well as for IOA-289. Roginolisib overcomes cancer-induced immune suppression by re-balancing the immune cell subsets and thus enables patients to fight cancer. Because this process occurs in other malignancies, we expect that our findings will have an application in tumor types other than uveal melanoma. "

If you would like to meet with the iOnctura team, please contact us using the details provided below. For more information, please visit us at View Source