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

On June 1, 2023 Landmark Bio, a collective endeavor bringing together leaders in industry, academia, and research hospitals to accelerate development and industrialization of next-generation genomic medicine, and InnDura Therapeutics ("InnDura"), a newly formed company advancing Natural Killer (NK) cell research, reported a new collaboration to develop and execute product development, regulatory, and chemistry, manufacturing and control (CMC) strategies to progress InnDura’s lead program to the clinic (Press release, InnDura Therapeutics, JUN 1, 2023, View Source [SID1234632369]).

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InnDura’s technology stems from original research and related discoveries under an exclusive license from the Dana-Farber Cancer Institute and the Massachusetts Institute of Technology (MIT) that focuses on EVE16 engineering of NK cells to provide enhanced cancer cell killing with greatly reduced cellular exhaustion and fratricide. The EVE16 technology can also be applied to T cells and other forms of cell therapy. Landmark Bio will serve as InnDura’s strategic partner in the research, development and manufacturing of their pipeline products.

"Working with Landmark Bio as our strategic partner saves us the time, resources and capital of building out CMC development and manufacturing capabilities ourselves, so we can focus all our efforts on creating and advancing safer, more effective cancer treatments for patients," said John Beadle, M.D., MBA, chief executive officer (CEO) of InnDura Therapeutics. "Landmark Bio’s cell and gene therapy development, manufacturing expertise and state-of-the-art facilities are perfect for InnDura’s needs and we look forward to shaping our strategies together as our progress continues."

"We are thrilled to partner with InnDura to translate their promising research into life-saving medicines," said Ran Zheng, CEO of Landmark Bio. "This partnership is a great example of why Landmark Bio exists. In collaborating with innovators like InnDura, we can bring more advanced therapies to patients faster."

On June 1, 2023 IMPACT Therapeutics ("Impact"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, and Eikon Therapeutics ("Eikon"), a biotechnology company that is advancing breakthrough therapeutics through the purposeful integration of engineering and science reported that the companies have entered into a global license and collaboration agreement for PARP1 selective inhibitors including IMP1734, which is anticipated to enter into Phase I clinical study in 2023 (Press release, Impact Therapeutics, JUN 1, 2023, View Source [SID1234632368]).

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Under the collaboration agreement, Eikon received an exclusive license from Impact to co-develop, register, manufacture, and commercialize IMP1734 and other PARP1 selective inhibitors globally, excluding Greater China (mainland China, Hong Kong, Macau, and Taiwan).

"We are delighted to establish the global partnership with Eikon, whose leadership team has a well-documented track record of developing some of the world’s most therapeutically meaningful and commercially successful oncology medicines." said Sui Xiong Cai, Ph.D., Chief Executive Officer of IMPACT Therapeutics. "As a company committed to develop innovative medicines globally, based on our deep understanding of synthetic lethality, we believe this partnership will allow us to accelerate the development of our PARP1 selective inhibitor program combining Impact and Eikon’s scientific, clinical, regulatory expertise and financial resources. We look forward to working with Eikon in bringing new cancer medicines to patients in China and across the globe."

"Impact has a sophisticated discovery engine that has generated an extensive pipeline of new molecules, including the development of senaparib, a dual PARP1/2 inhibitor that has been recently reported to improve outcomes in patients with advanced ovarian cancer. Eikon is delighted to partner with Impact scientists to help develop IMP1734 and other selective PARP1 inhibitors that exploit DNA damage response aberrations often found in tumors to selectively kill cancer cells," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon Therapeutics. "Eikon is confident that we can leverage our expertise, resources and proprietary technology platforms, in partnership with Impact, to bring these important new PARP1 inhibitor therapies to patients who are awaiting new and better treatment options."