On December 6, 2022 OmniSpirant Limited and EVerZom are delighted to announce the launch of INSPIRE, a €12.8 million lung cancer project funded by Horizon Europe (Press release, OmniSpirant, DEC 6, 2022, View Source [SID1234624871]). The project gathers European partners spanning across biotechnology, medical devices, cancer research, academia and patient advocacy including Aerogen Limited (Ireland), Trinity College Dublin (Ireland), RemedyBio (Ireland), Myriad Associates (Ireland), EVerZom (France), Biopharma Excellence (Pharmalex) (Germany), Deutsches Krebsforschungszentrum (DKFZ) (Germany) and Lung Cancer Europe (Switzerland). Over the next 3 years of the project, this world-class consortium will progress the development of a regenerative gene therapy as a transformative new treatment for lung cancer. The INSPIRE programme aims to make an important and tangible impact on Europe’s Beating Cancer Plan and the EU Mission on Cancer.

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Lung cancer presents a significant health policy challenge with over 470 thousand cases reported annually in Europe, accounting for 11% of all cancers and 15% of healthcare expenses in cancer. The state-of-the-art approved treatments, such as targeted therapy and immune checkpoint inhibitors are prone to treatment resistance. The overall 5-year survival rates for people with lung cancer remain extremely poor, highlighting the desperate need for innovative treatments.

OmniSpirant is an Irish biotech founded in 2016 to develop first-in-class inhaled regenerative gene therapies. This development is based on its proprietary OmniSome platform technology, which utilises tiny particles carrying cellular cargoes, known as extracellular vesicles (EVs) secreted by stem cells. Targeted indications are pulmonary diseases like cystic fibrosis or alpha-1 antitrypsin deficiency (AATD), and now, lung cancer via the INSPIRE project.

"We are delighted to collaborate with our pan-European partners in developing this exciting new approach" said OmniSpirant CEO Gerry McCauley. "We are at the forefront of harnessing extracellular vesicles to deliver RNA based therapeutics in the fight against lung cancer and in developing our platform to address a host of chronic pulmonary conditions"

"We are delighted to collaborate with OmniSpirant to bring our technologies and know how to manufacture extracellular vesicles at large scale and affordable costs to develop this future breakthrough treatment." said Jeanne Volatron, EVerZom CEO.

For more information, please visit inspire.lungcancereurope.eu and www.omnispirant.com or contact Gerry McCauley, CEO at [email protected] or Jeanne Volatron, CEO at [email protected]

On December 6, 2022 Exscientia plc (Nasdaq: EXAI) today highlighted new data to identify patients that are more likely to respond to its A2A receptor antagonist, EXS-21546 (‘546) as well as the relationship to potential impact of adenosine on PD-1 inhibitor response (Press release, Exscientia, DEC 6, 2022, View Source [SID1234624870]). The research identified a novel patient selection multi-gene transcript signature, the adenosine burden score (ABS), that will be confirmed in the Company’s Phase 1/2 study, IGNITE-AI. The data are being presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Annual Congress, being held December 7-9 in Geneva, Switzerland.

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In this study, researchers leveraged Exscientia’s translational oncology platform with transcriptomics, to develop and begin pre-clinical biological confirmation of the ABS, a measure of adenosine burden. Data was also presented showing ABS outperformed other published adenosine signatures in specificity and sensitivity for detecting adenosine-rich microenvironments.

Additionally, the research identified an inverse relationship between ABS and another published signature that has been shown to be predictive of anti-PD-1 therapy success, the Tumour Inflammation Score (TIS). This suggests that reduction of adenosine burden through A2AR antagonism with ‘546 could result in the restoration of checkpoint inhibitor response. The combination therapy approach will be validated in the IGNITE-AI Phase 1/2 clinical trial, combining ‘546 with a checkpoint inhibitor in solid tumours.

"We believe that the signature identified by thoroughly assessing adenosine activity in primary patient samples through our functional precision medicine platform provides us with a guided way to enrich for patients that may respond to ‘546 therapy," said Gregory Vladimer, VP of Translational Research at Exscientia. "Adenosine in the tumour microenvironment is immuno-suppressive and only patients with high adenosine will benefit from A2A receptor antagonist therapy. That is why we want to design our clinical programmes to specifically identify those patients and potentially improve the probability of response."

Poster Presentation Details:
Title: Enriching for response: Patient selection criteria for A2AR inhibition by EXS-21546 through ex vivo modelling in primary patient material
Abstract Number: 23P
Session Title: Biomarker development
Date/Time: Thursday, December 08 / 12:30 PM – 13:15 PM CET

The poster is available on Exscientia’s website.

About EXS-21546

EXS-21546 is a highly selective A2A receptor antagonist ​​co-invented and developed through a collaboration between Exscientia and Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; Nasdaq: EVO). In June 2022, Exscientia reported topline data from a healthy volunteer study which confirmed Exscientia’s target product profile design, including potency, high receptor selectivity and expected low brain exposure with no CNS adverse events reported. Exscientia recently initiated a Phase 1/2 clinical trial of ‘546 in combination with a checkpoint inhibitor in patients with relapsed or refractory renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) who previously received treatment with an immune checkpoint inhibitor.

On December 6, 2022 Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests initially focused on non-invasive detection of high-mortality cancers in high-risk patient populations before symptoms appear, reported the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date (Press release, Bluestar Genomics, DEC 6, 2022, View Source [SID1234624868]). The trial will use Bluestar Genomics’ proprietary epigenomic methods for detection of the disease.

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With research showing that patients recently diagnosed with Type 2 diabetes are almost eight times more likely to develop pancreatic cancer, Bluestar Genomics aims to directly address the unmet need for early disease detection by further validating the utility and accuracy of its pancreatic cancer detection test in high-risk patients. The company’s new DNA-based test uses a standard blood draw to identify pancreatic cancer signal at its earliest stages by measuring levels of the 5-hydroxymethylcytosine (5hmC) in cell free DNA before symptoms appear. This large, prospective, multi-site study is designed to clinically validate the Bluestar Genomics test to detect whether an individual has an abnormal DNA signal associated with pancreatic cancer.

"Most people are unaware that patients recently diagnosed with Type 2 diabetes are at a higher risk for pancreatic cancer, typically resulting in late diagnosis and lack of effective treatments, which is why it’s critical that we identify new methods for early detection of the disease in at-risk populations," said David Halpert, M.D., principal investigator at JEM Research, a Headlands Research Site in Atlantis, Fla. "We are proud to be among the first clinical practices to enroll in the trial that represents an important contribution in a field crying out for something that can give patients a chance."

The NODMED trial, conducted in collaboration with the PPD clinical research business of Thermo Fisher Scientific Inc., aims to enroll 6,500 patients 50 years of age and older. Trial participants will receive Bluestar Genomics’ DNA-based blood test designed to analyze their changing biology, which can detect when cells become cancerous using the novel 5hmC-based epigenomic analysis.

"Our goal is to enable community doctors to practice medicine at the forefront of innovation, bringing the most cutting-edge care to patients whose lives might be saved with early detection of one of the most lethal cancers," said Samuel Levy, PhD, chief science officer of Bluestar Genomics. "We want to expand our base of clinical evidence to include even larger and more diverse pools of patient samples to further solidify our 5hmC-based approach for early cancer detection that can also be utilized for many other high mortality cancers."

To learn more about the NODMED trial, visit: View Source or View Source

On December 6, 2022 Systems Oncology reported that they will be presenting positive preclinical data on the company’s next generation estrogen receptor positive drug candidate, SERA2 (Selective Estrogen Receptor Activator). SERA2 has a unique mechanism that can exploit and overcome therapy resistance to create long-term and durable complete responses in patients with ER+ cancers (Press release, Systems Oncology, DEC 6, 2022, View Source [SID1234624867]). The selective hyper-activation of the Unfolded Protein Response (UPR) leads to ER+ cancer specific lethality; this is a new form of inescapable cell death in ER positive cancers, including and beyond breast cancer. The SERA2 compound has the unique ability to kill all ER positive breast cancer cells, even cancer cells with ER mutations that cause resistance to aromatase inhibitors, SERMs, and SERDs.

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In the preclinical data presented at J.P. Morgan, treatment with SERA2 in animal models of human breast cancer results in multiple, complete, durable tumor regressions. In comparison to earlier generation SERA family members, SERA2 shows superior tolerability in multiple mammalian species. These data support the rationale for SERA2 as a novel therapeutic for the treatment of breast cancer and potentially other estrogen receptor positive cancers.

"There is still an unmet need for patients who progress on all current breast cancer treatment options. This new next-generation SERA compound has proven to have outstanding efficacy and tolerability, which is a strong indicator that SERA2 should produce durable and complete responses clinically," said Dr. Spyro Mousses, CEO and Co-Founder of Systems Oncology.

"I fully expect that this exciting compound has the potential to create a real paradigm-shift for breast cancer care," said Dr. Joyce O’Shaughnessy, Baylor University Medical Center, Texas Oncology, US Oncology.

Systems Oncology will be having partnering meetings during the J.P. Morgan conference from January 9 to January 11, 2023. To schedule, please reach out to Katy Marhenke at [email protected].

About SERA

Scientists at Systems Oncology entered into a strategic research collaboration with two professors at the University of Illinois, Dr. David Shapiro and Dr. Paul Hergenrother, who respectively conducted pioneering research into the biology and chemistry of anticipatory activation of UPR in breast cancer. The research led to intellectual property (IP) that covered small molecule agents that can activate the UPR. Inspired with a multi-scalar systems understanding of this mechanism, Systems Oncology acquired a license to the IP from the University and invested to drive pre-clinical studies and manufacturing development, eventually establishing the SERA program as a promising investigational compound.

On December 6, 2022 Kurome Therapeutics, Inc., a late pre clinical stage biotech company developing novel IRAK1/4 inhibitors for oncology indications, reported two abstracts have been accepted for oral and poster presentations at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 9-13, 2022, in New Orleans (Press release, Kurome Therapeutics, DEC 6, 2022, View Source [SID1234624866]). The presentations highlight preclinical data supporting the importance of inhibiting both IRAK1 and IRAK4 in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).

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ASH 2022 Presentation Details:

Oral Presentation Title: IRAK1 Contributes to IRAK4 Inhibitor Resistance Via Non-Canonical Signaling Mechanisms in MDS/AML
Presenter and Lead Author: Josh Bennett, BS, Cincinnati Children’s Hospital Medical Center, and Daniel T. Starczynowski, PhD, Cincinnati Children’s Hospital Medical Center
Session Name: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Immune Signaling and Antibody-therapeutic Targeting in Myeloid Neoplasms
Presentation Date/Time: Monday, December 12, 2022, at 4:30 p.m. CST
Location: Ernest N. Morial Convention Center, 353-355

Poster Presentation Title: Inhibition of Both IRAK1 and IRAK4 Is Required for Complete Suppression of NF-Kb Signaling across Multiple Receptor-Mediated Pathways in MDS and AML
Publication Number: 2647
Authors: Jan S Rosenbaum, PhD, Kurome Therapeutics, Scott B. Hoyt, Ph.D., National Center for Advancing Translational Sciences, National Institutes of Health, Amal S. Kolt, MS, Kurome Therapeutics, Daniel A Luedtke, PhD, Kurome Therapeutics, Craig J. Thomas, PhD, National Center for Advancing Translational Sciences, National Institutes of Health, and Daniel T. Starczynowski, PhD, Cincinnati Children’s Hospital Medical Center
Session Name: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II
Session Date/Time: Sunday, December 11, 2022, 6:00 – 8:00 p.m. CST
Location: Ernest N. Morial Convention Center, Hall D

Abstracts are available on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org