On December 6, 2022 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies to treat solid tumors, reported an encouraging interim Phase I/IIa update on the use of clonal neoantigen reactive T cells (cNeT) from the CHIRON study in advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and the THETIS study in recurrent or metastatic malignant melanoma at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022 (ESMO IO) (Press release, Achilles Therapeutics, DEC 6, 2022, View Source [SID1234625326]).

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"The early safety, tolerability, and durable clinical benefit in heavily pre-treated patients presented today are encouraging and illustrate the promising therapeutic potential of cNeT monotherapy. Further, the strength of our translational science platform was shown by our ability to track key elements of activity that correlated to cNeT presence," said Dr Iraj Ali, CEO of Achilles Therapeutics. "We look forward to providing further updates in 2023, including additional monotherapy data from CHIRON and THETIS, and initial THETIS combination data evaluating cNeT with a PD-1 checkpoint inhibitor."

"The partial response and stable disease observed with low doses of cNeT in this difficult to treat patient population are encouraging, and coupled with the well-tolerated safety profile, highlight a favorable therapeutic window to further dose escalate and help drive deeper, more durable responses," added Dr. Karl Peggs, Chief Medical Officer of Achilles Therapeutics. "We believe this is the first time a response in lung cancer has been demonstrated using a cell therapy with a low dose conditioning and IL-2 regimen, which importantly, could expand eligibility of this therapy to include patients with comorbidities or reduced fitness that may not be candidates for traditional TIL therapy."

Dr. Sergio Quezada, Chief Scientific Officer of Achilles Therapeutics added, "In addition to the durable clinical benefit, our translational science platform begins to deliver key mechanistic insights for our cNeT therapy that are not possible with a standard TIL product, including assessment of phenotypic markers as well as proliferative and cytolytic capacity of the tumor reactive cNeT component. By virtue of knowing the cNeT targets and being able to characterize and track specific cNeT in the product and in the blood of patients, we can monitor cNeT dose, markers of function and exhaustion, engraftment, activation, and other features related to the patient, product, and performance in vivo."

Early, encouraging proof-of-concept data support the potential of cNeT monotherapy to deliver durable clinical benefit
14 patients treated (8 NSCLC in CHIRON, 6 melanoma in THETIS) with median of two prior lines of therapy
Two additional patients dosed since ESMO (Free ESMO Whitepaper) IO cut-off: one in CHIRON and one in THETIS Cohort B (checkpoint combination)
Confirmed partial response and stable disease achieved with low doses of cNeT and reduced dose lymphodepletion and IL-2 in NSCLC
1 partial response (PR, 56% tumor reduction maintained at week 36) and 6 patients with stable disease (SD) with overall durable clinical benefit at 12 weeks in 71% of evaluable patients (5/7) with advanced NSCLC
cNeT driven anti-tumor activity in the partial responder is supported by T cell engraftment and cytokine profiles
Stable disease in 50% of evaluable patients (3/6) with melanoma
cNeT product characterization supports a polyfunctional active component
Encouraging early safety and tolerability profile for cNeT
Safety and tolerability observations of cNeT compare favorably to standard tumor infiltrating lymphocytes (TIL) due to less IL-2 related toxicity
Lymphopenia and neutropenia were the most common adverse events, which are principally associated with the conditioning regimen, and no dose limiting high-grade toxicities associated with IL-2 were reported
Reduced dose lymphodepletion and IL-2 may expand patient eligibility criteria to include those with greater co-morbidities
Robust translational science platform correlates cNeT to activity
cNeT display an activated and functional phenotype including markers associated with tissue migration and a transcriptional profile supporting proliferation and cytotoxic function
Effective lymphodepletion and subsequent immune reconstitution were observed in all patients despite lower doses of lymphodepleting agents
Functional activity of cNeT supported by the observation of peak expansion of cytokine-secreting cNeT 21 days post infusion, coinciding with a peak in IL-6, with detection of cNeT beyond 12 weeks by TCR analysis
Manufacturing process evolution continues to increase cNeT doses
78 million median cNeT dose of first Process 2 products (n=3, CHIRON), with median 17% reactivity
47 million median cNeT dose across patient products since last update vs. 14 million in the first eight patients reported at SITC (Free SITC Whitepaper) 2021

Webcast and Conference Call Details

The company will host a live webcast and conference call today, Tuesday, December 6, 2022 at 8:00am ET / 1:00pm UK to review the interim update presented at ESMO (Free ESMO Whitepaper) IO. The live conference call will be webcast in listen-only mode and a slide presentation will be made available in the Events & Presentations section of the Company website at View Source For listeners who wish to participate in the question-and-answer session via telephone, please pre-register here.

On December 6, 2022, HCW Biologics Inc. was granted U.S. Patent No. 11,518,792 by the United States Patent and Trademark Office which contains claims for construction of novel multi-function fusion immunotherapeutic compounds comprised of a multi-chain chimeric polypeptide where the first target-binding domain and the second target-binding domain is a soluble human transforming growth factor-β ("TGF-β") receptor (Press release, HCW Biologics, DEC 6, 2022, View Source [SID1234624894]).

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This patent provides intellectual property protection for the Company’s lead drug candidate, HCW9218, a heterodimeric, bifunctional fusion protein complex comprising extracellular domains of human tissue factor as a scaffold with target binding domains of TGF-β receptor II, as a TGF-β trap for TGF-β neutralization, and a human interleukin ("IL")-15/IL-15 receptor α complex for immune cell stimulation.

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