On May 2, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported that two abstracts have been accepted for poster presentations at the 25th Annual Meeting of the American Society of Gene & Cell Therapy, scheduled for May 16 – May 19, 2022, in Washington, DC (Press release, Lyell Immunopharma, MAY 2, 2022, View Source [SID1234613292]).

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The presentations will highlight preclinical data characterizing two investigational products in Phase 1 clinical development that incorporate Lyell technologies designed to address major barriers to successful Adoptive Cell Therapy (ACT): Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality.

The first abstract presents preclinical data for LYL797 demonstrating that Gen-R and Epi-R can enhance and prolong anti-tumor functions of ROR1-targeting CAR T-cell therapy in solid tumor model systems. The second abstract presents preclinical data for LYL132 demonstrating that Epi-R creates populations of stemlike NY-ESO-1-targeting TCR T cells that lead to products with increased proliferative capacity and prolonged functional activity in the presence of persistent antigen exposure.

Details on the presentations are below:

Preclinical Development of LYL797, a ROR1-Targeted CAR T-Cell Therapy Enhanced with Genetic and Epigenetic Reprogramming for Solid Tumors

Session: Cancer – Immunotherapy, Cancer Vaccines II
Presentation Date, Time & Location: May 17, 5:30 – 6:30 PM, Hall D, Tu-166
Abstract number: 661
Epigenetic Reprogramming (Epi-R) Yields T-Cell Receptor Products with Improved Stemness, Metabolic Fitness, and Functional Activity in the Presence of Persistent Antigen Exposure

Session: Cancer – Targeted Gene and Cell Therapy II
Presentation Date, Time & Location: May 18, 5:30 – 6:30 PM, Hall D, W-241
Abstract: 1115
About LYL797 and LYL132

LYL797 is an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors. LYL797 incorporates Lyell’s novel Gen-R and Epi-R reprogramming technologies. The Phase 1 trial will assess LYL797 in patients with relapsed/refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). More information can be found on ClinicalTrials.gov by searching NCT05274451.

LYL132 (GSK4427296) is an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) being developed in collaboration with GSK. LYL132 incorporates Epi-R reprogramming technology and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development. The Phase 1 trial will assess LYL132 in patients with NY-ESO-1+ advanced synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS). Lyell will manufacture LYL132 in its LyFE Manufacturing Center and GSK will conduct the Phase 1 trial. More information can be found on ClinicalTrials.gov by searching NCT04526509.

On May 2, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research reported the acceptance of an abstract for a poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting, which is taking place both online and in-person at hub27 – Messe Berlin in Berlin, Germany from May 3-5, 2022 (Press release, Oncolytics Biotech, MAY 2, 2022, View Source [SID1234613308]).

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The accepted abstract (#364) is available on the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting website. Included in the abstract are new results from cohort 1 and cohort 2 of the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, each of which enrolled ten HR+/HER2- early-stage breast cancer patients. These patients were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Evaluation of these cohorts was the primary focus of AWARE-1 as HR+/HER2- is the breast cancer subtype Oncolytics intends to investigate in a future registrational study.

Results of this exploratory study described in the abstract show pelareorep’s potential to induce an inflamed tumor phenotype and its synergy with atezolizumab. They also support pelareorep’s immune-based mechanism of action and suggest that the combination of pelareorep and atezolizumab may improve outcomes in breast cancer. Additional details on analyses and results described in the abstract will be provided following the publication of its corresponding poster, in accordance with the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting’s embargo policies.

Details on the abstract and upcoming poster presentation are shown below.

Title: The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients – results from AWARE-1 study

Category: Biomarkers and translational research and precision medicine

Abstract Number: 364

Presentation Date: May 4, 2022

Presentation Time: 12:15 p.m. CET

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

On May 2, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the availability of Shield, the company’s first blood-based test for the detection of early-stage colorectal cancer (CRC) (Press release, Guardant Health, MAY 2, 2022, View Source [SID1234613324]). The test, which only requires patients to complete a simple blood draw, is intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC.

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Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S.1 Today, one in three adults have not completed the recommended CRC screening even though colorectal cancer is curable if caught early. Barriers associated with currently available methods, such as a colonoscopy or a stool-based test, can make the process unpleasant, time-consuming and difficult to complete.2 With a simple blood draw, the Shield test overcomes these barriers because it requires no special preparation, no sedation, no dietary changes, no extra time away from family or work, and it can be completed as part of any patient office visit.3

The clinical performance of the Shield assay was validated using a set of 309 patient samples, including 92 with CRC, 51 with advanced adenomas and 166 normal cases. CRC patient samples were accrued across six unique cohorts collected in the U.S., Canada and the EU, and samples with advanced adenoma and normal cases were collected in the U.S. Subjects were balanced by age (a mean of 64 years old) and gender. The Shield assay demonstrated 91% sensitivity (detection rate) for CRC (95% confidence interval [CI]: 84% – 95%), including 90% for Stage I, 97% for Stage II, and 86% for Stage III CRC. The assay also demonstrated 20% sensitivity for advanced adenomas (95% CI; 11% – 32%) and 92% specificity (true negative rate) in normal cases.

"The availability of the Shield test represents a major milestone in our commitment to transform cancer screening. We have developed highly sensitive technology to detect early-stage cancers with a simple blood draw," said AmirAli Talasaz, Guardant Health co-CEO. "Colorectal cancer screening is the start of this journey. We will soon expand into multi-cancer screening, including lung, pancreas and others, where we believe cancer screening can save lives."

Why CRC screening compliance matters

More than 75% of people who die from CRC today are not up to date with recommended screening.4 Cancer underscreening is an important factor contributing to the high cancer mortality rate in underserved populations. For example, in the area of CRC, only 59% of individuals age 50 and older who are Hispanic and 65% of individuals who are Black/African American are up to date with recommended screenings, compared to 68% of individuals who are white.5

"The value of colorectal cancer screening is well-established for individuals at average risk, age 45 and older," said J. Leonard Lichtenfeld, MD, MACP, Chief Medical Officer, Jasper Health. "But the benefits of screening have been limited due to the suboptimal completion rates of stool tests and colonoscopy. A high-sensitivity test that can be completed with a convenient blood draw during any healthcare provider visit can help patients overcome the barriers to adherence and help healthcare professionals identify more cancers at their earliest stages, when they are most treatable."

"Colorectal cancer is largely preventable if caught early, yet barriers to screening tests remain. It can be especially challenging for underserved populations to get screened. These barriers include lack of healthcare access, limited capacity in healthcare systems, transportation challenges, childcare, and lack of paid leave from work," said Anjee Davis, MPPA, president of Fight Colorectal Cancer. "As the research continues to progress for blood-based tests, the availability of a test like this is a welcomed addition to the tools we can use to prevent cancer. This has the potential to improve access to screening for underserved populations and dramatically improve overall screening rates."

How the Shield assay was developed

The Shield test detects early signs of CRC signals in the bloodstream. The assay was developed using multiple cohorts comprising 2,089 subjects with CRC, 357 with advanced adenoma and 3,757 normal subjects. The samples were collected within both prospective screening collections designed to capture the intended use population and retrospective case-control cohorts designed to enrich for subjects with CRC.

Where the Shield test is available currently

Shield is now available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation.

What’s next for the Shield test

This year Guardant Health plans to share results of the ECLIPSE clinical study (NCT04136002) to demonstrate the performance of the Shield test to detect early signs of CRC in individuals ages 45-84 who are at average risk. The prospective, multi-site registrational study is one of the largest cancer screening studies of its kind, with enrollment of more than 12,750 patients from across the U.S. Subject to positive results, the study will support a premarket approval (PMA) submission to the U.S. Food and Drug Administration.

On May 2, 2022 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported it will report its first quarter 2022 financial results and operational highlights on Monday, May 9, 2022, following the close of U.S. financial markets (Press release, Novavax, MAY 2, 2022, https://www.prnewswire.com/news-releases/novavax-to-host-conference-call-to-discuss-first-quarter-2022-financial-results-and-operational-highlights-on-may-9-2022-301537188.html [SID1234613340]). Details of the event and replay are as follows:

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To ensure a timely connection, it is recommended that participants join at least 10 minutes prior to the scheduled webcast

On May 2, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported a poster presentation highlighting the Company’s membrane-bound interleukin-15 (mbIL-15) program as a potentially potent cell therapy targeting hotspot mutations expressed in solid tumors at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) being held in Washington, D.C. and virtually May 16-19, 2022 (Press release, Alaunos Therapeutics, MAY 2, 2022, View Source [SID1234613293]).

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"We are excited at the opportunity to present new preclinical data in our mbIL-15 program at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. In this study we observed the potential of our Sleeping Beauty transposed mbIL-15 TCR-T cells to deepen clinical responses and improve durability of TCR-T cells targeting hotspot mutations expressed in solid tumors," stated Drew Deniger, Ph.D., Vice President, Research & Development at Alaunos Therapeutics. "We continue to be encouraged by the data and intend to file an IND application for this program in the second half of 2023."

Details of the poster presentation are as follows:

Poster Presentation: Stem-cell memory TCR-T cells targeting hotspot EGFR, KRAS and p53 neoantigens generated through co-expression of membrane-bound Interleukin-15

Session Title: Cancer – Targeted Gene and Cell Therapy I

Session Date/Time: Monday May 16, 2022, 5:30 PM—6:30 PM EST

Poster Board Number: M-234

Location: Walter E. Washington Convention Center, Hall D

Alaunos’ mbIL-15 program has been developed to augment the function of TCR-T cells by co-expression of a more potent and proprietary membrane-bound interleukin-15. In this preclinical study, Alaunos observed that mbIL-15 TCR-T cells specifically targeted and killed tumors expressing matching neoantigen and HLAs with negligible off target effects. Furthermore, Alaunos observed the potential of mbIL-15 to establish long-lived tumor-specific TCR-T cells that have the potential to survive within the circulation and the tumor microenvironment.