On September 6, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company, reported early clinical findings from its ongoing TCR-T Library Phase 1/2 trial (Press release, Alaunos Therapeutics, SEP 6, 2022, View Source [SID1234619073]).

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"We are excited to announce early findings from our TCR-T Library trial. This is the first time that an objective clinical response has been observed in a solid tumor cancer in connection with non-viral TCR-T cell therapy," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We believe this reinforces our approach targeting shared tumor-specific hotspot mutations using our non-viral Sleeping Beauty technology. We look forward to presenting additional details at the CICON conference on September 30."

The TCR-T Library Phase 1/2 trial is an open label, dose escalation study being conducted at The University of Texas MD Anderson Cancer Center. The trial is enrolling patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers that have a matching human leukocyte antigen (HLA) and hotspot mutation pairing in Alaunos’ TCR library. The first patient dosed was diagnosed with non-small cell lung cancer with a KRAS G12D mutation, matching one of the ten TCRs within the Company’s TCR library. The patient received TCR-T cells, which were produced using Sleeping Beauty at the Company’s in house cGMP manufacturing facility. The patient had a confirmed objective partial response. The Company has dosed a second patient in the study, diagnosed with colon cancer, who has been treated at the second dose level and has cleared the 28-day safety window.

"While cell therapies have demonstrated success in hematological cancers, there remains a significant unmet medical need for effective and cost-efficient cell therapies for patients with solid tumors, which account for nearly 90% of all cancer diagnoses. These early clinical findings show the potential for the first time that we may be able to use a non-viral TCR-T cell therapy to achieve measurable regression in solid tumors," added Marcelo V. Negrao, MD, Department of Thoracic-Head & Neck Medical Oncology, Division of Cancer Medicine at MD Anderson. "We are encouraged by these findings, and we look forward to continuing enrollment in the study."

Data is scheduled to be presented during a proffered talk at CICON, which is being held in New York, NY from September 28 – October 1, 2022.

On September 6, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that new data from its portfolio of blood tests will be presented at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, September 9-13 in Paris, France (Press release, Guardant Health, SEP 6, 2022, View Source [SID1234619091]). Among the seven abstracts are an oral presentation and posters highlighting the use of Guardant Health’s blood tests and real-world evidence dataset to advance cancer therapy trials, predict and monitor patient response to therapy, and identify genomic mechanisms of acquired resistance to cancer therapy.

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"We look forward to sharing new data at ESMO (Free ESMO Whitepaper) demonstrating the utility of our blood tests to increase the understanding of potential new biomarker targets and the mechanisms of therapy resistance in patients with cancer," said Helmy Eltoukhy, Guardant Health co-CEO. "The data from retrospective and real-world analyses show how comprehensive genomic profiling tests provide critical insights at every step of a patient’s treatment journey, and ultimately contribute to the development of more effective therapies and improved patient outcomes."

Full List of Guardant Health Presentations

GuardantOMNI

Genomic mechanisms of acquired resistance of patients (pts) with BRAF V600E mutant (mt) metastatic colorectal cancer (mCRC) treated in the BEACON study (Oral Presentation 316O)
Interim biomarker analysis of a phase 1b/2 study of anti-TIGIT etigilimab (MPH313) and nivolumab in subjects with select locally advanced or metastatic solid tumors (ACTIVATE) (Presentation 111P)
Clinical potential of circulating tumor DNA (ctDNA)–based molecular response (MR) and baseline blood-based tumor mutational burden (bTMB) for monitoring response to first-line (1L) chemoimmunotherapy in advanced squamous non-small cell lung cancer (sqNSCLC) (Presentation 1092P)
Early decreases in KRAS mutant allele frequency (MAF) predicts clinical benefit to the PLK1 inhibitor onvansertib in combination with FOLFIRI/bev in 2L treatment of metastatic colorectal carcinoma (mCRC) (Presentation 397P)
The PLK1 inhibitor onvansertib overcomes irinotecan resistance in RAS-mutated (mRAS) metastatic colorectal cancer (mCRC) in vivo and in patients (pts) (Presentation 366P)
Guardant360

Resistance mechanisms to lorlatinib or crizotinib in treatment-naive patients (pts) with ALK+ advanced non-small cell lung cancer (NSCLC) (Presentation 1008P)
GuardantINFORM

Real-world outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and tumors with androgen receptor (AR) 878/875 mutations (Presentation 1407P)
The full abstracts are available on the official ESMO (Free ESMO Whitepaper) 2022 website.

On September 6, 2022 Milestone Pharmaceuticals Inc. ( Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported that Joseph Oliveto, President and Chief Executive Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12, 2022 at 12:00 p.m. ET in New York, NY (Press release, Milestone Pharmaceuticals, SEP 6, 2022, https://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-the-hc-wainwright-24th-annual-global-investment-conference-301617233.html [SID1234619109]).

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A live webcast of the presentation can be accessed in the News & Events section of Milestone’s website at www.milestonepharma.com. An archived replay of the presentation will be available on the same website for approximately 90 days following the presentation.

On September 6, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will host a virtual R&D Day, "Innovations in Oncology: The Science of Trilaciclib", on Thursday, September 15, 2022, from 9:00 a.m. to 11:00 a.m. ET (Press release, G1 Therapeutics, SEP 6, 2022, View Source [SID1234619019]).

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G1 will review the development and expansion strategy for trilaciclib, its innovative investigational therapy to improve the lives and outcomes of people living with cancer. The Company will also present new preclinical data supporting potential of trilaciclib to work synergistically with other anti-cancer therapies. Trilaciclib is currently in clinical trials assessing its myeloprotective and anti-tumor immunomodulatory effects in a range of tumor types and in combination with a variety of treatments, including ADCs and checkpoint inhibitors.

Additionally, the program will feature insights from leading clinicians on the differentiated and broadly applicable immune-based mechanism of action of trilaciclib; the importance of transient CDK4/6 inhibition; and the urgent need to improve treatment options for patients with colorectal cancer:

Shom Goel, B Med Sci, MBBS, FRACP, PhD, Peter MacCallum Cancer Centre, The University of Melbourne
Richard Goldberg, MD, Professor Emeritus and former Director, West Virginia University Cancer Institute (WVUCI)
A webcast of the event can be accessed on the Events & Presentations page of www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On September 6, 2022 Freenome, a privately held biotech company, reported the launch of the Sanderson Study, the company’s latest study of its multiomics platform, in combination with real-world data to detect multiple cancers (Press release, Freenome, SEP 6, 2022, View Source [SID1234619039]).

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The study will encompass both traditional and real-world data to generate evidence of clinical validation for certain high- and elevated-risk populations while also refining the platform’s cancer classification and risk prediction models. In addition, the Sanderson Study will build the necessary infrastructure to bridge the gap between clinical research and day-to-day clinical impact.

Freenome is developing a tailored multi-cancer screening approach that assesses a patient’s individual risk and identifies cancer signals to provide patients with a clear path forward. Freenome uses a multiomics platform, combining tumor and non-tumor signals with machine learning to detect cancer in its earliest stages using a standard blood draw.

The Sanderson Study will enroll approximately 8,000 patients through Freenome’s clinical study partner network and numerous regional health systems across the United States. The study will focus on those cancers with significant unmet needs such as pancreatic and lung cancer.

"We’re incorporating real-world data with a precision health mindset on clinical actionability," said Lance Baldo, M.D., chief medical officer at Freenome. "Our goal is to identify the right patient for the right screening tests at the right time, with clear next steps. We believe this approach will ultimately save more lives."

Key collaborators include Oracle Cerner and its Learning Health Network (LHN), a group founded in 2020 of more than 90 diverse health systems across the U.S. that are working together to advance research and increase equitable access to clinical trials by contributing de-identified data to the LHN. In addition, Elligo Health Research will collaborate with LHN members using existing health data to identify and enroll patients significantly faster than traditional recruitment models.

Trial participation will help LHN members bring innovative cancer prevention testing to the communities they serve.

"Early cancer detection with more convenient screening will expand available treatments with better outcomes for patients," said Christy Dueck, vice president of Cerner Enviza, an Oracle company. "Oracle Cerner is thrilled to be working with Freenome to help expedite the study process, from hospital and health system readiness to patient participation and identification. The Learning Health Network acts as an accelerant by addressing the current challenge of the scarcity in sites in the traditional clinical-trial model by creating an abundance of patients who are already actively engaged in healthcare."

"Achieving earlier detection of cancer is critical to improving health outcomes and we’re honored to bring this groundbreaking research to our community," said Ruth Colby, president and chief executive officer of Silver Cross Hospital, a Learning Health Network member in the Chicago area. "This opportunity enables us to expand clinical research opportunities for patients and further our mission to care for members of our community."

Freenome’s clinical studies are named for employees’ loved ones who battled cancer. This study honors Tim Sanderson, the father of a Freenome engineer.