Immunocore Ltd.

Provider of Accessible Blood-Based Tests for Cancer Detection Highlights Results of Clinical Trial in Preeminent Peer-Reviewed Publication BALTIMORE and PALO ALTO, Calif., Oct. 21, 2024 /PRNewswire/ -- Today, DELFI Diagnostics, Inc., developer of accessible blood-based liquid biopsy tests that deliver a new way to enhance early cancer detection, is announcing the publication of a new paper, "Cancer treatment monitoring using cell-free DNA fragmentomes," in Nature Communications that demonstrates the effectiveness of cell-free DNA (cfDNA) fragmentomes as a means of assessing tumor burden for treatment response, monitoring, and clinical outcome prediction. cfDNA fragmentomes are tumor and mutation-independent, and the approach described in the paper (called DELFI-Tumor Fraction or "DELFI-TF") requires only 800ul of plasma. The company currently has an active pipeline of biotech and pharmaceutical companies using the DELFI-TF tumor uninformed assay for early efficacy data of developmental drugs tested in phase I and II clinical trials. In February of this year, DELFI announced a DELFI-TF RUO partnership with Immunocore. This study details the DELFI-TF development and its independent validation. "We have a vision of the future where cancer is routinely detected early, and patients have more options and better outcomes as a result. We are excited to share this important new application of our proprietary whole genome fragmentomics technology to monitor therapy response with a simple blood test at a breakthrough cost structure," said Susan Tousi, CEO of DELFI Diagnostics. DELFI's flagship product, FirstLook Lung, was commercialized last year and is a simple blood-based test that provides health systems and their clinical operations with a solution that can be offered to screen eligible patients during a routine visit. Lung cancer remains the biggest cancer killer and still accounts for 1 in 5 cancer-related deaths in the U.S. Moreover, 94% of eligible U.S. adults aren't currently being screened for lung cancer. Both FirstLook Lung and DELFI-TF provide decision-making support for providers whose mission is to detect, treat, and monitor patients at risk for lung cancer. The new paper further demonstrates the characteristics of DELFI-TF in two independent validation cohorts. "DELFI-TF is a locked machine learning classifier validated in two independent cohorts of colorectal and lung cancer patients and can detect clinical outcomes earlier than imaging. This work demonstrates the potential of DELFI-TF to estimate tumor burden for accurate treatment-response monitoring and clinical outcome prediction, " added Lorenzo Rinaldi, PhD and Head of Translational Science at DELFI. About DELFI Diagnostics DELFI Diagnostics is developing next-generation, blood-based tests that are accurate, accessible, and deliver a new way to help detect cancer. DELFI tests are built to solve the highest-burden population health issues, including in historically underserved demographics, and have the potential to save lives on a global scale. FirstLook Lung, for individuals eligible for lung cancer screening, is our first laboratory-developed screening test and requires a simple blood draw that can be incorporated with routine blood work. The test is based on fragmentomics, the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments in the blood. The DELFI platform applies advanced machine-learning technology to whole-genome sequencing data to assess individuals' cfDNA fragments against populations with and without cancer. FirstLook Lung uses these millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early-stage disease, with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. To learn more about the FirstLook Lung test, visit or . SOURCE DELFI Diagnostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immatics said its PRAME-targeted T cell therapy shrank tumors by at least 30% in just over half of melanoma patients in an early-stage trial, and the company plans to start a pivotal study by the end of this year. In 26 melanoma patients enrolled in Immatics’ Phase 1b study, 14 had a confirmed response to its T cell receptor-based therapy — seven of those responses are ongoing. The median progression-free survival was six months, while the median overall survival was not reached, Immatics reported on Thursday. In a statement, Immatics CMO Cedrik Britten said the results and a meeting with the FDA “[position] us to advance the development of IMA203 in the second-line or later metastatic melanoma setting.” Immatics also announced that it is seeking $150 million via a stock sale. The company’s shares $IMTX were down 11% on Thursday. Immatics is developing IMA203 for patients with a cell marker called HLA-A*02. (HLA types are often used in transplants to determine a match between donor and recipient.) Immatics takes a patients’ own cells and engineers the cell therapy to express T cell receptors against PRAME, which is highly expressed in melanomas. Patients were given lymphodepleting chemotherapy and low-dose IL-2 along with the TCR cell therapy. On safety, there were eight cases of grade 3 or higher cytokine release syndrome and three grade 3 or higher ICANS — two serious conditions associated with immunotherapies. Immatics said that it is planning to start a Phase 3 study called SUPRAME in December to test IMA203 in second-line or later melanoma patients whose cancers have metastasized or can’t be removed by surgery. Earlier this year, Iovance won approva l for its tumor-infiltrating lymphocyte-based cell therapy in advanced melanoma, which it markets as Amtagvi. Immatics, as well as Immunocore, are also developing bispecific antibodies targeted at PRAME.

In Barcelona, at the European Society of Medical Oncology (ESMO) Congress, researchers from Harvard presented a company-by-company analysis of the clinical value of their recent cancer approvals based on the ESMO-Magnitude of Clinical Benefit Scale. The standout companies were Astellas, AstraZeneca, Daiichi Sankyo, Gilead and Novartis. Two of the simplest ways to measure the success of companies that develop and commercialize drugs is to count their approvals and sales.But a group of Harvard researchers has found another way to measure the impact individual drugmakers have had in bringing oncology treatments to the market—by assessing the clinical value of their new approvals.Using a scoring system established a decade ago by the European Society of Medical Oncology (ESMO) to identify which approvals provide the highest clinical benefit, the researchers sorted the results by company. The scoring system is called the ESMO-Magnitude of Clinical Benefit Scale (MCBS).Drugmakers at the top of the list were Astellas, AstraZeneca, Daiichi Sankyo, Gilead Sciences and Novartis. The five companies accounted for 71% of the high-benefit approvals over the past four years.“I was surprised how concentrated it was. Five companies essentially counted for three-quarters of those high-benefit approvals and a lot of companies had no indications with high benefit,” Thomas Hwang, M.D., the founder of the Cancer Innovation and Regulation Initiative at the Dana-Farber Cancer Institute in Boston and a member of the ESMO-MCBS Extended Working Group, said in an interview.Hwang recognizes the limitations of the analysis given its small sample size. For the purposes of the study, researchers tallied the high-benefit approvals gained by each company since 2020 from the European Medicines Agency (EMA). Additionally, since the ESMO scoring system applies only to solid tumor cancer approvals, there are many approved oncology treatments that are not included in the analysis.To help round out the analysis, Hwang said the working group expects future research to include hematologic cancers and drugs approved by the FDA that are not yet endorsed in Europe.Two major drugmakers at the bottom of the list—with no high-benefit solid tumor approvals over the span—were Roche and Eli Lilly. Also scoring poorly, with less than half of their approvals graded as high benefit, were Johnson & Johnson, Bristol Myers Squibb, Takeda and Amgen.“These are companies that have large cancer R&D budgets.” Hwang said. “A lot of companies show up at ESMO with tons of presentations but some of those are for products that are pretty marginal at best.”The results were presented Friday morning at the ESMO Congress in Barcelona. Perhaps the most significant revelation in the analysis was that only one-third of the solid tumor cancer new drug approvals issued during the time frame cleared the high-benefit bar. For already approved drugs adding indications, 40% of the nods made the grade.Novartis led the way with new approvals for three high-benefit drugs—Tevimbra for esophageal squamous cell carcinoma, Piqray for breast cancer and Tabrecta for lung cancer. AstraZeneca had a pair of new drugs that made the grade—Imjudo for liver and lung cancer and Truqap for breast cancer.Daiichi Sankyo had the best batting average as all four of its EMA approvals for powerhouse combination treatment Enhertu were categorized as high benefit. Among other approvals tabbed as practice-changing were Astellas’ Padcev as the new standard of care for the first-line treatment of metastatic urothelial carcinoma. Another was Gilead’s Trodelvy as the top treatment option for unresectable or metastatic triple-negative HR+/HER2 breast cancer.Other approvals that made the grade were GSK’s Jemperli (endometrial), Bayer’s Nubeqa (prostate). Seagen’s Tukysa (breast/colorectal) and Immunocore’s Kimmtrak (melanoma).“Hopefully, this scoring system, which is public and reproducible, allows stakeholders to re-cast what we think of as beneficial and important to patients,” Hwang said. “Our analysis shows that a small number of pharmaceutical companies are responsible for most clinically valuable innovations in cancer in recent years. Better understanding and ultimately scaling the drivers for their success could transform the cancer R&D pipeline.”