On June 3, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate LB1908 in a Phase 1 clinical trial in the United States (Press release, Legend Biotech, JUN 3, 2022, View Source [SID1234615536]). LB1908 is an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy selectively targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with relapsed or refractory gastric, esophageal (including gastro-esophageal junction) or pancreatic cancers. Claudin18.2 is a tight junction protein commonly expressed in patients with these cancer subtypes.1

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The Phase 1, first-in-human, open-label, multicenter clinical study seeks to characterize the safety and tolerability of LB1908, as well as determine the recommended dose for Phase 2 and evaluate preliminary efficacy. Study will have dose escalation and dose expansion phases. Patients enrolled in the study must sufficiently express Claudin 18.2.

A Phase 1 investigator-initiated trial evaluating LB1908 for advanced gastric cancers is also ongoing in China (NCT04467853).

"Treatment options for patients with esophageal, stomach and pancreatic cancers have improved in the last ten years, but patients in the advanced stages still face poor prognoses worldwide. Thousands of people have no symptoms until their cancers have moved into late phases and at that point, surgery is no longer an option," said Lida Pacaud, M.D., Vice-President of Clinical Development. "Based on prevailing research, we are optimistic that a CAR-T therapy targeting Claudin 18.2 can be integrated in future treatment strategies for those with relapsed or refractory gastrointestinal cancers. We look forward to the start of the trial."

About Gastric, Esophageal and Pancreatic Cancers
Stomach, esophageal and pancreatic cancers affect the tissue or glands lining these organs. They are often diagnosed when the diseases have progressed to advanced stages. In the U.S., there are an estimated 123,920 people living with stomach cancer and 49,084 living with esophageal cancers.2,3 An estimated 89,248 people in the U.S. live with pancreatic cancer. While all three cancers are treatable, the five-year survival rate is just 32% for gastric cancer; 20% for esophageal cancer; and 11.5% for pancreatic cancer, with definitive treatment at all stages of progression.4,5,6

On June 3, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and Ochsner Health (Ochsner) reported a multi-faceted partnership to improve cancer detection rates in Louisiana using Galleri, GRAIL’s multi-cancer early detection (MCED) blood test (Press release, Grail, JUN 3, 2022, View Source [SID1234615535]). Ochsner, through a collaboration between its Ochsner Cancer Institute and Precision Medicine program, will offer the Galleri test by prescription to eligible patients in Louisiana to advance the delivery of cancer care.

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The partnership includes the launch of a MCED Health Equity Demonstration Program, an initiative to improve cancer detection rates for underserved populations in Louisiana and to develop a model for deployment of innovative technologies in community settings. In addition to deploying Galleri, the initiative includes identification of educational and access gaps and barriers to cancer screening, co-creation and development of patient education materials, and community outreach to improve awareness and education about early cancer detection. Utilization of GRAIL’s REFLECTION registry program and other Ochsner data will evaluate the impact of the three-year program, with results to be published following the program’s conclusion.

"Unfortunately, Louisiana has some of the nation’s highest cancer death rates, but we are making strides every year in identifying cancers early through screenings," said Brian Moore, MD, FACS, medical director, Ochsner Cancer Institute. "For those cancers that are historically not diagnosed quickly, offering Galleri to our patients will be revolutionary."

More than 600,000 people die from cancer each year in the U.S., including more than 9,600 in Louisiana, according to the American Cancer Society. This is in large part because some of the deadliest cancers are found too late when outcomes are often poorer. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and, in high-risk adults, lung. In fact, 71% of cancer deaths have no recommended early detection screening.

"This partnership with GRAIL reinforces and aligns with our Healthy State initiative, a 10-year commitment to improving the overall health of the state, which includes collaborations and continued investment in the health of our communities," said Warner Thomas, president and CEO, Ochsner Health. "Through this partnership, we have an opportunity to take a key step toward our goals by addressing an important health equity issue in Louisiana and supporting more than 7,500 underserved patients who visit our community centers."

In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 45 of which lack recommended screening tests today. GRAIL’s Galleri test has a false positive rate under 1% and it can predict where cancer originated with 89% accuracy.

"We are excited to join forces with Ochsner in this effort as both organizations have a shared vision for increasing early cancer detection and a focus on improving outcomes in underserved communities," said Bob Ragusa, chief executive officer at GRAIL. "By jointly launching a real-world evidence program to evaluate the impact of Galleri, we can not only help make a difference for underserved populations, but also collect critical insights that will help us develop a best-practice roadmap for integrating MCED testing that can be scaled and brought to other communities, helping to bridge the health equity gap in cancer detection."

Ochsner’s academics and research team will also begin enrolling participants aged 50 years and older who are not actively being evaluated or treated for cancer in the ongoing PATHFINDER 2 study. This is a prospective, multi-center interventional study of the Galleri test that aims to enroll 20,000 participants through healthcare systems in North America. Participants who have a "cancer signal detected" test result will undergo a targeted diagnostic evaluation based on predicted cancer signal origin(s) through the Ochsner Cancer Institute to determine if cancer is present.

On June 3, 2022 Medidata, a Dassault Systèmes company, reported that new research on predicting cytokine release syndrome (CRS) resulting from longitudinal CAR T-cell therapy (CAR T) at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7 in Chicago (Press release, Medidata, JUN 3, 2022, View Source [SID1234615534]).

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"CAR T therapy has been a significant innovation in cancer care – but as with any new and complex therapy, it has brought its own challenges and problems to solve. CRS – a life-threatening toxic immune reaction to CAR T therapy – has been seen in a meaningful number of patients and has led to at least 15 clinical trial failures for new therapies since 2016," said Jacob Aptekar, MD, vice president at Medidata. "Many known physiological markers that could indicate risk for severe CRS are difficult to measure but the study presented at ASCO (Free ASCO Whitepaper) is an important step in demonstrating how commonly collected laboratory tests – like a complete blood count (CBC) – can be used to assess CRS risk in a large number of patients across multiple clinical trials, indications, and CAR T products."

Titled "Predictors of severe CRS in longitudinal CAR T-cell clinical trial data," the study used the company’s Medidata Acorn AI platform to analyze 542 patients pooled from multiple clinical trials. These are significantly more patients than previous CRS studies, which have traditionally used a limited number of patients from a single clinical trial or clinical site. The Medidata study demonstrated notable differences in commonly measured biomarkers including platelet counts, serum albumin concentration, creatinine levels, and neutrophil counts between patients who experience severe CRS versus those who do not.

The Medidata study includes a conclusion that a Risk Evaluation and Mitigation Strategy for CRS may be warranted for CAR T therapy, both during clinical trials and in real-world use, using periodic monitoring of common lab markers to assess the risk level and enable early intervention when warranted.

"The trend across oncology is towards precision treatment and research. This Medidata study is a critical piece of that puzzle for CAR T therapy, empowering both researchers and health care providers to better understand the safety and efficacy of treatments in specific patients," said Michael Kattan, PhD, the Dr. Keyhan and Dr. Jafar Mobasseri Endowed Chair for Innovations in Cancer Research and chairman, Department of Quantitative Health Sciences at the Cleveland Clinic. "By understanding where the warning signs for CRS are, we can design safer trials, avoid and better understand trial failures, and get better and safer innovative treatments to more patients in more care settings."

Medidata Acorn AI leverages the company’s rich, regulatory grade clinical data, machine learning and AI capabilities, and pharmaceutical product development expertise to drive value for the life sciences community. Built upon the Medidata platform, comprising more than 28,000 trials and more than eight million patients and healthy volunteers across 140-plus countries, Acorn AI solutions feature the industry’s largest structured, standardized clinical trial data repository connected with real-world, translational, and other datasets.

To learn more about this study and about Medidata Acorn AI, please visit Medidata’s booth (#3037) or visit its show website.

Medidata is a wholly-owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

On June 3, 2022 Naveris, Inc. reported the presentation of an abstract related to its flagship diagnostic test for TTMV-HPV DNA (NavDx) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from June 3 through June 7, 2022 in Chicago and virtually (Press release, Naveris, JUN 3, 2022, View Source [SID1234615533]).

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Results of TTMV-HPV DNA testing in the NRG-HN002 phase II clinical trial for patients with p16-positive oropharynx cancer treated with intensity-modulated radiation therapy (IMRT), with or without cisplatin chemotherapy, will be shared in the presentation.

Details of the presentation are as follows:

Oral Presentation
Abstract: 6006
Title: Association of plasma tumor tissue modified viral HPV DNA (TTMV) with tumor burden, treatment type, and outcome: A translational analysis from NRG-HN002.
Presenter: Sue S. Yom, M.D., Ph.D., Professor and Vice Chair, Strategic Advisory, Department of Radiation Oncology; Professor, Otolaryngology-Head and Neck Surgery, Univ. of California San Francisco (UCSF)
Presentation Session Date/Time: The oral presentation will take place on Friday, June 3, 2022 from 3:45 – 6:45 p.m. EDT, during the session titled "Head and Neck Cancer"
Location: In-Person & Live Stream | S406

Following the presentation, the data presented will be available on the Naveris website at View Source

On June 3, 2022 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported that it will participate in the Jefferies Healthcare Conference taking place June 8-10, 2022 (Press release, Forma Therapeutics, JUN 3, 2022, View Source [SID1234615532]). Forma will present on June 9, 2022 at 2:00 p.m. Eastern Daylight Time (EDT).

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A webcast of the conference presentation will be available in the "News & Investors" section of Forma’s website at www.FormaTherapeutics.com.