On September 8, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported final results from the interventional PATHFINDER study will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris (Press release, Grail, SEP 8, 2022, View Source [SID1234619286]). PATHFINDER data evaluating the Galleri multi-cancer early detection (MCED) blood test will be shared in a September 11 proffered paper session. Participant-reported outcomes will also be presented, including satisfaction related to MCED testing, ongoing adherence with standard of care screening, and information related to participants’ anxiety and distress. Interim results from the PATHFINDER study were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The PATHFINDER single-arm interventional study was designed to evaluate the clinical care pathways following a "cancer signal detected" Galleri test result, measure the time required to achieve diagnostic resolution (primary endpoint), and assess the implementation and performance of Galleri in a clinical care setting.

"Despite 50 years of waging a war on cancer, cancer is poised to become the world’s number one killer, in large part because most cancers are diagnosed too late. While current screening tests are saving lives, they are not enough, and the status quo in cancer screening is simply unacceptable. In the United States, we routinely screen for only five cancers yet most cancer deaths occur from cancers we are not looking for. Our current approach using decades old technology with suboptimal adherence is simply not finding enough cancer in the population. We must transition from only looking for individual cancers to also looking at individuals for many cancers," said Josh Ofman, MD, MSHS, president at GRAIL. "We are excited to share the final PATHFINDER results, which provide important insights about the feasibility of our first-of-its-kind MCED technology, the clinical care pathways following a "cancer signal detected" result, and Galleri’s potential to detect more cancers in their earlier stages as a complement to standard screenings."

The PATHFINDER study enrolled 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer, but with no suspicion of active cancer. Participants were enrolled across 11 sites, including the Cleveland Clinic, Dana-Farber Cancer Institute, Mayo Clinic, Oregon Health & Science University, Sutter Health and the US Oncology Network. Results will be presented from both an earlier version of Galleri (MCED-E) and a pre-specified retrospective analysis evaluating the current version of the Galleri test (MCED-Scr) using banked blood samples.

Selected GRAIL presentations at ESMO (Free ESMO Whitepaper) include:

A Prospective Study of a Multi-Cancer Early Detection Blood Test (Presentation #903O)

Session Type: Proffered Paper Session
Date/Time: Sunday, Sept. 11, 16:30 – 16:40 p.m. CEST (10:30 – 10:40 a.m. EST)
Location: 7.3.O – Orleans Auditorium
Speaker: Deborah Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK)

Evaluation of Anxiety, Distress and Satisfaction With a Multi-Cancer Early Detection Test (Presentation #908P)

Session Type: e-Poster
Date/Time: Sunday, Sept. 11
Speaker: Deborah Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK)

Time to Diagnosis Among Patients with Cancer in the US (Presentation #1318MO)

Session Type: Mini Oral Session
Date/Time: Monday, Sept. 12, 17:10 – 17:15 CEST (11:10 – 11:15 a.m. EST)
Location: 7.3.M – Marseille Auditorium
Speaker: Matthew Gitlin, PharmD, BluePath Solutions

Abstracts are available on the ESMO (Free ESMO Whitepaper) Congress 2022 website. Additional data from the PATHFINDER study will be presented at the Congress.

About GRAIL’s MCED Clinical Development Program

The Galleri clinical development program consists of studies that collectively include more than 335,000 participants – and what is believed to be the largest linked datasets of genomic and clinical data in the cancer field. GRAIL’s program includes the foundational CCGA development and validation study, the interventional PATHFINDER and PATHFINDER 2 studies, the NHS-Galleri randomized, controlled clinical study, the STRIVE and SUMMIT observational studies, and the REFLECTION real-world registry. The largest of these, the NHS-Galleri trial, has enrolled 140,000 participants with the primary objective of a reduction in late-stage cancer diagnoses, thought to be a necessary prerequisite for a mortality reduction.

On September 8, 2022 InnoCare Pharma (HKEX: 09969) reported that the first patient was dosed in the phase II registrational trial (Registry number: CTR20221519) of tafasitamab in combination with lenalidomide for adult patients in China who have relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and are not eligible for autologous stem cell transplantation (ASCT) (Press release, InnoCare Pharma, SEP 8, 2022, View Source [SID1234619285]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "DLBCL is the most common type of non-Hodgkin lymphoma1. We will accelerate the clinical development of registrational trial of tafasitamab in combination with lenalidomide to help address the unmet needs of eligible DLBCL patients in China."

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, is not approved by the NMPA for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filed in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for ASCT.

About Tafasitamab
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.

In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

XmAb is a registered trademark of Xencor, Inc.

On September 8, 2022 Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, and Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, reported a collaboration to accelerate the discovery of novel biomarkers and drug targets using the latest spatial imaging and machine learning technologies (Press release, Lunaphore Technologies, SEP 8, 2022, View Source [SID1234619284]).

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"We are thrilled to announce the partnership with Lunaphore and combine Lunaphore’s best-in-class flagship COMET, a hyperplex staining and imaging platform, with Nucleai’s ATOM platform that uniquely supports multiplex, IHC, and H&E data," said Avi Veidman, Chief Executive Officer of Nucleai. "This strategic partnership will allow us to utilize multiplex technology and provide a complete, actionable, and scalable solution to improve drug target discovery and development of our pharma and biotech partners."

Mapping biological microenvironments with spatial mapping technology is an exciting area of discovery. Lunaphore’s novel COMET technology unlocks the power of immunofluorescence spatial biology with a robust and user-friendly system, permitting the use of any non-conjugated antibodies and enabling the wide adoption of spatial biology in laboratories. Nucleai has built a platform that makes spatial analysis scalable and operational, enabling the next generation of actionable insights from massive pathology data sets that have not been analyzed to their fullest potential and could provide significant value to pharmaceutical companies and diagnostic labs.

The partnership will utilize Lunaphore’s innovative COMET platform for hyperplex staining and imaging with Nucleai’s cutting-edge AI spatial models to derive new insights from tissue biopsies, including novel drug targets, mechanisms of action, and biomarkers to advance the field of precision medicine. The combined solutions will provide laboratories with an integrated end-to-end spatial biology workflow from automated, hyperplex sequential immunofluorescence staining and imaging to AI-enabled, state-of-the-art image processing, and data analytics. As part of the partnership, the companies also plan to develop predictive and prognostic spatial biomarker assays.

"Our partnership with Nucleai is based on our shared vision to advance next-generation spatial multiplex immunofluorescence imaging to accelerate drug and biomarker discovery and development," said Déborah Heintze, Chief Marketing Officer of Lunaphore. "Connecting Nucleai’s solution with COMET, we have the potential to more precisely characterize the immune system and disease microenvironment to provide deeper biological insights to drug developers."

"Nucleai brings innovative spatial biology and machine learning platform (ATOM) to empower researchers with novel insights into drug discovery," said Mridula Iyer, Ph.D., Vice President of Strategic Partnerships at Nucleai. "The technology is designed to unlock and analyze valuable data from pathology slides previously inaccessible, leading to the development of new precise targeted therapy that is important for patient outcomes. This collaboration is another example of how both Lunaphore and Nucleai are accelerating efforts to partner with pharmaceutical and biopharmaceutical companies, as well as medical research institutions and other biomedical organizations."

About COMET

COMET is a fully automated sequential immunofluorescence (seqIF) instrument, able to perform hyperplex staining and imaging, producing high-quality data in a robust and reproducible manner. With superior tissue profiling capabilities, the system allows multiplex analysis of up to 40 different spatial markers per tissue slide without human intervention. COMET has a wide range of research applications, allowing for a dramatic improvement in the understanding of disease pathology in areas such as immuno-oncology, neuroscience, and infectious diseases. The technology has the ability to revolutionize clinical applications such as drug discovery and biomarker development. To learn more about the COMET platform, please visit: View Source

On September 8, 2022 The Board of Directors of Sanford Burnham Prebys reported the appointment of David Brenner, M.D., as the Institute’s next president and chief executive officer (Press release, Sanford Burnham Prebys Medical Discovery Institute, SEP 8, 2022, View Source [SID1234619283]). Brenner joins Sanford Burnham Prebys following more than 15 years as vice chancellor for Health Sciences at UC San Diego. He will assume his new role effective September 14.

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"Our Board is thrilled to introduce a leader of David’s caliber," says James C. Blair, chairman of Sanford Burnham Prebys’ Board of Trustees. "David is a highly respected physician-scientist with tremendous administrative and fundraising experience. He is the ideal candidate to grow the Institute into an even greater, more successful scientific enterprise dedicated to research that can improve human health."

At UC San Diego, Brenner guided the nearly $2 billion expansion of health sciences that included the opening of the Jacobs Medical Center and the Altman Clinical and Translational Research Institute, where scientists try to speed research discoveries into new drugs and therapies. He also led the development of the Herbert Wertheim School of Public Health and Human Longevity Science, centered on justice, equity, diversity and inclusion in its approach to public health research, education and service.

"I could not be more grateful to accept the position of president/CEO at this world-class biomedical research institute," says Brenner. "My roots are in biomedical research, and it’s an honor to be selected to lead Sanford Burnham Prebys’ extremely talented, innovative researchers."

Brenner is a leader in the field of liver research and is widely respected for his work advancing laboratory discoveries to the clinic setting. At Sanford Burnham Prebys, he will continue his research on fibrotic liver disease and liver cancer, using this as the foundation for preventing and treating liver disease. Brenner is a former editor-in-chief of Gastroenterology, the premier journal in the field.

"I’ve known about Sanford Burnham Prebys for many years—it has so much to offer. The culture of encouraging scientists to pursue opportunities and collaborating with institutions in San Diego and beyond leads to breakthrough research and makes it possible to achieve incredible goals," adds Brenner.

Brenner has been instrumental in starting several multidisciplinary efforts in San Diego, including the Institute for Engineering in Medicine, the Institute for Genomic Medicine, the Sanford Consortium for Regenerative Medicine, the UC San Diego Sanford Clinical Stem Cell Program, and the C3 Cancer Center Consortium (comprising UC San Diego, the Salk Institute for Biological Studies and Sanford Burnham Prebys).

Brenner earned his M.D. from the Yale University School of Medicine. He was chief of Gastroenterology at the University of North Carolina and Chair of Medicine at Columbia University, before joining UC San Diego in 2007. His professional memberships include the National Academy of Medicine, the American Society for Clinical Investigation, the Association of American Physicians (of which he is a past president), and an NIH National Council. At UC San Diego, he led the unprecedented expansion of the medical school. He has also served as a Pew Scholar and as a Clinical Investigator in the Veteran Affairs system.

Brenner succeeds Kristiina Vuori, M.D., Ph.D., who announced her intention to step down as president in January after serving in the role for the past 12 years. Vuori will continue as professor at the Sanford Burnham Prebys NCI-designated Cancer Center. Brenner is assuming the role of CEO from C. Randal Mills, Ph.D., who left the Institute earlier this year.

On September 8, 2022 TumorGen Inc., and PhenoVista Biosciences LLC reported that they have successfully isolated and characterized metastatic cancer cell clusters (MCCCs) from the blood of lung cancer patients’, validating TumorGen’s novel MCCC capture technology (Press release, TumorGen, SEP 8, 2022, View Source [SID1234619282]). This achievement is a critical milestone in developing anti-metastatic drugs, called "cluster busters," which will target these cells and prevent cancer metastasis.

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"Anti-metastatic therapies that can stop tumors from forming in other organs is a tremendous unmet medical need," said TumorGen Founder / President, Jeffrey K. Allen, Ph.D. "Our platform can identify where MCCCs are vulnerable so researchers can develop drugs targeting these deadly clusters. TumorGen will partner with oncology drug development companies to bring these new therapies to the clinic."

Metastasis causes around 90% of cancer deaths. While scientists have long known that MCCCs drive metastasis, no one has efficiently collected them from patient blood. This study, supported by the National Cancer Institute shows that MCCCs can be readily captured, allowing for genomic and other analyses to identify their vulnerabilities and enable new therapies.

"Utilizing our high-content imaging expertise in conjunction with TumorGen’s platform, we consistently detected a number of metastatic clusters from several lung cancer patients," said James Evans, Ph.D., CEO of PhenoVista Biosciences. "These MCCCs from cancer patients contain both cancer and non-cancer cells. We are excited to enable cancer researchers to work with these rare and, up to now, inaccessible patient samples."

On a research and discovery level, the ability to characterize MCCCs from circulating blood will help illuminate how human cells form distant metastases. The technology showed tremendous sensitivity and specificity, surpassing previous efforts to collect and characterize MCCCs. These developments offer new hope for newly diagnosed cancer patients.

"Working with and treating cancer patients every day, I always encounter the need for new drugs that can benefit my patients," said Sandip Patel, M.D., Associate Professor and Co-Leader of Experimental Therapeutics at UCSD Moores Cancer Center. "Soon, I hope to see treatment plans that focus on both the primary tumor and the prevention of distant metastases. We need this comprehensive approach to significantly improve patient outcomes."