On September 22, 2020 Humanigen, Inc., (Nasdaq: HGEN) ("Humanigen"), reported that management will present a company overview and business update at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 10:50 a.m. EDT, Wednesday, September 23, 2020 (Press release, Humanigen, SEP 22, 2020, View Source [SID1234565498]).

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The conference is being held in a virtual format. A live webcast of the presentation may be accessed at View Source Archived replay will be available on the Company website for 30 days following the event.

On September 22, 2020 CURE Media Group, the industry-leading multimedia platform devoted to cancer updates and research that reaches more than 1 million patients, reported the four winners of the inaugural 2020 Lung Cancer Heroes awards and the winner of the Lifetime Achievement award (Press release, CURE Media Group, SEP 22, 2020, View Source [SID1234565497]).

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"Each of these esteemed individuals has contributed to improving the lives of lung cancer patients," said Mike Hennessy Jr., president and CEO of MJH Life Sciences, parent company of CURE Media Group. "We are so grateful to work with supporters such as Takeda and our advocacy groups to bring together the lung cancer community and celebrate these remarkable heroes for their amazing efforts."

The inaugural recognition event, which will be held in a virtual format, will recognize the heroes who have gone above and beyond, making a difference in the lives of those affected by lung cancer. The Lifetime Achievement award, which honors those who over the long term have made a significant impact and inspiring contributions to a large number of individuals and organization in the lung cancer community, also will be presented.

The 2020 Lung Cancer Heroes winners are:

Carolyn Baggett, RN, is a lung cancer screening program coordinator at Baptist MD Anderson Cancer Center (BMDACC) in Jacksonville, Florida. Baggett started working at Baptist Medical Center in 2014 as an oncology nurse navigator caring for several stage 4 lung cancer patients and assisting their families. When lung cancer screening was recommended by the U.S. Preventive Services Task Force in 2013, Baggett was very motivated to develop a program to help find lung cancer at an early stage. In December 2015, the program launched and has grown substantially. As of July 2020, BMDACC has completed almost 10,000 screenings at 10 locations and found 129 lung cancers, of which almost 70% were early stage. For the last two years, Baggett has been an American Lung Association cabinet member, which has helped her to expand this work.
Jennifer L. Garst, M.D., is a thoracic medical oncologist and professor of medicine at Duke Cancer Center Raleigh in North Carolina. As a lung cancer specialist, Garst has provided extraordinary cancer care, and, as a tireless advocate for her patients, she has made significant and lasting contributions to the lung cancer advocacy community. She is the founder and current board chair of the Lung Cancer Initiative (LCI) of North Carolina and was the founding chair of LCI’s Scientific Advisory Committee. Garst has numerous publications, including 42 refereed journals, eight non-refereed, one book chapter and more than 30 published scientific reviews and selected abstracts. She has also received numerous awards, honors and recognitions throughout her career.
Fred R. Hirsch, M.D., Ph.D., is executive director of the Center for Thoracic Oncology in The Tisch Cancer Institute (TCI) at Mount Sinai and the Richard Stein, Joe Lowe and Louis Price Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York. As an internationally renowned authority on lung cancer treatment and research for more than 25 years, Hirsch has received several awards and honors, including the International Association for the Study of Lung Cancer (IASLC) Mary J. Matthews Award for Translational Research in Lung Cancer in 2007 and the Addario Foundation Lectureship Award in 2015. The IASLC also has established an annual Fred R. Hirsch Lectureship Award in Translational Lung Cancer Science. Hirsch’s research has helped identify and validate prognostic markers for lung cancer outcomes and biomarkers for personalized lung cancer therapies that illustrate how these therapies work and who is most likely to benefit from them.
Deborah Pickworth was diagnosed with stage 4 lung cancer in 2013 when she was 43 and has undergone several treatments and surgical procedures over the last seven years. In between and during treatments, Pickworth has been highly motivated to find better treatment options, better trial protocols and more patient support groups, and to raise money for additional lung cancer research. In 2014, she started Team Pickworth for the annual LUNG FORCE Walk in Detroit, and she has raised more than $17,300 over the past six years. Pickworth founded the Michigan Lung Cancer and BRAF Bombers groups on Facebook, and she is an Imerman Angels mentor. She also is a member of IASLC and the American Lung Association’s Patient Advisory Group.
The winner of the Lifetime Achievement award is Bonnie J. Addario, lung cancer survivor, cofounder and board chair of GO2 Foundation for Lung Cancer. As an activist, advocate and educator, Addario has empowered patients and given them a voice since she received a stage 3B lung cancer diagnosis more than a decade ago. Recognizing the need to provide hope through education, empowerment, advocacy and research for patients and families, Addario and her family founded the Bonnie J. Addario Lung Cancer Foundation (ALCF) in 2006. In 2019, ALCF and the Lung Cancer Alliance merged, forming the GO2 Foundation for Lung Cancer, dedicated to saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer. Addario acts as an adviser to industry leaders, clinicians and policy makers, and she is a member of the Personalized Medicine Coalition board.

In addition, Addario founded the Addario Lung Cancer Medical Institute (ALCMI) in 2008 as an international research consortium driving research otherwise not possible. Working with the GO2 Foundation, ALCMI powers collaborative initiatives in genetic (molecular) testing, therapeutic discoveries, targeted treatments and early detection of lung cancer.

"At Takeda, we remain committed to developing effective and personalized medicines for people diagnosed with non-small cell lung cancer." said Fatima Scipione, head of Takeda Oncology Patient Advocacy and Engagement. "We’re proud to be the sponsor of the Lung Cancer Heroes program, a collaborative effort with CURE and the patient advocacy community, to honor and recognize the incredible work being done in the lung cancer community to advance research and improve patient outcomes."

The 2020 Lung Cancer Heroes virtual celebration will take place Thursday, Oct. 15, 6-7:30 p.m. EDT, in conjunction with IASLC 2020 North America Conference on Lung Cancer, a worldwide virtual event taking place Oct. 16-17.

For more information on the winners and to register to attend, click here.

This event is supported and partner by Takeda and in partnership with The American Lung Association, GO2 Foundation for Lung Cancer, Lung Cancer Foundation of America, Lung Cancer Research Foundation, and LUNGevity.

On September 22, 2020 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported that the first patient has been dosed in a multicenter Phase 1 clinical trial of JSP191, a first-in-class humanized monoclonal antibody (Press release, Jasper Therapeutics, SEP 22, 2020, View Source [SID1234565496]). The trial is evaluating JSP191 as a conditioning agent in patients with two types of hematologic disorders – myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) – who are undergoing blood or hematopoietic cell transplantation.

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Hematopoietic cell transplantation offers the only potentially curative therapy for MDS and many forms of AML. However, standard-of-care conditioning regimens given prior to blood cell transplantation are highly toxic and associated with increased rates of relapse due to the persistence of disease-causing hematopoietic stem cells and insufficient graft versus leukemia effect.

"JSP191 is a very targeted therapy that causes the hematopoietic stem cells that occupy the bone marrow in MDS/AML patients to be depleted, leaving room for the transplanted stem cells to engraft," said Andrew Artz, M.D., M.S., co-principal investigator of the Phase 1 trial and Associate Clinical Professor, Department of Hematology & Hematopoietic Cell Transplantation; Director, Program for Aging and Blood Cancers; Deputy Director, Center for Cancer and Aging, City of Hope Comprehensive Cancer Center. "We look forward to further evaluating JSP191 to determine its potential as a biologic conditioning regimen."

The trial is currently open for enrollment at City of Hope Comprehensive Cancer Center and Stanford University; additional clinical trial sites in the United States will initiate enrollment in the coming weeks.

"As an anti-CD117 antibody, JSP191 is the first targeted antibody of its kind to be evaluated as a conditioning agent in patients with hematologic malignancies – an area of great unmet medical need," said Kevin N. Heller, M.D., Head of Research and Development at Jasper Therapeutics. "We have seen preclinical proof-of-concept with JSP191 as a single agent in MDS/AML, and this study may provide clinical proof-of-concept, which will support advancing the compound as an antibody-based alternative to chemotherapy- or radiation-based conditioning regimens to prepare patients for a stem cell transplant or gene therapy."

He added, "With the Phase 1 trial in hematologic disorders now underway, we are currently evaluating JSP191 in the second of a long line of indications we plan to seek. This is just the beginning, as we plan to conduct additional studies in pursuit of our goal of curing more patients with cancer and other life-threatening diseases."

About the Phase 1 Study Design

The open-label, multicenter Phase 1 study (JSP-CP-003) is designed to evaluate the safety, tolerability and efficacy of adding JSP191, an anti-CD117 monoclonal antibody, to the standard conditioning regimen of low-dose radiation and fludarabine (a chemotherapy agent) in adults with MDS or AML undergoing hematopoietic cell transplantation. Three different doses of JSP191 will be assessed for dose-limiting toxicities. The primary outcome measure is the safety and tolerability of JSP191 as a conditioning regimen up to one year following a donor cell transplant.

About MDS and AML

Myelodysplastic syndromes (MDS) are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.1 In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells.1 Both are diseases of the elderly with high mortality. Each year, about 5,000 patients with MDS and 8,000 people with AML in the G7 countries receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.

About JSP191

JSP191 (formerly AMG 191) is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow. JSP191 binds to human CD117, a receptor for stem cell factor (SCF) that is expressed on the surface of hematopoietic stem and progenitor cells. The interaction of SCF and CD117 is required for stem cells to survive. JSP191 blocks SCF from binding to CD117 and disrupts critical survival signals, causing the stem cells to undergo cell death and creating an empty space in the bone marrow for donor or gene-corrected transplanted stem cells to engraft.

Preclinical studies have shown that JSP191 as a single agent safely depletes normal and diseased hematopoietic stem cells, including in an animal model of myelodysplastic syndromes (MDS). This creates the space needed for transplanted normal donor or gene-corrected hematopoietic stem cells to successfully engraft in the host bone marrow. To date, JSP191 has been evaluated in more than 80 healthy volunteers and patients.

JSP191 is currently being evaluated as a sole conditioning agent in a Phase 1/2 dose-escalation and expansion trial to achieve donor stem cell engraftment in patients undergoing hematopoietic cell transplant for severe combined immunodeficiency (SCID), which is potentially curable only by this type of treatment. JSP191 is also being evaluated in a Phase 1 study in patients with MDS or acute myeloid leukemia (AML) who are receiving hematopoietic cell transplant. For more information about the design of these clinical trials, visit www.clinicaltrials.gov (NCT02963064 and NCT04429191). Additional studies are planned to advance JSP191 as a conditioning agent for patients with other rare and ultra-rare monogenic disorders and autoimmune diseases.

On September 22, 2020 Genosity, Inc., an innovative biotechnology company that provides comprehensive software and technical solutions to enable precision medicine reported that it has entered into a strategic collaboration with Personal Genome Diagnostics Inc. (PGDx), one of the leading companies in cancer genomics, that recently received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio tissue complete, a comprehensive diagnostic kit for genomic profiling of cancer (Press release, Genosity, SEP 22, 2020, View Source [SID1234565495]).

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Under the terms of this non-exclusive partnership agreement, PGDx and Genosity will collaborate to co-market their respective services and products. As part of the agreement, Genosity will incorporate the PGDx elio tissue complete assay into its software platform and professional consulting services. PGDx will co-market Genosity’s Integrated Genomic Toolkit (IGT) designed to support integration of next generation sequencing based testing into precision medicine programs across biopharmaceuticals, commercial laboratories, and health systems.

Genosity’s IGT SaaS solution is a HIPAA-compliant platform that supports end to end workflows for clinical next generation sequencing (NGS) along with EMR integration for return of results and data analytics. IGT is a modular platform built with independent but integrated applications, including Gateway, LIMS, Pipeline, Case Analyzer, and Cortex. Genosity will pre-configure the LIMS workflows for PGDx elio tissue complete assay to enable easier and faster implementation of wet-lab workflows with appropriate quality monitoring. In addition, Genosity will integrate its Case Analyzer application with PGDx’s bioinformatic pipeline to enable labs to integrate assay results into physician centric reports. Genosity’s Cortex organizes the genomic and clinical data in a knowledgebase to enable population-level analysis and cohort identification to support research collaborations.

"Genosity has established a novel software and technical approach that allows laboratories to more effectively implement genetic testing," said Dr. Marc D. Grodman, MD, co-founder and chief executive officer of Genosity."PGDx has gained approval for an important assay to help improve the outcomes of cancer patients. We see informatics as an essential component to allow greater adoption of genetic testing and we appreciate working with a partner like PGDx who is bringing best of breed testing to laboratories globally."

"PGDx elio tissue complete is a first of its kind FDA cleared kit to enable any molecular lab to perform comprehensive tumor profiling. Every lab is unique, but the importance of data integration is consistent in maximizing the value of NGS data in improving clinical care," said Megan Bailey, Chief Executive Officer of PGDx. "We’ve built the PGDx elio software to be flexible in meeting the integration needs of any lab. The addition of Genosity provides labs an option for a comprehensive solution, built from the ground up for the needs of molecular testing and NGS data."

On September 22, 2020 Promega Corporation reported its intent to develop the Promega OncoMate microsatellite instability (MSI) Assay as a companion diagnostic test for retifanlimab, Incyte’s anti-PD-1 drug candidate, in endometrial cancer (Press release, Promega, SEP 22, 2020, View Source [SID1234565494]). Financial terms of the global agreement with Incyte were not disclosed.

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Microsatellite instability-high (MSI-H) is a key feature of Lynch syndrome tumors, indicative of a germline mutation in mismatch repair genes, but can also arise sporadically. It occurs frequently in endometrial cancer. The importance of the MSI-H biomarker has been further emphasized since the 2015 finding that MSI-H tumors have a prolonged and durable response to PD-1 inhibitors.

"This announcement further underscores Promega’s dedication to advance the promise of MSI technology globally, building on over 20 years of expertise in this field," said Heather Tomlinson, Director of Clinical Diagnostics at Promega Corporation.

Promega and Incyte intend to work together in the future to develop the Promega OncoMate MSI Assay as a companion diagnostic in other markets.

The OncoMate MSI Assay received CE marking in Europe earlier this year. Promega MSI technology is one of the leading standard tests for MSI status detection in research laboratories and achieved innovation status and priority review by the National Medical Products Administration (NMPA) in China. It has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications. Promega intends to seek regulatory clearance for OncoMate MSI in the United States and China.

To learn more about Promega MSI testing, visit: www.promega.com/MSI