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 BioCanRx, Canada’s Immunotherapy Network, reported funding of $10M for 14 cancer immunotherapy research projectsand eight core and biomanufacturing facilities (Press release, BioCanRx, SEP 22, 2020, View Source [SID1234565514]). In addition to BioCanRx’s investment, matching partner contributions of $16.5M increase the total investment in Canadian translational cancer immunotherapy research and manufacturing facilities to $26.5M.

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Cancer is one of the biggest health challenges facing Canadians. Nearly 1 in 2 Canadians is expected to develop cancer in their lifetime. BioCanRx is working to turn the tide and improve outcomes for patients by accelerating the development of promising immunotherapy treatments which could be more effective, affordable and safe than conventional cancer therapies.

"We’re collaborating and building teams across Canada to find new ways for the body’s immune system to outsmart and kill cancer. This new funding is helping to bridge the research gap between lab discoveries and clinical trials to ultimately benefit patients," said Dr. John Bell, BioCanRx’s Scientific Director and a senior cancer research scientist at The Ottawa Hospital and the University of Ottawa.

BioCanRx’s investments in the development of novel therapies continue to be guided and benchmarked by its Research Management Committee composed of internationally renowned academics and industry leaders in the field of cancer immunotherapy. The focus of the newly funded projects includes highly innovative and novel approaches to cancer treatment, targeting difficult to treat cancers where current options are limited. The project investment portfolio includes cross-disciplinary teams from across the country working on new, rational combination approaches and unique cell, vaccine/virus-based and antibody immunotherapies.Investments in Canada’s biomanufacturing capacity also feature prominently and additional sites across the country will be added to our point-of-care cell manufacturing network to enhance access to life-saving therapies to patients across the country.

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 Lantern Pharma, a clinical-stage biopharma company using its proprietary RADR AI platform to improve drug discovery & development and identify patients who will benefit from its targeted oncology therapeutics, reported that it has announced a collaboration and research agreement with Fox Chase Cancer Center for the further development of Lantern’s LP-184 in pancreatic cancer (Press release, Lantern Pharma, SEP 22, 2020, View Source [SID1234565612]). Based in Philadelphia, Fox Chase is a research center for pancreatic cancers and one of the four original cancer centers to receive comprehensive cancer center designation from the National Cancer Institute (NCI).

The Fox Chase collaboration will focus on advancing the targeted use of LP-184 in molecularly-defined sub-types of pancreatic cancer. The goal of the collaboration is to create a more biologically relevant and robust gene signature in preparation for future clinical trials, enabling pancreatic cancer patients to potentially benefit from a more effective and personalized cancer therapy.

"Collaborations with world-leading cancer centers are an essential part of our strategy to rapidly advance the insights driving our therapeutic programs and grow our RADR A.I. platform by adding millions of new, unique, and proprietary data points," said Panna Sharma, CEO of Lantern Pharma. "This relationship with Fox Chase will allow us to use state-of-the-art models and biological methods to add more physiologically relevant data and insights into the mechanisms of LP-184, and will further shape our algorithms for how certain compounds interact with specific tumor types. The unique insights we gain will equip Lantern with critical advantages in our aim of accelerating LP-184’s path to clinical trials and ultimately commercialization, while saving millions of dollars in development costs. This data-enabled, and biomarker-based approach has the potential to meaningfully bend the cost curve of cancer drug development and help bring personalized cancer therapies to patients with reduced economic burden, and greater efficacy."

The research will be led by Igor Astsaturov, MD, Ph.D., a researcher in gastrointestinal cancers at the Molecular Therapeutics Program at Fox Chase where he specializes in investigating signaling pathways that inform the choice of biomarkers and innovative therapy combinations in clinical trials.

LP-184 is a DNA-damaging small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors, including pancreatic cancer. As a next-generation alkylating agent that preferentially damages DNA in cancer cells that overexpress certain biomarkers, LP-184 has the potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs.

"We are very pleased to partner with Lantern Pharma in establishing a collaboration that will play an important role in our research," said Astsaturov. "Our advanced research approach using patient-derived cancer models will provide us with critical insights into the efficacy of LP-184 in pancreatic cancers. We look forward to sharing these results with the broader scientific community and hopefully bringing this drug to cancer patients that can best benefit from this compound."

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Research Goals

The research program is at the forefront of translational cancer medicine and will use patient-derived cancers that are grown in the lab and transformed into physiologically relevant 3D organoids and PDx models. This innovative approach allows researchers to more precisely understand the biology of what actually happens inside the cancer tumor, which will more accurately establish the precise biomarker signatures and help provide data-driven insight into additional mechanisms that can be leveraged in the fight against pancreatic cancer.

Among several objectives, the research will determine whether the overexpression of the gene PTGR1, a biomarker that has been linked to cancer cell proliferation, will indicate heightened sensitivity to LP-184 and a more favorable response rate and efficacy as compared to standard of care agents. LP-184 has been advanced using Lantern’s proprietary RADR A.I. platform that leverages over 500 million data points, machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action, and genomic and biomarker signatures that correlate to drug response in cancer patients.

Although significant recent advances have been made in the use of targeted and biomarker-based therapies in cancer, pancreatic cancer remains an area that has not experienced significant improvement in patient outcomes. The overall five-year survival rate for pancreatic cancer across all stages remains at only 10.0% in the US and 8.2% globally, and pancreatic cancer is expected to become the 2nd leading cause of cancer death in the USA in 2020 behind lung cancer according to the National Cancer Institute’s SEER Stat Database.

On September 22, 2020 AQILION AB reported that TAK1 as the target of the internal drug discovery program Alnitak and will present data from the discovery phase at the international partnering event BIO-Europe 2020 Digital in October (Press release, Aqilion, SEP 22, 2020, View Source [SID1234565462]). Alnitak was initiated as an internal program last year with focus on chronic inflammation and autoimmune diseases in addition to genetically driven cancers.

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The internally generated Alnitak program is aimed at discovering and developing small molecule inhibitors of TAK1. The target TAK1 has been shown to act as a master regulator of inflammatory signaling. The Aqilion team, consisting of experienced former AstraZeneca R&D management team members and scientists, has identified TAK1 as a highly promising drug target. A TAK1 inhibiting drug has the potential to treat inflammatory and autoimmune diseases in addition to certain genetically driven cancers.

Among the key inflammatory processes is the formation of a multi-protein complex called inflammasome. The inflammasomes are part of the innate immune system and they play a vital role that help to recruit immune cells to sites of infection and inflammation. Dysfunctional inflammasomes are involved in harmful inflammations, which can become chronic in many diseases. NLRP3 is the most studied inflammasome in the scientific litterature to date. Recent publications have shown that TAK1 functions as a central mediator of NLRP3 activation in human cells.

Aqilion believes that new research and knowledge regarding human immunology and availability of novel research models, re-evaluates and positions TAK1 as an ideal drug target.

"Using structure-based drug discovery methods in collaboration with leading research laboratories, the project has already developed proprietary best in class inhibitors with excellent druglike properties. This is Aqilion’s first internal project to deliver results since we initiated the implementation of our new strategy with a focus on chronic inflammatory and immunological driven diseases. I am proud of our team and collaborators and very pleased to acknowledge that we have reached an important milestone in the development of Aqilion as a biotech company," says Sarah Fredriksson, CEO of AQILION AB.