Puma Biotechnology to Present at the Cantor Virtual Global Healthcare Conference

On September 21, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 8:00 a.m. EDT on Tuesday, September 28, at the 2021 Cantor Virtual Global Healthcare Conference (Press release, Puma Biotechnology, SEP 21, 2021, View Source [SID1234590089]).

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A webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

Persephone Biosciences Inc. Announces Collaboration with Janssen Biotech, Inc.

On September 21, 2021 Persephone Biosciences Inc., ("Persephone") a privately held, data-driven microbiome-focused biotechnology company, reported that it has entered into a collaboration agreement with Janssen Biotech, Inc. (‘’Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, Janssen Biotech, SEP 21, 2021, View Source [SID1234590087]). The agreement was facilitated by Johnson & Johnson Innovation.

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Under the collaboration, Persephone will analyze stool samples collected as part of a Janssen oncology clinical trial using Persephone’s proprietary stool collection kit, and the company will have exclusive licensing rights to any biomarkers discovered.

"We are excited for this collaboration as it will provide us with an opportunity not only to further our understanding of the microbiome’s role in disease, but also to build upon the growing body of evidence highlighting the microbiome’s role in influencing patient treatment outcomes," said Stephanie Culler, CEO and Co-founder of Persephone Biosciences.

Persephone’s laboratories are currently located at the Johnson & Johnson Innovation – JLABS incubator in San Diego, CA and the company is also part of BLUE KNIGHTTM, a joint initiative between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority (BARDA) dedicated to anticipating potential health security threats, activating the global innovation community, and amplifying scientific and technological advancements with the aim to prepare for and respond to our rapidly evolving global health environment.

Personal Genome Diagnostics and Cleveland Clinic Collaborate to Expand Utility of Liquid Biopsy Applications in Oncology Clinical Research

On September 21, 2021 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported a collaboration with the Center for Immunotherapy and Precision Immuno-Oncology (CITI) and the Cleveland Clinic Lerner Research Institute, Cleveland, Ohio (Press release, Personal Genome Diagnostics, SEP 21, 2021, View Source [SID1234590084]).

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Both parties will collaborate to enhance capabilities within elioTM plasma complete reporting, as well as collaborate on the development of proprietary methods for complex biomarker detection and assay iterations to meet emerging liquid biopsy applications in solid tumors. This strategic collaboration combines Cleveland Clinic’s world-class research and commitment to innovation with the comprehensive PGDx portfolio and actionable genomic information. Both organizations are driven to elevate the standard of care for patients and increase utilization of precision diagnostics within the cancer care continuum.

"We are thrilled to collaborate with Cleveland Clinic, whose dedication to empowering the best care and research possible for patients with cancer, along with an immense track record of superior outcomes, makes them an ideal partner in this venture," said PGDx CEO Megan Bailey. "We look forward to expanding upon the capabilities of elioTM plasma complete and paving the way for a Center of Excellence enabling enhanced testing of ctDNA in cancer."

The CITI ctDNA team will work closely with the Cleveland Clinic Taussig Cancer Institute and the Pathology and Laboratory Medicine Institute to accelerate progress in ctDNA work in cancer patients. This effort is a partnership with Jame Abraham, M.D., Interim Chair, Cleveland Clinic Taussig Cancer Institute and Brian Rubin, M.D., Chairman of the Pathology and Laboratory Medicine Institute at Cleveland Clinic.

Timothy Chan, M.D., Ph.D., Chair of Cleveland Clinic’s Center for Immunotherapy & Precision Immuno-Oncology, said "This collaboration allows us to continue exploring new options to improve treatment strategies and patient outcomes in cancer. By investing in comprehensive testing solutions that utilize non-invasive sampling techniques, we intend to explore the clinical utility of high impact biomarkers such as blood TMB, clonal hematopoiesis, and others, with the aim to improve therapeutic modalities for human cancers."

PharmaCyte Biotech Releases More Positive Results From FDA-Required Biocompatibility Tests

On September 21, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the results of a second U.S. Food and Drug Administration (FDA)-required test of biocompatibility of its CypCaps product for pancreatic cancer, which showed that the empty capsule material is "non-hemolytic (Press release, PharmaCyte Biotech, SEP 21, 2021, View Source [SID1234590083])."

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The Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, said of the positive results, "We’re pleased to report that we have received positive results from the second of the biocompatibility tests performed under Good Laboratory Practices and required by the FDA in connection with PharmaCyte’s clinical hold. The data shows that, as expected, the capsule material does not cause blood cells to lyse either after direct or indirect contact with blood. Moreover, it confirms prior data that was observed previously in animal models and previous clinical trials."

The study, which was performed by a third-party Contract Research Organization in accordance with ISO 10993-4:2017 and ISO 10993-12:2021(E), was designed to determine if the device component of CypCaps (the empty capsule material) can cause the in vitro hemolysis (destruction) of red blood cells. Two different methods were used for the evaluation: (i) a direct contact method where the capsule material was mixed with rabbit blood; and (ii) an indirect method where the capsule material was extracted with saline and mixed with rabbit blood. The hemolytic index of both the empty capsules and the extraction material was such that the Contract Research Organization concluded that the test item in both the direct contact method and indirect contact method is considered as "non-hemolytic."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

Triumvira Announces First Patient with HER2-overexpressing Cancer Dosed with TAC-T Cell Therapy Using the Lonza Cocoon Platform

On September 21, 2021 Lonza and Triumvira Immunologics ("Triumvira") reported that the first patient has been dosed with Triumvira’s investigational T-cell antigen coupler (TAC-T cell) adoptive immunotherapy, TAC01-HER2, in development for the treatment of HER2-overexpressing cancers (Press release, Triumvira Immunologics, SEP 21, 2021, View Source [SID1234590081]). Triumvira’s TAC01-HER2, which harnesses natural T cell activation, was manufactured on Lonza’s proprietary Cocoon Platform at C3i Center Inc in Montréal, Canada. The Cocoon Platform is an automated and closed platform for patient-scale cell therapy manufacturing, designed to overcome manufacturing challenges associated with patient-scale personalized medicines.

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This collaboration aims to bring novel immunotherapies to patients for the treatment of HER2-overexpressing cancers. The Cocoon Platform will enable manufacturing efficiencies, robustness, and cost reductions by decreasing the necessary manpower, time, and space requirements and ultimately allow the delivery of potentially curative cellular immunotherapies to more patients, at a higher quality and for a reduced cost. From the start of the collaboration, Triumvira’s TAC-T cell treatment was efficiently translated to Lonza’s Cocoon Platform, involving technology transfer to C3i and engineering runs, to support an investigational new drug (IND) submission in under a year.

Eytan Abraham, Vice President Personalized Medicine, Lonza, commented: "Treating the first HER2-overexpressing cancer patient at MD Anderson with Triumvira’s therapy demonstrates the potential of the Cocoon Platform to manufacture therapies at third party manufacturing sites using a decentralized model. The fact that the timeline for moving a fully automated manufacturing process to IND submission using the Cocoon Platform at a new manufacturing site was less than a year demonstrates the ability to truly accelerate timelines from lab to clinic using the Cocoon Platform. Our goal remains to enable partners to provide personalized immunotherapies at a lower cost, higher quality, and more quickly to critically ill patients."

Paul Lammers, President and CEO, Triumvira, added: "We’re proud to be the first company in the US to dose a patient with a cell therapy manufactured on the Cocoon Platform, which is an innovative and elegant solution that addresses challenges of manufacturing autologous cell therapies. Our proprietary TAC-T technology combined with Lonza’s manufacturing expertise enables us to deliver a high-quality and truly personalized cell therapy and manufacturing process that may one day be used at the point-of-care. We look forward to our continued partnership with Lonza and C3i as we move forward with the clinical trial of TAC01-HER2."

Louisa Petropoulos, CEO, C3i, commented: "C3i Center Inc. is founded on the principle that Canadian breakthroughs in cell and gene therapy for serious diseases like cancer should remain in Canada for the benefit of our health and economy. Experimental treatments like TAC01-HER2 won’t become a reality unless we can produce and refine cells quickly, reliably and affordably, and that is what an automated closed system like the Cocoon Platform brings to the table. We are thrilled to put the Cocoon Platform to the test as part of our suite of cutting-edge technologies as we support this critical clinical trial."

The TAC01-HER2 clinical trial is actively enrolling patients across numerous clinical study sites in the US. More information on Triumvira’s pipeline and programs can be found at www.triumvira.com and details on this clinical trial can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04727151.