Sexton Biotechnologies Partners with BioSpherix to Create a Fully-Enclosed, Modular Fill-Finish System with Rapid Deployment

Sexton Biotechnologies | June 11, 2020

Sexton Biotechnologies has announced a new collaboration with BioSpherix Medical. As a tool and technologies partners of the Cell and Gene industry, Sexton and BioSpherix both recognize the need for cost-effective and flexible automation solutions during cell and gene therapy process development. While some upstream bioprocesses have been successfully automated, the final steps of downstream bioprocess, namely Fill-Finish, are often done manually with associated risks of contamination and user error. The inefficiencies and lack of traceable GMP controls make manual Fill-Finish processes unacceptable if companies are to scale up and scale out for late-stage clinical or commercial phases. The new collaboration will combine Sexton's off-the-shelf fill system, the Sexton Biotechnologies AF-500, with BioSpherix' exclusive Cytocentric® isolator technology, allowing rapid process development and implementation of GMP Fill-Finish. The recent global pandemic has resulted in an unprecedented acceleration of therapeutic candidates paired with significant supply chain challenges. Development of clinical and commercial stage manufacturing systems to meet this rapid expansion is likely to lead to significant delays in scale up and completion of clinical studies.

Spotlight

With fewer successful drug launches in the market and expiring patents, competitive intelligence, and commercial R&D decision makers are hard-pressed to make sound forecasting and planning decisions based on highly reliable data analysis. That’s a big challenge because, even with access to big data from many sources, the tasks associated with collecting, organizing and mapping datasets is time-consuming, costly and labor-intensive. As result, decision making takes longer and innovation suffers.

Spotlight

With fewer successful drug launches in the market and expiring patents, competitive intelligence, and commercial R&D decision makers are hard-pressed to make sound forecasting and planning decisions based on highly reliable data analysis. That’s a big challenge because, even with access to big data from many sources, the tasks associated with collecting, organizing and mapping datasets is time-consuming, costly and labor-intensive. As result, decision making takes longer and innovation suffers.

Related News

Biotechnology Leader LuminUltra Submits COVID-19 Clinical Diagnostic Testing Kit for Regulatory Authorization in U.S., Canada

LuminUltra | September 14, 2020

Canada-based biotechnology front-runner LuminUltra announced today that it has submitted its GeneCount® COVID-19 RT-qPCR Assay Kit (COVID-19 Assay) to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and to Health Canada for an Interim Order (IO). With authorization to use this key testing component, LuminUltra, a leader in field-based molecular diagnostic testing for over 20 years, will provide a complete clinical COVID-19 testing solution that can be customized for testing facilities throughout North America. LuminUltra's accurate GeneCount® COVID-19 RT-qPCR Testing Solution comprises multiple components that together make up an end-to-end solution, including: sample collection kits; isolation reagents; the COVID-19 Assay; and a range of quick-detection qPCR testing devices with software for simple interpretation of COVID-19 test results in under two hours. With the authorization of the COVID-19 Assay, LuminUltra will be able to offer flexibility to appropriate facilities around the world by providing some or all of the necessary COVID-19 testing components from a single, reputable company. This reduces the need to source components from multiple suppliers, allowing facilities to onboard additional testing capacity quickly. Underscoring its reliable supply chain, LuminUltra responded promptly to the Government of Canada's testing needs earlier in the year, and has been a key supplier of the isolation reagents for the national testing program since April, providing 500,000 tests a week.

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INDUSTRIAL IMPACT

Leica Biosystems and Leap Therapeutics Partner on Companion Diagnostic to Advance Care for Cancer Patients

Leap Therapeutics, Inc. | February 01, 2022

Leica Biosystems, a cancer diagnostics company, has entered into an agreement with Leap Therapeutics, a biotechnology company, to develop a companion diagnostic to detect Dickkopf-related protein 1. The assay will be used to support clinical development of Leap Therapeutics' anti-DKK1 cancer therapy, DKN-01, currently being studied in clinical trials. DKK1 is a protein often implicated in cancer, enabling tumor cells to suppress the immune system and lead to unregulated growth. Overexpression of DKK1 is associated with poor survival in cancer patients. Leap Therapeutics is currently advancing the development of DKN-01, a humanized monoclonal antibody that targets DKK1, to treat cancer. The company is currently studying the drug as part of a combination therapy regimen in a Phase 2 clinical trial in patients with gastric or gastroesophageal junction cancer. The assay developed by Leica Biosystems will utilize RNAscope™ technology from Bio-Techne on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity, to help identify patients most likely to benefit from DKN-01 treatment. "Companion Diagnostics are a step toward treating cancer patients based on the biomarker makeup of their disease.We are excited to partner with Leap to advance cancer care." Rachel Skelton, Senior Director of Pharma Partnerships at Leica Biosystems Companion Diagnostics are tests that may be used to determine if a patient's tumor has the biomarker that will predict the outcome of a treatment with a specific therapy. With expertise in assay development, regulatory approval and commercialization, the Leica Biosystems Companion Diagnostics team partners with pharmaceutical companies to develop assays for a diverse range of technologies. Our flexible approach to partnerships, along with the robust capabilities of the BOND Advance Staining Solutions, supports our mission of Advancing Cancer Diagnostics, Improving Lives. "DKK1 is novel and broadly applicable biomarker that is often elevated in patients with poor outcomes," said Jason Baum, Vice President and Head of Translational Medicine at Leap Therapeutics. "Patients whose tumors express elevated levels of DKK1 have shown compelling clinical responses when treated with DKN-01-based regimens. We are pleased to partner with Leica to advance the clinical development of our therapy and improve patient lives." About Leica Biosystems Leica Biosystems is a cancer diagnostics company and a global leader in workflow solutions. Only Leica Biosystems offers the most comprehensive portfolio that spans the entire workflow from biopsy to diagnosis. With unique expertise, we are dedicated to driving innovations that connect people across radiology, pathology, surgery and oncology. Our experts are committed to delivering Improved Quality, Integrated Solutions, and Optimized Efficiencies leading to breakthrough advances in diagnostic confidence. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of corporate culture. Visit LeicaBiosystems.com for more information. About Leap Therapeutics Leap Therapeutics is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 protein. DKN-01 is in clinical trials in patients with esophagogastric, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. About Bio-Techne Bio-Techne Corporation is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnosis. With thousands of products in its portfolio, Bio-Techne generated approximately $931 million in net sales in fiscal 2021 and has approximately 2,700 employees worldwide.

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MEDTECH

Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy Designation in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Daiichi Sankyo | December 24, 2021

Daiichi Sankyo Company, Limited announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to patritumab deruxtecan, a potential first-in-class HER3 directed antibody drug conjugate, for the treatment of patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor and platinum-based therapies. Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide, with 80% to 85% classified as NSCLC.1,2,3 While the efficacy of targeted therapy with EGFR TKIs is well-established in the treatment of advanced EGFR-mutated NSCLC, which comprises approximately 30% of patients, the development of a broad range of resistance mechanisms commonly leads to disease progression.4,5,6 After failure of an EGFR TKI, platinum-based chemotherapy has limited efficacy with progression-free survival (PFS) of approximately 4.4 to 6.4 months.7 Subsequent salvage therapies after EGFR TKI and platinum-based chemotherapy have PFS of 2.8 to 3.2 months.8 The U.S. FDA’s BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines. The FDA granted the BTD based on data from the dose escalation portion and two expansion cohorts of a three-cohort phase 1 study of patritumab deruxtecan. Extended follow-up data from the dose escalation portion and dose expansion cohort 1 of the study were recently presented at the 2021 American Society of Clinical Oncology annual meeting and published in Cancer Discovery. This is the first BTD for patritumab deruxtecan and the seventh BTD across Daiichi Sankyo’s oncology portfolio. “The Breakthrough Therapy Designation for patritumab deruxtecan acknowledges the need for new treatment approaches to overcome resistance and improve survival in patients with metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer. We are proud that the FDA has once again recognized our innovative science and technology and we look forward to bringing this potential first-in-class HER3 directed antibody drug conjugate to patients with this specific type of lung cancer as quickly as possible.” Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo About Non-Small Cell Lung Cancer Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide, with 80% to 85% classified as NSCLC.1,2,3 There were an estimated 2.2 million new cases of lung cancer and 1.8 million deaths in 2020.9 NSCLC is diagnosed at an advanced stage in more than 50% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.10,11,12 The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic NSCLC. For patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and PFS compared to chemotherapy.13 However, most patients eventually develop resistance to these therapies and subsequent therapy after EGFR TKI with platinum-based chemotherapy have limited efficacy with PFS of approximately 4.4 to 6.4 months.7,14 Subsequent salvage therapies after EGFR TKI and platinum-based chemotherapy have PFS of 2.8 to 3.2 months.8 New treatment approaches are needed to overcome resistance and improve survival in this subtype of NSCLC. About HER3 HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.15 Approximately 25% to 30% of lung cancers have an EGFR-activating mutation, and it is estimated that about 83% of all NSCLC tumors express the HER3 protein, which can be associated with an increased incidence of metastases, reduced survival and resistance to standard of care treatment.16,17,18 Currently, no HER3 directed medicines are approved for the treatment of cancer. About the Phase 1 Non-Small Cell Lung Cancer Study The global, multicenter, open label, two-part phase 1 study is evaluating patritumab deruxtecan in previously treated patients with metastatic or unresectable NSCLC. The dose escalation part of the study evaluated patients with EGFR-mutated disease either with progression on osimertinib or T790M-negative after progression on erlotinib, gefitinib or afatinib. The primary objective of this part of the study was to assess the safety and tolerability of patritumab deruxtecan and determine the recommended dose for expansion. The dose expansion part of the study is evaluating patritumab deruxtecan at the RD in three cohorts. Cohort 1 includes patients with locally advanced or metastatic EGFR-mutated NSCLC who experienced disease progression after taking one or more EGFR TKIs and one or more platinum-based chemotherapy regimens. Cohort 2 includes patients with squamous or non-squamous NSCLC without EGFR-activating mutations following platinum-based chemotherapy and following an anti-PD-1 or anti-PD-L1 antibody regimen. Cohort 3 includes patients with NSCLC with EGFR-activating mutations including any histology other than combined small cell and non-small cell lung cancer; patients in Cohort 3 are randomized 1:1 to receive the 5.6 mg/kg RDE regimen or an escalating up-titration regimen of patritumab deruxtecan. The primary objective of the dose expansion part of the study is to assess efficacy of patritumab deruxtecan as measured by confirmed objective response rate assessed by blinded independent central review. Secondary study endpoints include investigator-assessed ORR, safety and pharmacokinetics. The study enrolled patients at multiple sites in Asia, Europe and North America. For more information, visit ClinicalTrials.gov. About Patritumab Deruxtecan Patritumab deruxtecan is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is comprised of a fully human anti-HER3 IgG1 monoclonal antibody attached to a topoisomerase I inhibitor payload via a stable tetrapeptide-based cleavable linker. Patritumab deruxtecan is currently being evaluated in a comprehensive development program across multiple cancers as both a monotherapy and in combination with other anticancer treatments. The development program includes HERTHENA-Lung01, a pivotal phase 2 study in patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with a TKI and platinum-based chemotherapy; a phase 1/2 study in HER3 expressing metastatic breast cancer; a phase 1 study in combination with osimertinib in locally advanced/metastatic EGFR-mutated NSCLC; and, a phase 1 study in previously treated patients with metastatic or unresectable NSCLC. Patritumab deruxtecan is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo in Oncology The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon, our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025. About Daiichi Sankyo Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”

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