PHARMA TECH

AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer

Daiichi | January 20, 2021

Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland.

The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday.

An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer.

In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm.

Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu.

Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.

Spotlight

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless-steel infrastructure to flexible, multi-product facilities using single-use technology. Though single-use is being widely adopted, there still exists a lag in automation and measurement to make the most use of the technology and data integration. The next set of biomanufacturing challenges go handin-hand: (1) the scale-down of the bioprocess, and (2) perfusion/continuous processing (CP). The first is driven by the fact that production titers continue to increase; a 6 g/L titer is not uncommon anymore, and this figure is already past the limit of a lot downstream processing capabilities. The progress in production titers has created a gap in single-use processing, where the upstream productivity is mismatched with the throughput and capacity of the downstream equipment.

Spotlight

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless-steel infrastructure to flexible, multi-product facilities using single-use technology. Though single-use is being widely adopted, there still exists a lag in automation and measurement to make the most use of the technology and data integration. The next set of biomanufacturing challenges go handin-hand: (1) the scale-down of the bioprocess, and (2) perfusion/continuous processing (CP). The first is driven by the fact that production titers continue to increase; a 6 g/L titer is not uncommon anymore, and this figure is already past the limit of a lot downstream processing capabilities. The progress in production titers has created a gap in single-use processing, where the upstream productivity is mismatched with the throughput and capacity of the downstream equipment.

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VIEWS AND ANALYSIS

CMIC and Lokavant Collaborate to Deploy Machine Learning-Powered Clinical Trial Intelligence Platform

CMIC | June 25, 2021

CMIC Co., Ltd., a leading Japanese Contract Research Organization (CRO), and Lokavant, a leading clinical trial intelligence company, announced today that they have agreed to use Lokavant's predictive analytics capabilities to assist CMIC's clinical operations. This strategic collaboration, Lokavant Oversight, monitoring, and operational risk management platform, will be implemented throughout CMIC studies. CMIC was the first firm in Japan to provide CRO services, and the company has over 28 years of pharmaceutical development expertise in the Asia-Pacific (APAC) area. CMIC Group supports more than 80% of new drug research in Japan. CMIC and Lokavant are some of the first predictive analytics collaborations for clinical trial operations in the rapidly expanding APAC region. Trial management has gotten more complex and inefficient as the quantity of data points gathered in clinical trials has increased rapidly. The procedure for detecting and managing risks in clinical trials is still largely manual, and it is often too delayed to prevent severe consequences. The collaboration between CMIC and Lokavant goes beyond conventional risk-based monitoring by implementing an end-to-end solution backed by Lokavant's past operational data and CMIC's data. This will enable CMIC to perform next-generation risk-based monitoring, which will be capable of predicting data quality problems, research schedule delays, and budget overruns. CMIC clinical teams will be proactive, rather than reactive, in reducing problems and eventually enhancing trial results by using historical data to predict future issues. Lokavant and CMIC will also collaborate to create data-driven metrics to track study success across previous and current CMIC trials, delivering critical insights to CMIC's 1,200+ clinical trial operators. About Lokavant Lokavant's data-driven solutions, including its flagship product, Lokavant Oversight, a tech-enabled risk-based monitoring solution, and Lokavant Insight, a clinical operations benchmarking tool, allow next-generation clinical trials. Lokavant Oversight collects and distributes real-time data from various trial data sources, anticipates problems throughout clinical development to reduce trial risks, and empowers monitoring teams by displaying critical research data. Lokavant Insight enables clinical teams to assess clinical trial performance and analyze critical trial success and failure indicators. About CMIC Group CMIC Group was established in 1992 as Japan's first Contract Research Organization (CRO). CMIC Group is now Japan's biggest clinical CRO with a worldwide presence, offering complete services in drug development, clinical site management, clinical to commercial GMP manufacturing, regulatory consultancy, and contract sales and marketing solutions. CMIC Group assists pharmaceutical, biotech, and medical device firms in entering the Japanese market, conducting clinical trials in Asia, and bridging drug development and manufacturing requirements in the United States, Europe, Japan, and the rest of Asia. CMIC Group employs approximately 7,000 people and operates from 25 locations across the globe.

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BUSINESS INSIGHTS

Humanigen and Cenexi Announce Collaboration to Manufacture Lenzilumab in France

Humanigen and Cenexi | February 09, 2022

France Humanigen, Inc. a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ and Cenexi, a French CDMO specializing in the formulation, analytical development, and manufacture of complex molecule drugs, announced a collaboration aimed at making Cenexi a preferred supplier of lenzilumab in France and the European Union. The initial step of the collaboration includes the execution of a Master Supply Agreement (“MSA”) providing for Cenexi to provide aseptic fill and finish services for lenzilumab for the next five years. Under the terms of the agreement, Humanigen will transfer the technology and knowledge to Cenexi to allow them to establish drug product processes utilizing their state-of-the-art high speed filling line at their Herouville-Saint-Clair facility in Normandy. Humanigen and Cenexi will enter into discussions to potentially expand the agreement to other services Cenexi offers. These include labeling and packaging, importation of bulk drug substance and quality release of materials in France and throughout Europe. Humanigen plans to include the Cenexi Normandy site in certain of its future regulatory filings for lenzilumab for COVID-19 and other indications. The companies will collaborate to secure potential funding and investment in capital equipment from AD Normandie, the regional authority and the Government of France, the national authority. In addition, Cenexi will assist Humanigen as it seeks an advanced purchase agreement for lenzilumab in France. “The goal of the collaboration with Cenexi is to further our efforts to establish a supply of lenzilumab made in Europe. Cenexi is an ideal partner for sterile filling and with their strong base of resources and aggressive growth plan, we may expand our collaboration beyond the typical customer/vendor relationship. We may work with Cenexi to become our preferred partner for multiple services and to establish a stable and secure supply chain for lenzilumab in France and Europe longer-term.” Cameron Durrant, chief executive officer of Humanigen In 2021, French authorities modified existing regulations to provide for early access to unauthorized medicinal products. The early access authorization allows for a manufacturer to supply product to a cohort of individuals for a specific use, for example, lenzilumab for COVID-19. Humanigen plans to file a request for AAP with the Haute Authorite de Sante in February 2022. “Cenexi desires a leadership position in France to assist in establishing a strong supply chain for COVID-19 and for future pandemics. Since 2004, Cenexi has been at the forefront of bringing critical medicines to patients and we continue to build on our strong reputation for value, high quality, flexibility and timeliness,” commented Christophe Durand, chief executive officer of Cenexi. “Our partnership with Humanigen will use our core competencies of sterile filling and to potentially expand into to an end-to-end solution for lenzilumab in France and other countries in Europe.” Pending positive results from the NIH-sponsored ACTIV-5/BET-B study, Humanigen plans to amend the Emergency Use Authorization application in the United States. For the European Union, Humanigen anticipates submission of a Conditional Marketing Authorization with a request for Accelerated Approval in the third quarter of 2022. Lenzilumab is an investigational product and is not approved or authorized in any country. About Humanigen Humanigen, Inc. is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. In addition, Humanigen is progressing a Phase 1 program focused on another proprietary monoclonal antibody, ifabotuzumab, in solid tumors. About Cenexi Cenexi, a major French CDMO operating in Europe with 1,500 employees and some €200 million in turnover (2021), is experiencing steady growth with four production sites and a center of expertise dedicated to new product introduction.

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BUSINESS INSIGHTS

Enclara Pharmacia Earns Five Year Contract Extension with VITAS Healthcare

Enclara Pharmacia | February 18, 2022

Enclara Pharmacia the market leader in comprehensive pharmacy benefits management (PBM) services to the hospice community, has announced a five-year contract extension to continue providing comprehensive patient medication management services to VITAS Healthcare, the nation’s leading provider of hospice and palliative care. The contract extension affirms the longstanding collaboration between the two companies based on excellence, innovation and quality care for hospice patients and their families. “The goal of hospice is to provide care and comfort that helps patients maintain the best possible quality of life. Pain and symptom management are central to that work. Our team relies on proper medication management so we value Enclara’s combination of powerful technology and personal service that supports and empowers our team to deliver the best quality care.” Nick Westfall, president and CEO, VITAS Mark Morse, CEO, Enclara, said, “VITAS is an industry leader, and with their scale and commitment to continuous improvement in hospice and palliative care, we are able to better identify and respond to the changing needs of the hospice community. This ultimately positions Enclara to better serve hospices of all shapes and sizes.” Scott Quilty, Chief Commercial Officer, Enclara, noted the VITAS renewal comes as Enclara is completing development of the next generation of its E3 mobile and desktop nurse-facing medication management tools. He said, “I’m grateful to continue this relationship as we prepare to roll out the next generation of our E3 application, E3 ProTM. VITAS’ feedback was essential as we worked to prioritize new features that will empower nurses to efficiently administer clinically appropriate symptom management.” About Enclara Pharmacia Enclara Pharmacia is a national full-service PBM and mail order supplier of medications and clinical services developed specifically for the hospice and palliative care industry. Enclara serves over 400 hospice providers and 97,000 patients nationally, helping to reduce pharmacy costs through a clinically driven model that enables home delivery of pharmaceuticals as well as access to a network of over 65,000 local pharmacies, including an actively managed network subset of over 7,000 retail pharmacies, institutional pharmacies, and Enclara’s own automated fulfillment solutions. About VITAS® Healthcare Established in 1978, VITAS Healthcare is a pioneer and leader in the American hospice movement. Headquartered in Miami, Florida, VITAS operates 49 hospice programs in 14 states and the District of Columbia. VITAS employs 10,618 professionals who care for patients with advanced illness, primarily in the patients’ homes, and also in the company’s 28 inpatient hospice units as well as in hospitals, nursing homes and assisted living communities/residential care facilities for the elderly. At the conclusion of the third quarter of 2021, VITAS reported an average daily census of 18,026.

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