BUSINESS INSIGHTS

Athira Pharma Announces Topline Results from ACT-AD Phase 2 Proof of Concept Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Athira Pharma, Inc. | June 27, 2022

Athira Pharma
Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. Fosgonimeton is a small molecule designed to enhance the activity of Hepatocyte Growth Factor and its receptor, MET, which are expressed in the central nervous system to promote brain health and function.

“Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer’s patients on fosgonimeton monotherapy, this Phase 2 trial provides valuable insights into the nature of this novel intervention over 26 weeks. ACT-AD was designed as a learning study to further investigate the ERP P300 biomarker signal over 6 months, assess safety in a patient population more representative of the real world, by allowing the use of add-on standard-of-care acetylcholinesterase inhibitors (AChEIs, e.g., donepezil), and explore fosgonimeton’s effect on psychometric outcomes, including ADAS-Cog11, to inform the ongoing Phase 3 LIFT-AD study. To that end, this study achieved its goal,” said Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira.

“The study was intended to show differences on the biomarker ERP P300 latency. This primary endpoint was not met by protocoled analysis, however a pre-specified subgroup analysis indicated a potential diminished effect of fosgonimeton when given in combination with AChEIs. A subsequent post hoc analysis of the data from patients on fosgonimeton monotherapy showed a meaningful improvement in both ERP P300 latency and cognitive performance compared to placebo at 26 weeks.

These data points are very encouraging as they indicate the expected pharmacological activity of fosgonimeton by parallel improvement on ERP P300 latency and ADAS-Cog11 and show a favorable safety profile over six months. This is the first time monotherapy fosgonimeton has shown an effect on ADAS-Cog11, suggesting a potential cognitive benefit. We will use these insights for a rational optimization of the ongoing LIFT-AD trial. We plan to seek advice from our scientific advisors, investigators, and ultimately regulators on how to expeditiously analyze and potentially adapt the LIFT-AD study,” 

Dr. Moebius

“The data from the fosgonimeton monotherapy analysis are encouraging and show biologic activity that may support the potential role of the HGF/MET pathway in neurodegenerative diseases,” said Marwan Sabbagh, M.D., FAAN, professor of neurology at Barrow Neurological Institute, Phoenix, AZ. “ACT-AD adds to the body of literature suggesting ERP P300 latency as an important biomarker for cognitive status.”

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BUSINESS INSIGHTS

BD Completes Acquisition of Parata Systems

BD | July 19, 2022

BD announced it has completed the acquisition of Parata Systems. Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. "Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations." Tom Polen, chairman, chief executive officer and president of BD The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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BUSINESS INSIGHTS

Cellusion and Celregen a member of Fosun Pharma, Enter into Exclusive License Agreement of CLS001 for a Corneal Endothelial Cell Regenerative

Cellusion and Celregen | September 12, 2022

Cellusion Inc. a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells for bullous keratopathy novel treatment and Hangzhou Celregen Therapeutics Ltd. a member of Shanghai Fosun Pharmaceutical Co., Ltd. and focus on regenerative medicine and cell therapy and incubated by New Drug Fund of Fosun Health Capital announced an exclusive license agreement in the Greater China region for Celregen to develop, manufacture and commercialize CLS001. Under the Agreement, Celregen will have the exclusive right to develop, manufacture and commercialize CLS001 for bullous keratopathy in the Greater China region, including Mainland China, Hong Kong, Macau and Taiwan. On the other hand, Cellusion retains the rights of development, manufacturing and commercialization of CLS001 in other regions including Japan, the USA, and EU. Under the terms of the agreement, Cellusion will potentially receive over 100 million US dollars including upfront payment, development milestones and sales milestones as well as tiered royalties. “We are very enthusiastic about combining our knowledge of the underlying iPS cellular biology with Celregen and Fosun Pharma in the development and commercialization of innovative medicine in China. Together, we are committed to make best efforts on launching CLS001 for the patient suffering from bullous keratopathy due to the cornea donor shortage in the greater China region.” Shin Hatou, M.D. Ph.D., CEO of Cellusion “Today’s announcement with a global industry leader in iPS cells derived corneal endothelial regenerative therapy such as Cellusion, is an important and strategic step to build a long-term foundation for cell therapy in China,” said Cui Zhiping, the Chairman of Celregen, Fosun Global Partner, Chief Consultant of VC investment of Fosun Pharma and CEO of Fosun New Drug Fund. “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.” According to reports, there are about millions of people in China who are blind due to corneal diseases, and this number is increasing at a rate of 100,000 per year. Most of the patients with corneal blindness need corneal transplantation to restore their sight, but only less than 20,000 corneal transplants are conducted due to severe donor cornea shortage issues. Cellusion has already announced that the patient recruitment began for the First-in-Human Investigator-Initiated Study of CLS001 to initiate in 2022 at the Keio University Hospital and has been preparing to start Cellusion initiated clinical trial in Japan within a few years followed by global studies in the US and EU region. Cellusion is developing CLS001, CECSi cells for Corneal Endothelial regeneration to cure Bullous Keratopathy which is applied to more than half of all cases of corneal transplantation. CLS001 is expected to replace the current supply limitations by combining “CECSi Cells made from iPS cells with excellent proliferative properties” and “a simple injection cell delivery procedure without needs of human expertise.” About Celregen Celregen, incubated by New Drug Fund of Fosun Health Capital, focuses on stem cell and transformed cellular regenerative medicine. This platform adopts a variety of modes of cooperation with leading biotech and scientists. It is expected to be a head biotech in regenerative medicine in China. About Fosun Pharma Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. About Fosun New Drug Fund New Drug Fund, under the management of Fosun Health Capital, is the first VC established by Fosun Pharma. The Fund focuses on innovative biopharmaceutical-based drug fields at the start-up and expansion stages, including gene therapy, cell therapy, bio-conjugate drugs, and medical aesthetics, etc. The Fund has committed to incubate cutting-edging science and revolutionary technologies from world top universities, research institutes and biotech, through which path we can establish and adopt a variety of models of cooperation.

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PHARMA TECH

Innate Pharma to Present Lacutamab PTCL Phase 1b Design and ANKET™ Platform at ESMO 2022

Innate Pharma | September 06, 2022

Innate Pharma SA announced that the following presentations will be presented at the ESMO Annual Meeting 2022 taking place from 9 to 13 September 2022, in Paris, France. About Lacutamab Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma an orphan disease, and peripheral T cell lymphoma. Rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma. It has a restricted expression on normal tissues. About ANKET™ ANKET™ is Innate's proprietary platform for developing next-generation, multi-specific natural killer cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. It leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells. Our latest innovation, the tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors via a single molecule. About Monalizumab Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells. NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies1. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies, including, in early lung cancer, the Phase 3 PACIFIC-9 study in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based concurrent chemoradiotherapy, and the Phase 2 NeoCOAST-2 study in the neoadjuvant early-stage setting of NSCLC. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer. Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need. Innate is a pioneer in the understanding of Natural Killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca.

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BUSINESS INSIGHTS

Kubota Vision Announces Collaboration Agreement with Leading Diabetes Center

PBOS | September 30, 2022

Kubota Vision Inc. a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. announced today that the Company and Joslin Diabetes Center have entered into a material transfer and collaboration agreement for our Patient Based Ophthalmology Suite in-home optical coherence tomography device. Joslin Diabetes Center is conducting two clinical studies to evaluate the ability of PBOS to identify cases of diabetic macular edema that may need treatment compared to a commercially-available OCT device. The studies will be led by Dr. Paolo S. Silva at Joslin Diabetes Center. Dr. Silva is the Co-Chief of Telemedicine at the Beetham Eye Institute of the Joslin Diabetes Center. His work is focused on innovative and investigative work in a field at the intersection of clinical care and technology with the hope of providing an ideal model for the delivery of evidence-based, highly effective, and efficient diabetes eye care to the population that needs it the most. Joslin Diabetes Center, which is affiliated with Harvard Medical School, is a one-of-a-kind institution on the front lines of the world epidemic of diabetes — leading the battle to conquer diabetes in all of its forms through cutting-edge research and innovative approaches to clinical care and education. Dr. Silva stated, “Through these studies, we will determine if home-based in-home optical coherence tomography is useful in the evaluation of diabetic macular edema and how we monitor patients at risk for losing vision from the condition.” “Diabetic retinopathy is one of the most common diseases in the world. The use of our technology brings us great excitement as we continue to focus on the development of medical devices and explore further possibilities.” Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc. About PBOS PBOS is a low cost, home-based, ophthalmic self-monitoring OCT device. This small handheld device addresses needs in mobile Health applications for self-monitoring of retina health by patients, in the home and in remote field locations. The PBOS aims to improve ophthalmic treatment outcomes in patients diagnosed with and treated for wet age-related macular degeneration, diabetic macular edema and other neovascular retinal diseases. PBOS is being designed to detect nascent disease progression and support patient re-treatment prior to irreversible vision loss due to disease progression. Key features are low cost and a patient-friendly design, to be used directly by patients at home. PBOS is being designed to capture changes in retinal anatomy. Network connectivity and cloud-based technologies are used to alert the patients and their physicians of disease progression and re-treatment needs. About Kubota Vision Inc. Kubota Vision Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s pipeline includes a wearable device for myopia control using Kubota GlassTM technology and a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients.

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