Breakthrough status for Janssen’s RSV vaccine

PharmaTimes | September 05, 2019

Janssen has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults 60 or older. The designation was based on clinical data with Janssen’s prophylactic RSV senior vaccine that “may demonstrate substantial improvement compared to available standard of care on a clinically significant endpoint,” announced the company. The investigational prophylactic vaccine is currently in a Phase IIb proof of concept study to investigate the safety and efficacy of the vaccine against RSV in adults aged 65 years and older. “With no preventive vaccines or effective antiviral treatments currently available, RSV remains a significant cause of illness in at-risk populations, particularly older adults,” said Johan Van Hoof, global therapeutic area head, vaccines, and managing director, Janssen Vaccines & Prevention.

Spotlight

Large molecule discovery and development is a complex series of interwoven cycles that span many teams within a research and development organization. By making a commitment to informatics, Amgen pioneered the shift to large molecules and was on the forefront of addressing the complexity of large molecule discovery.

Spotlight

Large molecule discovery and development is a complex series of interwoven cycles that span many teams within a research and development organization. By making a commitment to informatics, Amgen pioneered the shift to large molecules and was on the forefront of addressing the complexity of large molecule discovery.

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BUSINESS INSIGHTS

AMPLICORE, INC. ANNOUNCES US FDA CLEARANCE OF FIRST INVESTIGATIONAL NEW DRUG APPLICATION (IND) AND ADDITION OF EXPERIENCED FINANCIAL LEADER TO BOARD

Amplicore, Inc. | July 15, 2022

Amplicore Inc., a Mason, OH-based, early-stage biopharmaceutical company specializing in the development of minimally invasive therapeutic solutions for musculoskeletal disorders, today announced that the Food and Drug Administration has cleared their first application for AM3101, a novel treatment to promote healing of acute meniscal tears. The move enables the initiation of a Department of Defense-sponsored phase 1/2b clinical study in concert with the University of Cincinnati. The FDA clearance marks the company's transition into a clinical stage company. In addition to AM3101, the company's pipeline also includes AM1101, which is being developed for osteoarthritis, and AM2101, with an indication to treat degenerative disc disease. "We are very proud to announce the clearance for AM3101. Despite their commonality, service men and women have limited treatment options for acute meniscal tears. While suturing is often the most frequent approach, the failure rate for surgery is quite high due to the limited reparative capacity of much of the tissue. Our research has found that our Active Pharmaceutical Ingredient (API) provides pain relief and promotes regeneration of the meniscus, as well as several other structurally related joint tissues. In this way, the transition of Amplicore into a clinical stage company represents a critical development for all patients suffering from musculoskeletal conditions." Chief Executive Officer/Founder Dr. James Lin Amplicore also announced the addition of Steve Schrader to its advisory board. A high-impact financial leader with three decades of experience in corporate finance, Schrader has held Chief Financial Officer positions in a variety of industries, including an international auto glass company, a private healthcare company, a Fortune 500 public utility, and a NASDAQ-listed startup. Throughout his career, Steve has increased revenue and raised over $1.3 Billion in capital for companies. He has also taken two firms from start-up to manufacturing. Schrader will advise on financial planning and fundraising efforts. "Amplicore is a leader in developing injectable therapeutics for musculoskeletal disorders. I am excited to join the board during this pivotal time as they work to close their Series A investment round, and I look forward to being a part of their future success." ABOUT AMPLICORE, INC. Amplicore, Inc. is an early-stage biotech start-up company based on technology developed in the laboratory of CEO/Founder Dr. Chia-Ying Lin at the University of Cincinnati. Headquartered in Mason, OH, the company is dedicated to developing novel injectable therapeutics to serve unmet medical needs for degenerative musculoskeletal disorders. Unlike current therapies that focus solely on palliative treatment, Amplicore is also taking a regenerative approach to treating these disorders. The company's lead products, AM3101, AM1101, and AM2101, address significant deficiencies in the current standard of care for the treatment of acute meniscal tear, osteoarthritis, and degenerative disc disease, respectively. Amplicore's overall mission is to translate scientific innovation into effective but minimally invasive products that can be easily delivered to patients.

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PHARMA TECH

Zerion Pharma and Hovione extend partnership to cover use of the Dispersome® technology platform in nutraceuticals

Zerion Pharma and Hovione | August 24, 2022

Hovione and Zerion Pharma announced an extension of their collaboration on Zerion's Dispersome® technology into the nutraceutical/dietary supplements field. Many dietary supplements suffer from low solubility. This results in poor bioavailability and consequently limits the physiological effect of the supplement. To overcome these limitations, the two companies will collaborate and apply the solubility enhancing Dispersome® technology for the development and commercialization of certain nutraceutical products. The first product candidate selected for joint development is an antioxidant with multiple health benefits and known for its extremely low solubility and bioavailability. By applying the Dispersome® technology, Zerion has been able to demonstrate significant solubility improvements of this antioxidant. Under their collaboration, Hovione and Zerion will now upscale and develop commercial formulations of the antioxidant using the Dispersome® platform and make these products available for distribution by partners globally. Under the terms of the collaboration agreement, the two companies will share income from the commercialization of these products according to their respective contributions. In addition to the joint development projects, Zerion has granted Hovione an exclusive license to exploit the Dispersome® technology for other nutraceuticals/dietary supplements. In return, Hovione will pay Zerion license fees and royalties on sales of the licensed products. "The low oral bioavailability of some of the health-promoting nutraceutical compounds is a well-known challenge. The problem is compounded by the fact that some of the solutions used in pharma cannot be used in foods. Hovione is thrilled to be Zerion´s exclusive partner for the application of Dispersome® to the fields of nutraceuticals and dietary supplements. The Dispersome® platform and its enabling ingredient – beta-lactoglobulin or BLG – afford formulators new options which address unmet needs of the industry." Jean-Luc Herbeaux, CEO of Hovione "I am extremely pleased with this extension of our collaboration", says Ole Wiborg, CEO of Zerion and continues: "The Dispersome® technology is actually very well suited for use in dietary supplements because it employs BLG as its solubility enabling component. BLG is a sustainable natural material and in itself a beneficial nutritional product that we source in high quality from Arla Food Ingredients. Since we as a company only have limited resources to exploit these promising applications of the Dispersome® technology in the nutraceutical field, the collaboration with Hovione is a win/win situation." In February 2022, Zerion and Hovione announced a strategic partnership aimed at commercializing the Dispersome® technology within the drug development field. Under this partnership, Hovione and Zerion are offering pharma and biotech companies worldwide access to an innovative drug delivery platform combined with an unparalleled experience in formulation development, scale up and GMP manufacturing. This unique combination provides customers in the pharma industry with a line of sight over the entire drug development life cycle from the preclinical phase to commercial drug product. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Zerion Pharma A/S Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems. By applying the Dispersome® technology, the solubility of poorly soluble, oral drugs is greatly enhanced, which improves their bioavailability and therapeutic outcomes for the patients. Zerion was established in 2019 as a spinout from the University of Copenhagen based on almost a decade of research.

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PHARMA TECH

GNS and Servier Announce AI Collaboration to Advance Multiple Myeloma Drug Discovery and Clinical Development

Servier Group and GNS | August 25, 2022

GNS, the leader in the use of "Digital Twins" and Causal AI & biosimulation technology for biopharmaceutical drug discovery and development, and Servier, a global pharmaceutical group, today announced a collaboration to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma (MM). "This collaboration furthers Servier's goal to accelerate its drug discovery and clinical development efforts through AI and biosimulation and other digital initiatives. We believe GNS' Digital Twin and unique causal AI models will help our research and early development group improve our understanding of MM disease biology and, ultimately, transform our drug discovery and clinical development process". Claude Bertrand, EVP of Research and Development at Servier "We are delighted to collaborate with Servier to help advance research in MM and leverage our Gemini Digital Twin models to help uncover novel insights and reveal the hidden biological circuity of this disease," said Joe Donahue, Chief Business Officer at GNS. "Working together with the outstanding Servier team, we hope to make a difference in the lives of patients with MM." The collaboration will address key questions about how MM progresses in different patient subpopulations, including discovering what are the most synergistic pathways for new combination therapies and will help Servier gain insights that can advance their translational and clinical development efforts. This work will initially leverage the GNS Gemini Digital Twin for MM developed using the rich clinico-genomic data from the Multiple Myeloma Research Foundation CoMMpass study. GNS' MM Digital Twin leverages the rich patient multi-modal data generated by MMRF to create a transparent, accurate, quantified representation of complex biological mechanisms, revealing new circuitry of human disease. By conducting biosimulations, which are essentially computational experiments, one can discover new drug targets and disease mechanisms, and can also determine which drug candidates are more effective than others and why certain molecular profiles of patients lead to better and more durable response. Ultimately, the MM Digital Twins will radically change how Pharma R&D is conducted by helping to accelerate the identification of new targets and target combinations, new biomarkers, and enabling the in silico design of better trials. About Servier Group Servier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2021, Servier employs 21,800 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities. A leader in cardiology, the ambition of the Servier Group is to become a renowned and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, neuroscience and immuno-inflammatory diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies. About GNS GNS is the leader in the application of Causal AI and simulation technology to discover and validate novel drug targets, simulate clinical trials, and help pharmaceutical and biotech companies discover and develop new medicines faster. GNS' patented AI uncovers new insights from multi-omics and real-world data leading to the discovery and prioritization of novel biological targets, and more efficient clinical trials with patients who are likely to respond to therapies. The Gemini Digital Twin models across oncology, auto-immune diseases, and neurology enable the simulation of disease progression and drug response at the individual patient level to simulate clinical trials in diverse patient cohorts.

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