Pfizer’ Talzenna leads latest CHMP highlights

pharmatimes | April 29, 2019

Pfizer’s PARP inhibitor, Talzenna (talazoparib), has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for adults with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, heading up April’s recommendations list. Thirteen medicines were recommended for approval at the Committee’s April 2019 meeting, including two orphan medicines; Novo Nordisk’s Esperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A; and Alexion’s Ultomiris (ravulizumab), for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

Spotlight

The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution. The importance of successfully executing a digital health strategy, as well as creating new financial models and partnerships, cannot be understated. Nevertheless, this revolution is not often witnessed in current practice. While incorporation of digital practices has been slow, the future will move quickly. However, instead of fearing the future, the digital health transformation should have pharmaceutical leaders enthusiastic about the possibilities of the very near future. There are clear opportunities on the horizon, and those pharma organizations and leaders who are prepared for the potential, can soon capitalize on them.

Spotlight

The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution. The importance of successfully executing a digital health strategy, as well as creating new financial models and partnerships, cannot be understated. Nevertheless, this revolution is not often witnessed in current practice. While incorporation of digital practices has been slow, the future will move quickly. However, instead of fearing the future, the digital health transformation should have pharmaceutical leaders enthusiastic about the possibilities of the very near future. There are clear opportunities on the horizon, and those pharma organizations and leaders who are prepared for the potential, can soon capitalize on them.

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QHP Capital Acquires Lexitas Pharma Services

Lexitas and QHP Capital | July 08, 2022

QHP Capital the management company for NovaQuest Private Equity announced its acquisition of Lexitas Pharma Services a full-service ophthalmology contract research organization supporting biopharmaceutical and medical device clinical trials. Since 2011, Lexitas has provided clinical trial and medical strategy solutions to biopharmaceutical and medical device companies developing ophthalmic products. The Company provides end-to-end support and development expertise in the anterior and posterior segments of ophthalmology. Lexitas has conducted clinical trials for dry eye disease, glaucoma, cataract, uveitis, pediatric myopia, diabetic macular edema, age-related macular degeneration, and retinitis pigmentosa, among others. The Company’s therapeutic area expertise, relationships with ophthalmic KOLs, and network of high-performing research sites has led to strong outcomes for its international customer base. “For the past decade, Lexitas has had the incredible opportunity and privilege to partner with talented companies with amazing science as they develop their ophthalmic drugs and devices. Partnering with the QHP team brings deep expertise and domain knowledge that is going to allow Lexitas to improve and increase the scope, quality, and efficiency of our capabilities. We couldn’t be more thrilled to be working with QHP and are excited at the prospect of getting safe and efficacious ophthalmic drugs to patients efficiently and quickly,” George Magrath, M.D., CEO of Lexitas “Lexitas is an excellent fit with QHP’s philosophy and strategy of providing strategic capital to growing clinical trial services providers in niche, specialized therapeutic areas,” said Vern Davenport and Jeff Edwards, Partners at QHP. “We look forward to supporting the Lexitas team as they continue to build out their capabilities and provide best-in-class ophthalmic drug development services.” Additionally, Lexitas appointed Jeanne Hecht as Executive Chairwoman of the Board. Jeanne is a seasoned ophthalmology CRO industry executive having previously served as CEO of Ora, an ophthalmic CRO, where she expanded Ora’s international presence, introduced new lines of business, and furthered its goals along numerous strategic paths. About Lexitas Lexitas is a full-service ophthalmic biopharmaceutical solutions company focused on providing end-to-end eyecare support and exceptional service to biopharma and medical device clients globally. About QHP Capital QHP Capital, L.P. is the management company for NovaQuest Private Equity NQPE is a private equity firm that invests in lower middle market healthcare companies primarily in North America. The Firm invests in services and technology companies where a strategic partner and operating resources can accelerate growth, targeting companies in healthcare and pharmaceutical services industries. NQPE invests in the form of buyouts, growth equity, and recapitalizations.

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Mission Bio Announces Pharma Assay Development Services for Solid Tumor Research

Mission Bio | July 13, 2022

Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced the launch of solid tumor assays through its Pharma Assay Development services. The availability of this new service offering will help to accelerate the development of cancer therapeutics by reducing the time and cost associated with the characterization of solid tumor cells. Precision therapeutics for solid tumors have been historically bottlenecked due to technical challenges associated with the ability to deeply profile thousands of individual cells for a rich characterization of tumor evolution and heterogeneity. This must be done at a much higher resolution compared to bulk next-generation sequencing to enable detection of rare events, at a much earlier stage before progression. Utilizing Mission Bio's Tapestri™ platform, the company's PAD services for solid tumors partner with researchers to provide high-resolution data to unmask the underlying genetic diversity across cell populations. Insights into the clonal landscape and co-occurrence of mutations enable improved patient stratification for clinical trials and the identification of druggable targets for precision therapeutics. Researchers can also monitor treatment resistance by analyzing the acquisition of rare mutations driving tumor progression over the course of treatment. The expansion of Mission Bio's PAD services to solid tumor research comes just three months after the launch of the Solid Tumor Solution on the Tapestri™ Platform, demonstrating Mission Bio's commitment to continuously developing innovative single-cell technologies for its pharma customers. "We have seen tremendous uptake and interest from top-tier pharma companies for our blood cancer Pharma Assay Development program, and we expect the same momentum for our solid tumor services. With our solid tumor services, Mission Bio partners with pharma customers to elucidate the mechanisms of drug resistance through mutation acquisition, determine how cells transform from benign to malignant states, and reveal the genomic changes enabling cancer cells to metastasize – without having to bring single-cell technology or resources in-house. From a customer's perspective, it is as easy as shipping out samples and getting a fully analyzed report back." Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio Mission Bio's PAD services deliver comprehensive support across the therapeutic development process. The company has a dedicated team that works with researchers to develop assays, identify high-impact samples, and analyze the data. As part of the service, pharma partners have access to Mission Bio's innovative technology, assay development team, R&D organization, and bioinformatics support. About Mission Bio Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others. The company's Tapestri™ platform gives researchers around the globe the power to interrogate every molecule in a cell together, providing a comprehensive understanding of activity from a single sample. Tapestri™ is the only commercialized multi-omics platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution. The Tapestri™ Platform is being utilized by customers at leading research centers, pharmaceutical, and diagnostics companies worldwide to develop treatments and eventually cures for cancer.

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Iktos and Zealand Pharma to Develop Artificial Intelligence Technology for Peptide Drug Design

Iktos | June 22, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, announced a research collaboration with Zealand Pharma A/S a biotechnology company changing lives with innovative peptide-based medicines to co-develop generative and predictive AI technologies for peptide drug design. Iktos’ AI technology, based on a comprehensive data-driven chemical structure generation technology, brings new insights into the drug discovery process. This technology automatically designs virtual novel molecules with all the characteristics of a successful drug molecule. Iktos has recently diversified its R&D efforts into the development of an AI technology for peptide-based therapeutics and has developed state-of-the-art generative and predictive models to facilitate design of novel peptide therapeutics with desired properties. Zealand Pharma A/S has a track record of successfully inventing and developing novel peptide-based drugs. This success is based on the extensive experience in improving the therapeutic characteristics of peptides. Zealand Pharma has a keen interest in expanding its computational chemistry toolbox to include AI and machine learning based approaches for the design of novel therapeutic peptides. Under the agreement, Zealand will contribute its expertise in peptide drug discovery to Iktos’ generative modelling technologies and expertise in machine learning and AI. “We are very pleased to join forces with Zealand Pharma and leverage their deep know-how in peptide therapeutics with our state-of-the-art existing technology assets to peptide drug discovery. We look forward to working with Zealand’s experienced R&D team to build leading/state of the art peptide generative and predictive modelling technology in the field of peptides - a new area for Iktos.” Yann Gaston-Mathé, President and CEO of Iktos About IKTOS Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis. Iktos has recently diversified its R&D efforts into the development of an AI technology for peptide-based therapeutics and has developed state-of-the-art generative and predictive models to facilitate design of novel peptide therapeutics with desired properties.

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