LabCorp's CRO unit Covance doubles down on cell, gene therapy offerings

FierceBiotech | January 21, 2020

LabCorp has unveiled a new suite of cell and gene therapy development offerings from Covance as it looks to get in on this burgeoning new trend. “These solutions are designed to reduce time and risk for sponsors at each phase and across the full continuum of their therapy development needs in one of the industry’s fastest-growing segments,” Covance, the CRO unit of diagnostics giant LabCorp, said in a statement. This follows the first CAR-T cell therapy approvals from Novartis and Gilead/Kite Pharma over the past few years in blood cancers, with CAR-T 2.0 also in the works (which could also target solid tumors) alongside the latent early work being done on gene editing and CRISPR, which could help across a range of diseases.

Spotlight

Microsoft is best known for its key role in the computing revolution. Less well known is the role Microsoft plays today in the health industry, but a similar revolution is underway and once again the company is at the center. Responsible for helping customers and partners navigate that change is Dr. Simon Kos, chief medical officer. What is a doctor doing working for a technology company? “No, I don’t provide medical services to employees!” Kos quips.

Spotlight

Microsoft is best known for its key role in the computing revolution. Less well known is the role Microsoft plays today in the health industry, but a similar revolution is underway and once again the company is at the center. Responsible for helping customers and partners navigate that change is Dr. Simon Kos, chief medical officer. What is a doctor doing working for a technology company? “No, I don’t provide medical services to employees!” Kos quips.

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CELL AND GENE THERAPY

Amyris Partners with Inscripta to Enhance Development of Sustainable Ingredients Using the Onyx™ Genome Engineering Platform

Amyris | October 06, 2021

Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company active in the Clean Health and Beauty markets through its consumer brands, and a top supplier of sustainable and natural ingredients, today announced that Amyris has licensed the Onyx genome engineering platform from Inscripta, a leading gene editing technology company. Amyris and Inscripta will also explore joint research and development opportunities to expand the Onyx platform functionality. Amyris' product development and formulation team uses a proprietary Lab-to-Market™ operating system to develop and scale a growing portfolio of sustainable ingredients. The Onyx platform automates benchtop biofoundry activity and will bring greater genetic diversity and value to Amyris' ingredient development pipeline, complementing Amyris' existing Lab-to-Market operating system with the goal of improving efficiency and reducing timelines for the development of future molecules. To date, Amyris has successfully commercialized 13 sustainable ingredients, which are formulated in over 20,000 products and used by over 300 million consumers, demonstrating the growing demand for sustainable products with clean and effective ingredients. Automated, high-throughput gene editing is revolutionizing the writing of genomes the way next-generation sequencing transformed the reading of genomes. Inscripta is the first company to deliver an integrated and intuitive benchtop platform that will expand access to scalable, robust genome engineering and help scientists develop solutions to some of today's most pressing challenges. "Amyris has shown the world how new products can be made more sustainable through biology. Their team has high proficiency in utilizing cutting-edge technology, and we are excited they will be pioneering the use of our platform," said Sri Kosaraju, President and CEO of Inscripta. "We have great regard for Amyris' mission, and we are committed to seeing the Onyx platform become a substantial contributor to new clean chemistry products in the future." "The Onyx platform offers significant potential for generating greater genetic diversity in our projects, which we expect to lead to more efficient product innovation," said Sunil Chandran, Senior Vice President of Research and Development at Amyris. "Inscripta's platform seamlessly integrates with our own and opens up new experimentation avenues for our scientists to continue bringing unique bio-based products to customers. We pride ourselves on continuous innovation and expect Onyx to help us expand our pipeline, while achieving lower costs and reducing time to market." For more information about Amyris visit amyris.com and to learn about Onyx, visit www.inscripta.com/products. About Inscripta Inscripta is a life science technology company enabling scientists to solve some of today's most pressing challenges with the first benchtop system for genome editing. The company's automated Onyx platform, consisting of an instrument, consumables, assays, and software, makes CRISPR-based genome engineering accessible to any research lab. Inscripta supports its customers around the world from facilities in Boulder, Colorado; San Diego and Pleasanton, California; and Copenhagen, Denmark. To learn more, visit Inscripta.com and follow @InscriptaInc. About Amyris Amyris (Nasdaq: AMRS) is a science and technology leader in the research, development and production of sustainable ingredients for the Clean Health & Beauty and Flavors & Fragrances markets. Amyris uses an impressive array of exclusive technologies, including state-of-the-art machine learning, robotics and artificial intelligence. Our ingredients are included in over 20,000 products from the world's top brands, reaching more than 300 million consumers. Amyris is proud to own and operate a family of consumer brands - all built around its No Compromise® promise of clean ingredients: Biossanceâ clean beauty skincare, Pipetteâ clean baby skincare, Purecane™, a zero-calorie sweetener naturally derived from sugarcane, Terasanaâ clean skincare treatment, Costa Brazil luxury skincare, OLIKA hygiene and wellness, Rose Inc.™ clean color cosmetics and JVN™ clean haircare.

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MEDICAL

Palatin Announces Initiation of Pivotal Phase 3 PL9643 MELODY-1 Clinical Trial in Patients with Dry Eye Disease

Palatin Technologies, Inc | December 29, 2021

Palatin Technologies, Inc. a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced the initiation of the pivotal Phase 3 MELODY-1 clinical study of PL9643 in patients with dry eye disease. The study is designed to enroll up to 400 patients at multiple U.S. sites, and top-line results are currently expected second half calendar 2022. "We are excited to initiate the MELODY-1 study of PL9643 in patients suffering from dry eye disease. This is the second melanocortin peptide Palatin has advanced into Phase 3, demonstrating Palatin's expertise and efficiency in melanocortin peptide development for indications with unmet medical need." Carl Spana, Ph.D., CEO and President of Palatin The pivotal Phase 3 MELODY-1 clinical study is a multi-center, randomized, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in subjects with dry eye disease . The study design is based on positive Phase 2 results of PL9643 for the treatment of dry eye disease, and an end-of-phase 2 meeting with the with the U.S. Food and Drug Administration, reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, to support a New Drug Application filing, a second phase 3 study and long-term safety study will be required. If the program progresses as planned, top-line results from MELODY-1 would be available second half calendar 2022, MELODY-2 data read out second half calendar 2023, with a potential NDA submission first half calendar 2024. "Progressing PL9643 into Phase 3 is a significant milestone for the Company and patients with DED," said Michael Raizman, MD, Chief Medical Officer of Palatin. "PL9643, with its differentiating factors, could provide a more tolerable and effective treatment option for patients suffering from dry eye disease." About Dry Eye Disease Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires week or months to demonstrate activity. About Melanocortin Receptor Agonists and Inflammation The melanocortin receptor system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential.

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CELL AND GENE THERAPY

BeiGene Initiates First-in-Human Phase 1 Clinical Trial of Investigational TYK2 Inhibitor BGB-23339

BeiGene | November 23, 2021

BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines, announced that the first patient has been dosed in a Phase 1 clinical trial of BGB-23339, a potent, allosteric investigational tyrosine kinase 2 (TYK2) inhibitor internally developed by BeiGene scientists. TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders, such as psoriasis and inflammatory bowel disease. BGB-23339 is a potent, highly selective, investigational TYK2 inhibitor targeting the regulatory pseudokinase (JH2) domain. “Discovered and developed by BeiGene, BGB-23339 is a highly selective, potent, allosteric TYK2 inhibitor that has shown promising activity in preclinical evaluation. Building on our proven track record in oncology, BeiGene is expanding its clinical focus to discover new modalities and platforms in areas of high unmet need, including inflammation and immunology, to bring innovative, impactful medicines to patients.” Lai Wang, Ph.D., Global Head of R&D at BeiGene The first-in-human Phase 1 trial (NCT05093270) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of BGB-23339. The trial is expected to enroll up to 115 healthy volunteers in Australia and/or China. In addition to its broad portfolio focused on hematological malignancies and solid tumors, BeiGene is applying its research excellence and clinical expertise to address inflammation and immunology, an area of high unmet medical need. BeiGene’s internally developed, highly selective next-generation BTK inhibitor BRUKINSA® (zanubrutinib) is currently being evaluated in a Phase 2 trial in patients with active proliferative lupus nephritis. About BGB-23339 BGB-23339 is a potent, highly selective, allosteric, investigational tyrosine kinase 2 (TYK2) inhibitor discovered and being developed by BeiGene. TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders. Designed to target the regulatory pseudokinase (JH2) domain on TYK2, BGB-23339 has demonstrated strong selectivity in preclinical studies with potent inhibition of interleukin (IL)-12, IL-23, and Type 1 interferons (IFNs)—pro-inflammatory cytokines that play a determinant role in the induction of inflammation. BGB-23339 is currently being evaluated in a Phase 1 clinical study. About BeiGene BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,700 colleagues across five continents. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding plans for the Phase 1 trial and development of BGB-23339, the potential for BGB-23339 to address unmet medical needs, BeiGene’s plan to expand its clinical focus to discover new modalities and platforms in areas of high unmet need, including inflammation and immunology, and BeiGene’s plans, commitments, aspirations and goals under “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

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