Maravai Lifesciences | August 25, 2020
Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech innovators, is expanding its contract development and manufacturing organization (CDMO) capabilities at TriLink BioTechnologies for the second time in less than a year. The expansion is expected to be completed in the first quarter of 2021 and will increase TriLink's small molecule manufacturing capacity with a focus on additional scale-up of CleanCap®, its proprietary messenger RNA (mRNA) capping technology, for global mRNA vaccine and therapeutic programs. To further address the increasing demand for mRNA development and clinical programs, the company is currently completing the construction of its plasmid DNA production facility as well. Last November, TriLink opened their new headquarters in San Diego, CA and expanded mRNA and small molecule capacity as it opened five Current Good Manufacturing Practice (cGMP) suites. The current investment will further expand the operation with an additional three cGMP suites and four cGMP manufacturing support suites.
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.
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.
WhiteLab Genomics | June 01, 2021
As part of this collaboration, teams from the Accelerator for Technological Research in Genomic Therapies (ART-TG, Inserm US35) and WhiteLab Genomics will use the WhiteLab Genomics CatalystTM platform to generate a database specific to the bioproduction of lentiviral vectors, which will be used to identify the parameters allowing for a significant increase in vector quality as well as their production yields, and to reduce the production costs.
Cell and gene therapy is a new biomedical approach that can treat a growing number of genetic and acquired diseases such as cancer. To keep up with their growth, the pharmaceutical manufacturing of these Advanced Medicinal Therapies needs to accelerate in terms of standardization and process control. Because purifying lentiviral vectors remains complex and at critical capacity, the partnership is focused on manufacturing lentiviral vectors, which are used in many gene therapies approaches, including the manufacture of CAR-T cells.
The teams will utilize AI to analyze information from multiple sources to optimize existing processes and develop new ones. The approach used with the lentiviral vectors will apply to various bioproducts.
This initiative is made possible due to funding from the Ile de France Region, which supports bioproduction efforts as part of its Ile-de-France Leader Bioproduction scheme, which was launched at the end of 2020.
RT-TG is an Inserm innovation center located in Génopole d'Evry with the mission of promoting research excellence in gene and cell therapy by facilitating the transfer of therapeutic discoveries to clinical or industrial applications. ART-TG is a pre-industrial laboratory for testing technological innovation and pharmaceutical product and process development. ART-TG is now leading several innovative projects based on lentiviral vectors, or CRISPR genome editing tools for ex vivo uses, focusing on immunotherapy and hematology. ART-TG is a subsidiary of the industrial integrator MAGENTA (MAnufacturing Cell and GEN Therapy Advances) of the French Government Biomedicines Challenge.
About WhiteLab Genomics
WhiteLab Genomics, founded in 2019 by David Del Bourgo, Julien Cottineau, and Lucia Cinque, is a French start-up specialized in artificial intelligence solutions for biotherapies such as gene and cell therapies. Its proprietary technology enables multi-parametric analysis of complex biological data to optimize and reduce treatment development costs. WhiteLab Genomics makes this one-of-a-kind technology available to its clients through the Catalyst platform, which is available in SaaS mode. The start-up is presently based in Genopole - Evry, France's first biocluster, and Station F.