Kodiaks AMD med posts promising phase 1b data in 3 eye diseases

Fiercebiotech | July 29, 2019

Kodiak Sciences anti-VEGF drug improved vision and reduced retinal thickening in patients with three diseases of the retina in a phase 1b study, results of which were presented this weekend at the annual meeting of the American Society of Retina Specialists (ASRS). The drug is on track to enter a phase 2 study in wet age-related macular degeneration (AMD) in the third quarter. Vascular endothelial growth factor (VEGF) is not a new target in eye disease—it is, after all, the target of Regeneron and Bayer’s blockbuster Eylea, which is approved for all three of the diseases Kodiak looked at in the phase 1b study. Eylea, a drug that’s injected directly into the eye can be—understandably—unappealing to patients. This is where Palo Alto, California-based Kodiak thinks it has an advantage. Eylea and Kodiak’s KSI-301 are both anti-VEGF biologics. They work by blocking VEGF to prevent the growth of leaky blood vessels in the eye. But KSI-301 has an extended ocular half-life, meaning it sticks around in the eyes for longer, which would allow patients to go longer between injections. The hope is that more patients will continue with treatment if injections are less frequent. The phase 1b study tested KSI-301 in patients with AMD, diabetic macular edema (DME) or macular edema stemming from retinal vein occlusion (RVO). The growth of leaky blood vessels in the eye leads to retinal scarring and the death of photoreceptors, hallmarks of wet AMD. Macular edema is the buildup of fluid in the macula, which is in the center of the retina. The swelling of the macula leads to distorted vision. RVO is swelling caused by the blockage of veins in the retina, while DME is a consequence of diabetic retinopathy, a complication of diabetes in which high blood sugar damages the retina’s blood vessels.

Spotlight

Bacteriophage (phage) therapy, i.e., the use of viruses that infect bacteria as antimicrobial agents, is a promising alternative to conventional antibiotics. Indeed, resistance to antibiotics has become a major public health problem after decades of extensive usage. However, one of the main questions regarding phage therapy is the possible rapid emergence of phage-resistant bacterial variants, which could impede favorable treatment outcomes.

Spotlight

Bacteriophage (phage) therapy, i.e., the use of viruses that infect bacteria as antimicrobial agents, is a promising alternative to conventional antibiotics. Indeed, resistance to antibiotics has become a major public health problem after decades of extensive usage. However, one of the main questions regarding phage therapy is the possible rapid emergence of phage-resistant bacterial variants, which could impede favorable treatment outcomes.

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MEDTECH

Benchling is expanding into the early development market to accelerate the creation of breakthrough products

Benchling | September 17, 2021

Benchling , innovator of the research and development (R&D) cloud for the biotechnology industry, today announced its entry into the early development market. The company brings new solutions to market that enable scientists for the first time to work seamlessly from research to development in a single system. By expanding the range of services, the Benchling R&D cloud is designed to offer both the flexibility and speed required for research efficiency as well as the control and conformity required for compliance with regulations. The market and society are putting unprecedented pressure on R&D companies to develop new products and get them to market faster. Vaccines typically take years to develop. But in developing COVID-19 vaccines and therapies, researchers have been able to get them ready for clinical trials in a matter of months. Faster time to market for innovative biotech products can mean that patients can receive new treatments for life-changing diseases faster, such as the COVID-19 vaccines. It can also mean producing more food with less energy, enriching consumer lives with ethically sourced products, and making businesses more climate-friendly. The development of such complex, important products requires modern technologies. Different individual solutions for electronic laboratory notebooks (ELN), laboratory information management systems (LIMS) and laboratory execution systems (LES) form silos that exacerbate the challenges of complex collaboration. They force scientists to spend time comparing data between different systems instead of gaining important insights that accelerate product development. With more than 600 customers spanning a wide range of company sizes, industries and scientific use cases, Benchling relies on customer partnerships to expand its product range. Here are examples of benchling customers who have improved their development speed, scientific knowledge and collaboration within their R&D organizations: Syngenta is one of the world's largest producers of novel seeds. Worldwide, 35 percent of food is rendered unusable by pests and diseases. New biological solutions and better built-in defense mechanisms not only protect against food waste, but also reduce the need for harmful chemicals that pollute the environment. Syngenta's work relies on scaling, as our researchers: internally test hundreds of thousands of seeds in a variety of growing environments. When we discover viable varieties that meet the needs of farmers, we need to replenish our seed stocks quickly for testing in laboratories, greenhouses and field trials around the world,“Thanks to benchling, we said goodbye to paper. Our global seed R&D teams can efficiently work together on a single platform to standardize the development of seed varieties from the laboratory to the test field. This has enabled us to restructure much of our work and accelerate the time-to-market for new seed products. - Charlie Baxter, Head of Traits, Regulatory and Product Safety at Syngenta. New workflows: Benchling has expanded the workflows application to support collaboration between specialized R&D teams. Users can now coordinate tasks and processes across teams with full traceability, including methods, samples and inventory. Project managers gain insight into ongoing processes in order to reduce bottlenecks and increase productivity. Workflows help teams from research to development to work together more efficiently and to reach important milestones more quickly. Structured Templates: With Benchling's new, more structured templates, product development teams can easily create common, standardized processes for repeatable experiments, analytical tests, QC protocols and more. These procedures can be regulated in a targeted manner in order to meet compliance requirements. Validated cloud: At the beginning of 2021, Benchling switched to a validated cloud in order to be able to provide the platform for customers in a GxP environment. About Benchling Benchling is the pioneer for the R&D cloud, software that supports the biotechnology industry. Globally, more than 200,000 scientists in over 600 companies and 7,000 research institutions use Benchling's R&D cloud to make groundbreaking discoveries and bring the next generation of drugs, food and materials to market faster than ever before. The R&D cloud is helping these companies modernize their scientific processes and accelerate collaboration so they can transform the complexities of biology into world-changing results.

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MEDICAL

HTL Announces Its Incubator's Equity Investment In GelMEDIX, An Early-Stage Biotech Aiming At Revolutionizing Ocular And Regenerative Therapies

HTL | March 14, 2022

HTL Biotechnology, a pioneer and world leader in the development and production of innovative pharmaceutical grade biopolymers, today announced its incubator's first equity investment in GelMEDIX Inc., an early-stage biotechnology company committed to developing the next generation of ocular and regenerative therapies. This investment supports continued development of the GelMEDIX platform, which enables the delivery of therapeutics from small molecules to cell and gene therapies. Initial research focuses on ophthalmology with lead programs in vision restoring cornea and retina cell therapies and sustained release small molecule therapies. GelMEDIX's most advanced program is focused on developing a sustained release corticosteroid subconjunctival implant which aims to improve patient care in ocular surface inflammation (postoperative pain and inflammation, dry eye disease, allergic conjunctivitis). One drug-loaded implant replaces 70 patient administered eye drops over the course of one month. Instead of using drops, one easy treatment will be administered in the operating theater or in the clinic without any loss of efficacy. In addition to anti-inflammatories, the platform technology can be used for delivery of pro-regenerative therapies that restore ocular health, As such, this product represents one of the most promising innovations deriving from our proprietary hydrogel platform." Reza Dana, M.D., M.P.H., M.Sc., Scientific Co-founder of GelMEDIX. This initial implant constitutes only one of the several research opportunities deriving from GelMEDIX's proprietary photocrosslinkable hydrogel platform, which uniquely enables tunable bioadhesion, tissue regeneration, and biodegradation. HTL's partnership with GelMEDIX also facilitates the development of new applications in regenerative medicine both in ophthalmology and other therapeutic areas. HTL's incubator will support GelMEDIX through a direct investment and industrial and scientific support throughout its development thanks to its expertise in biopolymers and ophthalmology sectors. HTL will also produce methacrylate hyaluronic acid, a key component for tailoring application specific parameters across the GelMEDIX pipeline including viscosity, bioadhesion, and therapeutic release profiles. Additionally, HTL will help GelMEDIX in the industrialization of its hydrogel production. It is an honor to have the support of such a renowned company as HTL. Beyond the financial aspect, its keen understanding of ophthalmology issues, its industrial know-how and the high quality of its products are all crucial assets to accelerate GelMEDIX's development." Arthur Driscoll, President and Chief Development Officer of GelMEDIX. HTL's incubator is a financial vehicle allowing HTL to take minority investments in innovative biotechs in the biopolymer sector, either as seed funds or as series A investments. The incubator also aims to support these biotechs thanks to HTL's unique knowledge and expertise in the production of biopolymers. Innovation is the core of HTL's DNA, which is why we aim at supporting tomorrow's medicine by investing in biotechs that are pushing away the limits of biopolymer use in the medical sector, We are really excited about this partnership with GelMEDIX, which is a perfect example of the type of biotechs to which we wish to provide strategic and financial support". Charles Ruban, Deputy CEO of HTL. This incubator represents one of the strategic axes of HTL's ambitious R&D strategy which positions the French company as the global driver of innovation in the biopolymer sector, developing new markets and applications for biopolymers to address unmet medical needs. The company also relies on its state-of-the-art research facility and numerous partnerships with entities at the forefront of world research to nurture its biopolymer platform for the healthcare industry. About GelMEDIX GelMEDIX Inc. is an early-stage biotechnology company committed to innovating the next generation of ocular and regenerative therapies through its proprietary hydrogel platform. GelMEDIX's programs are based upon its photo crosslinked hydrogels, originally developed by Prof. Nasim Annabi (UCLA) and Prof. Reza Dana (Mass Eye and Ear, Harvard Medical School). These hydrogels uniquely enable bioadhesion, tissue regeneration, tunable mechanics, and therapeutic loading across modalities from small molecules to cell and gene therapies. GelMEDIX is developing drug products for indications across the eye focused on cell-based therapies for vision restoration, intraocular sustained release of small molecules and peptides, and in situ forming bioadhesives. GelMEDIX is backed by Safar Partners and HTL Biotechnology along with leading angel investors and is currently raising a Series-A financing. GelMEDIX is based in Cambridge, MA., USA. About HTL HTL is a leading biotech and industrial player in the development and production of innovative, pharmaceutical-grade biopolymers that are used by leading pharmaceutical and medical device companies to transform the lives of millions of patients in multiple therapeutic areas such as ophthalmology, dermatology, medical aesthetics, rheumatology, and urology.

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CELL AND GENE THERAPY

AbbVie and Caribou Biosciences Announce Collaboration and License Agreement for the Research and Development of CAR-T Cell Therapeutics

AbbVie | February 11, 2021

AbbVie and Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome altering biotechnology organization, reported today that they have gone into a cooperation and permit arrangement for the innovative work of fanciful antigen receptor (CAR)- T cell therapeutics. Albeit allogeneic, "off-the-shelf" CAR-T cell therapies have indicated early guarantee in some malignancy patients, the requirement for beating the dismissal of allogeneic CAR-T cells by the host immune system stays a vital test to their more extensive turn of events. Utilizing Caribou's CRISPR genome editing platform to engineer CAR-T cells to withstand have resistant assault would empower the advancement of the next-generation of "off-the-shelf" cellular therapies to benefit a broader patient population. "We are excited to partner with AbbVie on the development of new CAR-T cell therapies. This collaboration validates Caribou's differentiated next-generation CRISPR genome editing technologies that provide best-in-class efficiency and specificity," said Rachel Haurwitz, Ph.D., President and Chief Executive Officer of Caribou. "We believe AbbVie is an ideal partner for Caribou as we expand upon the number of targets and diseases addressable by our technologies. Genome-edited CAR-T cell therapies hold tremendous potential for patients, and this partnership accelerates our ability to address significant unmet medical need." About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. About Caribou Biosciences, Inc. Caribou is a leading clinical-stage CRISPR genome editing biotechnology company founded by pioneers of CRISPR biology. Outside of this collaboration, Caribou is advancing an internal pipeline of allogeneic cell therapies for oncology. CB-010, Caribou's lead allogeneic CAR-T cell program, targets CD19 and is being evaluated in a Phase 1 clinical trial for patients with relapsed/refractory B cell non-Hodgkin lymphoma. CB-011, Caribou's second allogeneic CAR-T cell therapy, targets BCMA for multiple myeloma, and CB-012, Caribou's third allogeneic CAR-T cell therapy, targets CD371 for acute myeloid leukemia. CB-011 and CB-012 are in preclinical development. Additionally, Caribou is developing iPSC-derived allogeneic natural killer (NK) cell therapies for solid tumors. Through its next-generation CRISPR genome editing technologies, Caribou is implementing multiple strategies to boost CAR-T and NK cell persistence to overcome cell exhaustion and to prevent rapid immune-mediated clearance. These sophisticated edits drive the durability of clinical benefit of these off-the-shelf medicines.

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