PIGF

Pictured: Healthcare worker conducting an eye exam on a female patient/iStock, peakSTOCK 4D Molecular Therapeutics on Saturday unveiled topline results from its Phase II PRISM study, showing that its investigational gene therapy 4D-150 can significantly ease treatment burden in patients with wet age-related macular degeneration. Over 24 weeks of follow-up, 84% of patients treated with 4D-150’s higher 3E10-vg/eye dose did not need supplemental injections with Regeneron and Bayer’s Eylea (aflibercept), a cornerstone anti-VEGF therapy for wet age-related macular degeneration (AMD). At the lower dose group of 1E10 vg/eye, only one patient needed supplemental Eylea. Also, 63% and 50% of patients in the high- and low-dose groups, respectively, did not need supporting Eylea treatment. Overall, the high dose level of 4D-150 reduced annual Eylea injections by 89%, while the lower dose cut Eylea rates by 85%. In terms of safety, PRISM found no instance of significant inflammation, even in the high-dose group. In addition, 97% of treated patients completed their 20-week prophylactic topical corticosteroid taper according to schedule, while none of the patients were on steroids at the time of data collection. 4DMT reported these data at the Angiogenesis, Exudation, and Degeneration 2024 Conference, held virtually on Friday. CEO David Kirn said in a statement that the company is “thrilled” about these data, which “strongly validate 4D-150’s potential as a safe, convenient, durable and transformational intravitreal therapeutic for wet AMD patients, with a goal of preserving vision for the longer term.” “We believe 4D-150 has the potential to disrupt the current treatment paradigm in these patients,” Kirn added. 4D-150 is an investigational gene therapy that delivers a transgene cassette that expresses both aflibercept and an RNA interference molecule that blocks the VEGF-C protein. The double-payload approach allows 4D-150 to inhibit four VEGF family members—VEGF A, B, C and PIGF—which are central to the pathology of wet AMD and diabetic macular edema. The investigational gene therapy also uses 4DMT’s proprietary R100 vector, which enables its single, low-dose intravitreal delivery that avoids significant inflammation. 4DMT is planning to take 4D-150 into late-stage studies based on ongoing talks with the FDA and European Medicines Agency. The first Phase III study, which is set to launch in the first quarter of 2025, will be a non-inferiority study versus Eylea using the higher dose of 4D-150. In the latter half of 2024, the company is expecting interim 24-week landmark data analysis from PRISM’s population extension cohort, which is looking at 4D-150 in a patient population with broader disease severity. 4DMT is also trialing the gene therapy in diabetic macular edema, for which it is running the Phase II SPECTRA study. Initial data and analysis are also expected in the latter half of 2024. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Oxurion said Monday that it will file for bankruptcy after its only ongoing clinical study failed to meet its primary endpoint. The Phase II KALAHARI trial was investigating the experimental plasma kallikrein (PKal) inhibitor THR-149 in patients with diabetic macular oedema (DME) who have previously shown a suboptimal response to anti-VEGF therapy.However, top-line results showed that in Part B of the study – which included 112 patients - THR-149 did not improve vision as much as Sanofi and Regeneron Pharmaceuticals’ anti-VEGF therapy Eylea (aflibercept) at month three. Specifically, the mean change in best corrected visual acuity (BCVA) from baseline at was -0.2 letters forTHR-149 and +3.5 letters for Eylea.CEO Tom Graney said he is “deeply disappointed” in the results, adding that combined with Oxurion’s low cash position, the board “has made the difficult decision to take the necessary steps to file for bankruptcy.”Last year, the company stopped development of the integrin antagonist THR-687 in DME after the first portion of a Phase II study failed to meet its efficacy endpoints. Prior to this, Oxurion’s PIGF inhibitor THR-317 did not show an increase in BCVA in the same indication.

Chime Biologics and Panolos Bioscience have entered into a global strategic collaboration agreement on a novel multi-specific protein drug. Chime Biologics will provide development and manufacturing services to Panolos Bioscience for PB203, a next-generation immuno-oncology drug. WUHAN, China and HWASEONG-SI, South Korea, Sept. 22, 2023 /PRNewswire/ -- Chime Biologics, a leading CDMO that enables biologic therapeutics development announced a strategic cooperation agreement with Panolos Bioscience, a South Korean biotech company to accelerate multi-specific protein development, at a signing ceremony held in Optics Valley Wuhan, Hubei Province on the 19th of September. Dr. HyeSeong Lim, Founder and CEO of Panolos Bioscience, and Mr. YoungHoon Cho, Chief Business Officer of Panolos Bioscience, as well as Chime Biologics' team attended the signing ceremony. Panolos Bioscience, located in the suburb of Seoul, Korea, is a biopharmaceutical company focused on the development of multi-specific therapeutics to treat cancer, auto-immune diseases and rare diseases. Panolos Bioscience has entered into a collaboration with Chime Biologics for a novel multi-specific protein drug, PB203, for solid tumors (PDAC/ICC), which is in the preclinical stage with plans to conduct clinical trial Phase I in the US. Chime Biologics will provide an one-stop biologic CMC solution for the development and manufacturing of PB203 from cell line development, process development, and GMP manufacturing service. And it will be based on the unique Chime's CHOrus platform, which has a highly productive, rapid, and stable cell line development capability to select the optimal stable expression clones based on expression titer and quality. The leaders from the Consulate General of the Republic of Korea, Foreign Affairs Office of Wuhan Municipal People's Government, Wuhan East Lake High-tech Development Zone, and Wuhan National Bio-Industry Base Construction Management Office witnessed the signing ceremony, and this agreement underlines the strong collaboration between China and Korea. Dr. HyeSeong Lim, Founder and CEO of Panolos Bioscience, said, "We are pleased to be a global strategic partner with Chime Biologics, and the co-development of PB203 is an important start in establishing our long-term strategic cooperation in Wuhan, China, covering commercial manufacturing. This is the first step in our shared mission to the commercialization of innovative medicines, starting from China and spreading to the world. By partnering with global CDMO Chime Biologics, we will do our best to bring hope and a new life to our patients." Dr. Jimmy Wei, President of Chime Biologics, said, " We are very excited to work with Panolos Bioscience to drive the project to Wuhan, China, taking unique advantage of Chime's CHOrus cell line development platform that enables the US clinical trials and global sampling. This is not only a recognition of Chime Biologics' new business model and international quality system, but also an important development journey for Chime Biologics to go globally. We believe that Chime Biologics' high-quality platform and rich experience will facilitate the global R&D, clinical trials and future commercial manufacturing of multi-specific therapeutic proteins." About PB203 PB203, a multi-specific protein targeting VEGF, PIGF, and PD-L1, is currently in pre-clinical development as a potential remedy for solid tumors, notably pancreatic cancer. Its promising efficacy, published in Nature Communication in 2022, was further accentuated during an oral presentation at this year's Immuno-Oncology Summit in the US. This notable discourse emphasized its clear therapeutic mechanism and potential impact on pancreatic cancer treatment. About CHOrus Chime Biologics has a highly productive, rapid, and stable cell line development platform to select the optimal stable expression clones based on expression titer and quality. The cell line development is based on our proprietary and highly expressed CHO system. Chime's CHO-K1-derived cell lines have a clear history of use and are tested and qualified. We use advanced single-cell printers and high-resolution imaging systems to ensure cell line monoclonality and shorten the screening time. Cell line generation and monoclonality are fully documented and traceable according to regulatory requirements. Expression titer can exceed 10 g/L. About Panolos Bioscience Panolos Bioscience is a clinically staged frontrunner in structure-based protein design and development. Panolos focused on the development of therapeutics for cancer, anti-immune and rare diseases, with a proprietary αART technology that enhances the efficacy of mono-specific or multi-specific antibody therapies through the use of the VEGF receptor backbone. For more information, please visit . About Chime Biologics Chime Biologics is a leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners' success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health. For more information, please visit .