Metastatic gastric adenocarcinoma

Phanes’ PT217 is a delta-like ligand 3 (DLL3) and a cluster of differentiation 47 (CD47- targeting bispecific antibody. Image Credit: Huen Structure Bio / Shutterstock. The US Food and Drug Administration (FDA) has granted an orphan drug designation to Phanes Therapeutics’ PT217 in neuroendocrine carcinoma (NEC) indication. This is the second orphan drug designation the therapy has received from the FDA. In 2022, PT217 received the designation for the treatment of small cell lung cancer (SCLC). The orphan drug status gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity for the therapy after approval, compared to the usual five years. PT217 is a delta-like ligand 3 (DLL3) and a cluster of differentiation 47 (CD47)-targeting bispecific antibody. Phanes is investigating the therapy in patients with advanced or refractory cancers expressing DLL3, including SCLC, extrapulmonary NECs, and large cell neuroendocrine carcinoma of the lung (LCNEC). The Phase I SKYBRIDGE trial (NCT05652686) is evaluating the safety, tolerability and pharmacokinetics of PT217 in combination with Roche’s PD-L1 therapy Tecentriq (atezolizumab). Multiple pharmaceutical companies have invested in the development of bispecific antibody therapies . Earlier this month, Merck & Co (MSD) unveiled plans to acquire a CD3 and CD19-targeting T cell engager bispecific antibody, CN201, from Curon Biopharmaceutical. The deal is worth approximately $1.3bn in upfront and milestone-based payments. It is expected to close in Q3 this year. In May, Johnson & Johnson (J&J) paid $1.25bn to acquire global rights for Numab Therapeutics’ IL-4R and IL-31-targeting bispecific antibody. The therapy is being evaluated as a treatment for atopic dermatitis in a Phase I trial (NCT05859724). See Also: AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting Hoth and Aronnax partner for HT-KIT cancer therapy development Other therapies in Phanes’s pipeline are a CD73-targeting monoclonal antibody PT199, a Claudin 18.2 (CLDN18.2), and the CD47-targeting bispecific antibody PT886. The company is evaluating PT199 as a combination treatment with BeiGene’s Tivimbra (tislelizumab) for solid tumours in a Phase I MORNINGSTAR trial (NCT05431270). The bispecific antibody PT886 is being trailed in combination with MSD’s Keytruda (pembrolizumab) in a Phase I/II TWINPEAK study (NCT05482893). The trial is expected to enrol approximately 114 participants with either unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC).

PRINCETON, N.J. and SUZHOU, China, Dec. 13, 2023 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the preclinical anti-tumor efficacy and safety results of [177Lu]Lu-TST001 have been published on European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI). In this preclinical studies, [177Lu]Lu-TST001 demonstrated significant antitumor efficacy with acceptable toxicity. It exhibits strong potential for clinical translation, providing a new promising treatment option for CLDN18.2-overexpressing tumors, including gastric cancer. This research was conducted in collaboration between Transcenta and the team of Professor Hua Zhu from Beijing Cancer Hospital. In this study, a [177Lu]Lu-TST001 radionuclide antibody conjugate was developed that targets CLDN18.2 using a DOTA-TST001 as a precursor and is labeled with 177Lu, a therapeutic radionuclide. The clear molecular imaging, favorable biodistribution, and pharmacokinetics of [177Lu]Lu-TST001 were validated in a mouse xenograft GC model. Moreover, this study explored the short-term therapeutic efficacy of [177Lu]Lu-TST001 radioimmunotherapy (RIT) against CLDN18.2-positive tumors and determined the optimal therapeutic dose in a GC tumor model. Safety under the treatment dose of the probe was also examined. Significant therapeutic effects with acceptable short-term toxicity were achieved in the mouse model. "The study represents the first application of the therapeutic radionuclide [177Lu]Lu-labeled CLDN18.2-targeting antibody TST001. This radionuclide antibody conjugate demonstrates great potential as an RIT drug for clinical application, which may offer a promising new treatment option for CLDN18.2-overexpressing tumors, such as gastric cancer, pancreatic cancer, esophageal cancer, and lung cancer, leading to improved survival outcomes." said Prof. Hua Zhu from Beijing Cancer Hospital. "Compared to localized gastric cancer, advanced metastatic gastric cancer often cannot be cured by chemotherapy or external radiation alone. In such cases, targeted RIT provides an opportunity to deliver radiation selectively to disease sites in patients with metastases, regardless of disease stage, offering a potential clinical treatment strategy for advanced tumor patients. We look forward to continuing our work with Prof Zhu and his team in an effort to bring [177Lu]Lu-TST001 radionuclide antibody conjugate to patients in the near future." said Dr. Xueming Qian, CEO of Transcenta. About Osemitamab (TST001) Osemitamab (TST001) is a high affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer. About Transcenta Holding Limited Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing. Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing 13 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. For more information, please visit and . Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta's competitive environment and political, economic, legal and social conditions. Transcenta, the Directors and the employees of Transcenta assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. Transcenta and Osemitamab are trademarks of Transcenta Holding Limited. All other brands and product names may be trademarks and/or registered trademarks of their respective owners. SOURCE Transcenta Holding Limited

TAIPEI, Nov. 23, 2023 /PRNewswire/ -- EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®. Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). Breast and gastric cancers are among the most frequently occurring in Europe, and combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines. The impact of both breast and gastric cancer in Europe is significant. Each year, over 355,000 women are diagnosed with breast cancer, and with 92,000 deaths per year, it is the number one cause of cancer death among women. Gastric cancer is the sixth most common of all cancer types and with 107,000 deaths annually it is the fourth most common cause of cancer-related death in Europe. In up to 20% of breast cancers and up to 30% of gastric cancers diagnosed, a HER2 protein overexpression (or HER2 gene amplification) is detected resulting in an uncontrollable growth and division of cells. HER2 cancers are particularly aggressive cancer types that respond well to targeted treatment. The authorisation of EG12014 in Europe expands access to a vital, high-quality treatment for breast and gastric cancers helping to ease the burden of these diseases on patients and delivering important savings for healthcare systems to ensure sustainability. EirGenix's trastuzumab biosimilar drug (EG12014) (150 mg lyophilized powder for injection) also received market approval by TFDA in June. The application of the health insurance pricing was approved by the National Health Insurance Administration under the Ministry of Health and Welfare in mid-September, paving the way for the formal launch of the product in Taiwan. EirGenix develops a series of HER2-positive breast cancer product combinations, including the second-generation HER2-positive targeted antibody drug Perjeta® (Pertuzumab), which are continuously advancing into the Phase III clinical trial. With the successful market introduction of the products, further market expansion and strengthening of the product's international competitive advantage will be realized. Website: