Ipsen has joined the slew of companies developing antibody-drug conjugates (ADC) with the announcement of a new global licensing agreement with Sutro Biopharma for the development of the latter’s STRO-003. Ipsen declared that the deal would give it exclusive worldwide rights to develop and commercialise the ROR1-targeting ADC STRO-003. Ipsen is accountable for Phase I preparations, including investigational new drug application (IND) submissions. The Paris, France-headquartered company will also be responsible for the later clinical development and global commercialisation of STRO-003. Under the partnership, Sutro Biopharma could receive up to $900m in prospective upfront, development, and commercial milestone-based payments. This is inclusive of $90m in near-term payments in the form of tiered royalties on global sales, and an equity investment, dependent on Ipsen’s successful development and commercialisation strategy. STRO-003 is one of three named ADCs being developed in Sutro’s clinical pipeline. In June 2023, Sutro announced plans to submit INDs ...
Recently, the 33rd Annual Meeting of the Asia-Pacific Association for the Study of the Liver (APASL 2024) presented a study (GM-DILI-002) analyzing the efficacy of Chiatai Tianqing magnesium isoglycyrrhizinate (MgIG) in the treatment of liver injury associated with a novel antitumor drug based on real-world data from China, and the results of the study (No. 100906 and No. 100910) fill the evidence-based Gap. This real-world, non-interventional, multi-center, retrospective study was conducted in three main settings. The study was based on an e-diagnostic system that screened and analyzed data from a population of 1,710 patients who met international liver biochemical criteria related to DILI (drug-induced liver injury) during treatment with novel antineoplastic agents. In recent years, the emergence of new antitumor drugs, such as molecular targeting and immune checkpoint inhibitors, has led to a continuous improvement in the survival of tumor patients, but at the same time the problem of drug-related ...
Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
SHANGHAI and NANJING, China and SAN JOSE, Calif., March 29, 2024 /PRNewswire/ — IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the ...
Today (March 29), according to the official website of CDE, Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “Hengrui Pharmaceutical”) class 1 new drug SHR-1139 injection indicated for psoriasis application obtained approval. Psoriasis is a chronic inflammatory skin disease that is stimulated by environmental factors, genetic control, and immune media. According to relevant data, there are more than 7 million psoriasis patients in China. Fhstrilin predicts that China’s psoriasis market will increase to US $ 9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of patients with psoriasis is on the rise. At present, biopharmaceuticals have gradually become one of the mainstream therapies of psoriasis in China. Related drugs are mainly focused on targets such as TNF-α and IL families. Hengrui Pharmaceutical also deployed psoriasis therapy drugs, of which Fu Niqizumab (SHR-1314) targets IL-17A targets. Following the CDE acceptance of the listing of ...
Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines. Univercells is a global life sciences company creating platforms for developing and manufacturing biologics, including mRNA vaccines and therapeutics, in a simple, scalable and cost-efficient way. Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform. Should the experiments prove successful, Univercells and Altamira intend to discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines using Univercells’ production platform. Covadonga Pañeda, PhD, Altamira’s ...
The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases Strand Therapeutics, a Massachusetts Institute of Technology (MIT) spinout, has developed a new class of advanced mRNA molecules for more targeted and powerful treatments for cancer. The new class of mRNA molecules is designed to sense what type of cells they encounter in the body and express therapeutic proteins once they have entered diseased cells. Most next-generation cancer immunotherapies are based on recombinant proteins, which are challenging to deliver to specific targets in the body and do not remain active for long enough to create a durable response. Strand has developed the world’s first mRNA programming language to improve mRNA molecules’ ability to sense their environment and generate targeted responses where needed most, allowing the company to specify the tissues its mRNAs express proteins in. In addition, the company uses techniques such as ...
ROCKVILLE, Md. and SUZHOU, China, March 27, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy. Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant ...
Sepsis poses a grave risk in which a severe immune reaction to infection leads to organ damage. Identifying sepsis in children is complex since the symptoms mirror those of many pediatric illnesses. Presently, if sepsis is suspected, medical practitioners administer antibiotics, increase fluids, and intensify monitoring for the child, leading to some receiving unneeded treatments. Now, a new technique developed by researchers can predict the likelihood of a child developing sepsis and succumbing to organ failure. The research by investigators at the University of Queensland (Brisbane, Australia) involved more than 900 critically ill children in the emergency departments and intensive care units across four hospitals. Blood samples collected during the acute stage of their infection were examined for gene activation or suppression. This analysis allowed the researchers to identify gene expression patterns that could predict the child’s risk of organ failure within the next 24 hours, as well as whether ...
Cancer treatment isn’t always a one-size-fits-all solution, but the field of cancer research is making strides in matching patients with the most effective treatments for their specific conditions. A groundbreaking study now points to a significant finding related to testing that could enable thousands of cancer patients to receive the precise treatment they need. The research led by the University of Oklahoma (Oklahoma City, OK, USA) compared the effectiveness of immunohistochemistry (IHC) and next-generation sequencing (NGS) tests in newly diagnosed cancer patients to guide their treatment plans. These tests target the detection of high levels of microsatellite instability, a condition indicating the DNA’s diminished capacity to correct replication errors. Identifying microsatellite instability is crucial, particularly in colon and endometrial cancer patients, as it marks a higher likelihood of a positive response to immunotherapy, which enhances the immune system’s ability to fight cancer, compared to other treatments. IHC detects the absence ...
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