Rucaparib Camsylate

The National Institute of Health and Care Excellence (NICE) has recommended pharmaand’s (pharma&) Rubraca (rucaparib) as a first-line maintenance treatment option for a subset of advanced ovarian cancer patients. The health technology assessment agency has recommended in final draft guidance that the drug be used on the NHS in England, Wales and Northern Ireland to treat advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have had a complete or partial response to first-line platinum-based chemotherapy. Eligible patients must also be without a BRCA mutation and have homologous recombination deficiency (HRD) positive or negative disease, as well as not be able to receive bevacizumab. NICE’s decision follows an approval from the Medicines and Healthcare products Regulatory Agency in January 2024 and is supported by positive results from the late-stage ATHENA trial. In the ATHENA-MONO arm of the study, Rubraca monotherapy significantly improved investigator-assessed progression-free survival as a first-line maintenance treatment compared to placebo. The safety profile observed in the ATHENAMONO arm was also consistent with both the current US and European licenses for Rubraca. Ovarian cancer is the sixth most common cause of cancer-related death among women in the UK, with an estimated 7,500 new cases of the disease diagnosed between 2017 and 2019. Despite recent advances in newly diagnosed ovarian cancer, advanced cases of the disease are still considered incurable for the majority of patients. Rubraca belongs to a class of drugs called PARP inhibitors, which are designed to block the actions of proteins that help repair damaged cancer cells. Frank Rotmann, founder and managing director, pharma&, said: “[This] decision marks a significant step forward for women with advanced ovarian cancer in England, Wales and Northern Ireland. “We are committed to ensuring that all eligible patients are able to access and to potentially benefit from [Rubraca].” pharma& acquired Rubraca from Clovis Oncology in 2023 as part of an auction associated with Clovis’ bankruptcy proceedings. The company paid $70m upfront for the rights to the drug, according to a regulatory filing at the time, which also outlined that the company could pay another $65m if certain regulatory and sales milestones are met.

LONDON and MONTREAL, Oct. 24, 2024 /PRNewswire/ -- Cancer Research UK, one of the world's largest funders of cancer research, and KisoJi Biotechnology Inc., a company focussed on the discovery and development of antibody therapeutics, have signed a landmark agreement to bring KisoJi's lead asset, KJ-103, into a first-in-human clinical trial. KJ-103 is a naked anti-TROP2 antibody that has been created by KisoJi using its proprietary antibody technology. Continue Reading Cancer Research UK Logo Under the agreement, Cancer Research UK's Centre for Drug Development (CDD) will sponsor, design and deliver a Phase 1/2a clinical trial of KJ-103, in selected TROP2 expressing solid tumours. KisoJi will supply the antibody for the clinical trial and work with CDD to complete the preclinical package. Cancer Research Horizons, Cancer Research UK's innovation arm, will manage the commercial relationship. Unlike antibody drug conjugates (ADCs), KJ-103 does not require a cytotoxic payload but instead functions by recruiting immune cells to kill tumour cells. KJ-103 binds to TROP2 in a location distinct from where current TROP2 ADCs bind. It uses TROP2 as a way of directing macrophage activation and phagocytosis of the tumour cells expressing it, leading to tumour cell death. KJ-103 may provide an alternative treatment option for TROP2-expressing cancers in which TROP2 ADCs have proven ineffective or are not suitable due to their toxicity profile. Tumour types expressing TROP2 include: colorectal, head and neck, ovarian, breast, bladder and lung cancers. Lars Erwig, Director of the CDD, said: "We are excited to collaborate with KisoJi to bring KJ-103 into clinical development. This partnership aligns with our mission to explore innovative therapeutic approaches for hard-to-treat cancers. With KJ-103's unique mechanism of action, which harnesses the body's immune system without the potential toxicity of a drug conjugate, we hope to offer new treatment options for patients with TROP2-expressing solid tumours." David Young, co-founder and CEO of KisoJi said: "We are thrilled to be advancing KJ-103 into the clinic in partnership with Cancer Research UK. As the first naked antibody to target TROP2 cancers, KJ-103 is the first of a new wave of antibodies to come from our modernised technology platform that leverages AI grounded in biology to create transformative antibody therapeutics." About Cancer Research UK's Centre for Drug Development Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. Six of these new agents have made it to market, including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase 3 trials. Thirteen agents remain in active development with the potential to reach the market. It currently has a portfolio of 16 projects in preclinical development, Phase 1 or early Phase 2 clinical trials. About KisoJi Biotechnology KisoJi is a Canadian biotechnology company that deploys the latest scientific and AI tools to conduct therapeutic antibody discovery in a fundamentally new way. KisoJi has developed a multi-species transgenic mouse to generate highly diverse single domain antibodies, as well as a modular multi-specific antibody scaffold with high stability and productivity. Most recently, KisoJi has used advanced AI tools to visualise the universe of all antibodies against a target in order to uncover novel biology and new therapeutic antibody capabilities for its partners and its own pipeline. About KJ-103 KJ-103 is a single domain antibody that binds to a unique epitope on TROP2. It acts via effector cell mechanisms, including the activation of macrophages, to kill tumour cells. KJ-103 has been shown to have significant anti-tumour potency with no evidence of toxicity or resistance across a number of preclinical solid tumor models. KJ-103 was humanised by LifeArc. Cancer Research UK Contact: Tim Bodicoat [email protected] +44 203 469 8300 +44 203 469 8301 (out of hours) KisoJi Biotechnology Contact: Investors and Media Argot Partners Sam Martin/Cameron Willis [email protected] +1 212 600 1902 SOURCE KisoJi Biotechnology Inc.; Cancer Research UK WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED