Shanghai, December 10, 2023 – Dizal today presented the full analysis of the multinational pivotal study of golidocitinib for r/r PTCL (JACKPOT8 PART B) in an oral presentation at the 65th American Society of Hematology Annual Meeting and Exposition (2023 ASH, San Diego). The results were simultaneously published in the prestigious peer-reviewed journal The Lancet Oncology (Impact Factor: 54.4). This follows the publication of the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PART A) in Annals of Oncology (Impact Factor: 51.8) three months ago. Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. A total of 104 patients with r/r PTCL were enrolled in the JACKPOT8 PART B study to evaluate the efficacy and safety of golidocitinib as a monotherapy. At the cut-off date of August 31, 2023, per independent review committee ...
IGM Biosciences plans to axe 22% of its workforce, becoming the latest company to downsize in a bid to free cash resources. Amid the layoffs, the US-based biotechnology company will also reprioritise its pipeline, discontinuing operations for all haematologic oncology and targeted cytokine product development while doubling down on its efforts in the clinical development of T cell engagers for autoimmune diseases and a DR5 agonist for colorectal cancer. IGM expects the restructuring to extend the company’s cash runway into Q2 2026. The restructuring comes less than a month after the company said it anticipated an increase in headcount to support the research and development of its pipeline candidates, citing its intent to advance and expand its antibody product pipeline, in its 13 November 10-Q filing. In the same filing, the company acknowledged that it had significant net losses to date and that achieving profitability sufficient enough to offset the ...
As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs. Together, those meds will help the company deliver pharmaceutical sales growth of 5% to 7% between 2025 and 2030, the company said Tuesday. That phalanx of novel products will be essential as J&J’s longstanding immunology star, Stelara, nears its tumble over the patent cliff. Last year, the drug generated $9.7 billion and was J&J’s top product by sales. During an enterprise business review Tuesday, J&J laid out its expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast 10 or more drugs with peak sales potential of at least $5 billion, including cancer launches Talvey and Tecvayli, plus another 15-plus products with sales potential of at least $1 billion. The latter group of therapeutics ...
Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
Cancer Research UK (CRUK), its innovation unit, Cancer Research Horizons, and Guardant Health have announced a collaboration to advance the development and precision of cancer detection and treatment. The mission-focused collaboration aims to accelerate the discovery and development of cancer drugs and diagnostics for patients. Affecting 20% of people in the UK, rare cancers are forms of cancer that can occur in unusual places in the body, requiring special treatment. Challenging to treat, rare cancer types include melanoma skin cancer, kidney cancer, brain tumours, non-Hodgkin lymphoma and pancreatic cancer. As part of the agreement, the parties will be able to discuss opportunities for collaboration to support CRUK’s research and development activities. In particular, the agreement will focus primarily on the charity’s clinical trials run by its Centre for Drug Development (CDD), including the DETERMINE trial, as well as other CRUK and Cancer Research Horizon research collaborations. The DETERMINE trial is ...
Canada-based Phenomic AI has landed two strategic collaborations this week with Boehringer Ingelheim and Astellas-owned cell therapy biotech Xyphos Biosciences to develop cancer therapies. Phenomic and Boehringer have teamed up on a target identification collaboration, announced on 29 November. Under the deal, Phenomic will receive an upfront payment of $9m and may be entitled to up to $500m in research funding and milestones. The Canadian company hasn’t disclosed the financial terms of the deal with Astellas, but the companies aim to develop cell therapies with an antibody directed at a novel target of the tumour stroma, utilising Phenomic’s scTx platform. The company singled out colorectal and pancreatic cancers as being stroma-rich, which would be amenable to being targeted by Phenomic’s platform. These developments mark the first deals announced by Phenomic in three years since the company launched in 2020 with $6m in seed funding. Phenomic’s scTx is a single-cell RNA ...
By Tyler Patchen AbbVie is the latest big pharma to target the hot antibody-drug conjugate market by acquiring ImmuoGen and its Elahere ADC for platinum-resistant ovarian cancer. The deal worth $10.1 billion was announced Thursday. Under the terms of the agreement, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share. The board of directors of AbbVie and Immunogen have approved the acquisition, which is expected to close sometime in the middle of 2024. The deal will give AbbVie access to Elahere (mirvetuximab soravtansine-gynx), which was granted FDA accelerated approval last year, and ImmunoGen’s follow-on pipeline of ADCs. ImmunoGen currently has several ADCs in development for treatments such as solid tumors, acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm, among other conditions. “The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid ...
Pharmaceutical Executive Editorial Staff AbbVie acquiring all outstanding shares of ImmunoGen, Inc. for $31.26 per share, valuing the company at a total equity value of approximately $10.1 billion. AbbVie Inc. has announced the acquisition of ImmunoGen, Inc. along with its first-in-class antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (Elahere), which has been FDA-approved to treat platinum-resistant ovarian cancer.1 With the transaction, AbbVie acquires in cash all outstanding shares of ImmunoGen for $31.26 per share, valuing ImmunoGen at a total equity value of approximately $10.1 billion. Boards of directors for both AbbVie and ImmunoGen approved the transaction, which they anticipate closing in mid-2024, subject to approval by ImmunoGen shareholders and regulatory agencies, as well as other customary closing conditions. The pending transaction is anticipated to be accretive to diluted earnings per share starting in 2027. In a press release, AbbVie said the acquisition accelerates its commercial and clinical presence in the solid tumor ...
Boehringer Ingelheim and IBM have announced a partnership aimed at advancing generative artificial intelligence (AI) and foundation models for therapeutic antibody development. The collaboration agreement will see Boehringer use an IBM-developed, pre-trained AI model that will be “further fine-tuned” on the German drugmaker’s specific proprietary data to help accelerate the pace at which it can create new antibody therapeutics. The companies noted that, despite “major” technological advances, the discovery and development of therapeutic antibodies against diverse targets remains a “highly complex and time-consuming process”. IBM’s foundation model technologies, which have already shown success in generating biologics and small molecules with relevant target affinities, are used to design antibody candidates for specific disease targets. These are then screened with AI-enhanced simulation to select and refine the best binders for the target. Boehringer Ingelheim outlined that it will produce small quantities of the candidates that can be tested experimentally. Andrew Nixon, global ...
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