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News and publications
Pan-cancer analysis of whole genomes: In a massive international effort, researchers of the Pan -Cancer Analysis of Whole Genomes (PCAWG) consortium published a series of papers reporting the results of whole genome analyses of 2.658 tumors from 38 cancer types. This constitutes the largest collection of comprehensive cancer genomes to date, and has yielded a wealth of knowledge, including the identification of driver mutations for over 90% of tumors. Approximately 25% of tumors had potential driver mutations in non-coding regions, which would not have been detected by conventional exome sequencing. Moreover, the PCAWG database allowed analysis of clustered mutations, revealing the early occurrence of a catastrophic event called chromothripsis or ‘chromosome shattering’ in many tumors, often preceding the accumulation of point mutations. Results were published in Nature and affiliated journals. PCAWG data resources can be accessed here.
CAR-transduced NK Cells in CD19-Positive lymphoid tumors: Previous trials have shown clinical efficacy of Chimeric Antigen Receptor (CAR) T cell therapies, but at the risk of significant long-lasting toxicity. Liu et al developed a new therapy using CAR-transduced Natural Killer (NK) cells targeting CD19. In a Phase I/II trial, treatment of patients with relapsed/refractory non-Hodgkin’s lymphoma or chronic lymphocytic leukemia with this novel therapy led to a 73% objective response rate (and a 64% complete response rate) at a median follow-up time of 13.8 months. Moreover, toxicity was limited to transient hematological events, with no incidences of cytokine release syndrome, graft-versus-host disease or increased release of inflammatory cytokines. These early results indicate CAR-NK cell treatment is clinically effective with low toxicity. The paper was published in The New England Journal of Medicine.
- Aduro Biotech achieves milestone under Merck collaboration, for initiation of a Phase II trial evaluating efficacy and safety of the anti-CD27 agonist MK-5890 combined with pembrolizumab in non-small cell lung cancer (NSCLC). The development milestone of $10.0 million earned by Aduro shows the determination of Merck to further advance the development of MK-5690.
- Bicycle Therapeutics and Genentech enter exclusive collaboration, for developing and commercializing novel peptide-based immune-oncology therapies. Under the terms of this collaboration, Bicycle will receive a $30 million upfront payment and potential discovery, development, regulatory and commercial milestones up to $ 1.7 billion.
- Cantargia completed a directed share issue of approx. SEK410 million, with a price per share of SEK22.5. Investors are a wide range of Swedish and international companies including Swedbank Robur, HBM Healthcare Investments, Granite Point Capital, and Unionen. The net proceeds are intended to advance Cantargia’s lead drug candidate, the CAN04 antibody against the interleukin-1 receptor accessory protein, currently under evaluation in phase I/II clinical trials, towards Phase III trials.
The Committee for Medical Products for Human Use (CHMP) adopted a positive opinion for:
Extensions of indications:
- Brigatinib (Alunbrig, Takeda Pharma), for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer previously not treated with an ALK inhibitor.
The FDA granted approval for:
- Neratinib (Nerlynx, Puma Biotechnology), in combination with capecitabine, for treatment of adult patients with advanced/metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Approval was based on the Phase III NALA trial, whose results reported a progression-free survival rate of 29% at 12 months, a median overall survival of 32.8%, and an overall response rate of 32.8%.
The FDA also granted breakthrough therapy designation to the following drugs/devices to advance their development:
- Debio 1143 (Debiopharm), a novel inhibitor of apoptosis protein (IAP) antagonist used in combination with current standard of care, cisplatin-based chemoradiation, for frontline treatment of high-risk, locally advanced, unresectable squamous cell carcinoma of the head and neck.
- Enfortumab vedotin-ejfv (Padcev, Seattle Genetics and Astellas) combined with pembrolizumab, for treatment of patients with unresectable advanced/metastatic bladder cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
The new draft guidance published on 06Feb2020 by the FDA explains its new review process of biosimilars or interchangeable products. FDA will not license such a compound for an indication protected by orphan-drug exclusivity. Nevertheless, after expiration of the patent/exclusivity for the protected indication, the applicant can submit a supplement to the already-licensed biologics application. In this guidance, FDA now reduced the review time for these supplements from 10 to 6 months. Nevertheless, if the applicant does not want FDA to act before a specified date, the applicant can now request this to the FDA using pre-specified language.