The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
As attendees of last year’s American Society of Hematology (ASH) meeting heard, B-cell maturation antigen (BCMA)-targeting therapies are steadily gaining ground on various fronts, even as companies such as Springworks Therapeutics Inc. bring forward candidates that might boost activity of the class.
LONDON – Researchers have discovered a T-cell receptor (TCR) that is both capable of targeting a range of solid tumors and independent of human leukocyte (HLA) type, opening up the prospect of developing a universal anticancer T-cell therapy.
When they work, T cells work great. And the folks at Avidea Technologies Inc. want to make them work more often. Combining expertise in immunology and polymer chemistry, the Baltimore-based startup is developing antigen delivery technology to improve T cell-targeted vaccines.
Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.
Physician, scientist and investor Patrick Soon-Shiong might be considered a "square peg in a round hole," he admits. But the Abraxane inventor's work to enlist natural killer, dendritic and T cells in what he calls a "triangle offense" against cancer is finally coalescing, he recently told BioWorld.
SANTA CLARA, Calif. – Just as it does with treatments, the National Comprehensive Cancer Network (NCCN) offers detailed guidelines on genomic testing by cancer type. These are key in determining what physicians can prescribe routinely and what insurers will cover. But those guidelines aren’t followed regularly outside a major research hospital setting, thereby obviating access to tumor genetic information that could help to better guide treatment. Even if current guidelines are followed, physicians and patients can get information back from the tests that neither party is prepared to process.
LONDON – Ionctura SA has closed a €15 million (US$16.6 million) series A to fund phase I development of its lead cancer program, IOA-244, and prepare a second product, IOA-289, for clinical development.
PDC*Line Pharma SA raised €13.9 million (US$15.4 million) in a series B round plus another €6.1 million in loans and grants from the Walloon region of Belgium to take its allogeneic cell-based cancer immunotherapy, PDC*lung-01, into a phase I/II trial in patients with metastatic lung cancer.
HONG KONG - Singapore-based biotech Aum Biosciences Pte. Ltd., and Toronto, Canada-based biotech Cyclica Inc. have agreed to work together to apply Cyclica’s drug discovery platform in Aum’s R&D programs for the discovery of potential new cancer therapies. Aum will deploy its drug R&D skills including a biomarker-driven approach while Cyclica will contribute its AI-augmented platforms, Ligand Design and Ligand Express.
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