Accuray Inc. offered a classic good news-bad news set-up for investors on Wednesday, with a notable FDA 510(k) clearance balanced by a miss on fourth quarter revenue and projections for fiscal year 2024 significantly below consensus expectations. Still, the takeaway is generally positive, with several strong catalysts expected to build momentum for the company in the coming year and much of the underperformance attributable to foreign exchange headwinds that have plagued many med-tech companies.
Nanobiotix SA has landed Johnson & Johnson Inc. subsidiary Janssen Pharmaceutica NV as commercialization partner for NBTXR-3, a radioenhancer for boosting the effectiveness of standard radiotherapy, in a deal worth up to $1.86 billion for the initial indications. That headline figure covers current programs in head and neck cancers and lung cancers. There is the potential for Nanobiotix to earn up to $650 million more if Janssen decides to pursue up to five new indications that it will select, while for new indications that Nanobiotix selects to develop in alignment with Janssen, Nanobiotix will receive up to $220 million per program.
In a study published in Cancer Cell on May 25, 2023, researchers from the University of Chicago and colleagues reported that the inhibition of YTHDF2, an immune suppressor protein, can be a valuable strategy to improve radiotherapy outcomes by overcoming resistance while enabling extra help from the immune system.
Abdera Therapeutics Inc. emerged from stealth mode with $142 million in equity funding and plans to develop a pipeline of radiopharmaceutical drugs that will employ engineered heavy-chain-only antibody domains as targeting agents. It has already identified a lead, which targets delta-like ligand 3, a Notch pathway protein, which is overexpressed in about 80% of small-cell lung cancer cases, but which is absent from healthy tissue. A manufacturing campaign is now underway, and an IND submission is in the offing.
By using a statin to preferentially increase the expression of HER2 on tumor cells, researchers at Memorial Sloan Kettering were able to sensitize gastric cancers to a HER2-targeted radioligand in animal models of gastric cancer. Lovastatin aided the radioligand via two distinct mechanisms. First, it increased the availability of HER2 on the cell surface, allowing greater binding. It also had radioprotective effects on normal cells, reducing the toxicity of higher doses of radiation.
In its first trial designed to evaluate boron neutron capture therapy (BNCT) in the treatment of advanced refractory malignant tumors, Neuboron Medtech Ltd. has performed 14 irradiations on a dozen patients.
The other shoe dropped in a good way for backers of Actinium Pharmaceuticals Inc. as the firm popped the lid off full data from the phase III study called Sierra testing Iomab-B in patients age 55 and older with active relapsed or refractory acute myeloid leukemia (r/r AML). Antibody radiation conjugate (ARC) Iomab-B met the primary endpoint of durable complete remission of six months following initial complete remission after bone-marrow transplant with a high degree of statistical significance.
Reflexion Medical Inc. has been granted U.S. FDA marketing clearance for biology-guided radiotherapy to treat early and late-stage cancers. An expansion of the company’s existing X1 platform, Scintix is indicated for patients with lung and bone tumors which may arise from primary cancers or from metastatic lesions spread from other cancers in the body.
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first patient in the world underwent treatment with a Halcyon system with Hypersight last week.
Perception Vision Medical Technologies Co. Ltd. (Pvmed) raised around $14 million in a series A financing round, to further develop artificial intelligence (AI) cancer treatment solutions for the two major tumor treatment methods, radiotherapy, and surgery.