Shares of Biolinerx Ltd. (NASDAQ:BLRX) shot up 61% by midday on news that adding its lead candidate, motixafortide, to standard of care G-CSF for hematopoietic stem cell mobilization helped achieve significantly better mobilization than G-CSF alone in a phase III trial. The company said it's working "aggressively" to gain regulatory approval to market the drug for use in autologous bone marrow transplants for multiple myeloma patients, with plans to make an NDA submission in the first half of 2022.

Briefing docs on avacopan sting Chemocentryx; rough adcom ahead?

Shares of Chemocentryx Inc. (NASDAQ:CCXI) were trading midday at $25.01, down $23.81, or 48%, after briefing documents were disclosed related to the FDA advisory panel meeting on avacopan for anti-neutrophil cytoplasmic antibody-associated vasculitis. The Arthritis Advisory Committee will take up the matter of avacopan’s risk-benefit profile on May 6, and the compound bears a PDUFA date of July 7. Reviewers highlighted various “uncertainties” in what was called the “complicated” clinical program designed by Chemocentryx. Cited were “multiple variables, such as removing standard-of-care glucocorticoids and replacing it with avacopan,” as well as comparing a prednisone taper over 20 to 26 weeks to avacopan treatment for 52 weeks.

Ophthalmology-focused Oculis preps for phase III with $57M series C

LONDON – A year on from delivering positive phase IIb data, Oculis SA has raised $57 million in an oversubscribed series C, to take OCS-01, a topical nanoparticle formulation of dexamethasone, through two phase III trials. One trial will be in the treatment of pain and inflammation after cataract surgery, the second in diabetic macular edema. Both represent  areas of unmet need, with OCS-01 potentially providing a topical formulation for a retinal disease that currently is treated with anti-VEGF injections, laser surgery or corticosteroid implants, and once-a-day eye drops for patients who currently have to administer drops several times each day to manage discomfort following cataract removal.

Dueling bills focus of House drug pricing debate

Nearly a week after U.S. President Joe Biden called on Congress to get prescription drug pricing reform done, a House subcommittee took up dueling bills to do that May 4. Democrats on the Energy and Commerce Subcommittee on Health pushed for passage of H.R. 3, which calls for Medicare to negotiate prices for certain drugs based on an international price index. Republicans backed H.R. 19 that tackles patients’ out-of-pocket costs. Neither of the bills is new. The House passed H.R. 3 on party lines, knowing it would never get through what was then a Republican-controlled Senate. Although H.R. 19 had bipartisan support, it didn’t get through the Democrat-controlled House in 2019, but parts of the original package have been signed into law.

Newco news: Israel’s Lutris shares positive readout from early stage trials of B-Raf inhibitor

HONG KONG – Lutris Pharma Ltd., a company taking on the dermal toxicity common to cancer therapy with EGFR inhibitors, has begun testing its lead product, the B-Raf inhibitor LUT-014, in a phase II trial, with partial results expected by the end of 2021. The move follows a phase I study assessment in EGFR inhibitor-induced acneiform lesions among metastatic colorectal cancer patients, results of which were recently published in the American Association for Cancer Research’s Cancer Discovery journal.

Next up, Novavax, after April’s vaccine woes and therapeutic failures

Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc. While both mRNA vaccines from Pfizer Inc./Biontech SE and Moderna Inc. also have shown clotting in rare instances, thrombocytopenia (low blood platelets) appears absent in those cases. Nevertheless, global access to a fifth vaccine, another that was part of the U.S. government’s Operation Warp Speed (OWS) effort, could reduce increasing pressures on global supply, following a contamination issue at Emergent Biosolutions Inc. that resulted in the loss of 15 million doses of the J&J vaccine. According to Johns Hopkins University data, global cases and deaths rose between April 1 and May 1 by 12% and 6%, respectively, while U.S. cases have dropped 43% and deaths are down 35%. In contrast, data show cases in India have skyrocketed by 456% over the last month, and deaths are up 684%. Since the start of the pandemic, BioWorld has tracked 921 therapeutics and vaccines in development for the SARS-CoV-2 virus.

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