Positive final phase II data in cervical cancer is giving Nykode Therapeutics ASA even more momentum to take its vaccine candidate, VB10.16, further into oncology. In the study, VB10.16 was combined with Roche Holding AG’s Tecentriq (atezolizumab) in treating advanced or recurrent, non-resectable HPV16-positive cervical cancer. The phase II VB-C-02 study results showed a median overall survival greater than 25 months and 6.3 months median progression-free survival in PD-L1-positive patients. The 52-patient study, 48% of whom had PD-L1-positive tumors, saw participants treated for up to one year, then followed for another 12 months. The company said it plans to initiate a potentially registrational trial in the U.S. during the fourth quarter of 2023 in advanced cervical cancer and to expand the VB10.16 program to patients with HPV16-positive cancers. Nykode shares, trading as NYKD on the Oslo Stock Exchange, rose 25.48% on April 19 to close at NOK29.94 (US$2.83).
Gritstone data due this year as cancer vaccines advance; Merck, Moderna in play
Cancer vaccines have drawn more interest since last October when Merck & Co. Inc. exercised its option for joint development and commercialization in a deal with Moderna Inc. at the phase II stage. The compound as adjuvant therapy for melanoma, known as mRNA-4157/V940, was granted breakthrough designation by the U.S. FDA, used in combination with Merck’s Keytruda (pembrolizumab). Investors await phase II/III data this year from Gritstone Bio Inc.’s closely watched trial with Granite, an individualized neoantigen vaccine for microsatellite-stable colorectal cancer.
AACR 2023: Myeloid cell biology is 'growth area' for antitumor immunity
Antitumor immunotherapy has notched big wins, but in a small proportion of patients. And one possible explanation for why is that approved immunotherapies are not yet planting their flag on most of the battlefields where tumors and the immune system engage in combat. At the opening AACR 2023 plenary session, Ralph DeNardo celebrated the successes of the current, mostly T-cell-based approaches – more than 20% of cancer patients now receive and immunotherapy as part of their treatment regimen – but also encouraged his colleagues to think more broadly about the antitumor immunity.
Zephyrm nets ¥200M in financing to step up efforts in stem cell drug development
Zephyrm Biotechnologies Co. Ltd. raised ¥200 million (US$29 million) in a series B financing that helped it fill its coffers to develop stem cell drugs. The funds will be used for phase I and II trials of the company’s human pluripotent stem cell candidates to treat lung diseases, degenerative joint diseases, CNS diseases, inherited retinal degenerations and retinal degenerative diseases. The money will also be used for the construction of its technology platform and cell manufacturing bases.
Australia begins first overhaul of its health technology assessment process in 30 years
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment (HTA) process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer. “This is a once in a 30-year opportunity to initiate bold reforms and set Australia’s health system up for future success that keeps pace with evolving science,” Medicines Australia CEO Elizabeth de Somer told BioWorld.
Nitric oxide firm 30 Technology sells wound care unit to focus on antibiotic-resistant infections
30 Technology Ltd. has divested its wound care business, leaving it to focus on pharmaceutical applications of its patented nitric oxide-generating chemistry in the treatment of antibiotic-resistant respiratory infections. The wound care platform is being acquired by the health care products company Convatec Group plc in a deal worth up to £176 million (US$219 million). Of that, £45 million will be paid up front, with a further payment of £47 million to come on the achievement of specific U.S. and Europe regulatory approvals, followed by commercial milestones of £84 million. Convatec said it expects to launch the first product based on the technology in 2025.
Acting director of US NIH says agency is wary of using march-in rights to control drug prices
The annual U.S. budget scrum is well underway in Washington, D.C., with drug pricing a persistent theme on Capitol Hill. Lawrence Tabak, acting director of the National Institutes of Health, said NIH’s view is that federal government exercise of march-in rights “is not the instrument to regulate drug pricing” as it would alienate drugmakers and their investors, but Tabak vowed that the appropriate use of march-in rights is the subject of intense focus at the Department of Health and Human Services.
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