Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
Fennec Inc. received the complete response letter (CRL) it had expected from the FDA, sidelining U.S. development of Pedmark, a formulation of sodium thiosulfate for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than 1 month to those 18 years of age with localized, non-metastatic, solid tumors.
Ursula Matulonis, a co-principal investigator in the latest study with Immunogen Inc.’s antibody-drug conjugate mirvetuximab soravtansine in stubborn ovarian cancer, said the top-line data are “truly spectacular” and bring “the potential to be transformative for patients.”
The Netherlands-based Synaffix BV has expanded a deal focusing on its antibody-drug conjugate (ADC) linker tech with U.S. cancer biotech Mersana Therapeutics Inc., with the revised contract potentially paying out more than $1 billion. Privately owned Synaffix is hoping to ride a wave of interest in ADC technology, which is finally coming of age more than two decades after the first drug of this type was approved.
Bright Peak Therapeutics Inc. has licensed rights to use Livzon Mabpharm Inc.’s anti-PD-1 candidate, LZM-009, to develop its own PD-1 targeted immunocytokines (PD-1 ICs). Bertolt Kreft, chief scientific officer for Bright Peak, told BioWorld that Livzon’s phase II anti-PD-1 “exhibits a promising initial safety and efficacy profile, making it well-suited to the task.
Another drug from the emerging menin inhibitor drug class has hit safety issues, after the FDA put an early stage acute myeloid leukemia trial of Kura Oncology Inc.’s KO-539 on partial clinical hold because of a patient death. The news from Kura follows safety issues that emerged from Syndax Pharmaceuticals Inc.’s rival SNDX-5613, where an issue with QT prolongation emerged in at least 5% of patients in otherwise encouraging phase I/II trial results announced in April.
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
DUBLIN – A meaty licensing deal with Regeneron Pharmaceuticals Inc. is as good a time as any to unveil a new corporate identity. Nykode Therapeutics AS, the Norwegian immunotherapy firm formerly known as Vaccibody, is banking $30 million up front, another $20 million as an equity investment, and could earn up to $875 million more in development and commercial milestones across a multiproduct deal to develop vaccines for cancer and infectious disease.
The first approval for treating advanced malignant perivascular epithelioid cell tumor (PEComa) in adults has been awarded by the FDA to Aadi Bioscience Inc.’s Fyarro. The number of patients is low, from 100 to 300 patients annually in the U.S., but the geography the company hopes to sell to is wide as it takes in Europe and China.
Immune system B cells secrete the neurotransmitter gamma amino-butyric acid (GABA), which promotes generation of anti-inflammatory macrophages and blunts the cytotoxic T cell-based response to tumors in mice.
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