Two phase III failures with Genentech Inc.’s gantenerumab in staving off mild cognitive impairment tied to Alzheimer’s disease revealed the level of beta amyloid removal was lower than the company expected. Top-line results from Genentech’s phase III Graduate I and II studies show gantenerumab missed the primary endpoints of slowing clinical decline in those with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia. The data showed a relative reduction in clinical decline of 8% in Graduate I and 6% in Graduate II with gantenerumab compared to placebo.

Bumpy road continues for Ardelyx's tenapanor

Ardelyx Inc. could have a tough row to hoe Nov. 16 when it makes its case for tenapanor as a therapy to manage phosphate levels in chronic kidney disease before the U.S. FDA's Cardiovascular and Renal Drugs Advisory Committee. The big question is whether the drug's change in baseline serum phosphorus levels, considered a surrogate endpoint, is clinically meaningful. The adcom meeting follows a complete response letter and two formal dispute resolution requests.

Que sees phase II success in reducing hot flashes after breast cancer

Que Oncology Inc.’s Q-122 significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, or hot flashes, in women taking endocrine therapy for breast cancer, and phase II results showed associated improvement in quality of life, compared with placebo. An orally available small molecule, Q-122 is a nonhormonal therapy that works through the hypothalamus where thermoregulation is controlled.

Zenas nets $118M in series B round to support phase III trial of obexelimab

Zenas Biopharma LLC has raised $118 million in a series B round to support a global phase III trial of its lead asset as well as other immunotherapy assets in its pipeline. The study will evaluate obexelimab for the treatment of patients with immunoglobulin G4-related disease in late 2022. The financing was led by Enavate Sciences.

Harbour’s Nona Biosciences to develop immunotherapies with Moderna

Nona Biosciences Co. Ltd., a subsidiary of Harbour Biomed Therapeutics Ltd., has struck a deal with Moderna Inc. to develop nucleic acid-based immunotherapies. The candidates will be based on Harbour’s heavy chain only antibody discovery platform. Nona Biosciences will receive $6 million up front as part of the deal and is eligible for up to $500 million more in regulatory, development, and sales milestone payments.

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