Roche's Alzheimer's drug spurred biomarker changes but no cognitive impact — paper; vTv out-licenses former lead program
22 Jun 2021
Gene TherapyCollaborateAntibodyAccelerated ApprovalADC
More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.
The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.
Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.
However, in a new study published on Nature Medicine, the investigators from the Washington University at St Louis noted that the two drugs didn’t perform exactly the same way.
“The solanezumab-treated group showed a greater cognitive decline on some measures and did not show benefits on downstream biomarkers,” they wrote. “Gantenerumab significantly reduced amyloid plaques, cerebrospinal fluid total tau, and phospho-tau181 and attenuated increases of neurofilament light chain.”
Notably, both drugs were said to have engaged the beta-amyloid target — the basis for the controversial FDA accelerated approval of Biogen’s Aduhelm.
Roche is running two other Phase III trials for gantenerumab involving patients with early sporadic Alzheimer’s disease. — Amber Tong
vTv out-licenses former lead Alzheimer’s program to Cantex
Once heralding a drug candidate that flopped multiple tests in Alzheimer’s disease, vTv Therapeutics has said au revoir to the program.
The small biotech announced Tuesday that it has licensed out the compound, azeliragon, to Cantex Pharmaceuticals. vTv is giving Cantex exclusive worldwide rights to develop and commercialize the candidate, effectively punting on what was once their lead program.
But azeliragon produced less than stellar results in Alzheimer’s disease about three years ago, a field that’s seen more than its fair share of clinical trial failures. The program failed to make a mark and mild and moderate disease, despite vTv’s efforts to highlight a potential positive in a subgroup of patients with lower maximal plasma concentrations of azeliragon.
Financial terms of the deal weren’t disclosed, but in a statement, Cantex said it’s looking to advance the RAGE antagonist in cancer. — Max Gelman
Gyroscope pairs up with Australian research center for gene therapy capsids
Gyroscope Therapeutics is teaming up with an Australian pediatric research institute in order to further develop gene therapies.
The London-based biotech will collab with Children’s Medical Research Institute to push forward R&D work in capsids for ocular gene therapies, the pair announced Tuesday. A team of researchers from CMRI and Gyroscope will work together in designing and screening capsid libraries to identify new capsids for enhanced delivery of such treatments. The CMRI team is led by Leszek Lisowski.
“Capsids are one of the most critical components of a gene therapy, however, there are some limitations with the capsids available today,” said Gyroscope CSO Jane Hughes in a statement. “We are excited to collaborate with associate professor Lisowski and the team at CMRI to engineer next-generation capsids.” — Max Gelman
LegoChem and Iksuda expand agreement for ADC platform
Following the success of their first agreement, Iksuda Therapeutics has reached a license agreement with South Korea-based LegoChem Biosciences to expand its research, it announced Tuesday.
The agreement will explore additional antibody drug conjugates. In April 2020, Iksuda licensed three of its programs using the LCB’s ADC linker/toxin platform, and has been granted the rights for three additional targets, bringing its total number of potential programs to six, the company said. Its programs target tumors that have limited treatment options and high treatment rates.
“Our partnership has validated the superiority of LCB’s ADC platform technology and the competitive potential of IKS03 (formerly known as LCB73) as an innovative ADC drug,” LegoChem CEO Yong-Zu Kim said in the press release. “This validation has led to the execution of this expanded license agreement. We will continue to cooperate closely with Iksuda to accelerate the advancement of all LCB-related ADC candidates into clinic.”
Iksuda recently completed a $47 million financing round to help support the advancement of its lead ADC programs. — Josh Sullivan
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