Clinical Catch-Up: Neuron23, QIAGEN, Ocugen, BMS and More
There's a new collaboration in the Parkinson's disease development space, Cardiff Oncology kicks off a mid-phase study in colorectal cancer and Ocugen published a new review of COVAXIN in COVID-19. See below for the top clinical highlights this week.
Neuron23 and QIAGEN Unite on LRRK2 Inhibitor for Parkinson's
Neuron23 and QIAGEN announced a collaboration to develop the first next-generation sequencing (NGS) companion diagnostic to Neuron23's LRRK2 inhibitor for Parkinson's disease.
Under the terms of the deal, QIAGEN will develop and validate a clinical trial assay that detects a combination of biomarkers discovered by Neuron23 to predict PD patients' responsiveness to LRRK2. This is in support of the latter's drug candidate, which is currently in the late stages of preclinical development.
The assay will become part of an NGS workflow that uses QIAGEN's Sample to Insight capabilities. It could later be enhanced to enable both companies to apply for FDA premarket approval.
Neuron23 plans to initiate first-in-human studies in the first half of 2023 for the LRRK2 inhibitor in PD, a representative for the companies told BioSpace.
Cardiff Preps Launch of Mid-Stage Colorectal Cancer
Cardiff Oncology is preparing to launch a randomized Phase II ONSEMBLE trial of onvansertib in combination with FOLFIRI/bevacizumab, the standard of care (SoC), in second-line RAS-mutated metastatic colorectal cancer (mCRC).
Cardiff intends to use the study to generate data on onvansertib's action compared to the SoC, and show patients with different KRAS mutations experience durable responses to treatment with the combination medication. The other goal is to confirm the best dosage levels in mCRC.
Around 150 patients will be enrolled in this trial. Topline data are expected to be released by the second half of 2024.
Amolyt Provides Update on Hypoparathyroidism Program
Amolyt Pharma shared positive safety and efficacy data from the first cohort of its ongoing Phase IIA trial of AZP-3601 for hypoparathyroidism.
In a presentation at the American Society for Bone and Mineral Research 2022 annual meeting, lead study investigator Istavan Takács, M.D., showed mean serum calcium levels stayed within the target range in the first three months of treatment with AZP-3601.
This outcome enabled the discontinuation of oral calcium and active vitamin D supplementation in most participants, while all patients achieved normalization of urinary calcium.
The company is set to release data from the second cohort soon, from which it will determine the design of a Phase III study.
Ocugen Storms Back with New COVAXIN Review
A review on the effectiveness and prospects of Ocugen's BBV152 vaccine, commercially known as COVAXIN for COVID-19, has been published in Frontiers in Immunology.
The review details the vaccine's immunogenicity, safety and efficacy versus different SARS-CoV-2 variants. The study concluded that BBV152, a whole-virion inactivated candidate, is a suitable alternative to mRNA vaccines.
COVAXIN is developed and manufactured by Ocugen and Bharat Biotech and is authorized by the World Health Organization in 28 countries under emergency use authorization.
Opdivo Meets Primary Endpoint in Melanoma Trial
Bristol Myers Squibb announced its Phase III CheckMate -76K study on Opdivo (nivolumab) for completely resected stage IIB/C melanoma met the primary endpoint of recurrence-free survival compared to placebo in the interim analysis period.
The trial is studying Opdivo and Opdivo-based combinations in early cancer stages, covering seven types of tumors. No new safety signals emerged in the latest results.
The company will thoroughly evaluate the data and share complete results at future medical conferences.
Alnylam and Regeneron to Move Forward in NASH Despite Missed Endpoint
Initial data from Alnylam and Regeneron's joint Phase I study of ALN-HSD targeting HSD17B13 for nonalcoholic steatohepatitis (NASH) showed the investigational drug failed to achieve the primary endpoint of the frequency of adverse events.
The most common adverse event was injection site reaction in five of 44 patients. However, because no treatment-related serious AEs have been reported, the trial will push forward to Phase II before the year ends, the companies stated.
In addition, patients from the first two Part B cohorts receiving 200 mg and 400 mg of ALN-HSD quarterly saw numerically lower liver enzymes and biopsy-derived nonalcoholic fatty liver disease (NAFLD) activity scores over six months.