23andMe doses first patient in ph2a anti-tumour monotherapy

Human genetics and biopharma company, 23andMe Holding Co has announced it has dosed the first patient in the phase 2a portion of its open-label phase 1/2a study (NCT05199272) evaluating 23ME-00610, an investigational antibody targeting CD200R1, in patients with advanced solid malignancies.

The phase 2a portion of the phase 1/2a study will evaluate the anti-tumour activity of the 23ME-00610 monotherapy in multiple, previously disclosed expansion cohorts and seek to further characterise the safety, tolerability, pharmacokinetic and pharmacodynamic profile of 23ME-00610.

The tumour indications for the expansion phase were selected based on pre-clinical and published data of the activity and expression of CD200R1 and its ligand, CD200, together with immune cell and tumour characteristics that have the potential to increase the likelihood of a response to CD200R1 inhibition.

The expansion cohorts will enrol patients with the following: clear cell renal cell carcinoma; epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; neuroendocrine cancers; small cell lung cancer; and microsatellite instability-high (MSI-H) or tumour mutational burden-high (TMB-H) cancers that have progressed on standard therapies. Additionally, adolescents with locally advanced unresectable or metastatic solid malignancies will also be enrolled.

The phase 2a component is to include assessment of objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) in the expansion cohorts, and 23andMe anticipates that it will present an update from the phase 1 dose escalation portion of the study “at a scientific conference this year”. It will also be making investor presentations today and 8th March.

Dr Jennifer Low, head of therapeutics development at 23andMe, said: “We’re pleased that 23ME-00610 has reached this next phase of clinical development and look forward to evaluating this drug candidate in a number of cancers that are inadequately treated with existing therapies.”

Dr Low further commented: “The initiation of the next phase in our evaluation of 23ME-00610 marks an important milestone on this journey, and we appreciate the dedication and contributions of the patients and investigators to our ongoing clinical trial.”

23andMe Holdings Co seeks to help people access, understand, and benefit from the human genome. The company has more than 13.4 million genotyped customers, over 80% of whom consent to participate in research.

Scientists at 23andMe study the aggregate, de-identified genetics of these participants, alongside more than 4 billion self-reported health data points, the bioinformatic analyses aiding discovery of an immuno-oncology genetic signature to pinpoint genes that may be promising targets for cancer immunotherapies. One such target is CD200R1: a receptor found predominantly on immune cells, by targeting CD200R1, 23ME-00610 blocks the receptor on T-cells and myeloid cells, which might restore their ability to kill cancer cells.

In October 2022, 23andMe signed a deal to acquire privately-held Lemonaid Health in a $400 million deal marking a move into the online health sector, having gone public earlier last year through a blank cheque company backed by Virgin Group founder Sir Richard Branson.

Image by Pete Linforth, sourced from Pixabay.