23andMe announces further expansion of 23ME-00610 Phase 1/2a clinical trial in advanced neuroendocrine and ovarian cancer patient cohorts
December 19 2023 - 8:00AM
23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human
genetics and biopharmaceutical company, announced the further
expansion of the ongoing 23ME-00610 Phase 1/2a study to include an
additional 30 patients with advanced neuroendocrine and ovarian
cancers, above the original enrollment goals. The ongoing study has
been enrolling the Phase 2a portion of the Phase 1/2a clinical
trial evaluating the anti-CD200R1 monoclonal antibody since
February 2023.
As previously presented at a scientific conference in November
2023, 23ME-00610 has an appropriate safety profile in the highest
doses tested, and met pharmacodynamic biomarker and pharmacokinetic
objectives, while not reaching a maximum tolerated dose in the
Phase 1 study. The Phase 2a portion of the study is being conducted
with the highest tested dose from the Phase 1, 1400 mg
intravenously every 3 weeks. In order to characterize potential
optimal dosing of 23ME-00610, and aligned with recent regulatory
guidelines, 23andMe is utilizing this clinical trial to further
characterize safety and efficacy of a second potentially
efficacious dose of 600 mg intravenously every 3 weeks in these
additional patients.
“23ME-00610 has been well-tolerated with a very manageable side
effect profile and we've also seen some encouraging signs of
activity, particularly in neuroendocrine cancers that we've
previously presented,” said Drew W. Rasco, MD, Associate Director
of Clinical Research at the START Center for Cancer Care, and a
principal investigator for the 23ME-00610 study. “CD200R1 is an
exciting new target in the immuno-oncology landscape, and we are
looking forward to enrolling additional patients in the
neuroendocrine and ovarian cancer expansion cohorts.”
“We are gratified by the patient and investigator enthusiasm
with this clinical trial, that allows us to continue enrolling
additional patients to better understand the potential for our
anti-CD200R1 program,” said Jennifer Low, MD, PhD, Head of
Therapeutics Development, 23andMe. “We look forward to evaluating
this new data as it emerges, in order to plan for the future of
this program.”
23andMe and the investigators for this clinical trial plan to
share Phase 2a data from the ongoing Phase 1/2a study at scientific
conferences in 2024.
About 23ME-0061023ME-00610 is a high-affinity,
fully humanized monoclonal antibody that is designed to bind to
CD200R1 and prevent the interaction of CD200R1 with CD200. The
CD200–CD200R1 axis is an immunological checkpoint that plays a
pivotal role in maintenance of immune tolerance. CD200R1 is an
inhibitory receptor expressed on T cells and myeloid cells while
CD200, the ligand for CD200R1, is highly expressed on certain
tumors. Binding of tumor associated CD200 to CD200R1 leads to
immune suppression and decreased immune cell killing of cancer
cells. Preclinical data indicate that this mechanism has the
potential to restore the ability for both T-cells and myeloid cells
to kill cancer cells.
The Phase 1/2a study is an open-label study to evaluate the
safety, tolerability, pharmacokinetics, pharmacodynamics, and
clinical activity of 23ME-00610 monotherapy in patients with
advanced solid malignancies who have progressed on all available
standard therapies. Clinical trials registry (clinicaltrials.gov):
NCT05199272.
About 23andMe23andMe is a genetics-led consumer
healthcare and biopharmaceutical company empowering a healthier
future. For more information, please visit www.23andMe.com.
Forward looking statementsThis press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended, including, without
limitation, statements regarding the future performance of
23andMe’s businesses in consumer genetics and therapeutics and the
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under Item 1A, “Risk Factors” in the Company’s most recent Annual
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Commission, and as revised and updated by our Quarterly Reports on
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may be required by law, 23andMe undertakes no obligation to update
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Contacts:Investor Relations Contact: investors@23andMe.comMedia
Contact: press@23andMe.com
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