23andMe Initiates Phase 1 Clinical Trial for its Dual Mechanism Antibody, 23ME-01473, Targeting ULBP6
March 20 2024 - 7:30AM
23andMe Holding Co. (Nasdaq: ME), a leading human genetics and
biopharmaceutical company, today announced the first participant
has been dosed in a Phase 1 clinical trial evaluating 23ME-01473
(‘1473) in advanced solid tumors. The target for the new
investigational antibody, ULBP6, was discovered through 23andMe’s
proprietary research platform, the world's largest recontactable
database of de-identified human genetic and phenotypic information.
This is the third drug target genetically validated by the 23andMe
research platform to enter the clinic in under 4 years.
“Entering the clinic with this exciting new dual-mechanism
NK-cell activator reinforces the ability of the 23andMe
Therapeutics team, and the potential of our research platform, to
discover and develop new therapies informed by human genetics,”
said Jennifer Low, Head of Therapeutics Development, 23andMe. “We
are excited to be underway in our study of ‘1473, and we are
grateful to the patients participating in this trial.”
About ‘1473
‘1473 targets ULBP6 to restore anti-tumor immunity through NK
and T cells. ULBPs are stress-induced ligands found on the surface
of cancer cells that bind to their receptor, NKG2D, on NK and T
cells. Cancers escape immune cell recognition by shedding ULBP
ligands from their cell surface, which act as immunosuppressive
molecular decoys.
Blocking the binding of soluble ULBP6 to NKG2D through ‘1473 may
restore immune cell recognition and killing of cancers. Further,
‘1473 is Fc-effector enhanced, which provides an additional
mechanism for NK cells to induce cell death of ULBP6-expressing
cancer cells.
ULBP6 was identified as a potential cancer drug target using the
23andMe immuno-oncology (I/O) genetic signature, an approach
developed by 23andMe to identify evidence for genetic variants that
increase immune function while decreasing cancer risk. Using
genetic data, 23andMe can identify immune-related genes that are
expected to have an impact on cancer biology. Specifically,
germline genetics can reveal which of the immune-related genes
harbor genetic variants that also alter an individual's
predisposition for developing cancer.
About the Phase 1 ‘1473 Study
The first-in-human, multi-center, open-label clinical trial will
determine the safety and tolerability of ‘1473 in people with
locally advanced or metastatic solid malignancies that have
progressed after standard therapy. This study will also evaluate
the pharmacokinetic and pharmacodynamic profile of ‘1473 to
identify the optimal dose and schedule for further clinical
studies. Clinical trials registry (clinicaltrials.gov):
NCT06290388. For information on enrolling on to this clinical trial
contact 650-963-8997 or studyinquiry@23andme.com.
About 23andMe 23andMe23andMe is a genetics-led
consumer healthcare and therapeutics company empowering a healthier
future. For more information, please visit
investors.23andme.com.
Forward-Looking Statements This 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 its future clinical trials and
plans of 23andMe’s therapeutics business. All statements, other
than statements of historical fact, included or incorporated in
this press release, including statements regarding 23andMe’s
strategy, the plans for and results of its clinical trials and
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although not all forward-looking statements contain these
identifying words. These forward-looking statements are predictions
based on 23andMe’s current expectations and projections about
future events and various assumptions. 23andMe cannot guarantee
that it will actually achieve the plans, intentions, or
expectations disclosed in its forward-looking statements and you
should not place undue reliance on 23andMe’s forward-looking
statements. These forward-looking statements involve a number of
risks, uncertainties (many of which are beyond the control of
23andMe), or other assumptions that may cause actual results or
performance to differ materially from those expressed or implied by
these forward-looking statements. The forward-looking statements
contained herein are also subject generally to other risks and
uncertainties that are described from time to time in the Company’s
filings with the Securities and Exchange Commission, including
under Item 1A, “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K, as filed with the Securities and Exchange
Commission, and as revised and updated by our Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K. The statements made
herein are made as of the date of this press release and, except as
may be required by law, 23andMe undertakes no obligation to update
them, whether as a result of new information, developments, or
otherwise.
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