23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human
genetics and biopharmaceutical company, announced data from its
ongoing first-in-human Phase 1/2a clinical trial evaluating the
safety and efficacy of 23ME-00610, an investigational antibody
targeting CD200R1. Updated data from the now completed dose
escalation phase continue to showcase the manageable safety profile
of 23ME-00610 at the dose levels tested, and highlight preliminary
efficacy results in patients with advanced solid tumors.
The data was presented in two posters at the Society of
Immunotherapy in Cancer Annual Meeting 2023 on Friday, November 3,
2023. The poster presentations are available on the 23andMe
Therapeutics and Investor websites.
The presentations include pharmacokinetic (PK), pharmacodynamic
(PD), safety, and efficacy data from 28 patients that enrolled
between January 5, 2022 and May 15, 2023 in the dose escalation
portion of the 23ME-00610 Phase 1/2a clinical trial who had
received a median of 3 prior anticancer treatment regimens, 54% of
whom had prior immunotherapy. Of the phase 1 patients enrolled
across all doses of the dose escalation, there was a 52% stable
disease rate. One patient with pancreatic neuroendocrine cancer had
a maximum reduction in sum of longest target lesion diameters of
19% and remained on treatment with stable disease at 40 weeks on
study at the time of data cut off. One of the tumor lesions in this
patient had a sustained 58% reduction in the longest diameter of
the tumor on imaging scan.
23ME-00610 monotherapy was well-tolerated, with no dose-limiting
toxicities or serious adverse events related to 23ME-00610, and no
maximum tolerated dose (MTD) was reached up to the maximum tested
dose of 1400 mg every 3 weeks. Immune-related adverse events (AE)
were observed at pharmacologically relevant doses (≥ 60 mg),
consistent with expected 23ME-00610-mediated immune modulation.
Preliminary immunogenicity assessments showed no evidence of
treatment-induced anti-drug antibodies (ADA). One treatment-related
AE (600 mg dose) leading to discontinuation was observed: a
non-serious grade 3 adverse event, maculopapular rash in Cycle 1,
which resolved to baseline after treatment with oral and topical
steroids.
Preliminary PK data support dosing 23ME-00610 every three weeks
(Q3W). 23ME-00610 has a favorable PK and PD profile, with median
half-life of 11 to 13 days for doses ≥ 200 mg, and saturated
peripheral PD and dose-proportional exposure for doses greater than
60 mg. The combined safety, PK, PD, and preliminary efficacy data
continue to support the evaluation of 23ME-00610 at the preliminary
recommended Phase 2a expansion dose (RP2D) of 1400 mg every three
weeks (Q3W), which is the dose expected to maximize CD200R1
inhibition in participants with cancer, based on the Cycle 1
predicted tumor concentration of 23ME-00610 that is above the tumor
cell-killing EC90 for all participants with evaluable data.
“In this Phase 1 study, 23ME-00610 was well-tolerated with a
very manageable side effect profile,” 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.
“We also saw some encouraging signs of activity, particularly in
neuroendocrine cancers. CD200R1 is an exciting new target in the
immuno-oncology landscape, and we look forward to seeing more
results from the ongoing enrollment in disease-specific expansion
cohorts.”
“The Phase 1 data from our first 23andMe-sponsored clinical
trial in patients with cancer continues to be encouraging,” said
Jennifer Low, MD, PhD, Head of Therapeutics Development at 23andMe.
“Our data demonstrate that 23ME-00610 is able to be dosed in our
participants over extended periods of time at the dose that should
inhibit this pathway in tumors.”
23ME-00610 Phase 2:The Phase 2a portion of the
Phase 1/2a study is currently enrolling, evaluating the anti-tumor
activity of the 23ME-00610 monotherapy in a number of expansion
cohorts, and further characterizing the safety, tolerability, PK
and PD profile of 23ME-00610. The Phase 2a portion will include
assessment of objective response rate (ORR), progression-free
survival (PFS) and overall survival (OS) in the expansion
cohorts.
The expansion cohorts will enroll patients with 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 tumor
mutational burden-high (TMB-H) cancers that have progressed on
standard therapies. A cohort of adolescents with locally advanced
unresectable, or metastatic solid malignancies will also be
enrolled.
About 23ME-0061023ME-00610 is a first-in-class
anti-CD200R1 monoclonal antibody in Phase 2 clinical development
for advanced solid malignancies that has been shown to rescue T
cell function in preclinical studies. CD200R1 was identified as an
immuno-oncology (IO) target from the 23andMe database, with
pleiotropic causal variants that have opposing effect on risks for
cancer and immune diseases, referred to as an IO signature,
observed in 3 components in this pathway.
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. In preclinical studies, 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. 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, the
growth and potential of its proprietary research platform and its
future clinical trial results. All statements, other than
statements of historical fact, included or incorporated in this
press release, including statements regarding 23andMe’s plans,
strategy, therapeutics development, clinical trials, projected
costs, product development and launches, the successful
commercialization and market acceptance of new products and
objectives of management, are forward-looking statements. The words
"believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," “predicts,” "continue," "will," “schedule,” and "would"
or, in each case, their negative or other variations or comparable
terminology, are intended to identify forward-looking statements,
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.
Contacts:Investor Relations Contact:
investors@23andMe.comMedia Contact: press@23andMe.com
23andMe (NASDAQ:ME)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
23andMe (NASDAQ:ME)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024