23andMe Therapeutics Announces Positive Preliminary Phase 2 Safety and Efficacy Results for 23ME-00610, targeting CD200R1, at the 2024 ASCO Annual Meeting
2024年6月3日 - 9:00PM
23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human
genetics and biopharmaceutical company, announced positive
preliminary Phase 2 safety and efficacy data from 23ME-00610, a
first-in-class anti-CD200R1 antibody, presented at the 2024
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, May 31-June 4.
23andMe presented two posters on 23ME-00610, one each from
neuroendocrine and ovarian cancer patient cohorts in its ongoing
Phase 1/2a clinical trial.
Key takeaways:
- Confirmed partial response (PR) in patient with
well-differentiated pancreatic neuroendocrine cancer (pNET) (>
24 cycles at data cut-off) and qualitative clinical benefit with
durable treatment duration (> 12 cycles at data cut-off) and
tumor shrinkage in patient with mesonephric adenocarcinoma (a form
of ovarian cancer).
- 23ME-00610 monotherapy demonstrates acceptable safety and
tolerability, and achieves the prespecified targets for maximal
pharmacology at 1400 mg dosed every three weeks.
- From archival tumor immunohistochemistry (IHC) analyses, over
70% of patients had detectable tumor cell CD200, and higher
expression tended to trend with clinical benefit.
- In addition to CD200, histology data suggest that
immunosuppressed (“cold”) tumors may be more likely to exhibit
disease control with 23ME-00610.
- Emerging data shows preliminary evidence of clinical benefit
from 23ME-00610 treatment associated with lower risk for chronic
immune-mediated diseases (e.g., psoriasis, asthma, eczema), yet
higher risk for acute immune reactivity and cancer. This aligns
with the 23andMe Immuno-oncology Signature, which identifies
promising IO targets by pinpointing areas of the genome associated
with opposing risk for auto-immune disease and cancer.
“We continue to be pleased with the progress of 23ME-00610 as
monotherapy, which continues to demonstrate therapeutic potential
for inhibiting CD200R1 in cancer patients,” said Jennifer Low,
M.D., Ph.D, Head of Therapeutics Development. “We are also seeing
evidence of CD200 emerging as a potential biomarker associated with
23ME-00610 monotherapy efficacy. Further, we are encouraged by the
continued safety and tolerability profile of 23ME-00610 which, as
presented at AACR earlier this year, points to potential
combination strategies for added therapeutic benefit in cancer
patients.”
Further details - neuroendocrine cancers
cohort
- Between February 23, 2023 and April 1, 2024, 16 adult patients
with advanced neuroendocrine neoplasms who received a median of 3.5
prior treatment lines (range: 1 to 10), were enrolled and received
≥ 1 dose of 23ME-00610.
- A patient from the Phase 1 portion of the Phase 1/2a trial with
well-differentiated pancreatic neuroendocrine cancer (pNET) and
high tumor CD200 expression has a confirmed partial response (PR)
and remains on treatment (> 21 months).
- Among the N=16 expansion cohort, the disease control rate was
50% (n=8), and 25.3% of patients were free from clinical
progression at 6 months, per RECIST v1.1.
- The safety and tolerability profile remains acceptable and
promising for potential anti-cancer combinations in neuroendocrine
patients.
- No treatment-emergent adverse events (TEAEs) leading to
23ME-00610 discontinuation were reported.
- Related treatment-emergent adverse events (TRAEs) occurred in 8
patients (50%); all were G1/G2, and the most common were
maculopapular rash (18.8%), pruritus (18.8%), nausea (12.5%), and
fatigue (12.5%).
- Patients with moderate to high tumor CD200 expression tended to
be more likely to derive clinical benefit (PR or durable SD)
relative to patients with low or undetectable tumor CD200.
Further details - ovarian cancer cohort
- Between March 27, 2023 and April 1, 2024, 16 adult patients
with advanced ovarian cancer who received a median of 4 prior
treatment lines (range: 1 to 12), were enrolled and received ≥ 1
dose of 23ME-00610.
- The safety and tolerability profile remains acceptable and
promising for potential anti-cancer combinations in ovarian cancer
patients.
- No TRAEs ≥ G4 or AEs leading to 23ME-00610 discontinuation or
death were reported.
- Related TEAEs occurred in 7 patients (43.8%); most were G1
(12.5%) and G2 (25.0%), and the most common were maculo-papular
rash (12.5%) and pruritus (12.5%). Immune-related AEs (irAEs) were
≤ G2 in severity and generally dermatologic and thyroid in
nature.
- A patient with well-differentiated mesonephric adenocarcinoma
progressing prior to study enrollment has shown qualitative
clinical benefit and durable treatment duration (> 12 cycles),
including decreasing CA-125, substantial decreases in malignant
ascites, and tumor reduction while on 23ME-00610 treatment.
Additional data from the 23andMe poster presentations at
ASCO 2024
- Eligible patients had histologically diagnosed locally advanced
(unresectable) or metastatic 1) neuroendocrine cancers who had
progressed on standard therapies, or 2) metastatic
platinum-resistant epithelial ovarian, fallopian tube, or
peritoneal carcinoma who have progressed on standard
therapies.
- Exploratory biomarkers included CD200R1 and CD200 tumor
expression, germline genotyping, and polygenic risk score
calculation for immune-mediated and cancer phenotypes.
- Patients received 1400 mg given IV every 3 weeks until disease
progression, and CT/MRI scans were conducted every ~ 8 weeks.
Posters are available on the 23andMe Therapeutics and Investor
websites.
About 23ME-0061023ME-00610 binds to CD200R1 to
prevent the interaction of CD200R1 with CD200. Using the world’s
largest proprietary database of health and genetic information,
23andMe identified genetic variants of CD200R1, CD200, and DOK2,
the downstream signaling protein, associated with higher risks of
immune disease and lower risks of cancer, pinpointing CD200R1 as a
promising immuno-oncology target.
Additional preclinical data validated the CD200-CD200R1 pathway
as an immune checkpoint, and potential target for reversing immune
tolerance in cancer as a monotherapy, or in combination with other
therapies. Clinical data from the dose escalation cohort of
patients with advanced solid tumors has shown 23ME-00610 has
favorable pharmacokinetics (PK) for dosing once every three weeks,
expected on-target pharmacologic activity, and a promising safety
and tolerability profile at the preliminary recommended phase 2
dose of 1400 mg.
About 23andMe23andMe is a genetics-led consumer
healthcare and biopharmaceutical company empowering a healthier
future. For more information, please visit www.23andMe.com.
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