23andMe Initiates Phase 1 Clinical Trial for its Dual Mechanism Antibody, 23ME-01473, Targeting ULBP6

  • 23ME-01473 (‘1473) seeks to restore anti-tumor immunity through NK and T cells by blocking the immunosuppressive effects of soluble ULBP6
  • ‘1473 also induces Fc receptor-mediated killing of ULBP6-expressing cancer cells through enhanced effector function

SOUTH SAN FRANCISCO, Calif., March 20, 2024 (GLOBE NEWSWIRE) — 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 23andMe
23andMe 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 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.

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