23andMe Therapeutics Announces Positive In Vivo Results for 23ME-01473, a Dual-Mechanism ULBP6-Targeting Antibody Currently in a Phase 1 Trial

Rhea-AI Summary

23andMe (Nasdaq: ME) announced positive nonclinical data for its first-in-class antibody 23ME-01473 at the ESMO Congress 2024. The antibody, targeting the NKG2D ligand ULBP6, showed inhibition of tumor growth in a non-small cell lung cancer mouse model. Elevated levels of ULBP6 were confirmed in squamous cell carcinomas and some adenocarcinomas, guiding potential clinical indications. The ongoing Phase 1/2a trial, which began in March 2024, has prioritized four expansion cohort cancer types: head and neck squamous cell carcinoma, squamous non-small cell lung cancer, colorectal cancer, and triple-negative breast cancer. This data supports the potential of human genetics in identifying new targets for immuno-oncology drug development.

Positive

• 23ME-01473 showed tumor growth inhibition in a non-small cell lung cancer mouse model
• Elevated ULBP6 levels identified in specific cancer types, guiding potential clinical indications
• Phase 1/2a trial ongoing with first patient dosed in March 2024
• Four expansion cohort cancer types prioritized for potential further investigation

Negative

• None.

Medical Research Analyst

The positive preclinical results for 23ME-01473 in non-small cell lung cancer are encouraging for 23andMe's oncology pipeline. The dual-mechanism antibody targeting ULBP6 shows promise in inhibiting tumor growth, which could translate to clinical benefits. The identification of elevated ULBP6 levels in specific cancer types provides a rational basis for patient selection in future trials, potentially increasing the chances of clinical success.

However, it's important to note that preclinical results don't always translate to human efficacy. The ongoing Phase 1 trial, which began in March 2024, will be critical in establishing safety and early efficacy signals. The prioritization of four expansion cohorts for Phase 2a is a strategic move, focusing on cancers with high unmet needs. This approach could accelerate the development timeline if positive results are observed.

Investors should monitor the progress of the Phase 1 trial closely, as early safety and efficacy data will be important in determining the potential of 23ME-01473 and its impact on 23andMe's valuation.

Oncology Doctor

The preclinical data for 23ME-01473 is intriguing from an oncological perspective. The inhibition of tumor growth in a patient-derived xenograft model of non-small cell lung cancer is promising, but we must be cautious about extrapolating these results to human patients. The dual-mechanism approach targeting ULBP6, a NKG2D ligand, represents an innovative strategy in immuno-oncology.

The elevated levels of soluble and tumor-bound ULBP6 in squamous cell carcinomas and some adenocarcinomas provide a rational biomarker strategy for patient selection. This could potentially improve the odds of observing clinical activity in the selected expansion cohorts. The focus on head and neck squamous cell carcinoma, squamous non-small cell lung cancer, colorectal cancer and triple-negative breast cancer is well-justified based on the preclinical findings.

As the Phase 1 trial progresses, we'll be looking for safety data and early signs of efficacy. The true test will come in later-stage trials, where we can assess the impact on patient outcomes.

Financial Analyst

23andMe's progress with 23ME-01473 represents a significant milestone in its transition from a genetic testing company to a biopharma player. The positive preclinical results and the initiation of the Phase 1 trial demonstrate the company's ability to leverage its genetic database for drug discovery and development.

However, investors should be aware that drug development is a long and risky process. While these early results are promising, the path to market is still long and uncertain. The company will need to invest significantly in clinical trials and success is not guaranteed.

From a financial perspective, the progress of 23ME-01473 could impact 23andMe's valuation and future funding needs. Positive clinical data could attract partnerships or additional investment, while setbacks could put pressure on the stock. The company's cash position and burn rate should be closely monitored as it advances its therapeutic pipeline.

Overall, this news is positive for 23andMe's long-term prospects, but investors should remain cautious given the early stage of development and the inherent risks in biotech investing.

23ME-01473 inhibited tumor growth in a patient-derived xenograft mouse model of non-small cell lung cancer

Elevated levels of soluble and tumor-bound ULBP6 confirmed in squamous cell carcinomas and a subset of adenocarcinomas, offering potential indications to assess clinical activity

Phase 1 trial ongoing with first patient dosed in March 2024

SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, announced nonclinical data supporting the anti-tumor activity of its first-in-class 23ME-01473 (’1473) antibody targeting the NKG2D ligand ULBP6 at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, September 13-17.

In a poster presentation at the 2024 ESMO Congress, 23andMe Therapeutics presented new data showing that 23ME-01473 inhibits growth of non-small cell lung cancer in a patient-derived xenograft mouse model. The presentation also included data showing elevated plasma soluble and tumor expression levels of ULBP6 in squamous cell carcinomas and a subset of adenocarcinomas. These findings have led to the prioritization of four expansion cohort cancer types for potential further investigation during the Phase 2a dose expansion portion of the Phase 1/2a trial, which began in March 2024: head and neck squamous cell carcinoma, squamous non-small cell lung cancer, colorectal cancer and triple-negative breast cancer. The design of this Phase 1/2a trial was presented in a second Trials-In-Progress presentation at the ESMO Congress. (The 23andMe ESMO posters are available on the 23andMe Therapeutics and Investor websites).

“We are excited to share this new preclinical data that support our ongoing clinical trial,” said Jennifer Low, M.D., Ph.D., Head of Therapeutics Development. “This additional data, coupled with our ongoing clinical studies, demonstrates the potential utility of human genetics to identify new targets and develop promising new drugs in the immuno-oncology space.”

About 23ME-01473
’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 is a genetics-led consumer healthcare and therapeutics company empowering a healthier future. For more information, please https://therapeutics.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. All statements, other than statements of historical fact, included or incorporated in this press release 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.

Contact
Investor Relations: investors@23andMe.com
Media: press@23andMe.com

FAQ

What are the key findings of 23andMe's 23ME-01473 antibody study presented at ESMO 2024?

23andMe's 23ME-01473 antibody showed inhibition of tumor growth in a non-small cell lung cancer mouse model. The study also found elevated levels of ULBP6 in squamous cell carcinomas and some adenocarcinomas, guiding potential clinical indications.

When did the Phase 1/2a trial for 23andMe's 23ME-01473 antibody begin?

The Phase 1/2a trial for 23andMe's 23ME-01473 antibody began in March 2024, with the first patient dosed at that time.

Which cancer types are prioritized for expansion cohorts in 23andMe's 23ME-01473 Phase 1/2a trial?

The prioritized cancer types for expansion cohorts in the 23ME-01473 Phase 1/2a trial are head and neck squamous cell carcinoma, squamous non-small cell lung cancer, colorectal cancer, and triple-negative breast cancer.

What is the target of 23andMe's 23ME-01473 antibody?

23andMe's 23ME-01473 antibody targets the NKG2D ligand ULBP6, which is a novel target in immuno-oncology.