23andMe Initiates Phase 1 Clinical Trial for its Dual Mechanism Antibody, 23ME-01473, Targeting ULBP6
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Insights
The initiation of a Phase 1 clinical trial for 23ME-01473 ('1473) by 23andMe marks a significant step in oncology therapeutics, particularly in the realm of immunotherapy. The mechanism of action for '1473, which involves the restoration of anti-tumor immunity via natural killer (NK) and T cells, is a promising approach. By targeting the soluble ULBP6, the antibody has the potential to alleviate the immunosuppressive environment often created by tumors, thus allowing the immune system to better combat cancer cells.
Furthermore, the Fc receptor-mediated killing signifies that '1473 can engage the immune system to directly destroy ULBP6-expressing cancer cells. This dual approach of immune activation and targeted cell destruction is at the forefront of personalized medicine and could offer a new treatment avenue for patients with advanced solid tumors, who often have limited options.
As an oncologist, the progress of such trials is of great interest because it expands our arsenal against cancer and provides hope for therapies with higher specificity and fewer side effects compared to traditional chemotherapy. However, it is important to note that Phase 1 trials primarily assess safety and tolerability and efficacy data will be needed from subsequent trials to fully understand the potential of '1473.
The announcement by 23andMe regarding the commencement of a Phase 1 trial for their investigational antibody '1473 is noteworthy for investors and stakeholders in the biotech sector. The company's use of its proprietary research platform, which leverages a vast database of genetic and phenotypic information, demonstrates an innovative approach to drug discovery and development.
This is the third drug target from 23andMe's platform to enter clinical trials in less than four years, showcasing the company's ability to rapidly translate genetic insights into potential therapeutics. Such a track record can be appealing to investors, reflecting the company's research capabilities and the potential for a robust pipeline of novel drugs.
However, the development of new drugs is a long and risky process, with no guarantee of success. The market often reacts to clinical trial results, which means that significant milestones, such as the progression to Phase 2 and Phase 3 trials and, eventually, FDA approval, will be critical in evaluating the company's long-term valuation and potential impact on the stock market.
The drug development process for cancer therapies is highly complex and competitive. 23andMe's strategic focus on leveraging its genetic database to discover drug targets like ULBP6 could give it a competitive edge in identifying novel therapeutic candidates. The ability to recontact participants in their genetic database for further studies is a unique aspect that could streamline the research process and potentially accelerate the development timeline.
While the announcement of the first dosing in a Phase 1 trial is an early step, it is a critical milestone in the drug's lifecycle. If '1473 proves to be successful in subsequent phases, it could have a significant impact on the treatment landscape for advanced solid tumors. It is also indicative of the broader trend in the industry towards personalized medicine and targeted therapies, which is reshaping how we approach the treatment of complex diseases like cancer.
Investors and stakeholders should monitor the progress of '1473 closely, as early clinical data will provide valuable insights into the safety profile of the drug and its potential efficacy. Positive data could lead to partnerships or additional funding, while setbacks could pose risks to the company's therapeutic development segment.
- 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.
Contact
Investor Relations: investors@23andMe.com
Media: press@23andMe.com
FAQ
What is the purpose of 23ME-01473 ('1473)?
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Who announced the dosing of the first participant in the Phase 1 clinical trial for 23ME-01473 ('1473)?
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