23andMe’s New ‘1473 Antibody Clinical Trial: What You Need To Know

23andMe announced today that the first participant has been administered a dose in a Phase 1 clinical trial.

This trial aims to evaluate 23ME-01473 (‘1473), a new investigational antibody for treating advanced solid tumors. The antibody targets ULBP6, a discovery made using the company’s proprietary research platform, which boasts the world’s largest contactable database of de-identified human genetic and phenotypic information.

It marks the third drug target identified by the company’s research platform to advance to clinical trials in less than four years.

This achievement is a good example of how, with your informed consent, your genetic data acquired via consumer tests (DTC) can be used for advancing medical research: Your genetic data can contribute to breakthroughs in understanding diseases, leading to the development of new treatments and preventive strategies. This can benefit society and potentially also aid in finding cures for rare genetic conditions.

Working with trustworthy companies such as 23andMe, your genetic data can be used for research while still recognizing the balance between contributing to scientific advancements and considering personal privacy concerns.

What Is a Phase I Clinical Trial?

A Phase 1 clinical trial is the first stage in the clinical trials process for testing new medical treatments in humans. These trials primarily focus on assessing the safety, tolerability, pharmacokinetics (how the drug gets absorbed, distributed, metabolized, and excreted in the body), and pharmacodynamics (the effects of the drug and its mechanism of action within the body) of a drug or therapeutic intervention. Phase 1 trials are crucial for determining the optimal dosage range and identifying potential side effects of the drug.

Typically, Phase 1 trials involve a small number of participants, often between 20 to 100 healthy volunteers or patients, depending on the drug’s intended use and its expected effects. The participants can be patients (having the condition the drug aims to treat) if researchers feel the drug might have significant effects. The main goal is not to test the drug’s efficacy in treating a condition but to gather initial data on its safety and how the body responds.

These trials are essential steps in developing new medications and treatments. They provide the foundation for further research in Phase 2 and Phase 3 trials, where they test for effectiveness and safety.

About the 23andMe Trial

According to their press release, the drug ‘1473 focuses on a critical aspect of cancer therapy: enhancing the body’s natural immune response to tumors. It does this by targeting ULBP6, a molecule found on the surface of cancer cells. ULBPs, including ULBP6, are ligands that can bind to a receptor called NKG2D present on Natural Killer (NK) cells and T cells, which are vital immune system components. When ULBPs bind to NKG2D, they alert the immune system to target and destroy the cancer cells.

However, cancer cells have developed a way to avoid this immune attack. It releases (or sheds) these ULBP molecules from its surface into the surrounding environment. Once shed, these ULBPs no longer signal the immune cells to attack because they are no longer attached to the cancer cells. Instead, they float around and bind to NKG2D receptors on NK and T cells in the bloodstream, acting as “decoys” that distract the immune cells and suppress their ability to target the actual cancer cells.

‘1473 aims to block these free-floating, or soluble, ULBP6 molecules from binding to the NKG2D receptor. By preventing this binding, ‘1473 helps to restore the immune system’s ability to recognize and kill cancer cells.

Moreover, they claim to have enhanced ‘1473 to activate Fc receptors on NK cells, providing an additional method for these immune cells to identify and destroy ULBP6-expressing cancer cells. This dual action—blocking the immunosuppressive effects of soluble ULBP6 and enhancing the NK cells’ ability to kill cancer cells—makes ‘1473 a promising therapeutic candidate.

23andMe immuno-oncology genetic signature uncovered the potential of ULBP6 as a cancer drug target. This innovative approach by 23andMe utilizes genetic data to find evidence of genetic variants that boost immune function and reduce cancer risk. By analyzing the genetics of the immune system, 23andMe can identify specific immune-related genes that play significant roles in cancer biology. It includes determining which genes contain variants that might change a person’s risk of developing cancer and offering a personalized approach to cancer therapy.

What Gaps in Cancer Research Does ‘1473 Aim to Address?

The 23andMe drug trial for ‘1473 addresses research gaps in cancer, notably in immunotherapy and personalized medicine. It focuses on enhancing the understanding and application of genetic information to improve cancer treatment outcomes.

Specifically:

Immunotherapy Outcomes: Exploring how to make immunotherapy more effective for a broader range of patients. By targeting specific mechanisms like the interaction between ULBP6 and the NKG2D receptor on immune cells, the research aims to improve the immune system’s ability to recognize and destroy cancer cells.
Personalized Medicine: Using genetic signatures to identify drug targets, such as ULBP6, is a step toward personalized or precision medicine. The trial leverages genetic information to tailor treatments based on individual genetic makeup, potentially increasing the efficacy of cancer therapies.
Understanding Resistance to Therapy: By focusing on the mechanisms that allow cancer cells to evade the immune system, such as the shedding of ULBP ligands, the trial contributes to understanding why some cancers become resistant to existing treatments and how new therapies can overcome this resistance.

Through its focus on these areas, the 23andMe drug trial demonstrates how genetic research can fill critical gaps in current cancer treatment strategies, particularly by enhancing the effectiveness of immunotherapy and advancing personalized medicine.

What Does this Trial Mean for You?

The initiation of the new 23andMe trial could potentially mark a significant advancement in personalized medicine and cancer treatment. For individuals diagnosed with advanced solid tumors, this trial might offer a glimpse into future treatment possibilities that are more aligned with their specific genetic profiles, potentially offering alternatives to conventional therapies. By targeting the genetically identified molecule ULBP6, the trial suggests an evolving landscape where treatments are increasingly tailored to the unique genetic makeup of each patient, hinting at a future where immunotherapy could become even more effective and personalized.

Although in its early stages, this Phase 1 trial is poised to contribute essential data on the safety, tolerability, and optimal dosing of ‘1473, laying the groundwork for further research. Moreover, its findings could enrich the field of genetic research, opening doors to further discoveries that might lead to innovative treatments.

Pros and Cons of Submitting Your Genetic Data for Research

Submitting your genetic data for research is a decision that comes with many pros and cons, reflecting the balance between contributing to scientific advancements and considering personal privacy concerns. Here is a look at both sides:

Pros

Advancing Medical Research: Your genetic data can contribute to breakthroughs in understanding diseases, leading to the development of new treatments and preventive strategies. It can benefit society and potentially aid in finding cures for rare genetic conditions.
Personal Health Insights: Participation in genetic research might provide you with access to personalized information about your health, including predispositions to certain conditions, which can inform your lifestyle choices and healthcare decisions.
Contributing to Precision Medicine: By adding your genetic information to research databases, you’re helping to build the foundation of precision medicine, which aims to tailor medical treatment to the individual characteristics of each patient.
Genetic Discoveries: Research using your genetic data can lead to discoveries about human history, evolution, and the migration patterns of different populations.

Cons

Privacy Concerns: Even with strict data protection protocols, there is a risk that your genetic information could be accessed by unauthorized parties, leading to privacy breaches.

Also Read: Understanding the Recent 23andMe data breach

Misuse of Data: There is a potential for genetic data to be misused by insurance companies, employers, or others, leading to discrimination based on genetic predispositions. This is illegal in the USA.
Emotional Impact: Learning about your genetic predispositions to certain diseases can be distressing and may lead to anxiety or unnecessary worry about your future health.
Understanding Limitations: Genetic research is still evolving, and not all findings may be immediately helpful or actionable. Sometimes, overstating findings and their significance can lead to misunderstandings about one’s health risks.
Ethical Considerations: There are ethical debates about consent, especially regarding how broadly they can use your genetic data and whether your contribution could lead to commercial products from which you will not benefit.

Ultimately, before submitting your genetic data for research, carefully weigh these pros and cons, considering the potential benefits to society and science and the personal implications for privacy and ethics.

Watch: LifeDNA’s Privacy Policy

References

*Understanding your genetics can offer valuable insights into your well-being, but it is not deterministic. Your traits can be influenced by the complex interplay involving nature, lifestyle, family history, and others.

Our reports and suggestions do not diagnose or treat any health conditions or provide any medical advice. Consult with a healthcare professional before making any major lifestyle changes or if you have any other concerns about your results.