Zacks Small Cap Research – DRTS: Company Seeks to Develop Significant Advance in Cancer Therapy with Alpha DaRT – Technologist

NASDAQ:DRTS

Alpha DaRT more precise compared to traditional radiation therapy; therefore minimizes damage to surrounding healthy tissue

Israel’s Alpha Tau Medical (NASDAQ:DRTS) is a therapeutics company developing an innovative alpha-radiation cancer therapy called Alpha DaRT™ (which stands for Diffusing Alpha-emitters Radiation Therapy). Alpha DaRT represents a novel approach to cancer treatment that leverages the use of alpha radiation to treat solid tumors. This localized alpha particle radiotherapy is designed to destroy solid tumors with precision, while minimizing damage to surrounding healthy tissue. Conventional gamma/beta radiation relies on oxygen-dependent, single-strand DNA breaks. Conversely, Alpha DaRT directly damages the cell DNA, inducing irreparable double-strand DNA breaks that are known to be highly destructive to cancerous cells regardless of the cell’s lifecycle stage or level of oxygenation. In this way, Alpha DaRT delivers more precise alpha radiation that minimizes damage to healthy tissue around the tumor.

Because the company’s technology platform can be used alone or in conjunction with other cancer treatment modalities, Alpha DaRT could be an alternative or an adjunct to conventional oncology therapy. The technology platform received FDA Breakthrough Device Designation in June 2021. Among other factors, the company sees the following as key advantages of the Alpha DaRT platform:

➢ Targeted delivery of high-energy alpha radiation

➢ Potential to treat a wide range of solid tumors

➢ Minimal damage to surrounding healthy tissues

➢ Possible stimulation of systemic anti-tumor immune responses

➢ Localized delivery and minimal capital equipment requirements

Development Pipeline, With Assets at Various Stages of Clinical Development

Management believes its technology platform holds broad potential, as preclinical data has demonstrated local and immune responses across a broad variety of tumor types in animal models. Overall, DRTS has pre-clinical evidence and 27 peer-reviewed preclinical papers that support moving forward to evaluate Alpha DaRT across multiple solid tumor types, including skin, pancreas, breast, GBM, and others. Having accumulated a significant body of preclinical data, DRTS is conducting multiple clinical trials in different indications that are in various stages.

Alpha Tau is advancing a pipeline of clinical trials evaluating Alpha DaRT in multiple cancer indications that include:

➢ ReSTART Trial: The company’s lead program is a pivotal U.S. multi-center study called ReSTART in recurrent cutaneous squamous cell carcinoma. Patient recruitment could be complete as early as year-end 2024.

➢ Pancreatic Cancer: Alpha Tau anticipates announcing initial data from its pancreatic cancer studies in early 2025. These trials are evaluating Alpha DaRT in patients with locally advanced, inoperable pancreatic tumors.

➢ Lung Cancer: The company plans to treat its first lung cancer patient in Israel in the 2H 2024

➢ Brain Cancer: The company also plans to initiate brain cancer treatments.

Upcoming milestones expected

Upcoming milestones expected in the 2024 – 2025 period include that DRTS is:

➢ Planning treatment of the first patient in the Israeli recurrent lung cancer safety and feasibility trial in H2 2024. The trial is currently open for recruitment.

➢ Targeting the first brain cancer treatment in H2 2024.

➢ Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma roughly by year-end 2024.

➢ Anticipating a response from Japan’s PMDA by year-end 2024 for pre-market approval for Alpha DaRT in patients with recurrent head and neck cancer.

➢ Targeting announcement of safety, feasibility and efficacy data from advanced inoperable pancreatic cancer studies in Montreal and in Jerusalem by the end of Q1 2025.

In recent months, Alpha Tau has reported encouraging results for Alpha DaRT across various cancer models:

➢ Long-Term Safety and Efficacy Data: In June 2024, Alpha Tau announced the publication of long-term safety and efficacy data from multiple clinical trials in the Cancers Journal. The pooled analysis included 81 treated tumors across skin, head and neck, and oral cavity cancers.

o With a median follow-up of 14 months, the overall response rate was 99%, including 89% complete responses.

o Two-year local recurrence-free survival was estimated at 77%.

o Importantly, no moderate or severe long-term toxicities were observed during follow-up periods extending up to 51 months.

➢ Liver Metastases: In May 2024, the company treated its first patient with liver metastases from colorectal cancer in a feasibility study at McGill University Health Center. This trial aims to assess Alpha DaRT in patients undergoing staged hepatectomy procedures.

➢ Mouse Models of Pancreatic Cancer: Alpha Tau presented data at the 2024 ESTRO congress demonstrating potential abscopal effects with Alpha DaRT treatment. In mouse models of pancreatic cancer, treating one tumor with Alpha DaRT led to significant growth inhibition of untreated distant tumors starting 3 weeks after treatment.

Manufacturing can scale to meet anticipated demand; Strong IP position

Alpha Tau has created disposable, user-friendly applicators for inserting Alpha DaRT sources, as illustrated below. These applicators are designed to support minimally invasive procedures that treat various anatomical areas safely and effectively. The process does not require upfront investment in capital equipment or special shielding. The Alpha DaRT technology uses short-lived radioactive atoms that emit high-energy alpha particles to destroy cancer cells. Small metal sources containing radium-224 are inserted directly into tumors, where they release radioactive atoms that diffuse and emit alpha radiation throughout the tumor mass in an approach designed to deliver targeted radiation therapy while minimizing damage to surrounding healthy tissues, as noted.

To protect its technology, the company has a robust intellectual property (IP) portfolio with over 100 patents issued and more than 200 pending worldwide. Alpha Tau anticipates its first U.S. marketing authorization sometime in the 2025 to 2026 timeframe. The company anticipates a regulatory response from Japan’s PMDA regarding potential approval in recurrent head and neck cancer by year-end 2024, as noted. Given the unfortunate prevalence of cancers, the company anticipates that, if approved, Alpha DaRT would have significant market opportunities across multiple tumor types.

Thus, DRTS’s strategy is to maintain global manufacturing capabilities that can scale to meet anticipated growth in demand. Alpha Tau seeks to establish manufacturing operations in several global regions in order to secure relatively short shipping times to its core markets. To fulfill its global manufacturing strategy, the company currently operates purpose-built facilities in the U.S., Israel, and Asia. Alpha Tau has also secured approvals for a new production facility in Hudson, New Hampshire to support potential future commercial supply needs. At the end of 2Q24, the company had cash and equivalents of $74.1 million to support its growth plans and believes this is sufficient to fund operations for at least two years.

Conclusion

Alpha Tau believes it is well-positioned to become a leader in localized alpha particle radiotherapy. With a strong clinical pipeline, strategic global manufacturing capabilities, and a focus on high unmet needs in the oncology space, Alpha Tau’s Alpha DaRT technology represents a potential breakthrough in cancer treatment. Alpha Tau has already made significant progress in advancing its Alpha DaRT technology and expanding its clinical pipeline. The company continues to build a long-term database to support moving forward with clinical efforts for the technology, particularly given the safety and durability of responses in preclinical efforts. With multiple ongoing trials and a strong cash position, the company appears well-positioned to maintain its development efforts across various tumor types.

Alpha Tau also faces potential challenges as it advances clinical development. The company will need to demonstrate clear clinical benefits over standard therapies in order to drive adoption. Additionally, expanding into internal organ cancers might present unanticipated technical hurdles, while regulatory pathways for this type of radiation therapy will also need to be clearly defined as programs advance. Nevertheless, if successful, Alpha DaRT could potentially offer a new treatment option for patients with difficult-to-treat solid tumors and represent a significant advance in cancer therapy.

SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.