Tel Aviv-based Alpha Tau Medical Ltd. raised $26 million in a series B financing. The round was led by previous investors, Savit Capital, Medison Ventures, and Ourcrowd, as well as new private and family office investors hailing from North America and Israel. The new funds will be used to continue trials of the company's Alpha DaRT (Diffusing Alpha Radiation Emitters Therapy) alpha-radiation cancer therapy for solid tumors and expand manufacturing facilities.

While many med-tech companies have reported challenges raising funds in the past few months because of the COVID-19 pandemic, Alpha Tau CFO Raphi Levy told BioWorld that current environment might have worked to the company’s advantage.

“We’ve been very fortunate that investors increasingly recognize the advantages of the Alpha DaRT treatment, especially considering the current health concerns associated with COVID-19,” he said.

Unlike most radiation therapy, the Alpha DaRT system does not require multiple sessions to treat a tumor. The extended courses of therapy recommended for some cancers has proved problematic for some patients, physicians, and hospitals during the pandemic.

“In many cases, the Alpha DaRT enables a highly potent and conformal single-treatment regimen in an outpatient setting, allowing the patient to limit their exposure to large medical facilities,” Levy said. “We also see great value in being able to offer a highly conformal local cancer treatment alternative that is may mitigate the immune system damage common in other treatment modalities.”

Alpha Tau will primarily use the new funds “for driving our clinical trials around the globe, as well as for activities associated with our preparation for commercialization, including the establishment of manufacturing facilities,” he said.

The system

In November 2019, Alpha Tau published results of its first-in-human clinical trial of Alpha DaRT with squamous cell carcinoma patients from Italy and Israel in the International Journal of Radiation Oncology, Biology, Physics. The outcomes also featured in a recent editorial in the same journal.

The prospective first-in-human, multicenter clinical study evaluated 31 lesions in 28 elderly patients with an average age of 81. All had squamous cell carcinoma of the skin and head and neck, with 39% having primary tumors and 61% have recurrent tumors of 5 cm or less.

Most patients were not eligible for surgery. Thirteen of the lesions had been previously treated using external beam radiation therapy.

Patients had between three and 169 interstitial radioactive seeds implanted in the tumors. The seed released short-live alpha-emitting atoms to attack the cancer.

Of the 28 evaluable lesions, 78.6% had complete response – tumor reduction of 100%. The remainder saw reductions of 30% to 100%, with most reduction seen in the 14 days immediately following treatment completion.

Fifteen of 16 treatment-naïve patients had complete response as did seven of the 12 who had previously received radiotherapy. Five lesions relapsed within five months.

“Favorable response achieved with Alpha DaRT therapy had similar effectiveness in recurrent as in primary treatment tumors. These findings may in part be attributed to the enhanced radiobiologic attributes associated with alpha particle therapy, which could potentially overcome radioresistant clones,” the researchers said.

Future plans

Alpha Tau is seeking the CE mark now for superficial tumors such as squamous cell carcinoma, “but we are working on multiple further exciting indications as well,” Levy said.

The company has a trial in process at Memorial Sloan Kettering Cancer Center in New York, which is being conducted under an investigational device exemption. It also has a trial ongoing for pancreatic cancer at CHUM in Montreal. Trials are in process in three institutions in Japan and for breast cancer in Russia. All the trials currently underway have 30 or fewer patients.

The company hopes to expand the trials and is “actively working with multiple leading centers around the world which have expressed interest in joining our clinical trials,” Levy said.

There has been “some slowdown in recruitment in certain geographies [for the trials], but they have not been significantly impacted,” Levy noted.

"We have been very fortunate to continue our progress at full speed across all fronts, including R&D, clinical and operations, and now financing as well, even during a period of global turmoil,” Levy said. “As concerns associated with systemic cancer therapies that affect the immune system have become more salient, we see strong interest in our trials from clinicians, patients and investors who recognize the advantages of a focused and highly potent cancer therapy."

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