FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer

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The FDA has granted Fast Track Designation to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, which is a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.¹

“Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are thrilled the FDA has recognized the potential of ABD-147 to become a transformative treatment option for SCLC and we are excited to begin clinical development and provide ABD-147 to patients in need.”

In the United States, approximately 10% to 15% of all lung cancers are SCLC. The American Cancer Society estimates that around 234,580 people will be diagnosed with lung cancer in the United States this year, with an estimated 125,070 deaths. In most cases, lung cancer occurs in older people, with an average diagnosis age of 70 years; however, a small number of people have been diagnosed under the age of 45 years.²

“Lung cancer is by far the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined,” reports the American Cancer Society. “On a positive note, the number of new lung cancer cases continues to decrease, partly because more people are quitting smoking (or not starting). The number of deaths from lung cancer continues to drop as well, due to fewer people smoking and advances in early detection and treatment.”

The chances of males developing lung cancer during their lifetime is slightly higher than women. Additionally, Black men are about 12% more likely to develop lung cancer than White men, while Black women have a 16% lower chance of getting it than White women. Despite having a higher chance of developing lung cancer, Black men are less likely to develop SCLC than White men.²

In an interview with Targeted Oncology, Qian Wang, MD, MPH explained that SCLC accounts for approximately 50% of all cases of lung cancer, with lung cancer overall remaining the highest cause of death in males.³

“We know that small cell lung cancer accounts for about 50% of all lung cancer cases, explained Wang. “Most of the epidemiological studies combine all small cell and non–small cell lung cancers as 1 group. The incidence and mortality data are both combined, and from looking globally in 2020, we know that lung cancer remains the second most common cancer in males, and the third most common cancer in females. It continues to be a leading cause of cancer-related death in males, and then is the second for females. Approximately in 2020, there were about 1.4 million lung cancer cases in males globally…Among those, approximately 15% of them are small cell lung cancers.”

Abdera plans on initiating a first-in-human Phase I clinical trial for ABD-147 in patients with SCLC or large cell neuroendocrine carcinoma who previously received platinum-based therapy later this year.¹

References

1. Abdera Therapeutics Announces FDA Fast Track Designation for ABD-147, a Next-Generation Precision Radiopharmaceutical Therapy, for the Treatment of Patients with Extensive-stage Small Cell Lung Cancer. Abdera. June 27, 2024. Accessed July 16, 2024. https://abderatx.com/press-releases/abdera-therapeutics-announces-fda-fast-track-designation-for-abd-147-a-next-generation-precision-radiopharmaceutical-therapy-for-the-treatment-of-patients-with-extensive-stage-small-cell-lung-cancer/

2. Key Statistics for Lung Cancer. American Cancer Society. Accessed July 16, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html#:~:text=In%20general%2C%20about%2010%25%20to,%25%20to%2085%25%20are%20NSCLC.

3. Prevalence of SCLC in the US and Globally. Targeted Oncology. March 31, 2023. Accessed July 16, 2024. https://www.targetedonc.com/view/prevalence-of-sclc-in-the-us-and-globally