Posted on 2023-09-07 in Newsletter

INOVIO’s INO-3107 Granted FDA Breakthrough Therapy Designation for RRP Treatment

INOVIO's INO-3107 Granted FDA Breakthrough Therapy Designation for RRP Treatment

INOVIO's INO-3107 Granted FDA Breakthrough Therapy Designation for RRP Treatment

INOVIO Pharmaceuticals, a leading biotechnology company, has received the FDA’s Breakthrough Therapy designation for INO-3107. This DNA medicine shows promise in treating Recurrent Respiratory Papillomatosis (RRP), a serious condition. This designation accelerates the drug’s development, offering hope for improved treatment over existing options for patients battling RRP, as well as HPV-related diseases, cancer, and infectious diseases.

Publish Date: 07-09-2023   Source: INOVIO Pharmaceuticals

Recurrent respiratory papillomatosis (RRP) is a chronic disease that occurs in both children and adults and is a rare disorder characterised by the development of small, wart-like growths in the respiratory tract. RRP spreads to the lungs, and affected individuals can potentially experience recurrent pneumonia, chronic lung disease and, ultimately, progressive pulmonary failure. In extremely rare cases, and can transform into malignant and leads to squamous cell carcinoma. Two primary HPV subtypes in RRP are HPV 6 and 11, and high-risk subtypes 16, 18, 31, 33 and 39 have been identified. HPV is a ubiquitous virus, with 75% to 80% of non-vaccinated adults having immunologic evidence of primary infection. HPV most commonly affects the skin, genitourinary tract, anus, and oropharynx. Two specific subtypes, HPV 6 and HPV 11 account for more than 90% of cases of RRP. RRP has a variable course, and predicting the timing and severity of recurrence has remained challenging. RRP is generally classified as adult-onset RRP (AORRP) and juvenile-onset RRP (JORRP) due to the bimodal distribution of presentation and its comparative natural history. JORRP is usually a more aggressive form with higher recurrence rates, while AORRP is thought to be more indolent, although adults can have a bold variation of the disease.

  • The estimated incidence of Recurrent respiratory papillomatosis (RRP) in the USA is 4.3 per 100 000 children and 1.8 per 100 000 adults.

However, the current Recurrent respiratory papillomatosis (RRP) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (PRGN-2012, INO-3107, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Recurrent respiratory papillomatosis treatment. The key companies in the advanced development stage are Precigen, Inc , Inovio Pharmaceuticals, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Recurrent respiratory papillomatosis (RRP) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

About Thelansis:

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

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