Precigen Announces Clearance of IND to Initiate Phase I Study of PRGN-2012 AdenoVerse™ Immunotherapy in Patients with Recurrent Respiratory Papillomatosis (RRP)

- First off-the-shelf AdenoVerse immunotherapy targeting infectious disease to enter the clinic -

- RRP is a rare, difficult-to-treat neoplastic disease with no proven effective systemic therapy -

GERMANTOWN, MD, USA I January 05, 2021 IPrecigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I clinical trial of Precigen's PRGN-2012, a first-in-class, investigational off-the-shelf (OTS) AdenoVerse immunotherapy in adult patients with recurrent respiratory papillomatosis (RRP). RRP is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts caused by human papillomavirus (HPV) type 6 (HPV 6) or HPV type 11 (HPV 11).1-4  

PRGN-2012 is an innovative therapeutic vaccine with optimized antigen design that uses Precigen's gorilla adenovector technology, part of Precigen's proprietary AdenoVerse platform, to elicit immune responses directed against cells infected with HPV 6 or HPV 11.  Gorilla adenovectors have numerous advantages, including the ability for repeat administration, the inability to replicate in vivo, which may improve safety, and the ability to deliver large payload capacity. In preclinical models, PRGN-2012 has demonstrated strong and specific immune response against HPV 6 and HPV 11.

The Phase I study will follow 3+3 dose escalation of PRGN-2012 as an adjuvant immunotherapy following standard-of-care surgical removal of visible papillomatosis disease. Patients will receive up to four injections of PRGN-2012. The primary objective of the study is to determine safety and tolerability and recommended Phase II dose (RP2D) of PRGN-2012. The study will enroll 3 to 6 subjects at each dose level, and 12 patients will be treated at the maximum tolerated dose.

PRGN-2012 is under development through a Cooperative Research and Development Agreement, or CRADA, with the Center for Cancer Research (CCR) at the National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2012 to the clinic. The Phase I clinical study of PRGN-2012 will be led by Clint T. Allen, MD, Principal Investigator, Section on Translational Tumor Immunology, of the National Institute on Deafness and Other Communication Disorders (NIDCD), and Scott M. Norberg, DO, Assistant Research Physician, Genitourinary Malignancies Branch, of CCR NCI. 

"For patients with RRP there is an urgent need for adjuvant treatment options to reduce the number of devastating repeat surgical procedures to remove papillomatous lesions," said Helen Sabzevari, PhD, President and CEO of Precigen. "This is our second AdenoVerse immunotherapy IND in collaboration with NCI and is a testament to our strong, collaborative relationship and our ability to work together to quickly advance promising assets where there is high unmet patient need." 

About Recurrent Respiratory Papillomatosis (RRP)
Recurrent respiratory papillomatosis (RRP) is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts that is caused by infection with HPV 6 or HPV 11.1-4 RRP is classified based on age of onset as juvenile or adult. Juvenile-onset disease has an incidence of 4 per 100,000 and adult-onset RRP has an incidence of 2 to 3 per 100,000. There is no cure for RRP and  the current standard-of-care is repeated endoscopic debulking with ablation or excision of papillomatous lesions.3,4 Recurrence of papilloma after surgical removal is very common and repeated procedures are required to debulk and monitor the disease, which exposes patients to anesthetic and surgical risks, and emotional distress. RRP morbidity and mortality results from the effects of papilloma mass on the vocal cords, trachea, and lungs, which may cause voice changes, stridor, airway occlusion, loss of lung volume, and/or post-obstructive pneumonia.5 Although rare, one to three percent of RRP cases can transform into invasive squamous cell carcinoma.6,7

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

References
1 Mounts, P et al. (1982). "Viral etiology of juvenile- and adult-onset squamous papilloma of the larynx." Proc Natl Acad Sci U S A 79(17): 5425-5429.
2 Smith, E et al. (1993). "Human papillomavirus infection in papillomas and nondiseased respiratory sites of patients with recurrent respiratory papillomatosis using the polymerase chain reaction." Arch Otolaryngol Head Neck Surg 119(5): 554-557.
3 Derkay, CS et al. (2008). "Recurrent respiratory papillomatosis: a review." Laryngoscope 118(7): 1236-1247.
4 Derkay, CS et al. (2019). "Update on Recurrent Respiratory Papillomatosis." Otolaryngol Clin North Am 52(4): 669-679.
5 Seedat, RY (2020). "Juvenile-Onset Recurrent Respiratory Papillomatosis Diagnosis and Management - A Developing Country Review." Pediatric Health Med Ther 11: 39-46.
6 Dedo, HH et al. (2001). "CO(2) laser treatment in 244 patients with respiratory papillomas." Laryngoscope 111(9): 1639-1644.
7 Silver, RD et al. (2003). "Diagnosis and management of pulmonary metastasis from recurrent respiratory papillomatosis." Otolaryngol Head Neck Surg 129(6): 622-629.

SOURCE: Precigen

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