Precigen Announces Clearance of IND to Initiate Phase I/II Study for First-in-Class PRGN-2009 AdenoVerse™ Immunotherapy to Treat HPV-positive (HPV+) Solid Tumors
The Phase I portion of the study will follow 3+3 dose escalation to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase II dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and an investigational bifunctional fusion protein in patients with recurrent or metastatic HPV-associated cancers. The Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with the bifunctional fusion protein in patients with newly-diagnosed stage II/III HPV16-positive oropharyngeal cancer.
PRGN-2009 leverages
PRGN-2009 is under development through a
"Globally, high-risk HPVs cause nearly 5% of all cancers, with about 570,000 women and 60,000 men diagnosed with HPV-related cancers each year," said
About HPV+ Cancers
HPV infects the squamous cells that line the inner surfaces of certain organs and, consequently, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are referred to as adenocarcinomas.1 HPV-related cancers include cervical, oropharyngeal, anal, penile, vaginal, and vulvar.1 Nearly 44,000 HPV-associated cancers occur in
For more information about
References
1HPV and Cancer,
2HPV-Associated Cancer Statistics,
Trademarks
Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical and clinical trials and discovery programs, the promise of the Company's portfolio of therapies, the Company's refocus to a healthcare-oriented business, and its continuing evaluation of options for the Company's non-healthcare businesses. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company's clinical trial might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the
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