Precigen (PGEN) enrolled the first patient who will be treated with PRGN-2009 in a Phase I/II trial, asserts biotechnology sector expert John McCamant, editor of The Medical Technology Stock Letter — and a participant in The Interactive MoneyShow Virtual Expo on Sept. 15-16.
The drug development candidate is an off-the-shelf immunotherapy that utilizes PGEN’s AdenoVerse platform to activate the immune system to recognize and target Human Papillomavirus (HPV) associated solid tumors.
HPV-associated cancers represent a large market opportunity and are prevalent in head and neck, cervical, vaginal and anal cancer.
The Phase I portion of the study will use 3+3 dose escalation scheme to evaluate the safety of PRGN-2009 as a monotherapy and to determine the recommended Phase II dose.
This will be followed by an evaluation of the safety of combination of PRGN-2009 and bintrafusp alfa (M7824), an investigational bifunctional fusion protein, in patients with recurrent or metastatic HPV-associated cancers.
Once safety is established, the Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with bintrafusp alfa as a neoadjuvant or induction therapy for newly-diagnosed Stage 2/3 HPV16-positive oropharyngeal cancer.
PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2009.
PGEN’s management team is executing well by getting a trial up and running despite the ongoing difficulties presented by COVID-19. Also important is having first class partners like the NCI who is leading the reopening of clinical trials in the U.S.
We will look for additional visibility from the company on when we can expect the first data from this trial. Our guess is that preliminary data could come as early as year end from this potential game changing off-the-shelf immunotherapy.
