On June 7, 2019, in the case of Phigenix, Inc. vs. Genentech, Inc., Genentech’s motion for attorney fees against Dr. Carlton D. Donald, President and CEO of Phigenix, was DENIED. Dr. Donald was joined to the case on August 13, 2018. The Court acknowledged counter-testimony and evidence provided by Dr. Donald that opposed Genentech’s claims. Subsequently, Genentech was unable to support their claim that Dr. Donald exhibited inequitable conduct. Furthermore, Genentech could not show that Dr. Donald is Phigenix’s alter ego as alleged. Dr. Donald also presented evidence challenging additional claims made by Genentech, which were the basis of the exceptional case finding. The Court’s Summary Judgment ruling is currently under appeal.
In line with the work of Dr. Carlton D. Donald, which demonstrated that drug inactivation of the AGTR1/MEK/ERK/STAT3/PAX2 pathway resulted in a sharp decrease of cell viability of prostate cancer cells, a newly published study by Zhang et al. (2019) observed a similar decrease in the protein expression of AGTR1, p-MEK1/2, p-ERK1/2, p-STAT3, PAX2 and p-PAX2. The study concluded that utilizing drug compounds that inhibit the STAT3/PAX2 signaling pathway may be leading candidates in developing preventive agents for the treatment of prostate cancer. Phigenix is currently developing novel compounds that inhibit PAX2 expression and activity for the treatment of prostate and breast cancer.
On April 5, 2019, Phigenix met with the Center for Cancer Research and Therapeutic Development (CCRTD) in Atlanta, GA to discuss a potential collaboration for the development of a prostate cancer therapeutic and a companion diagnostic. The meeting was hosted by CCRTD Director, Dr. Shafiq Kahn and the Chief Commercial and Technology Transfer Officer, Mrs. Lativia Ray-Alston . Representing Phigenix was President and CEO Dr. Carlton D. Donald, along with Dr. James P. Brown, Head of Research and Development, and Mr. Phillip Howard, Head of Business Development. Both parties were excited about the possibility forging a mutually beneficial business relationship and have planned further discussions.
In a new study by Sun et al., it was found that the tumor-suppressing effect of hBD-1 is associated with its ability to interact directly with the HER2 receptor, and modulate EGFR/HER2-associated signaling pathway in breast cancer. Phigenix’s technology invented by its founder Dr. Carlton Donald, focuses on targeting the PAX2 oncogene, which he discovered suppresses hBD-1 expression. He also was the first to demonstrate that inhibiting PAX2 results in the re-expression of hBD-1 and cancer cell death. This study further supports the development of a PAX2 inhibitor as a novel therapy for breast cancer.
Mr. Phillip Howard has joined Phigenix as Head of Business Development after serving as a consultant in the same capacity. Mr. Howard is a seasoned strategist and business development executive. In both the non-profit and commercial space, he has led efforts that transformed organizations. Mr. Howard served fourteen years as a Vice President of Development, where he led a team of development professionals that raised $200 million in private support during two major campaign efforts. Mr. Howard is no stranger to the innovation economy. His novel approach to business development led to his success as a head of Office of Technology Transfer and Innovation, which he largely credits to his training at Northwestern University’s Kellogg School of Business where he obtained his MBA. Within the last six months, Mr. Howard has connected Phigenix with various finance entities and a top 5 pharmaceutical company that has expressed interest in developing a first-in-class drug for inhibiting the PAX2 oncogene to treat multiple cancers.
In his speech at the Eastern District of Texas Bar Association, the Director stated, “Remarkably, in what I believe amounts to Orwellian “doublespeak," those who’ve been advancing the patent troll narrative argue that they do so because they are actually pro-innovation. That by their highlighting, relentlessly, the dangers in the patent system, they actually encourage innovation. Right!”
He we further to say, “Repeatedly telling “patent troll” stories is indeed odd, especially when they’re being told to the people who have been responsible for the greatest advances in human history. The narrative must change. And, at least as far as the USPTO is concerned, it has now changed. We are now focusing on the brilliance of inventors, the excitement of invention, and the incredible benefits they bring to all Americans and to the world.” His entire speech can be read here.
Based on exciting new data involving detecting and targeting the PAX2 oncogene for cancer treatment, Phigenix is seeking partnerships to advance current programs, and for the development of new products encompassing our unique cancer target and companion diagnostics for personalized medicine.
In a Final Written Decision issued on October 3, 2018 of an inter partes review initiated by Pfizer (IPR2017-00737) challenging the patentability of claims 1–17 of U.S. Patent No. 7,892,549 B2 entitled, “Treatment with Anti-ErbB2 Antibodies”, the Patent Trials and Appeal Board (PTAB) found that each of the challenged claims are unpatentable as set forth in the petition. In a separate challenge by Celltrion (IPR2017-01122), the PTAB also concluded that the patent would have been obvious over the combination Baselga 1996, Seidman 1996, Pegram, and the 1995 TAXOL PDR.
The patent covered a method for the treatment of patients with breast cancer that overexpresses the ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2 (e.g. trastuzumab), a taxoid (e.g. Taxol) and a further growth inhibitory agent.
According to a recent article in the New York Times, one of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and The Lancet. One of the articles published in The Lancet (Lancet Oncol. 2017 Jun; 18(6): 732–742) is entitled, “Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial”. The article states that:
“EMILIA was a randomised, international, open-label, phase 3 study of men and women aged 18 years or older with HER2-positive unresectable, locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane. Between Feb 23, 2009, and Oct 13, 2011, 991 eligible patients were enrolled and randomly assigned to either trastuzumab emtansine (n=495) or capecitabine and lapatinib (control; n=496). On May 30, 2012, the study protocol was amended to allow crossover from control to trastuzumab emtansine after the second interim overall survival analysis crossed the prespecified overall survival efficacy boundary. Approval of trastuzumab emtansine was based on the phase 3 EMILIA study, which showed that trastuzumab emtansine significantly improved progression-free survival and overall survival compared with capecitabine plus lapatinib in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane.”
The study was first posted on Clinicaltrials.gov on January 26, 2009. The researcher resigns after failing to disclose industry ties. A link to the article can be found here.
Dr. Carlton D. Donald was honored at the Atlanta Business League’s 12th Annual Men of Influence Reception & Induction Ceremony held on July 24, 2018. Dr. Donald was acknowledged for his research in medical oncology and leadership at Phigenix, Inc., where he currently serves as President and CEO.