Processa Pharmaceuticals Inc. (NASDAQ: PCSA) aims to develop products where existing clinical evidence of efficacy already exists in unmet medical need conditions. In support of this goal, the company has assembled an unparalleled management team, board of directors and product development team featuring experts in developing drug products, from IND-enabling studies to NDA submission. In total, the team’s combined scientific, development and regulatory experience has resulted in more than 30 drug approvals by the U.S. Food and Drug Administration (FDA) and more than 100 meetings with the FDA while working on more than 50 drug development programs, including drug products targeted to orphan disease and unmet medical need conditions.
Headquartered in Hanover, Maryland, Processa has built a pipeline of drugs which already have some proof-of-concept clinical data supporting clinical use in their selected indications.
The Processa process focuses on the advancement of drugs that are ready for clinical development or have minimal pre-IND enabling studies to complete. More specifically, Processa:
- Acquires drugs that already have some clinical data to support the targeted treatment – whether it be the drug itself, an analog of the drug or a drug with similar pharmacological targets;
- Navigates through the FDA, collaborating with the reviewers to define a complete development program; and
- Develops each drug over the course of 2-5 years, out-licensing the drug either just prior to pivotal study after Phase 2b or after the completion of the pivotal study.
Processa’s current development pipeline features multiple drug candidates, including PCS499 and PCS100. The company has also announced three additional licensing agreements since June 2020, further bolstering its clinical efforts. Each drug is briefly described below.
On August 27, 2020, Processa announced its entry into a contingent precedent exclusive licensing agreement with Elion Oncology Inc. to develop, manufacture and commercialize eniluracil (PCS6422) globally. PCS6422 is an oral drug to be administered with fluoropyrimidine cancer drugs (e.g., capecitabine, 5-FU) to decrease the breakdown of the cancer drug to inactive metabolites or metabolites that are known to cause unwanted side effects and to increase the anti-cancer related metabolites.
An IND for a Phase 1B study was cleared by the FDA in May 2020. The study will evaluate the safety and tolerability of several dose combinations of PCS6422 and capecitabine in advanced GI tumor patients. Processa intends to enroll the first patient in 1H2021, obtain interim results, and have a final report completed in 2H2022.
“Having worked on 5-FU and other cancer agents in the past, adding PCS6422 to our pipeline and expanding our involvement in oncology was an easy decision given the significant impact that PCS6422 may have on improving the efficacy and safety of capecitabine or other fluoropyrimidines,” CEO Dr. David Young said of the agreement.
PCS499 as a potential treatment for necrobiosis lipoidica (“NL”) was first presented to the FDA in a pre-IND meeting in 2018. In 2019, it was the subject of an IND submission and a promising Phase 2 safety study. On March 30, 2020, Processa announced a successful meeting with the FDA regarding the design and execution of the next clinical study to evaluate the ability of PCS499 to completely close ulcers in patients with NL.
“We are pleased with the outcome of the FDA meeting and the feedback we received from the FDA. We believe that the results from our completed Phase 2 trial in NL patients, especially those with more severe ulcerated forms of NL, are encouraging and we appreciate the guidance provided by the FDA regarding our next clinical trial and the requirements to support our NDA submission,” Dr. David Young, CEO of Processa, stated in the news release.
NL is a chronic, disfiguring condition affecting the skin and tissue under the skin, typically on the lower extremities, with no currently FDA-approved treatments. More severe complications can occur, such as deep tissue infections and osteonecrosis, threatening the life of the limb. Approximately 22,500 – 55,500 people in the United States and more than 150,000 – 400,000 people worldwide are affected by the ulcerated form of NL.
On August 20, 2020, Processa announced its entry into an agreement with Yuhan Corporation, a South Korean firm, to license YH12852, a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders. Under the terms of the agreement, Processa will acquire the rights to a portfolio of patents with an exclusive license to develop, manufacture and commercialize YH12852 globally, excluding South Korea.
YH12852 is a novel, potent and highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. Other 5-HT receptor agonists with less 5-HT4 selectivity have been shown to successfully treat GI mobility disorders such as chronic constipation, constipation-predominant irritable bowel syndrome, functional dyspepsia and gastroparesis. The less selective 5-HT4 agonists, such as cisapride, have been removed from the market because of the cardiovascular side effects associated with the drugs binding to other receptors, especially 5-HT receptors other than 5-HT4.
CEO Dr. David Young called the agreement “further evidence of Processa’s commitment to seek out novel treatments for unmet medical conditions.” Processa intends to meet with the FDA in early 2021 to further define the clinical development program. In 2021, Processa expects to initiate a Phase 2 trial in a functional GI motility-related disorder that that needs better therapeutic options, such as postoperative ileus and opioid-induced constipation.
On June 1, 2020, Processa announced its entry into a licensing agreement with Aposense Ltd. for the patent rights and know-how to develop and commercialize ATT-11T, a next generation irinotecan cancer drug. In the release, CEO Dr. David Young noted that the licensing deal fit with Processa’s strategy to “continue to bring innovative products to patients with an unmet medical need condition.”
ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Aposense molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell, with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan, such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.
The ATT-11T licensing agreement is conditioned upon Processa’s closing of a satisfactory financing round and the listing of the company’s shares on the Nasdaq or NYSE, among other conditions.
On September 3, 2020, Processa announced its entry into an exclusive worldwide license agreement with Akashi Therapeutics to develop and commercialization Akashi’s lead drug, HT-100. Rebranded PCS100, the candidate is an anti-fibrotic, anti-inflammatory drug demonstrated to have some clinical anti-fibrotic effect in children. Processa intends to develop PCS100 first in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis (FSGS), idiopathic pulmonary fibrosis (IPF) or Scleroderma, where there are still few therapeutic options.
David Young, Pharm.D., Ph.D. is the CEO and founder of Processa. He has over 30 years of pharmaceutical research, drug development and corporate experience. Young has served in leadership roles with a number of pharmaceutical firms throughout his career, including serving as founder and CEO of Promet Therapeutics LLC since 2015 and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. At Questcor, he was responsible for working with the FDA on modernizing the Acthar Gel label and for obtaining FDA approval in infantile spasms. In total, Young has met with the FDA more than 100 times on more than 50 drug products and has been a key team member on more than 30 NDA/supplemental NDA approvals.
Sian Bigora, Pharm.D., is Processa’s Chief Development Officer and founder. She has over 20 years of pharmaceutical research, regulatory strategy and drug development experience, working closely with Young. Prior to joining Processa, Bigora served as Co-Founder, Director and Chief Development Officer at Promet Therapeutics LLC and as Vice President of Regulatory Affairs at Questcor Pharmaceuticals from 2009 to 2015, where she led efforts to modernize the Acthar Gel label and obtain FDA approval in infantile spasms – events which were of material importance to Questcor’s subsequent success.
Patrick Lin is Chief Business & Strategy Officer and founder of Processa. He has over 20 years of financing and investing experience in the biopharma sector. Prior to joining Processa, Lin served as Co-Founder and Chairman of Promet Therapeutics LLC. He is also founder and managing partner of Primarius Capital, a family office that manages public and private investments focused on small capitalization companies.
James Stanker has served as CFO of Processa since 2018. He has over 30 years of financial and executive leadership experience in the areas of accounting principles and audit standards, regulatory reporting, and fiscal management and strategy. He served in a financial leadership role as an audit partner at Grant Thornton from February 2000 until his retirement in August 2016, where he was responsible for managing audit quality in the Atlantic Coast market territory.
Wendy Guy is the Chief Administrative Officer and founder of Processa. She has more than two decades of experience in business operations, having worked closely with Young over the last 18 years in corporate management and operations, HR and finance. Prior to joining Processa, she was Co-Founder, Director and Chief Administrative Officer of Promet Therapeutics LLC and Senior Manager, Business Operation over the Maryland office for Questcor Pharmaceuticals.