This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.

Start Date02 Oct 2024

Sponsor / Collaborator

Processa Pharmaceuticals, Inc.

NCT04861987 / CompletedPhase 1

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 with Escalating Doses of Capecitabine Administered Orally to Patients with Advanced, Refractory Gastrointestinal Tract Tumors

This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.

Start Date18 Jun 2021

Sponsor / Collaborator

Processa Pharmaceuticals, Inc.

NCT01231802 / Unknown statusPhase 2

A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer

The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.

Start Date01 Apr 2011

Sponsor / Collaborator

Fennec Pharmaceuticals, Inc.

100 Clinical Results associated with Eniluracil

100 Translational Medicine associated with Eniluracil

100 Patents (Medical) associated with Eniluracil

130

Literatures (Medical) associated with Eniluracil

01 Jan 2021·Therapeutic advances in medical oncologyQ2 · MEDICINE

Oral drugs in the treatment of metastatic colorectal cancer

Q2 · MEDICINE

ReviewOA

Author: Ortega Morán, Laura ; García-Alfonso, Pilar ; Grasso Cicala, Silvina ; Soto Alsar, Javier ; Calvo Ferrandiz, Pilar Aitana ; Muñoz Martín, Andrés Jesús ; Blanco Codesido, Montserrat ; Torres Pérez-Solero, Gabriela

Colorectal cancer (CRC) is one of the most common forms of cancer, with an estimated 1.36 million new cases and almost 700,000 deaths annually. Approximately 21% of patients with CRC have metastatic disease at diagnosis. The objective of this article is to review the literature on the efficacy and safety of oral drugs available for the treatment of metastatic colorectal cancer (mCRC). Several such drugs have been developed, and fluoropyrimidines are the backbone of chemotherapy in this indication. They exert their antitumour activity by disrupting the synthesis and function of DNA and RNA. Oral fluoropyrimidines include prodrugs capecitabine, tegafur, eniluracil/5-fluorouracil, tegafur/uracil, tegafur/gimeracil/oteracil and trifluridine/tipiracil (FTD/TPI). Oral drugs offer several advantages over injectable formulations, including convenience, flexibility, avoidance of injection-related adverse events (AEs) and, in some circumstances, lower costs. However, oral drugs may not be suitable for patients with gastrointestinal obstruction or malabsorption, they may result in reduced treatment adherence and should not be co-administered with drugs that interfere with absorption or hepatic metabolism. Oral fluoropyrimidines such as capecitabine, as monotherapy or in combination with oxaliplatin, irinotecan or bevacizumab, are as effective as intravenous 5-fluorouracil (5-FU) in first-line treatment of mCRC. Other oral fluoropyrimidines, such as FTD/TPI, are effective in patients with mCRC who are refractory, intolerant or ineligible for 5-FU. In addition, oral fluoropyrimidines are used in adjuvant treatment of mCRC. Regorafenib is an oral multikinase inhibitor used in patients in whom several previous lines of therapy have failed. Frequent AEs associated with oral drugs used in the treatment of CRC include hand-foot syndrome and gastrointestinal and haematological toxicities.

01 Oct 2019·Journal of cell scienceQ2 · BIOLOGY

Local inhibition of rRNA transcription without nucleolar segregation after targeted ion irradiation of the nucleolus

Q2 · BIOLOGY

Article

Author: Reindl, Judith ; Siebenwirth, Christian ; Schwarz, Benjamin ; Friedl, Anna A. ; Greubel, Christoph ; Sammer, Matthias ; Walsh, Dietrich W. M. ; Drexler, Guido A. ; Schmid, Thomas E. ; Baur, Iris ; Pospiech, Helmut ; Dollinger, Günther

ABSTRACT:

Nucleoli have attracted interest for their role as cellular stress sensors and as potential targets for cancer treatment. The effect of DNA double-strand breaks (DSBs) in nucleoli on rRNA transcription and nucleolar organisation appears to depend on the agent used to introduce DSBs, DSB frequency and the presence (or not) of DSBs outside the nucleoli. To address the controversy, we targeted nucleoli with carbon ions at the ion microbeam SNAKE. Localized ion irradiation with 1–100 carbon ions per point (about 0.3–30 Gy per nucleus) did not lead to overall reduced ribonucleotide incorporation in the targeted nucleolus or other nucleoli of the same cell. However, both 5-ethynyluridine incorporation and Parp1 protein levels were locally decreased at the damaged nucleolar chromatin regions marked by γH2AX, suggesting localized inhibition of rRNA transcription. This locally restricted transcriptional inhibition was not accompanied by nucleolar segregation, a structural reorganisation observed after inhibition of rRNA transcription by treatment with actinomycin D or UV irradiation. The presented data indicate that even multiple complex DSBs do not lead to a pan-nucleolar response if they affect only a subnucleolar region.

28 Jul 2017·Cochrane Database of Systematic Reviews

Oral versus intravenous fluoropyrimidines for colorectal cancer.

Review

Author: Lau, David ; Price, Timothy ; Tebbutt, Niall ; Yeung, Yvonne ; Chionh, Fiona

BACKGROUND:

Patients prefer oral to intravenous (IV) palliative chemotherapy, provided that oral therapy is not less effective. We compared the efficacy and safety of oral and IV fluoropyrimidines for treatment of colorectal cancer (CRC).

OBJECTIVES:

To compare the effects of oral and IV fluoropyrimidine chemotherapy in patients treated with curative or palliative intent for CRC.

SEARCH METHODS:

We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5), along with OVID MEDLINE, OVID Embase, and Web of Science databases, in June 2016. We also searched five clinical trials registers, several conference proceedings, and reference lists from study reports and systematic reviews. We contacted pharmaceutical companies to identify additional studies.

SELECTION CRITERIA:

We included randomised controlled trials (RCTs) comparing oral and IV fluoropyrimidine chemotherapy in patients treated with curative or palliative intent for CRC.

DATA COLLECTION AND ANALYSIS:

Three review authors extracted data and assessed risk of bias independently. We assessed the seven domains in the Cochrane 'Risk of bias' tool and three additional domains: schedules of outcome assessment and/or follow-up; use of intention-to-treat analysis; and baseline comparability of treatment arms.

MAIN RESULTS:

We included nine RCTs (total of 10,918 participants) that examined treatment with curative intent for CRC with neoadjuvant and/or adjuvant chemotherapy. We included 35 RCTs (total of 12,592 participants) that examined treatment with palliative intent for inoperable advanced or metastatic CRC with chemotherapy (31 first-line studies, two second-line studies, and two studies of first- or second-line chemotherapy). All studies included male and female participants, and no studies included participants younger than 18 years of age. Patients treated with curative intent for CRC with neoadjuvant and/or adjuvant chemotherapy • Disease-free survival (DFS): DFS did not differ between participants treated with oral versus IV fluoropyrimidines (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.87 to 1.00; seven studies, 8903 participants; moderate-quality evidence).• Overall survival (OS): OS did not differ between participants treated with oral versus IV fluoropyrimidines (HR 0.92, 95% CI 0.84 to 1.00; seven studies, 8902 participants analysed; high-quality evidence).• Grade ≥ 3 adverse events (AEs): Participants treated with oral fluoropyrimidines experienced less grade ≥ 3 neutropenia/granulocytopenia (odds ratio (OR) 0.14, 95% CI 0.11 to 0.16; seven studies, 8087 participants; moderate-quality evidence), stomatitis (OR 0.21, 95% CI 0.14 to 0.30; five studies, 4212 participants; low-quality evidence), and any grade ≥ 3 AEs (OR 0.82, 95% CI 0.74 to 0.90; five studies, 7741 participants; low-quality evidence). There was more grade ≥ 3 hand foot syndrome (OR 4.59, 95% CI 2.97 to 7.10; five studies, 5731 participants; low-quality evidence) in patients treated with oral fluoropyrimidines. There were no differences between participants treated with oral versus IV fluoropyrimidines in occurrence of grade ≥ 3 diarrhoea (OR 1.12, 95% CI 0.99 to 1.25; nine studies, 9551 participants; very low-quality evidence), febrile neutropenia (OR 0.59, 95% CI 0.18 to 1.90; four studies, 2925 participants; low-quality evidence), vomiting (OR 1.05, 95% CI 0.83 to 1.34; eight studies, 9385 participants; low-quality evidence), nausea (OR 1.21, 95% CI 0.97 to 1.51; seven studies, 9233 participants; low-quality evidence), mucositis (OR 0.64, 95% CI 0.25 to 1.62; four studies, 2233 participants; very low-quality evidence), and hyperbilirubinaemia (OR 1.67, 95% CI 0.52 to 5.38; three studies, 2757 participants; very low-quality evidence). Patients treated with palliative intent for inoperable advanced or metastatic CRC with chemotherapy • Progression-free survival (PFS): Overall, PFS was inferior in participants treated with oral versus IV fluoropyrimidines (HR 1.06, 95% CI 1.02 to 1.11; 23 studies, 9927 participants; moderate-quality evidence). Whilst PFS was worse in participants treated with oral compared with IV fluoropyrimidines when UFT/Ftorafur or eniluracil with oral 5-fluorouracil (5-FU) was used, PFS did not differ between individuals treated with oral versus IV fluoropyrimidines when capecitabine, doxifluridine, or S-1 was used.• OS: Overall, OS did not differ between participants treated with oral versus IV fluoropyrimidines (HR 1.02, 95% CI 0.99 to 1.05; 29 studies, 12,079 participants; high-quality evidence). OS was inferior in participants treated with oral versus IV fluoropyrimidines when eniluracil with oral 5-fluorouracil (5-FU) was used.• Time to progression (TTP): TTP was inferior in participants treated with oral versus IV fluoropyrimidines (HR 1.07, 95% CI 1.01 to 1.14; six studies, 1970 participants; moderate-quality evidence).• Objective response rate (ORR): ORR did not differ between participants treated with oral versus IV fluoropyrimidines (OR 0.98, 95% CI 0.90 to 1.06; 32 studies, 11,115 participants; moderate-quality evidence).• Grade ≥ 3 AEs: Participants treated with oral fluoropyrimidines experienced less grade ≥ 3 neutropenia/granulocytopenia (OR 0.17, 95% CI 0.15 to 0.18; 29 studies, 11,794 participants; low-quality evidence), febrile neutropenia (OR 0.27, 95% CI 0.21 to 0.36; 19 studies, 9407 participants; moderate-quality evidence), stomatitis (OR 0.26, 95% CI 0.20 to 0.33; 21 studies, 8718 participants; low-quality evidence), mucositis (OR 0.17, 95% CI 0.12 to 0.24; 12 studies, 4962 participants; low-quality evidence), and any grade ≥ 3 AEs (OR 0.83, 95% CI 0.74 to 0.94; 14 studies, 5436 participants; low-quality evidence). There was more grade ≥ 3 diarrhoea (OR 1.66, 95% CI 1.50 to 1.84; 30 studies, 11,997 participants; low-quality evidence) and hand foot syndrome (OR 3.92, 95% CI 2.84 to 5.43; 18 studies, 6481 participants; moderate-quality evidence) in the oral fluoropyrimidine arm. There were no differences between oral and IV fluoropyrimidine arms in terms of grade ≥ 3 vomiting (OR 1.18, 95% CI 1.00 to 1.40; 23 studies, 9528 participants; low-quality evidence), nausea (OR 1.16, 95% CI 0.99 to 1.36; 25 studies, 9796 participants; low-quality evidence), and hyperbilirubinaemia (OR 1.62, 95% CI 0.99 to 2.64; nine studies, 2699 participants; low-quality evidence).

AUTHORS' CONCLUSIONS:

Results of this review should provide confidence that treatment for CRC with most of the oral fluoropyrimidines commonly used in current clinical practice is similarly efficacious to treatment with IV fluoropyrimidines. Treatment with eniluracil with oral 5-FU was associated with inferior PFS and OS among participants treated with palliative intent for CRC, and eniluracil is no longer being developed. Oral and IV fluoropyrimidines have different patterns of side effects; future research may focus on determining the basis for these differences.

News (Medical) associated with Eniluracil

30 Oct 2024

·www.globenewswire.com

Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results

First patient dosed in Phase 2 clinical trial with NGC-Cap for metastatic breast cancer Positive data from preclinical studies support NGC-Iri’s ability to deliver more SN-38 to tumors compared with either irinotecan or Onivyde® HANOVER, Md., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the three and nine months ended September 30, 2024. “We continued to make progress with our programs as we further demonstrate the potential benefits of our oncology therapeutics,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is underway with the first patient dosed. As this is an open-label trial, we anticipate sharing initial data in the second half of 2025. Additionally, we reported positive findings from preclinical studies that support NGC-Iri’s potential for improved efficacy and a superior side effect profile compared with the commonly used FDA-approved chemotherapy drugs irinotecan and Onivyde®. We are pleased with our progress and remain committed to improving the lives of people with cancer.” Key Program UpdatesProcessa is focused on developing next-generation chemotherapies (NGC) by improving widely used U.S. Food and Drug Administration (FDA)-approved drugs to extend cancer patients’ survival and/or improve their quality of life. This is achieved by altering how drugs are metabolized and/or distributed in the body, including how they reach cancer cells. In addition, Processa utilizes its Regulatory Science Approach, including the principles associated with FDA’s Project Optimus Oncology initiative, in the development of its NGC drug products to achieve a more favorable benefit-risk profile. PCS6422: Next-Generation Capecitabine (NGC-Cap) NGC-Cap is a combination of PCS6422 and capecitabine, which is the oral prodrug of the cancer drug 5-fluorouracil (5-FU). PCS6422 alters the metabolism of 5-FU, resulting in more 5-FU distributed to cancer cells.Earlier this month, the first patient was dosed in a Phase 2 clinical trial (NCT06568692) evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. The Phase 2 study is a global, multicenter, open-label, adaptive-design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. The Company expects to announce interim data from this trial in the second half of 2025. PCS3117: Next-Generation Gemcitabine (NGC-Gem) NGC-Gem is an oral analog of gemcitabine (Gemzar®) that is converted to its active metabolite by a different enzyme system, with potential for a positive response in gemcitabine patients including those inherently resistant to or who acquire resistance to gemcitabine.Processa is evaluating the potential of NGC-Gem in patients with pancreatic and other cancers, as well as ways to identify patients who are more likely to respond to NGC-Gem than gemcitabine alone. The Company is requesting a meeting with the FDA to discuss potential trial designs, including implementation of the Project Optimus initiative. PCS11T: Next-Generation Irinotecan (NGC-Iri) NGC-Iri is an analog of SN-38, the active metabolite of irinotecan, that is expected to have an improved safety-efficacy profile in every type of cancer where irinotecan is currently used.As announced in August, two studies in a human melanoma xenograft mouse model measured SN-38 in tumors, plasma and other tissues following administration of NGC-Iri, irinotecan and Onivyde®, the liposomal formulation of irinotecan. One study compared NGC-Iri with irinotecan, and the other compared irinotecan with Onivyde®. The results found that mice administered NGC-Iri had greater accumulation of SN-38 in the tumor compared with other tissues and that less SN-38 accumulated in non-cancer tissues, which could lead to improved efficacy with a more favorable adverse event profile compared with irinotecan and Onivyde®.The Company is currently evaluating the manufacturing process and potential sites for NGC-Iri. In addition, Processa is defining the potential paths to approval, which includes defining the target patient population and the type of cancer, and expects to conduct IND-enabling toxicology studies in 2025. Third Quarter Financial Results Research and development expenses for the third quarter of 2024 were $2.3 million, compared with $1.2 million for the third quarter of 2023. General and administrative expenses for the third quarter of 2024 were $1.1 million, compared with $1.0 million for the third quarter of 2023. The net loss for the third quarter of 2024 was $3.4 million, or $1.03 per share, compared with the net loss for the third quarter of 2023 of $2.1 million, or $1.54 per share. All per-share figures reflect a 1-for-20 reverse stock split that was effective as of January 22, 2024. Cash and cash equivalents were $2.9 million as of September 30, 2024. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations Contact:Yvonne BriggsAlliance Advisors Investor Relations(310) 691-7100ybriggs@allianceadvisorsir.com [Financial Tables to follow]PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share information) (unaudited) September 30, 2024 December 31, 2023 ASSETS Current Assets Cash and cash equivalents $2,891 $4,706 Prepaid expenses and other 1,947 926 Total Current Assets 4,838 5,632 Property and Equipment, net 5 3 Other Assets Lease right-of-use assets, net of accumulated amortization 93 146 Security deposit 6 6 Total Other Assets 99 152 Total Assets $4,942 $5,787 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Current maturities of lease liabilities $94 $84 Accounts payable 712 312 Due to licensor - 189 Due to related parties - - Accrued expenses 413 146 Total Current Liabilities 1,219 731 Non-current Liabilities Non-current lease liabilities 2 67 Total Liabilities 1,221 798 Commitments and Contingencies - - Stockholders’ Equity Common stock, par value $0.0001, 100,000,000 shares authorized: 3,271,944 issued and 3,266,944 outstanding at September 30, 2024; and 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 - - Additional paid-in capital 88,511 80,658 Treasury stock at cost — 5,000 shares at September 30, 2024 and December 31, 2023 (300) (300)Accumulated deficit (84,490) (75,369)Total Stockholders’ Equity 3,721 4,989 Total Liabilities and Stockholders’ Equity $4,942 $5,787 PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share data)(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating Expenses Research and development $2,288 $1,152 $5,557 $4,479 General and administrative 1,137 1,016 3,760 4,509 Operating Loss (3,425) (2,168) (9,317) (8,988) Other Income (Expense) Interest income, net 40 86 195 271 Net Loss $(3,385) $(2,082) $(9,122) $(8,717) Net Loss per Common Share - Basic and Diluted $(1.03) $(1.54) $(3.13) $(6.81) Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted 3,275,998 1,350,188 2,909,941 1,279,298 # # #

Phase 2Financial StatementClinical ResultPhase 1

14 Oct 2024

·www.pharmaceutical-technology.com

ENHERTU gains conditional approval in China to treat NSCLC

ENHERTU is indicated for patients with unresectable or metastatic NSCLC with activating HER2 mutations who have previously undergone systemic therapy. Credit: Nemes Laszlo/Shutterstock. Daiichi Sankyo and AstraZeneca ‘s ENHERTU has been conditionally approved by China’s National Medical Products Administration (NMPA) as a single agent for adult patients with a specific type of non-small cell lung cancer (NSCLC). Free Whitepaper Intensified Biomanufacturing of monoclonal antibodies Using an intensified fed-batch process is a viable alternative for higher protein production at a large scale without expanding the current manufacturing footprint. Syngene’s expertise in the field is covered in this white paper. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. Go deeper with GlobalData Reports LOA and PTSR Model - DF-9001 in Non-Small Cell Lung Cancer Reports LOA and PTSR Model - Eniluracil in Metastatic Breast Cancer Data Insights The gold standard of business intelligence. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The therapy is indicated for patients with unresectable or metastatic NSCLC with activating HER2 mutations who have previously undergone systemic therapy. It marks the fourth approval in China for ENHERTU, which has been authorised for use in three different tumour types: HER2-low metastatic breast cancer, and HER2-positive advanced or metastatic gastric cancer . ENHERTU, a HER2-directed antibody-drug conjugate (ADC), was discovered by Daiichi Sankyo and is being developed and commercialised in collaboration with AstraZeneca. The conditional approval is based on the outcomes of the DESTINY-Lung02 and DESTINY-Lung05 Phase II studies. See Also: Evergreen Theragnostics Radiopharmaceutical Manufacturing Facility, New Jersey, US Merck Biotech Development Center, Corsier-sur-Vevey, Switzerland In the DESTINY-Lung02 trial, ENHERTU achieved the primary endpoint with a confirmed overall response rate (ORR) of 49%, 49 partial responses (PRs) and one complete response (CR), as evaluated by blinded independent central review (BICR). The DESTINY-Lung05 trial demonstrated a confirmed ORR of 58.3%, one CR and 41 PRs, as determined by an ICR. AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “This approval of ENHERTU represents the first HER2 directed therapy approved in China for the treatment of HER2 mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated. “It also reinforces the importance of testing for predictive biomarkers, including HER2 mutations in lung cancer at the time of diagnosis, to ensure patients can receive the most appropriate treatment for their specific disease.” The full approval of ENHERTU for this indication in China will depend on the clinical benefits observed in the confirmatory trial. Enhertu was approved in the US as the first tumour-agnostic HER2-directed therapy in April 2024 for previously treated patients with metastatic HER2-positive solid tumours. 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Clinical ResultDrug ApprovalPhase 2ADC

02 Oct 2024

·www.biospace.com

Processa Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of NGC-Cap in Metastatic Breast Cancer

Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabine Results from this Phase 2 trial will evaluate NGC-Cap’s safety-efficacy pro help to define the optimal dosage regimen in patients with metastatic breast cancer HANOVER, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. “Dosing the first patient in this Phase 2 trial is a significant step in the development of NGC-Cap as a more effective and better tolerated treatment than widely used capecitabine and 5-FU,” stated David Young, PharmD, Ph.D., President of Research and Development at Processa. “We expect this Phase 2 trial to build upon NGC-Cap’s positive Phase 1b findings and we look forward to announcing the results from our interim analysis of this Phase 2 trial in mid-2025.” The Phase 2 trial ( NCT06568692 ) is a global multicenter, open-label, adaptive designed safety-efficacy trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial is designed to evaluate the safety-efficacy pro NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. To date, three clinical trial sites, including some with multiple clinical locations, have received institutional review board approval to participate in this study and are recruiting patients. Processa plans to activate approximately 30 sites worldwide. Breast cancer is the second most common cancer and a leading cause of cancer-related death. More than 2 million cases of breast cancer were diagnosed in 2022 with more than 665,000 deaths globally. The five-year survival rate for those diagnosed with metastatic breast cancer is approximately 30%. About Capecitabine Administered with PCS6422 (NGC-Cap) NGC-Cap combines the administration of PCS6422, the Company’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of capecitabine. Capecitabine is the oral prodrug of 5-fluorouracil (5-FU), and along with 5-FU is among the most widely used chemotherapy drugs, particularly for the treatment of solid tumors. When metabolized (after oral ingestion) it becomes 5-FU in the body, which, in turn, metabolizes to molecules called anabolites that actively kill duplicating cells, such as cancer cells, and to molecules called catabolites that only cause side effects. The presence of the DPD enzyme plays an integral role in the undesirable conversion of 5-FU to catabolites causing side effects while simultaneously decreasing tumor exposure to 5-FU and its cancer-killing anabolites. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. For more information, visit our website at . Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact: Patrick Lin (925) 683-3218 plin@processapharma.com Investor Relations Contact: Yvonne Briggs LHA Investor Relations (310) 691-7100 ybriggs@lhai.com # # #

Phase 2

100 Deals associated with Eniluracil

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KEGG	Wiki	ATC	Drug Bank
D03998	-	-	DB03516

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Colorectal Adenocarcinoma	Phase 3	US	National Cancer Institute	01 Apr 1999
Rectal Adenocarcinoma	Phase 3	US	National Cancer Institute	01 Apr 1999
Recurrent Colon Cancer	Phase 3	US	National Cancer Institute	01 Apr 1999
Colorectal Cancer	Phase 3	US	GSK Plc	-
Colorectal Cancer	Phase 3	GB	GSK Plc	-
Pancreatic Cancer	Phase 3	GB	GSK Plc	-
HER2-negative breast cancer	Phase 2	US	Processa Pharmaceuticals, Inc.	02 Oct 2024
Triple Negative Breast Cancer	Phase 2	US	Processa Pharmaceuticals, Inc.	02 Oct 2024
Metastatic breast cancer	Phase 2	US	Fennec Pharmaceuticals, Inc.	01 Apr 2011
Metastatic breast cancer	Phase 2	RU	Fennec Pharmaceuticals, Inc.	01 Apr 2011

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GlobeNewswire Manual	Phase 1	Neoplasms	-	PCS6422+Capecitabine	obajzerkbp(vxenfwozsi) = the side effect profile for 5-FU exposures from NGC-Cap had a similar anabolite side effect profile to FDA-approved capecitabine. In addition, the side effects associated with FBAL (fluoro-beta-alanine, the primary catabolite formed from the metabolism of 5-FU), such as hand-foot syndrome, that can lead to capecitabine intolerance, were almost non-existent, likely because FBAL exposure was approximately 1% of the exposure seen after FDA-approved capecitabine administration. sdzplboqwu (ykqletdcjj )	Positive	19 Dec 2023
ASCO2007	Phase 1	Colorectal Cancer \| Metastatic Colorectal Carcinoma	5	Eniluracil (EU)	mogzbpanke(hllpanidpn) = wolyadynoc fkcpvgrxuv (pleuxnvfpd, 11)	-	20 Jun 2007

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