NGC-capecitabine (PCS6422) / Processa Pharma, Elion Oncology - LARVOL DELTA

Processa Pharmaceuticals Announces Pricing of $7 Million Public Offering (GlobeNewswire) - "The Company intends to use the net proceeds from this offering to continue the Phase 2 clinical trial for NGC-Cap, and for working capital and general corporate purposes."

Commercial • Breast Cancer • Oncology

Processa Pharmaceuticals to Engage Potential Partners and Investors at BIO International Convention 2025 (GlobeNewswire) - "During the conference, Processa’s CEO, Georg Ng and Dr. David Young, President R&D will conduct one-on-one meetings with potential partners, investors, and other industry stakeholders to provide updates on the company’s strategic direction and clinical progress. Discussions will highlight the advancement of Processa’s NGC platform, including its lead asset NGC-Cap, currently in a Phase 2 trial for metastatic breast cancer."

Clinical • Breast Cancer

Safety and efficacy of eniluracil + capecitabine (6422 + Cap) in phase 1b trial. (ASCO 2025) - P1 | "Although 5-FU exposure was up to 5-10x greater than for Mono-Cap, AEs from 5-FU catabolites were minimal while anabolite associated AEs for the highest dose cohorts were similar to those reported for Mono-Cap. In these evaluable refractory or intolerant cancer patients, 6422 + Cap efficacy occurred with a PR of 15.4%, SD of 46.2%, and median PFS of 93 days. The MTD was 225 mg BID and RP2DR was 75 mg BID to 225 mg BID."

Clinical • P1 data • Gastrointestinal Cancer • Neutropenia • Oncology • Solid Tumor

Adaptive designed eniluracil + capecitabine phase 2 trial in advanced or metastatic breast cancer patients. (ASCO 2025) - P2 | "The pharmacokinetics of Cap, 5-FU, and the FBAL catabolite will be evaluated using population PK analysis. Currently 3 patients have been enrolled in the study."

Clinical • Metastases • P2 data • Breast Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Processa Pharmaceuticals Announces Presentation and Publication of Three Abstracts at 2025 ASCO Annual Meeting (GlobeNewswire) - "Processa Pharmaceuticals, Inc...today announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. The abstracts highlight Processa’s pipeline of Next Generation Cancer (NGC) drug candidates, including PCS6422 (NGC-Cap) and PCS11T (NGC-Iri), showcasing both preclinical and clinical advances."

Clinical data • Preclinical • Breast Cancer

Eniluracil blocks AREG signalling-induced pro-inflammatory fibroblasts of melanoma in heart failure. (PubMed, ESC Heart Fail) - "The increased prevalence of melanoma in HF patients and its propensity for cardiac metastasis may be due to AREG-mediated systemic low-grade inflammation. Eniluracil holds promise as a therapeutic agent that may block AREG signalling, inhibiting the activation of iCAF mediated by regulatory T cell (Treg) and neutrophil."

Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Melanoma • Oncology • Solid Tumor • CAFs

Processa Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of NGC-Cap in Metastatic Breast Cancer (GlobeNewswire) - "Processa Pharmaceuticals...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....'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."

P2 data • Trial status • Breast Cancer

PCS6422-GI-01: A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Processa Pharmaceuticals | Active, not recruiting ➔ Completed

Metastases • Trial completion • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

Processa Pharmaceuticals Provides Product Pipeline and Financial Update (GlobeNewswire) - P1b | N=23 | NCT04861987 | Sponsor: Processa Pharmaceuticals | "The NGC-Cap Phase 1b study evaluated ascending doses of capecitabine when combined with a fixed dose of PCS6422 in patients with advanced, relapsed or refractory progressive gastrointestinal cancer....In all evaluable patients who received one dose of PCS6422 and seven days of capecitabine, partial responses or stable disease was observed in 66.7% (8 out of 12) of patients with progression-free survival of approximately 5 to 11 months across these patients."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Processa Pharmaceuticals

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer (GlobeNewswire) - "Processa Pharmaceuticals, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), its lead product candidate. The IND supports the initiation of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer, which is expected to begin enrollment this quarter....'Initial data from the Phase 2 trial are expected mid-2025'....Processa expects to enroll the first patient into this trial in the third quarter of 2024."

IND • New P2 trial • Breast Cancer • Oncology • Solid Tumor

A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors (clinicaltrials.gov) - P1 | N=23 | Active, not recruiting | Sponsor: Processa Pharmaceuticals | Recruiting ➔ Active, not recruiting | Phase classification: P1b ➔ P1 | N=42 ➔ 23 | Trial completion date: Mar 2024 ➔ Aug 2024 | Trial primary completion date: Jan 2024 ➔ Jun 2024

Enrollment change • Enrollment closed • Metastases • Phase classification • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

Processa Pharmaceuticals Announces Positive Efficacy Results from Preliminary Evaluation of Phase 1b Dose-escalating Trial with NGC-Cap in Gastrointestinal Cancer (GlobeNewswire) - P1b | N=42 | NCT04861987 | Sponsor: Processa Pharmaceuticals | "'From this Phase 1b trial, we have been able to define the MTD and the RP2DR to use in our Phase 2 Optimal Dosage Regimen trial in breast cancer in the third quarter of 2024'....At the MTD of 225 mg of capecitabine dosed twice daily after a single dose of PCS6422, all three evaluable patients (100%) had PFS with the time to progression being approximately 5 to 7 months. At the second highest dose of 150 mg capecitabine dosed twice daily after a single dose of PCS6422, 66.7% (2 out of 3) of evaluable patients had SD with the time to progression of approximately 3 to 7 months."

New P2 trial • P1 data • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Next generation capecitabine (NGC-Cap) in phase 1b trial significantly increases 5-FU exposure while improving safety profile compared to capecitabine (AACR 2024) - "NGC-Cap combines ethynyl-uracil (PCS6422), an irreversible inhibitor of the DPD catabolism enzyme, and Cape. The Phase 1b trial is a 3+3 design with up to 5 ascending Cape doses from 75 mg qd to 300 mg bid... The Phase 1b trial has already revealed some of the potential benefits of NGC-Cap over Mono-Cap. 1.NGC-Cap can provide a greater 5-FU exposure based on AUC and Cmax with a better or similar side effect profile.2.Side effects from the 5-FU catabolites are minimal and less severe for NGC-Cap.3.Side effects from 5-FU anabolites are dependent on 5-FU exposure with less exposure leading to fewer side effects that may also be less severe.4.NGC-Cap is to be further evaluated in a Phase 2 trial with the expectation that NGC-Cap will provide a better efficacy and safety profile than Cape."

Clinical • P1 data • Oncology

Processa Pharmaceuticals Presents Two Abstracts at the AACR Annual Meeting 2024 Including New Data on the NGC-Cap Phase 1b Trial (GlobeNewswire) - P1b | N=42 | NCT04861987 | Sponsor: Processa Pharmaceuticals | "Processa Pharmaceuticals...presented two abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2024, including new Phase 1b data on its Next Generation Capecitabine (NGC-Cap) product....18 patients were enrolled in the first four dose levels of capecitabine in NGC-Cap....As expected, with the greater 5-FU exposure for all the NGC-Cap cohorts, the incidence of anabolite related side effects was also greater than monotherapy treatment, suggesting that more drug was distributed to duplicating cancer cells and normal cells. The extremely low FBAL catabolite formation and exposure across all NGC-Cap doses resulted in the incidence of catabolite related side effects to be less with only one patient having Grade 1 hand-foot-syndrome, an FBAL related side effect often requiring dose modifications."

P1 data • Gastric Cancer • Gastrointestinal Cancer

Processa Pharmaceuticals to Present Data at the American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Processa Pharmaceuticals, Inc...announces that the Company will have two posters at the American Association for Cancer Research Annual Meeting 2024 in San Diego from April 5-10, 2024."

Clinical data • Oncology • Solid Tumor

Processa Pharmaceuticals Announces Successful Completion of Phase 1b Safety Evaluation of NGC-Cap in Patients with Advanced Cancer Resulting in Recommended Phase 2 Doses (GlobeNewswire) - P1b | N=42 | NCT04861987 | Sponsor: Processa Pharmaceuticals | "Processa Pharmaceuticals, Inc...announces the successful completion of the safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine ('NGC-Cap'). From the Phase 1b data, two dosage regimens have been selected for the Phase 2 trial...The NGC-Cap Phase 1b trial evaluated capecitabine doses from 75 mg once a day (QD) to 225 mg twice a day (BID)...At this time, of the 11 cancer patients receiving one of the two highest doses of NGC-Cap, five have completed an efficacy evaluation at this time, and four of these five patients (or 80%) showed a positive response....Two patients receiving the highest dose will potentially become eligible for an efficacy evaluation by the end of the first quarter of 2024. Of the remaining four patients in the two highest doses, two dropped out prior to their evaluation because of disease progression and two dropped out because of side effects."

P1 data • Trial status • Oncology • Solid Tumor

Processa Pharmaceuticals Announces Expansion of NGC-Cap Program into Advanced or Metastatic Breast Cancer (GlobeNewswire) - "Processa Pharmaceuticals...announces it plans to expand the development of Next Generation Capecitabine...into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial...This decision was supported through discussions with the FDA where Processa agreed with the FDA that pursuing breast cancer will lead to a more efficient development program while providing a greater likelihood of FDA approval. The FDA stated that the previously generated data in past and existing studies could be used to directly support the Phase 2 trial in breast cancer....'Based on this expansion to breast cancer we have identified breast cancer key opinion leaders to join our scientific advisory board, have already determined the Phase 2 study design which we expect to share with the FDA soon, and plan to initiate our Phase 2 study in the third quarter of 2024.'"

Clinical protocol • FDA event • New P2 trial • Breast Cancer • Oncology • Solid Tumor

Processa Pharmaceuticals Provides Interim Analysis from Ongoing Phase 1b Trial of Next Generation Capecitabine Showing Improved Safety Over Capecitabine (GlobeNewswire) - P1b | N=42 | NCT04861987 | Sponsor: Processa Pharmaceuticals | "Processa Pharmaceuticals, Inc...provides an interim analysis from its Phase 1b study of its Next Generation Capecitabine (NGC-Cap)...'We are encouraged to be near completion of the Phase 1b trial as we make preparations for a subsequent Phase 2 trial with NGC-Cap.'...These data confirm that the metabolic pathways that regulate how NGC-Cap is processed in the body suggest NGC-Cap may offer higher efficacy at lower doses of the underlying capecitabine agent, while simultaneously offering a better safety profile from less production of the side-effect producing catabolite FBAL that causes many of the dose-limiting side effects from treatment with capecitabine alone....The Company will conduct a Fireside Chat on December 20, 2023 at 4:30PM ET to discuss these data in further detail and lay out the Company’s corporate strategy with regard to the NGC platform."

P1 data • Trial status • Oncology • Solid Tumor

Processa Pharmaceuticals Announces Successful Phase 2 Meeting with FDA for Next Generation Capecitabine (GlobeNewswire) - "Processa Pharmaceuticals, Inc...announces the outcomes from a successful meeting with the U.S. Food and Drug Administration ('FDA') regarding the Company’s next Phase 2 study supporting the advancement of Next Generation Capecitabine ('NGC-Cap') for cancer patients....'The FDA provided helpful guidance on the overall design of our NGC-Cap Phase 2 study for which we anticipate beginning enrollment in mid-2024'....The FDA provided guidance on the study design, the protocol, and the determination of the optimal dosage regimen using the principles of Project Optimus. The meeting with the FDA was supported by the interim results from the ongoing Phase 1b study that should complete enrollment in the first quarter of 2024. These interim results are expected to be available for public release by the end of the year."

Enrollment status • FDA event • New P2 trial • P1 data • Oncology • Solid Tumor

A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors (clinicaltrials.gov) - P1b | N=42 | Recruiting | Sponsor: Processa Pharmaceuticals | Trial primary completion date: Sep 2023 ➔ Jan 2024

Metastases • Trial primary completion date • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

Processa Pharmaceuticals Provides Data Update Supporting a Potential Personalized Treatment Approach for Improved Cancer Care (GlobeNewswire) - "The first three of five cohorts in the Phase 1B trial have completed enrollment and the initial safety evaluation. The fourth cohort has completed enrollment, and the safety evaluation is ongoing. Enrollment in the last cohort is expected to be completed in 4Q23, leading to an assessment of the safety profile and potentially preliminary efficacy of NGC-Capecitabine in totality across all cohorts by year-end. This cumulative view of the safety profile will allow Processa to determine the appropriate dose regimens to be used in its planned Phase 2 study in patients with colorectal cancer to determine the Optimal Dose Regimen, as mandated by the FDA’s new Project Optimus Initiative."

Enrollment status • New P2 trial • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Processa Pharmaceuticals Provides Data Update Supporting a Potential Personalized Treatment Approach for Improved Cancer Care (GlobeNewswire) - P1b | N=42 | NCT04861987 | Sponsor: Processa Pharmaceuticals | "Processa Pharmaceuticals, Inc...provides an interim analysis from its ongoing Phase 1B trial of Next Generation Capecitabine (NGC-Cap) in patients with gastrointestinal cancer, which identifies a personalized treatment approach that may yield improved safety and treatment efficacy.... The data shows that DPD enzyme activity (as represented by FBAL levels) was extremely low for approximately 24-48 hours in patients who received PCS6422 plus capecitabine. The low level of the DPD enzyme activity during the first 24-48 hours resulted in capecitabine being metabolized mainly to its active cancer-killing metabolites instead of FBAL. Over the next 3-6 days, the amount of FBAL increased and the levels of 5-FU decreased as a result of the increased DPD activity due to newly formed DPD enzyme (de novo synthesis)."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Processa Pharmaceuticals to Conduct Next Generation Chemotherapy-Capecitabine Phase 2 Trial Based on FDA Guidance and Project Optimus Oncology Initiative (Yahoo News) - "Processa Pharmaceuticals, Inc...today announces it has received guidance from the U.S. Food and Drug Administration ('FDA') regarding the Company’s next trial for Next Generation Chemotherapy-Capecitabine ('NGC-Cap'). The trial for NGC-Cap, the combination of PCS6422 and capecitabine, will be a Phase 2 safety-efficacy trial in colorectal cancer patients following the principles of FDA’s Project Optimus Oncology Initiative, the recent FDA recommendation on how oncology drugs are to be developed going forward....The Phase 2 trial will be designed to determine the dose-and exposure-response relationships for both anti-tumor activity and safety/tolerability by evaluating different dosage regimens. The final dosage regimens to be used in the Phase 2 trial will be defined following the determination of the maximum tolerated dose from the Company’s ongoing Phase 1b trial and in collaboration with the FDA."

FDA event • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors (clinicaltrials.gov) - P1b | N=42 | Recruiting | Sponsor: Processa Pharmaceuticals | Trial completion date: Mar 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Metastases • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor