Actinic Cheilitis

-Sotigalimab in combination with neoadjuvant chemoradiation induced higher pathologic complete response rates, an important predictor of survival, in patients with both adenocarcinoma and squamous cell carcinoma-SAN CARLOS, Calif., Sept. 10, 2022 (GLOBE NEWSWIRE) -- Apexigen, Inc. (NASDAQ: APGN) a clinical-stage company focused on developing innovative antibody-based therapeutics for the treatment of cancer with a focus on immuno-oncology, today announced the presentation of new data from a Phase 2 multicenter clinical trial evaluating sotigalimab (sotiga), Apexigen’s agonist antibody targeting CD40, in combination with neoadjuvant chemoradiation for patients with resectable esophageal and gastroesophageal junction (GEJ) cancers. Encouraging pathologic complete response (pCR) rates were observed in patients with both adenocarcinoma (AC) and squamous cell carcinoma (SCC). These data were featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress, being held both virtually and in Paris from September 9-13, 2022. “We are excited to present new data at ESMO that highlight the clinical utility of sotiga and the potential to improve outcomes in patients with resectable esophageal and GEJ cancers,” said Andrew Ko, M.D., Professor of Clinical Medicine at the University of California San Francisco and Principal Investigator of the study. “The pathologic complete response rates, an important predictor of survival, compared favorably to historical pCR rates with standard of care treatment alone. Moreover, our study demonstrates that sotiga was able to be safely added to concurrent chemotherapy plus radiation. These results speak to the promise of sotiga-based combination therapies.” Frank Hsu, M.D., Chief Medical Officer of Apexigen commented, “The results from this ongoing study validate sotiga’s differentiated mechanism of action, which has the potential to expand anti-tumor immune responses and modulate the tumor microenvironment for maximal therapeutic effect. We believe sotiga has the potential to become a backbone of combination therapy to address the need for innovative treatment options, as demonstrated by the encouraging rates of pCR in the overall patient population and across histologic subgroups of both adenocarcinoma and squamous cell carcinoma. Additionally, a single dose of sotiga alone induced an inflammatory response in the tumor, which was quantitatively higher in patients achieving a pCR. These important correlative findings further highlight sotiga’s potential to turn cold tumors hot, and together with the emerging data across our broad Phase 2 development program, suggest there is significant opportunity for sotiga to provide meaningful clinical benefit across multiple solid tumor indications. We look forward to providing updates on our progress as we advance our clinical program.” Key data and conclusions featured in the ESMO presentation include:The primary objective of this study was to assess the efficacy of this novel combination, as measured by the pCR rate, and to further characterize the safety and feasibility of the combination of sotiga with standard of care chemoradiation in the neoadjuvant setting for patients with resectable esophageal and GEJ cancers. Safety: Sotiga combined with neoadjuvant chemoradiation for esophageal/GEJ cancers was generally safe and well tolerated. The majority of patients had Grade 1-2 adverse events (AEs).Six serious adverse events considered at least possibly related to sotiga included cytokine release syndrome observed in three patients, nausea and vomiting in one patient, dysphagia in one patient and Guillain-Barre Syndrome in one patient.There were no patient withdrawals due to sotiga and no sotiga/neoadjuvant chemoradiation-related deaths. Efficacy: Sotiga combined with neoadjuvant chemoradiation led to encouraging rates of pCR in the overall patient population and in the histologic subgroups of AC and SCC. Of the 29 evaluable patients, 11 (38%) patients had a pCR and 19 (66%) patients had a mPR (major pathological response) with less than 10% of the residual tumor remaining after treatment.By histology, the pCR rate was 33% (8/24) in patients with AC and 60% (3/5) in patients with SCC. The pCR rate was 41.2% for patients (n= 17) receiving four doses of sotiga versus 33.3% for patients (n= 12) receiving three doses.R0 resection was achieved in 86% (25/29) patients and progressive disease was only 7%.Paired biomarker analysis collected before and one to two weeks following a single run-in dose of sotiga alone demonstrated significantly increased tumor infiltration of activated dendritic cells, monocytes and both CD8 and CD4 T cells compared to baseline. The observed immune/inflammatory response in the tumor, changing the immune microenvironment from “cold” to “hot”, further validates sotiga’s mechanism of action. The e-Poster (1229P) is accessible on the ESMO Congress portal and additional details are provided below. Title: A multicenter phase 2 study of sotigalimab (CD40 agonist) in combination with neoadjuvant chemoradiation for resectable esophageal and gastroesophageal junction (GEJ) cancersPresenting author: Andrew Ko, M.D., Professor of Clinical Medicine at the University of California San FranciscoPoster Session Date and Time: Monday, September 12, 2022 at 12:00 p.m. CEST About Apexigen Apexigen is a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents designed to harness the patient’s immune system to combat and eradicate cancer. Sotigalimab and Apexigen’s other programs were discovered using Apexigen’s proprietary APXiMAB™ discovery platform. This platform has enabled Apexigen and its collaboration partners to discover and develop therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. Multiple product candidates have been discovered using the APXiMAB platform, one of which is commercially available and the others are in clinical development, either internally by Apexigen or by its licensees. For more information, please visit www.apexigen.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the transactions, such as the potential value for stockholders; the ability of the combined company to provide innovative oncology solutions, meet the needs of patients and provide meaningful clinical benefits; the potential attributes, uses and effectiveness of its lead candidate sotigalimab; the ability of the combined company to achieve value-creating milestones and pursue strategic partnerships; the combined company’s plans with respect to its clinical trials; and the combined company’s receipt of additional funds. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this press release are based on certain assumptions and analyses made by the management of Apexigen in light of their respective experience and their perception of historical trends, current conditions and expected future developments and their potential effects on the combined company, as well as other factors they believe are appropriate in the circumstances. There can be no assurance that future developments affecting the combined company will be those that the parties have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the parties) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, including the ability of the combined company to continue to meet the Nasdaq listing standards, achieve successful clinical results or commercial adoption of approved antibody candidates, or that the combined company will have sufficient capital following the transactions to operate as anticipated. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of the combined company’s filings with the SEC, and in its current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to the combined company, and Apexigen assumes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Investor Contact:Bruce MackleLifeSci Advisors+1-646-889-1200bmackle@lifesciadvisors.com Apexigen Contact:William DukeChief Financial OfficerApexigen, Inc.+1-650-931-6236ir@apexigen.com

DUBLIN, July 1, 2022 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced top-line results from its Phase 2 study of Collagenase Clostridium Histolyticum (or "CCH") in participants with adhesive capsulitis (AC) of the shoulder, commonly known as "frozen shoulder." While Phase 2 study participants receiving up to three doses of CCH showed some improvement in the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the Day 95 visit, the difference compared to those study participants receiving placebo was not statistically significant. The safety profile of CCH in the Phase 2 study was consistent with the known safety profile from other studies. Most treatment-emergent adverse events were of mild to moderate severity with the most common events following treatment with CCH being injection site bruising, arthralgia, injection site pain, injection site swelling and contusion. "We are disappointed in the study outcome, and based on these data, we will be reevaluating our path forward for CCH for the treatment of adhesive capsulitis of the shoulder. We will continue focusing on our pipeline, including with respect to other potential CCH indications," said James P. Tursi, M.D., Executive Vice President, Global Research & Development at Endo. "We are committed to advancing our strategic priority of expanding and enhancing our portfolio for growth." The Phase 2 trial enrolled 198 participants with unilateral idiopathic AC of the shoulder with restricted range of motion (ROM) and function in the affected shoulder. Participants were randomized 1:1 to receive CCH or placebo administered by ultrasound-guided injection. Participants received up to 3 injections separated by a minimum of 21 days. Participants completed standard home exercises and received physical therapy at designated time points during the study. The Phase 2 trial's primary endpoint was the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the Day 95 visit. This adapted scale measures pain and function parameters of the shoulder. Secondary endpoints included measures of passive and active range of motion improvement (PROM and AROM respectively). About Adhesive Capsulitis Adhesive capsulitis (AC) is characterized by a painful and gradual loss of active and passive shoulder motion resulting from fibrosis and contracture of the joint capsule. It is a specific pathologic entity in which chronic inflammation of the joint capsule produces thickening and fibrosis. Patients typically present with pain of insidious onset of several months' duration.1 AC is believed to affect from 3% to 5% of the U.S. general population with an incidence of up to 20% in those with diabetes.2 Treatment options include a range of conservative and potentially even surgical measures. Oral and intra-articular corticosteroids have been shown to have a limited benefit in reducing pain and increasing ROM in AC. Physical therapy (PT) to the limit of pain is widely accepted as part of the management of AC, commonly in the early stages of the disease.3 More invasive management options include nerve blocks, a variety of injection options with varying degrees of efficacy demonstrated and ultimately, hydrodilatation or manipulation under anesthesia (MUA) may be required. Arthroscopic capsular release has also been used to treat AC often as a last resort, with the associated risks of postoperative pain, recurrent postoperative AC, and axillary nerve damage, as well as the risks associated with general anesthesia.3 About Endo Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Dr. Tursi and any statements relating to clinical trials or studies, potential treatments or indications, future research, portfolio growth, timelines or expectations. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this press release reflect Endo's current expectations of future events based on existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, contingency planning and any potential restructuring; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust matters; actual or contingent liabilities; settlement discussions or negotiations; the impact of competition including loss of exclusivity and generic competition; our ability to satisfy judgments or settlements or to pursue appeals including bonding requirements; our ability to adjust to changing market conditions; our inability to maintain compliance with financial covenants and operating obligations which would expose us to potential events of default under our outstanding indebtedness; our ability to incur additional debt or refinance our outstanding indebtedness; a significant reduction in our short-term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs; the performance of and consumer and physician acceptance of our products; the impact that known and unknown side effects may have on market perception and consumer preference; the effectiveness of advertising and other promotional campaigns; and our ability to develop products and our pipeline of products. The occurrence or possibility of any such result has caused us to engage and may result in further engagement in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential corporate reorganization, restructuring or bankruptcy filing involving all or a portion of our business, asset sales or other divestitures, cost-saving initiatives, corporate realignments or strategic partnerships. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. References: Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004. PMID: 21885699. Le HV, Lee SJ, Nazarian A, et al. Adhesive capsulitis of the shoulder: Review of pathophysiology and current clinical treatments. Shoulder & Elbow 2017;9(2):75-84. Cho C-H, Bae K-C, Kim D-H. Treatment strategy for frozen shoulder. Clin Orthoped Surg 2019;11:249-257. SOURCE Endo International plc