Apexigen Presents New Data from a Phase 2 Trial Evaluating

SAN CARLOS, Calif., Sept. 10, 2022 (GLOBE NEWSWIRE) — Apexigen, Inc. (NASDAQ: APGN) a clinical-stage firm targeted on growing progressive antibody-based therapeutics for the remedy of most cancers with a give attention to immuno-oncology, right now introduced the presentation of latest knowledge from a Phase 2 multicenter scientific trial evaluating sotigalimab (sotiga), Apexigen’s agonist antibody concentrating on CD40, together with neoadjuvant chemoradiation for sufferers with resectable esophageal and gastroesophageal junction (GEJ) cancers. Encouraging pathologic full response (pCR) charges had been noticed in sufferers with each adenocarcinoma (AC) and squamous cell carcinoma (SCC). These knowledge had been featured in a poster presentation on the European Society for Medical Oncology (ESMO) Congress, being held each nearly 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,” mentioned Andrew Ko, M.D., Professor of Clinical Medicine on the University of California San Francisco and Principal Investigator of the research. (*2*)

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 knowledge and conclusions featured within the ESMO presentation embrace:
The main goal of this research was to evaluate the efficacy of this novel mixture, as measured by the pCR price, and to additional characterize the security and feasibility of the mix of sotiga with customary of care chemoradiation within the neoadjuvant setting for sufferers with resectable esophageal and GEJ cancers.

Safety:

• Sotiga mixed with neoadjuvant chemoradiation for esophageal/GEJ cancers was typically protected and properly tolerated.
  • The majority of sufferers had Grade 1-2 antagonistic occasions (AEs).
  • Six critical antagonistic occasions thought of no less than probably associated to sotiga included cytokine launch syndrome noticed in three sufferers, nausea and vomiting in a single affected person, dysphagia in a single affected person and Guillain-Barre Syndrome in a single affected person.
  • There had been no affected person withdrawals on account of sotiga and no sotiga/neoadjuvant chemoradiation-related deaths.

Efficacy:

• Sotiga mixed with neoadjuvant chemoradiation led to encouraging charges of pCR within the general affected person inhabitants and within the histologic subgroups of AC and SCC.
  • Of the 29 evaluable sufferers, 11 (38%) sufferers had a pCR and 19 (66%) sufferers had a mPR (main pathological response) with lower than 10% of the residual tumor remaining after remedy.
  • By histology, the pCR price was 33% (8/24) in sufferers with AC and 60% (3/5) in sufferers with SCC.
• The pCR price was 41.2% for sufferers (n= 17) receiving 4 doses of sotiga versus 33.3% for sufferers (n= 12) receiving three doses.
• R0 resection was achieved in 86% (25/29) sufferers and progressive illness was solely 7%.
• Paired biomarker evaluation collected earlier than and one to 2 weeks following a single run-in dose of sotiga alone demonstrated considerably elevated tumor infiltration of activated dendritic cells, monocytes and each CD8 and CD4 T cells in comparison with baseline. The noticed immune/inflammatory response within the tumor, altering the immune microenvironment from “cold” to “hot”, additional validates sotiga’s mechanism of motion.

The e-Poster (1229P) is accessible on the ESMO Congress portal and extra particulars are offered under.

• Title: A multicenter section 2 research of sotigalimab (CD40 agonist) together with neoadjuvant chemoradiation for resectable esophageal and gastroesophageal junction (GEJ) cancers
• Presenting writer: Andrew Ko, M.D., Professor of Clinical Medicine on the University of California San Francisco
• Poster Session Date and Time: Monday, September 12, 2022 at 12:00 p.m. CEST

About Apexigen

Apexigen is a clinical-stage biopharmaceutical firm targeted on discovering and growing a new technology of antibody therapeutics for oncology, with an emphasis on new immuno-oncology brokers designed to harness the affected person’s immune system to fight and eradicate most cancers. Sotigalimab and Apexigen’s different packages had been found utilizing Apexigen’s proprietary APXiMAB™ discovery platform. This platform has enabled Apexigen and its collaboration companions to find and develop therapeutic antibodies towards a number of molecular targets, together with targets which are tough to drug with standard antibody applied sciences. Multiple product candidates have been found utilizing the APXiMAB platform, one among which is commercially accessible and the others are in scientific improvement, both internally by Apexigen or by its licensees. For extra data, please go to www.apexigen.com.

Forward-Looking Statements

This press launch accommodates forward-looking statements throughout the that means of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, together with statements relating to the transactions, such because the potential worth for stockholders; the flexibility of the mixed firm to supply progressive oncology options, meet the wants of sufferers and supply significant scientific advantages; the potential attributes, makes use of and effectiveness of its lead candidate sotigalimab; the flexibility of the mixed firm to attain value-creating milestones and pursue strategic partnerships; the mixed firm’s plans with respect to its scientific trials; and the mixed firm’s receipt of extra funds. Any statements contained herein that aren’t statements of historic truth could also be deemed to be forward-looking statements. In addition, any statements that check with projections, forecasts or different characterizations of future occasions or circumstances, together with any underlying assumptions, are forward-looking statements. The phrases “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and comparable expressions could determine forward-looking statements, however the absence of those phrases doesn’t imply that a assertion is just not forward-looking. The forward-looking statements contained on this press launch are primarily based on sure assumptions and analyses made by the administration of Apexigen in gentle of their respective expertise and their notion of historic traits, present circumstances and anticipated future developments and their potential results on the mixed firm, in addition to different elements they imagine are acceptable within the circumstances. There could be no assurance that future developments affecting the mixed firm might be people who the events have anticipated. These forward-looking statements contain a variety of dangers, uncertainties (a few of that are past the management of the events) or different assumptions which will trigger precise outcomes or efficiency to be materially completely different from these expressed or implied by these forward-looking statements, together with the flexibility of the mixed firm to proceed to satisfy the Nasdaq itemizing requirements, obtain profitable scientific outcomes or business adoption of authorised antibody candidates, or that the mixed firm could have enough capital following the transactions to function as anticipated. Should a number of of those dangers or uncertainties materialize, or ought to any of our assumptions show incorrect, precise outcomes could range in materials respects from these projected in these forward-looking statements. Additional elements that might trigger precise outcomes to vary are mentioned below the heading “Risk Factors” and in different sections of the mixed firm’s filings with the SEC, and in its present and periodic experiences filed or furnished from time to time with the SEC. All forward-looking statements on this press launch are made as of the date hereof, primarily based on data accessible to the mixed firm, and Apexigen assumes no obligation to replace or revise any forward-looking assertion, whether or not as a results of new data, future occasions or in any other case, besides as could also be required below relevant securities legal guidelines.

Investor Contact:
Bruce Mackle
LifeSci Advisors
+1-646-889-1200
[email protected]

Apexigen Contact:
William Duke
Chief Financial Officer
Apexigen, Inc.
+1-650-931-6236
[email protected]