On July 27, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class medicines for cancer, reported that an abstract featuring the latest data from a Phase I/II study of the Claudin 18.2 antibody-drug conjugate (ADC), ATG-022, has been accepted for poster presentation at the 2025 European Society for Medical Oncology Annual Congress (ESMO 2025), taking place from October 17th to October 21st at the Messe Berlin in Berlin, Germany (Press release, Antengene, JUL 27, 2025, View Source;302514585.html [SID1234654553]).

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Details of the Poster Presentation:

ATG-022 (Claudin 18.2 antibody-drug conjugate)
Title: Phase I/II study of Claudin 18.2 ADC ATG-022 in patients with advanced gastric/ gastroesophageal junction cancer (CLINCH)
Abstract Number: 2907
Presentation Number: 2113P
Date: October 19, 2025

About ATG-022

ATG-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, and pancreatic cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATG-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study demonstrated that ATG-022 delivers robust efficacy across all levels of CLDN18.2 expression in gastric cancer patients, including those with high, low, and ultra-low expression. This broad activity positions ATG-022 as a potential market leader, capable of addressing the largest patient population with CLDN18.2-positive tumors. Furthermore, the strong efficacy observed in patients with low CLDN18.2 expression suggests promise for treating other tumor types with similar expression profiles.

On July 25, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported the entry into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 928,596 shares of common stock of the Company originally issued in December 2024 and January 2025, having exercise prices between $2.00 and $3.00 per share (Press release, Phio Pharmaceuticals, JUL 25, 2025, View Source [SID1234654552]). Warrants to purchase 100,000 shares of common stock at the existing exercise price of $2.00 per share will be exercised at their existing exercise price of $2.00 per share and warrants to purchase 828,596 shares of common stock will be exercised at a reduced exercise price of $2.485 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statement on Form S-1 (No. 333-284381). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $2.5 million, prior to deducting placement agent fees and offering expenses.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash and the payment of additional $0.125 per new unregistered warrant (additional $232,149 in the aggregate, which are included in the gross proceeds to the Company), the exercising holders will receive new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The new warrants will be exercisable for an aggregate of up to 1,857,192 shares of common stock, at an exercise price of $2.485 per share and will be immediately exercisable upon issuance and (i) will have a term of twenty-four months with respect to new warrants to purchase up to 1,538,596 shares of common stock and (ii) will have a term of five years with respect to new warrants to purchase up to 318,596 shares of common stock, in each case, following the effective date of the resale registration statement registering the shares of common stock issuable upon exercise of the new warrants.

The offering is expected to close on or about July 28, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On July 25, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that pathologic results are available for four of the five patients treated in the fourth cohort (Press release, Agenus, JUL 25, 2025, View Source [SID1234654551]). A complete pathologic response (100% tumor clearance) has been reported for one patient with cutaneous squamous cell carcinoma (cSCC). One patient with metastatic Merkel cell carcinoma was reported as a partial response (> 50% clearance). Two patients with cSCC were reported as having a pathologic non-response (<50% tumor clearance). Pathologic results for the remaining patient with cSCC are still pending.

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Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. To date, a total of 15 patients with cutaneous carcinomas have been treated across the four cohorts. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. No patients exhibited clinical progression of disease.

The cumulative pathologic response in 13 patients with cSCC include five complete response (100% clearance), one patient with a near complete response (>90% clearance) and one with a partial response (>50% clearance) and six patients with a pathologic non-response (< 50% clearance).

The one Merkel cell carcinoma patient with stage 4 metastatic disease had a partial response (>50% clearance). The melanoma patient was a non-responder (<50% clearance).

Phio is now enrolling what is expected to be the 5th and final cohort in the Phase 1b study.

"The positive safety and efficacy outcomes through the fourth cohort continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

On July 25, 2025 PDX Pharma reported it has successfully met the Year 1 milestones of its Phase II SBIR grant (R44CA285233) from the National Cancer Institute (NCI) for the development of PETTRA (PLK1 and EGFR Targeted Therapy and Radiation Sensitizer) for lung cancer treatment (Press release, PDX Pharmaceuticals, JUL 25, 2025, View Source [SID1234654548]). As a result, the NCI has issued a Notice of Award for approximately $1.09 million, bringing the total grant funding to $2.4 million. We thank the NCI for its continued support, as well as our dedicated staff and collaborators at OHSU, who worked tirelessly to achieve the project milestones. PETTRA demonstrated superior efficacy compared to the standard of care (SOC) in a metastatic non-small cell lung cancer (NSCLC) mouse model and exhibited strong synergy with radiation therapy. In the final phase of the project, we will conduct additional PK/PD and safety studies of PETTRA, advancing it toward clinical trials as both a monotherapy and a radiation sensitizer.

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On July 25, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that four abstracts highlighting clinical progress across its botensilimab and balstilimab immunotherapy programs have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place in Berlin, Germany from October 17-21 (Press release, Agenus, JUL 25, 2025, View Source [SID1234654537]). The highlight is an oral presentation that will feature emerging survival plateaus from a study of botensilimab plus balstilimab in 343 evaluable patients with refractory metastatic solid tumors across five tumor types. Three additional poster presentations will feature data from investigator-sponsored studies in cervical cancer, MSS metastatic colorectal cancer (mCRC), and non-melanoma skin cancers, underscoring the broad potential of botensilimab and balstilimab based combinations in difficult-to-treat cancers.

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Presentation Details:

1. Oral Presentation Title: Emerging survival plateaus with botensilimab and balstilimab: Pan tumor data from a large phase 1b trial of advanced solid tumors

Presenting Author:
Dr. Michael Gordon; HonorHealth Research Institute-AZ, USA

Mini Oral Session:

Investigational Immunotherapy

Session Date:

Friday, October 17, 2025

Session Time:

2:00-3:00 PM CEST / 8:00-9:30 AM EDT

Location:

Hall 5.2

Abstract Number:

3220

2.

Poster Presentation Title: Efficacy and safety of balstilimab with or without zalifrelimab in recurrent cervical cancer: Results from the global phase 2 RaPiDs trial

Presenting Author: Dr. David O’Malley; The Ohio State University Comprehensive Cancer Center- OH, USA
Session Date:

Saturday, October 18, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

2952

Poster Number:

1164P

3.

Presentation Title: A Phase I trial of botensilimab, balstilimab and regorafenib (BBR) in chemotherapy-resistant patients with microsatellite stable (MSS) metastatic colorectal cancer

Presenting Author:

Dr. Marwan Fakih; City of Hope- CA, USA

Session Date:

Sunday, October 19, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

6197

Poster Number:

851P

4.

Presentation Title: A phase 2, open label study to evaluate the safety and clinical activity of balstilimab in patients with advanced/metastatic non-melanoma skin cancers (AGENONMELA)

Presenting Author:

Dr. Iwona Lugowska; Maria Sklodowska-Curie National Research Institute and Oncology Center – Poland

Session Date:

Monday, October 20, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

7273

Poster Number:

1662P