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Antennova Presents Latest Phase I/II Data on ATN-022 in Advanced/Metastatic Gastric Cancer, Including an ORR of 42.9%, at ASCO GI 2025

On January 21, 2025 Antennova, a clinical-stage biotech company focused on oncology reported the presentation of latest data from its Phase I/II CLINCH study ongoing in China and Australia evaluating ATN-022 (CLDN18.2 antibody-drug conjugate [ADC]) in patients with advanced or metastatic gastric cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium 2025 (ASCO GI 2025) (Press release, Antennova, JAN 21, 2025, View Source;302356818.html [SID1234649804]).

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The CLINCH study is a Phase I/II study ongoing in China and Australia with a dose escalation phase followed by a dose expansion phase. As of November 22, 2024, among 21 gastric cancer patients in dose expansion phase with CLDN 18.2 expression of IHC 2+ ≥ 20% who had at least 1 tumor evaluation, the overall response rate (ORR) was 42.9%, and the disease control rate (DCR) was 95.2% (9 partial responses [PRs] including 8 confirmed PRs; and 11 stable diseases [SDs]).
Among 10 gastric cancer patients with CLDN 18.2 expression of IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg, the ORR was 30.0% (1 complete response [CR] and 2 PRs, all PR/CR were confirmed with CLDN 18.2 expression of IHC 2+ < 5%), and the DCR was 50.0%. The patient with CR has demonstrated durable response and has been on the study for over 14 months as of the cut-off date.
ATN-022 demonstrated a manageable safety profile and promising preliminary antitumor activity in late stage gastric cancer patients across various levels of CLDN18.2 expression, supporting further clinical investigations of ATN-022 in gastric cancer patients. The enrollment of gastric cancer patients for dose optimization and patients with other solid tumors is ongoing in China and Australia.
Details of the Poster Presentation:

ATN-022 (also known as ATG-022, CLDN18.2 antibody-drug conjugate)

Title: Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)

Abstract Number: 456

Session: Poster Session A: Cancers of Esophagus and Stomach and Other Gastrointestinal Cancers

Presenter: Jinfeng Ma Shanxi Cancer Hospital

Date: Thursday, January 23, 2025

Time: 11:30 AM – 1:00 PM (Pacific time)

3:30 AM – 5:00 AM, January 24, 2025 (Beijing time)

About ATN-022

ATN-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, pancreatic and other cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATN-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study of ATN-022 has shown promising clinical efficacy in gastric cancer patients with various levels of CLDN18.2 expression. The efficacy already observed across all levels of CLDN18.2 expression in patients with gastric cancer suggests that ATN-022 holds the promise as a competitive treatment option.

Phio Pharmaceuticals Announces Closing of $1.83 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On January 21, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company that develops therapeutics using its INTASYL siRNA gene silencing technology to make the body’s immune cells more effective in killing cancer cells, reported the closing of its registered direct offering previously announced on January 16, 2024, priced at-the-market under Nasdaq rules, for the purchase and sale of an aggregate of 610,000 shares of its common stock at a purchase price of $3.00 per share (Press release, Phio Pharmaceuticals, JAN 21, 2025, View Source [SID1234649802]). In addition, in a concurrent private placement, the Company issued short-term unregistered warrants to purchase up to an aggregate of 1,220,000 shares of common stock. The short-term warrants have an exercise price of $3.00 per share, are exercisable upon issuance and will expire twenty-four months following the date of issuance.

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

The aggregate gross proceeds to the Company from this financing were $1.83 million, before deducting the placement agent fees and other offering expenses payable by the Company. The total gross proceeds raised by the Company in registered direct offerings and concurrent private placements since the beginning of December 2024 are approximately $9.15 million, before deducting placement agent fees and other offering expenses payable by the Company. Additional gross proceeds of approximately $2.9 million were raised from the exercise of warrants previously issued on July 12, 2024 having an exercise price of $5.45 per share.

Phio intends to use the net proceeds from these financings for working capital and other general corporate purposes, including to fund the remaining clinical activities for Phio’s Phase 1b clinical trial of its lead product candidate, PH-762, for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. Phio expects that the proceeds will allow it to continue development activities on its second clinical target, PH-894, which silences the BRD4 protein implicated in a number of solid tumors.

"Procurement of these funds provides a financial pathway to realizing the completion of the PH-762 Phase 1b clinical trial, a critical milestone for the development program," commented Robert Bitterman, Phio President and CEO. "We are also excited to be able to move the PH-894 program forward."

The shares of common stock issued in the January 16, 2024 financing (but not the short-term warrants issued in the private placement or the shares of common stock underlying such short-term warrants) were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279557) filed with the Securities and Exchange Commission ("SEC") on May 20, 2024 and became effective on July 1, 2024. The registered direct offering of the shares of common stock were made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock offered in the registered direct offering have been filed with the SEC and are available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

The short-term warrants described above were issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the short-term warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the short-term warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

Unleashing the potential of Immuno-oncology therapies

On January 21, 2025 Xilio therapeutics presented its corporate presentation (Presentation, Xilio Therapeutics, JAN 21, 2025, View Source [SID1234649800]).

First patient enrolled in the VAR2 Pharma – TRACER Phase 0 oncology trial

On January 21, 2025 TRACER and VAR2 Pharma reported the first patient enrolled in the VARTUTRACE study, a Phase 0 first-in-human imaging trial (NCT06645808) (Press release, Var2 Pharmaceuticals, JAN 21, 2025, View Source [SID1234649798]). The patient, suffering from lung carcinoma received the Investigational Medicinal Product (IMP), a zirconium-89-labeled single-chain variable fragment (scFv), Vartumab, on Dec 17, 2024. The patient successfully completed all study visits.

The obtained data provides valuable insight into using the onco-fetal Chondroitin Sulfate (ofCS) binding Vartumab to selectively target tumors (Nat Commun. 2024 Aug 30;15(1):7553). The study will in total include 16 patients with various solid cancer types for each of the two Vartumab antibodies. Allowing the research team to evaluate the biodistribution and tumor accumulation of both Vartumabs prior to clinical testing of Vartumab-based Antibody Drug Conjugates (ADC).

"The enrollment of the first patient is always a big milestone in clinical research. Our team is very happy with the first patient-in and we’re excited to gather more data on the Vartumabs." – Noortje van Dijk, project manager at TRACER.

"I am thrilled to see our new pan-cancer antibodies moving forward in this first clinical study, paving the way for efficacy studies and hopefully one day a novel treatment for the many cancer patients with limited or exhausted clinical options" – Ali Salanti, CEO at VAR2 Pharma.

Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma

On January 21, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma (Press release, Replimune, JAN 21, 2025, View Source [SID1234649796]). The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. The FDA also informed the Company that they are not currently planning to hold an advisory committee meeting in relation to this application, and at this time have not identified any potential review issues. The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase 3 trial, IGNYTE-3, is currently underway with over 100 sites planned globally.

"There are limited treatment options and a significant unmet need for patients with advanced melanoma who previously received an anti-PD-1 containing regimen," said Sushil Patel, Ph.D., Chief Executive Officer, Replimune. "The BLA acceptance is an important milestone for Replimune, and we look forward to working closely with the FDA on the review of our application."

The FDA grants Priority Review to applications for medicines that, if approved, provide significant improvements in the safety or effectiveness of the treatment of a serious condition. Recently, Replimune received Breakthrough Therapy designation for RP1 in combination with nivolumab for the treatment of advanced melanoma, based on the safety and clinical activity observed in the anti-PD-1 failed melanoma cohort of the IGNYTE clinical trial.

The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. For more information, please visit View Source

About Melanoma
Melanoma is the fifth most common cancer, with approximately 100,000 new cases and 8,000 deaths estimated in the U.S. in 2024.i Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. Options are limited after immune checkpoint blockade therapy, with no standard of care available to patients.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.