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Sona Announces Ethics Committee Approval For Melanoma Clinical Trial

On June 27, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, reported that it has received ethics committee approval to proceed with its previously announced early feasibility study of its Targeted Hyperthermia Therapy ("THT") cancer treatment (Press release, Sona Nanotech, JUN 27, 2025, View Source [SID1234654155]).

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Sona CEO David Regan commented, "This ethics committee approval gives us the green light we’ve been waiting for to begin enrolling patients suffering from late-stage melanoma, for whom no other therapy has worked, to participate in our first-in-human clinical trial. Our clinical trial partner will now begin enrolling patients, and we will advise when a first dosing of our THT treatment has occurred. Sona’s CMO, Dr. Carman Giacomantonio, will provide clinical training and will observe the application of THT in the first patients enrolled."

The study is designed to assess safety, tolerability, and preliminary efficacy and will include two treatments of Sona’s THT, one week apart, for patients with advanced melanoma who are on, but have failed to respond to, a standard of care immunotherapy protocol. The study is anticipated to be conducted this summer with an initial read-out of final results expected by September, subject to enrollment rates.

First Patient Dosed in Australia for PD1-Vaxx Neo-POLEM Phase II trial

On June 27, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first patient dosed in Australia, as part of the investigator sponsored Phase II Neo-POLEM clinical trial (Press release, Imugene, JUN 27, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/4621b5ea-5e19-3f10-0982-51c3e3f18e9e/1st_Patient_Dosed_in_Australia_PD1_Vaxx_neo_POLEM_PhII_Trial.pdf [SID1234654143]).

Neo-POLEM is a Phase II study investigating the potential of PD1-Vaxx, a neoadjuvant PD-1 vaccine, to improve treatment outcomes for patients with mismatch repair-deficient / microsatellite instability high (dMMR/MSI-high) colorectal cancer. Approximately 15% of patients with colorectal cancer have the dMMR/MSI-high subtype.

The trial is an IST being conducted by Cancer Research UK Southampton Clinical Trials Unit in collaboration with Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trial Group (AGITG).

The primary objective of the study is to determine major pathological response rates, a measure of tumour size reduction post-treatment with PD1-Vaxx before surgery, with secondary objectives to assess the safety of PD1-Vaxx, evaluate biomarkers, and evaluate the objective response rates and overall survival.

This trial builds upon compelling early evidence that immunotherapy can deliver significant benefits in this patient population. The trial will recruit patients in both Australia and the United Kingdom.

Imugene’s CEO and Managing Director Leslie Chong said: "Dosing the first patient in the Neo-POLEM study represents hopeful treatment options for those suffering from these subtypes of colorectal cancer. We are encouraged by the potential of PD1-Vaxx to activate the body’s own immune system to fight cancer in this earliest stage of disease. Our focus remains firmly on improving outcomes for people living with this disease, and we’re grateful to the patients and clinical teams in Australia and the UK who are making this progress possible."

Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer, with a worldwide annual incidence of more than 1.2 million cases and a mortality rate of approximately 50%. About 80% of patients with colon cancer have localised and resectable disease at diagnosis.

Termination of a Material Definitive Agreement

On June 26, 2025 (the "Effective Date"), Elevation Oncology, Inc. (the "Company") reported to have entered into a Mutual Release and Termination Agreement (the "Termination Agreement") with CSPC Megalith Biopharmaceutical Co., Ltd. ("CSPC"), pursuant to which that certain License Agreement, dated July 27, 2022, by and between the Company and CSPC (the "License Agreement") was terminated as of the Effective Date (Filing, 8-K, Elevation Oncology, JUN 26, 2025, View Source [SID1234654215]).

Pursuant to the License Agreement, CSPC granted to the Company a worldwide exclusive right and license (outside of the People’s Republic of China, Hong Kong, Macau and Taiwan) under certain patents identified in the License Agreement and know-how to develop and commercialize products containing EO-3021, a Claudin 18.2 antibody-drug conjugate, in the treatment of cancer. As previously disclosed, on March 20, 2025, the Company announced its election to discontinue development of EO-3021.

Upon termination of the License Agreement, the rights and licenses granted to the Company thereunder from CSPC terminated, and all rights, title and interest in and to the licensed intellectual property under the License Agreement reverted to CSPC. The Termination Agreement includes a customary mutual release of claims and provides that no further payments shall be due between the Company and CSPC under the License Agreement.

CORMEDIX INC. ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK

On June 26, 2025 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that it intends to offer and sell $85.0 million of shares of its common stock in an underwritten public offering (Press release, CorMedix, JUN 26, 2025, View Source [SID1234654157]). All of the shares to be sold in the offering will be offered by CorMedix. In addition, CorMedix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

RBC Capital Markets is acting as sole bookrunner for the offering.

CorMedix intends to use the net proceeds from the offering for general corporate purposes, which may include working capital, expenses related to research and the development of product candidates, and potential strategic transactions, including acquisitions, joint ventures or collaborations, involving companies, products or assets that complement CorMedix’s business.

The securities described above are being offered by CorMedix pursuant to a shelf registration statement on Form S-3 which was initially filed by CorMedix with the Securities and Exchange Commission (the "SEC") May 6, 2024, and was declared effective by the SEC on May 22, 2024.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering, as well as copies of the final prospectus supplement, when available, may be obtained from RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by email at [email protected].

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 registration or qualification under the securities laws of any such state or jurisdiction. Any offer or sale will be made only by means of CorMedix’s prospectus supplement and prospectus forming part of the effective registration statement relating to these securities.

bioAffinity Technologies Scientists Present Breakthrough Cancer Research at RNA Therapeutics Conference

On June 26, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on cancer diagnostics and targeted therapeutics, reported it will present findings related to the discovery of a potential broad-spectrum cancer therapy that is the subject of the Company’s recently issued U.S. Patent No. 12,305,171 and the notification of patent grant from the China National Intellectual Property Administration (Press release, BioAffinity Technologies, JUN 26, 2025, View Source [SID1234654150]).

The presentation at the 2025 RNA Therapeutics Conference, titled "Silencing CD320 and LRP2 by siRNAs selectively kills cancer cells: mechanistic enigmas," highlights a novel therapeutic approach that uses small interfering RNAs (siRNAs) to selectively kill cancer cells by targeting two specific cell surface receptors, CD320 and LRP2. The data demonstrates that dual suppression of these proteins is highly effective in killing cancer cells while sparing normal cells, offering promising potential for the development of new RNA-based therapies. Research is underway to develop a topical treatment for cutaneous malignancies and neoplasms of the skin.

RNA-based cancer therapeutics represent one of the fastest-growing segments within oncology, driven by the urgent need for more targeted and effective treatments. bioAffinity’s approach, utilizing siRNAs to selectively silence cell surface proteins, holds substantial commercial promise due to its broad-spectrum effectiveness demonstrated across multiple tumor types including lung, breast, prostate, brain, and skin cancers. The potential to develop targeted therapies that could significantly enhance patient outcomes positions the Company favorably within this rapidly expanding market.

David Elzi, PhD, Vice President of Product Development, will present the research on behalf of fellow authors, William Bauta, PhD, Chief Science Officer, and Staff Scientist Reggie Jacob, MS.

"Our studies show that silencing the cell surface receptors CD320 and LRP2 using siRNAs selectively kills or halts the growth of cancer cells while leaving normal cells unaffected," Dr. Elzi said. "This effect was observed across multiple cancer types, regardless of mutation status."

"We’re proud to share this research with the scientific, academic and industry leaders who attend the leading conference on RNA innovation," bioAffinity President and CEO Maria Zannes said. "This work reflects our commitment to developing novel, highly selective treatments in the battle against cancer."

The RNA Therapeutics Institute at the University of Massachusetts (UMass) T.H. Chan Medical School in Worcester, MA, leverages RNA biology and clinical research to develop new therapeutics for multiple diseases based on the fundamental mechanisms of cellular RNAs.