On July 16, 2025 Imugene Limited (ASX: IMU), a clinical-stage immunooncology company, reported that it will hold a webinar presentation to update shareholders, investors and other interested parties on the latest data from its Phase 1b trial of azer-cel (Press release, Imugene, JUL 15, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/2de571a9-dbf5-1f0e-44f9-d5bfdd998ae5/Azer_cel_new_data_Webinar.pdf [SID1234654386]).

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The webinar will be hosted by Executive Chairman Paul Hopper, CEO & Managing Director Leslie Chong, and Chief Medical Officer Dr John Byon.

The webinar will be held at 11am AEST on Thursday 17 July 2025.

Shareholders, investors and interested parties can register to attend the webinar at the following link: View Source

Shareholders are encouraged to submit questions for the webinar in advance via email at: [email protected]

A recording will be available at the above link shortly after the conclusion of the live session, and the replay will also be available via the Company’s website and social media channels.

On July 15, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that its new drug Pidnarulex (CX-5461) has been selected by the U.S. National Cancer Institute (NCI) as part of a five-year cancer research program (Press release, Senhwa Biosciences, JUL 15, 2025, View Source [SID1234654387]). The first patient in the monotherapy clinical trial for advanced solid tumors has been successfully enrolled at the NIH Clinical Center in Bethesda, Maryland, USA.

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The NCI will fund the full cost of the clinical trial—estimated at approximately USD 4.8 million. In addition to this initial monotherapy trial, three other cutting-edge clinical studies led and sponsored by NCI are in progress. These include combination therapies with immunotherapy, antibody-drug conjugates (ADCs), and a monotherapy study targeting MYC-driven lymphomas. IND submissions and patient enrollment for these additional studies are expected to begin shortly.

Senhwa’s broad collaboration with the NCI not only highlights the innovative potential of CX-5461 as a first-in-class molecule targeting novel cancer mechanisms, but also reflects international recognition of Taiwan’s biotechnology achievements. This strengthens the company’s visibility and strategic position on the global stage in oncology drug development.

Trial Objectives and Research Focus
The first trial in the NCI program will investigate CX-5461 as a single agent in patients with and without homologous recombination deficiency (HRD) gene mutations, evaluating its ability to induce the Rad51 response. The study also aims to identify additional biomarkers associated with synthetic lethality to help define patient populations more likely to respond to treatment and potentially expand its clinical indications. The trial plans to enroll 40 patients, with allocated resources including clinical site operations, pharmacokinetic (PK) and biomarker analyses, as well as execution costs such as regulatory compliance, data management, and electronic platform infrastructure. With full financial support from NCI, the trial is expected to save the company an estimated USD 4.8 million in clinical development costs, significantly reducing the R&D burden and accelerating the advancement of CX-5461.

CX-5461 – A First-in-Class Investigational Drug
CX-5461 is a first-in-class small molecule drug with a unique mechanism of action. It acts by selectively targeting and stabilizing G-quadruplexes (G4s), preventing their unwinding and triggering replication-dependent DNA damage, ultimately resulting in cancer cell apoptosis. The frequent presence of G4 structures in tumors, especially in transcriptionally active genes, implies their potential functional involvement in the development of cancer. By targeting G4s and triggering DNA damage in cancer cells, Pidnarulex (CX-5461) emerges as a potential therapeutic candidate with significant promise across multiple cancer indications.

Growing Cancer Drug Market and the Need for Combination Therapies
With global cancer incidence on the rise, particularly among younger populations, the market for oncology drugs continues to expand. Demand for immunotherapies—which activate the human immune system to fight cancer—remains strong. According to the latest report by Grand View Research, Inc., the global cancer immunotherapy market is projected to reach USD 224.3 billion by 2030, with a compound annual growth rate (CAGR) of 8.3% from 2024 to 2030. However, current immunotherapies benefit only around 20–25% of patients, creating an urgent need for combination therapies that modulate multiple pathways within the tumor microenvironment to enhance treatment efficacy.

Senhwa is highly optimistic about its future clinical plans under the leadership of the NCI, particularly the combination studies involving CX-5461 and immunotherapies. These trials may help overcome the limitations of current immunotherapies and expand their benefit to a broader cancer patient population.

On July 15, 2025 Gain Therapeutics, Inc. (Nasdaq: GANX) ("Gain", or the "Company"), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, reported that it is proposing to offer and sell, subject to market conditions, shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase common stock in an underwritten public offering (Press release, Gain Therapeutics, JUL 15, 2025, View Source [SID1234654421]). Gain expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of common stock and/or the warrants offered in the offering. All of the securities are being offered by the Company.

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Gain intends to use the net proceeds from the offering to continue clinical and nonclinical development of its lead product candidate GT-02287 for the treatment of neurodegenerative diseases, including GBA1 Parkinson’s disease, and for general corporate purposes. The final terms of the offering will depend on market and other conditions at the time of pricing, 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.

Newbridge Securities Corporation is acting as the sole book-running manager for the proposed offering.

The securities described above will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-265061), which was previously filed with the Securities and Exchange Commission ("SEC") and became effective on June 1, 2022. A preliminary prospectus supplement and accompanying base 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 located at www.sec.gov, copies of which may be obtained, when available, for free by contacting Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected] or by telephone at (877) 447-9625.

The offering will be made only by means of a prospectus. This press release does 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 other 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 other jurisdiction.

On July 15, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been successfully enrolled in the registration Phase III clinical trial (AK112-312/HARMONi-GI6) of ivonescimab in first-line treatment for advanced metastatic colorectal cancer (mCRC) (Press release, Akeso Biopharma, JUL 15, 2025, View Source [SID1234654388]).

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This randomized, controlled, multi-center Phase III clinical trial for first-line treatment of mCRC is one of the company’s key initiatives to address the significant unmet clinical need worldwide with ivonescimab.

Colorectal cancer remains the third most common cancer globally and the second leading cause of cancer-related deaths. In 2022, over 1.9 million new cases were reported, with approximately 904,000 deaths. Of these, about 95% of mCRC cases are classified as microsatellite stable (MSS) or proficient mismatch repair (pMMR), which traditionally show poor responses to immunotherapy and the tumors are often referred to as an "immune desert."

For first-line treatment of MSS/pMMR-type mCRC, which represents up to 95% of cases, several PD-1/L1 inhibitors have been explored in multiple international studies. However, the efficacy has been limited, and as of now, no first-line immunotherapy has been approved globally for patients with pMMR/MSS-type mCRC.

Chemotherapy combined with targeted therapies (such as bevacizumab, cetuximab, etc.) remains the standard first-line treatment for mCRC, though its overall efficacy is limited, with a five-year survival rate for advanced patients of less than 20%. Bevacizumab is the most well-established and clinically impactful treatment in the mCRC space. It is also one of the core indications of bevacizumab.

At the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-sen University, presented promising Phase II efficacy data of ivonescimab in combination with chemotherapy for first-line treatment of MSS/pMMR-type mCRC.

The combination of ivonescimab with FOLFOXIRI demonstrated compelling anti-tumor activity in this hard to treat patient population, with an overall response rate (ORR) of 81.8% and a disease control rate (DCR) of 100%. After a median follow-up of 9 months, the median progression-free survival (mPFS) was not reached, with a 9-month PFS rate of 81.4%. Regardless of KRAS/BRAF mutation status, patients can benefit from ivonescimab combination therapy.

The results published at the 2024 ESMO (Free ESMO Whitepaper) suggest that ivonescimab may offer a significant improvement over existing treatment options for MSS/pMMR mCRC patients. The Phase III trial AK112-312/HARMONi-GI6 can potentially further validate the clinical benefits of ivonescimab in this setting, offering a novel first-line immunotherapy treatment option for patients with advanced mCRC.

On July 15, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612 ) in metastatic breast cancer (Press release, BriaCell Therapeutics, JUL 15, 2025, View Source [SID1234654405]).

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BriaCell’s Phase 3 study now has 69 active clinical sites across 15 states, including Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona.

"We are very excited to be working with renowned clinical experts at a leading cancer center like Mayo Clinic, who also participated in BriaCell’s Phase 2 study," stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We strongly believe that our novel immunotherapy has the potential to transform cancer care for patients and their families."

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor (CPI) versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. BriaCell recently (ASCO 2025) announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.