On July 29, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an upcoming poster presentation for the pivotal TACTI-004 (KEYNOTE-F91) Phase III trial at the IASLC 2025 World Conference on Lung Cancer (WCLC), taking place in Barcelona, Spain, from 6-9 September 2025 (Press release, Immutep, JUL 29, 2025, View Source [SID1234654608]).

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The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s antigen presenting cell (APC) activator, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression (Tumour Proportion Score or TPS of 0-100%) and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.

Immutep CMO, Stephan Winckels M.D., Ph.D, said, "Our engagement to date with physicians in the lung cancer community, including at ELCC in Paris and ASCO (Free ASCO Whitepaper) in Chicago, has yielded encouraging feedback with a shared view of efti as a safe, easy-to-administer immunotherapy with strong efficacy across two 1L NSCLC trials. We look forward to continuing our investigator discussions at WCLC and ESMO (Free ESMO Whitepaper) around the pivotal TACTI-004 Phase III, which has the potential to change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression."

Details for the poster presentation:
Title: TACTI-004, a Phase 3 trial of Eftilagimod Alfa plus Pembrolizumab (P) + Chemotherapy (C) vs Placebo + P + C in 1st line NSCLC
Presenter: Dr. Martin Sebastian, University Hospital of Frankfurt, Germany
Session: Clinical Trials in Progress
Date and Time: Tuesday, 9 September 2025 at 10:00 AM CEST

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

About Eftilagimod Alfa (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On July 29, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell "), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, and its majority owned subsidiary, BriaPro Therapeutics Corp. (" BriaPro "), reported that BriaPro is developing novel multivalent agents for cancer treatment (Press release, BriaCell Therapeutics, JUL 29, 2025, View Source [SID1234655035]). BriaPro has filed a provisional patent application for the underlying platform referred to as "TILsRx".

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The TILsRx platform enables simultaneous engagement of multiple tumor-associated and immune pathway targets. Multivalent agents (including antibodies, soluble receptors and cytokines) address immune suppression and T cell exhaustion often seen with tumor-infiltrating lymphocytes (TILs) and aim to improve T cell activation and persistence in the tumor microenvironment. Designed to activate TILs and enhance TIL binding to tumor cells as well as block immune checkpoints that suppress anti-tumor responses, TILsRx agents are multifunctional in their cancer killing actions. Specific elements in TILsRx agents include soluble CD80, which has a dual function as an immune checkpoint inhibitor and as an immunostimulator, anti-CD3, which is a potent T cell activator, IL-21, which is an enhancer of cytotoxic T cell function, and anti-STEAP1 (STEAP1 is a cancer antigen expressed in prostate cancer among others). An early candidate target is B7-H3, a tumor antigen which is overexpressed in prostate, lung, breast, pancreatic, and ovarian cancer while minimally expressed in normal tissue.

"We have developed novel multivalent anti-cancer agents which we expect to be both highly selective and highly effective, maximizing on-target efficacy while minimizing off-target toxicity to provide improved clinical responses in multiple indications," stated Miguel Lopez-Lago, PhD, BriaCell and BriaPro CSO.

"The TILsRx platform reflects our goal to develop an effective and safe class of therapeutics for cancer patients. TILsRx agents combine shared core components that improve manufacturing efficiency with elements that target specific cell surface antigens. This strategy provides the flexibility to include new immunotherapy targets identified in the future. We look forward to advancing this exciting technology through pre-clinical and clinical stages," stated Markus D. Lacher, PhD, a key inventor of the technology.

"Our advanced multivalent technology provides us with a platform to quickly expand our proprietary pipeline of novel immuno-oncology programs in BriaPro in a cost-effective manner," stated Dr. William V. Williams, BriaPro and BriaCell President & CEO. "We anticipate that the multivalent approach will have activity against multiple types of cancers and may also synergize with BriaCell’s cell-based cancer vaccine programs."

On July 29, 2025 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 135.6 million in the second quarter of 2025 (Q2 2024: NOK 122.4 million), and an EBITDA of NOK 14.8 million (Q2 2024: NOK 27.8 million, including a milestone payment of NOK 21.6 million) for the company (Press release, PhotoCure, JUL 29, 2025, View Source [SID1234654609]). Photocure expects product revenue growth in the range of 7% to 11% and year-over-year EBITDA improvement in 2025. While the company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year.

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"We delivered all-time high Hexvix/Cysview revenues, and the ninth consecutive quarter of positive EBITDA, while continuing to make smart decisions that accelerate and drive the topline growth. The Q2 results are driven by the solid performance from our U.S. franchise where the team continues to increase the number of active accounts by 24%. We continue to offset the decline in flexible cystoscopy kits and expect the U.S. unit growth to accelerate in 2025 onwards. In the second quarter alone, the rigid kit sales increased by 21 percent, " says Dan Schneider, President & Chief Executive Officer of Photocure.

The company continued to execute on its plan to expand blue light cystoscopy use in Q2 2025 with the installation of 12 new Saphira towers in the U.S. — 3 new accounts and 9 blue light tower upgrades. With the increasing momentum provided by ForTec’s mobile solution, Photocure had 359 active accounts in the U.S. at the end of the quarter, an increase of 24% versus the second quarter of 2024.

Across Europe, a total of 36 Olympus Visera Elite III blue light cystoscopy (BLC) capable systems were installed since the launch in Q1 2025.

"We fully expect this new state-of-the art equipment to fuel Hexvix growth in the Nordic region and throughout continental Europe this year and beyond," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care.

"Photocure continues to explore partnerships and collaborations that combine the use of BLC with emerging products and technologies. For example, our development partnership with Richard Wolf is progressing well while a flexible BLC interim solution has been made available in advance of the future launch of a state-of-the-art high definition 4k system. Lastly, our license agreement with Asieris for Cevira has potential to trigger a significant milestone payment when it receives regulatory approval in China. In all, we delivered another quarter of growth and reiterate our guidance of a product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025," Schneider concludes.

On July 29, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (the "Company"), reported the pricing of a public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants (Press release, AIM ImmunoTech, JUL 29, 2025, View Source [SID1234654593]). The warrants will have an exercise price of $4.00 per share, will be exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. The closing of the offering is expected to occur on or about July 30, 2025, subject to the satisfaction of customary closing conditions. Gross proceeds, before deducting placement agent fees and offering expenses, are expected to be approximately $8.0 million.

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Maxim Group LLC is acting as sole placement agent in connection with this offering.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-284443) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 28, 2025. The offering is being made only by means of a prospectus which is a part of the effective Registration Statement. A preliminary prospectus relating to the offering has been filed with the SEC. Copies of the final prospectus relating to this offering, when available, will be filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

This press release shall not constitute an offer to sell or a 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 29, 2025 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has received Australian ethics approval for the Phase 2 clinical trial of narmafotinib in combination with the chemotherapy FOLFIRINOX (Press release, Amplia Therapeutics, JUL 29, 2025, View Source [SID1234654610]).

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The ethics approval received covers two (2) clinical trial sites in Australia and follows US ethics approval received last month.

The open-label Phase 2a clinical trial will explore the combination of the Company’s FAK inhibitor narmafotinib with the chemotherapy FOLFIRINOX in newly diagnosed patients with advanced pancreatic cancer. Commonly employed in the USA for advanced pancreatic cancer, FOLFIRINOX chemotherapy is also utilized in Australia, particularly for younger patients.

The focus of the new trial is identification of the optimal daily dose of narmafotinib when combined with FOLFIRINOX which is administered intravenously every two (2) weeks. The trial will be run in two stages: the first being a dose exploration stage involving up to 27 patients, and the second comparing two doses of narmafotinib across 40 patients.

Dr Chris Burns, Amplia’s CEO and Managing Director commented: "With ethics approval now obtained in both Australia and the US, we look forward to initiating recruitment of the trial."