On July 29, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported that it will present Phase II clinical data on its next-generation, fully human heavy-chain-only anti-CTLA-4 antibody, porustobart (HBM4003), in combination with tislelizumab, for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC), at the ESMO (Free ESMO Whitepaper) Congress 2025, taking place October 17-21, 2025, in Berlin, Germany (Press release, Harbour BioMed, JUL 29, 2025, View Source [SID1234654612]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MSS mCRC remains a therapeutic challenge with limited response to immune checkpoint inhibitors. Preclinical evidence supports the synergistic antitumor activity of CTLA-4 blockade combined with PD-(L)1 inhibition in mouse models. In this multicenter, open-label, Phase II study (NCT05167071), heavily pretreated non-liver metastatic MSS mCRC patients were enrolled. Preliminary efficacy and safety data will be presented in a poster session during the ESMO (Free ESMO Whitepaper) Congress 2025.

Details of the poster presentation are as follows:

Title: Efficacy and Safety of HBM4003, an anti-CTLA-4 Antibody, Combined with Tislelizumab in MSS Metastatic Colorectal Cancer: A Multicenter, Phase II Study

Presentation Number: 807P

Speaker: Frank Zheng

All accepted abstracts will be published online on the ESMO (Free ESMO Whitepaper) website.

About Porustobart (HBM4003)

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favorable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. Harbour BioMed has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trials targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, CRC, NEN and HCC.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Calidi Biotherapeutics, Inc. ("Calidi" or the "Company") (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, reported that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company’s allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma (Press release, Calidi Biotherapeutics, JUL 29, 2025, View Source [SID1234654607]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fast Track designation is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. CLD-201 will benefit from this designation through more frequent interactions with the FDA along with potential eligibility for priority review and accelerated approval.

Guy Travis Clifton, M.D., Chief Medical Officer of Calidi commented, "FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the unmet medical need in sarcoma and provides scientific and regulatory validation of CLD-201. We believe CLD-201 has the potential to provide durable and transformational treatment to patients with sarcoma as well as patients with other advanced tumor types. We want to thank the FDA for its support and partnership and look forward to continued collaboration with the agency."

FDA Investigational New Drug (IND) clearance for CLD-201 was announced on April 17, 2025. The planned Phase 1 trial will be a first-in-human, open-label, multicenter study to evaluate the safety, tolerability and efficacy of CLD-201 in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.

About CLD-201

CLD-201 is comprised of adipose-derived mesenchymal stem cells (AD-MSC) loaded with oncolytic vaccinia virus, for the treatment of patients with advanced solid tumors including sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Stem-cell loading of an oncolytic virus helps protect the virus from clearance by the body’s immune system and allows virus to amplify within the stem cell, leading to an increase in potency and immune activation and enhanced efficacy in pre-clinical animal models.