On September 22, 2025 Akeso Inc. (9926.HK) reported that the Late-Breaking Abstract (LBA) from the registrational Phase III clinical study (AK112-306/HARMONi-6 study) of ivonescimab, a globally first-in-class bispecific antibody targeting PD-1 and VEGF, will be presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress (Press release, Akeso Biopharma, SEP 22, 2025, View Source [SID1234656155]). This study, which evaluates ivonescimab in combination with chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC), has been selected for the Presidential Symposium. The study’s principal investigator, Professor Lu Shun, Director of the Department of Oncology at Shanghai Chest Hospital, will present the results from this pivotal study.

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Additionally, the final results of the Phase III clinical study (COMPASSION-15/AK104-302 study) of cadonilimab in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, have been accepted for a Mini Oral Session at ESMO (Free ESMO Whitepaper). Cadonilimab is a first-in-class bispecific antibody targeting PD-1 and CTLA-4 developed by Akeso that is currently approved for first line treatment of gastric cancer, first line treatment of cervical cancer, and second/third line treatment of cervical cancer. The study’s principal investigator, Professor Shen Lin from Peking University Cancer Hospital, will present the findings in an oral presentation.

Phase Ⅲ Study of lvonescimab plus chemotherapy versus Tislelizumab plus chemotherapy as Firstline Treatment for advanced squamous non-small cell lung cancer (HARMONi-6)

Speakers: Professor Shun Lu (Shanghai, China)
Session: Presidential Symposium 2 Proffered Paper session
Presentation Time: 16:30 -16:42 (CEST) Sun. 19.10.2025
Room: Berlin Auditorium – Hub 27
The upcoming detailed results from the HARMONi-6 study, to be presented at ESMO (Free ESMO Whitepaper) 2025, will provide a comprehensive overview of the exceptional efficacy and favorable safety profile of ivonescimab in combination with chemotherapy for the treatment of first line advanced squamous NSCLC. These findings will further underscore ivonescimab’s role in advancing treatment strategies beyond first-generation immuno-oncology therapies.

The HARMONi-6 study represents the third Phase III trial of ivonescimab in NSCLC, showing significant positive outcomes. This trial is particularly important as it introduces an antiangiogenic mechanism-based therapy for sq-NSCLC, a subtype previously lacking such therapeutic options. Notably, it is the second Phase III head-to-head trial where ivonescimab has outperformed a PD-1 inhibitor-based regimen, reinforcing its breakthrough clinical value.

The promising results thus far affirm that ivonescimab provides significant advancements in clinical treatment for NSCLC, whether compared to PD-1 monotherapy, PD-1 plus chemotherapy, or VEGF-targeted therapies. The consistent superiority observed in these comparisons highlights ivonescimab’s potential to redefine treatment paradigms in oncology.

In April 2025, Akeso announced that the topline results from the registrational Phase III study, HARMONi-6, met its primary endpoint of progression-free survival (PFS), as confirmed by the Independent Data Monitoring Committee (IDMC). The results showed statistically significant and clinically meaningful improvements in PFS for ivonescimab plus chemotherapy compared to tislelizumab plus chemotherapy. In the intent-to-treat (ITT) population, patients receiving ivonescimab plus chemotherapy showed significantly superior PFS benefits compared to the control group. This PFS improvement was consistently observed across all subgroups, regardless of PD-L1 expression status.

On July 28, 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) accepted the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as a first-line treatment for advanced sq-NSCLC.

Cadonilimab (Cado) plus chemotherapy (chemo) versus chemotherapy as first-line (1L) treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: final results of the Phase Ⅲ COMPASSION-15 trial
Speaker: Professor Shen Lin, Peking University Cancer Hospital
Presentation Format: Mini Oral Session
Abstract Number: 2098MO
Presentation Time: 10:45–10:50 AM (CEST) , Saturday, 18 October 2025
The final results of the COMPASSION-15 study, to be presented at ESMO (Free ESMO Whitepaper) 2025, will further validate the groundbreaking clinical value of the cadonilimab-based regimen, reinforcing its potential as a transformative therapeutic option for advanced gastric cancer.

Preliminary findings from the COMPASSION-15 study were first presented by Professor Ji Jiafu of Peking University Cancer Hospital at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These results garnered international recognition and were subsequently published in the esteemed Nature Medicine journal. Due to the positive clinical results, cadonilimab received approval from the NMPA in September 2024 for the first-line treatment of advanced gastric cancer. Furthermore, the regimen was included as the only immunotherapy strategy with a Category I Recommendation (Level IA Evidence) in the 2025 CSCO Gastric Cancer Guidelines, facilitating its widespread adoption in clinical practice.

On September 22, 2025 Akeso Inc. (9926.HK) reported that the Late-Breaking Abstract (LBA) from the registrational Phase III clinical study (AK112-306/HARMONi-6 study) of ivonescimab, a globally first-in-class bispecific antibody targeting PD-1 and VEGF, will be presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress (Press release, Akeso Biopharma, SEP 22, 2025, View Source [SID1234656155]). This study, which evaluates ivonescimab in combination with chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC), has been selected for the Presidential Symposium. The study’s principal investigator, Professor Lu Shun, Director of the Department of Oncology at Shanghai Chest Hospital, will present the results from this pivotal study.

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

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Additionally, the final results of the Phase III clinical study (COMPASSION-15/AK104-302 study) of cadonilimab in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, have been accepted for a Mini Oral Session at ESMO (Free ESMO Whitepaper). Cadonilimab is a first-in-class bispecific antibody targeting PD-1 and CTLA-4 developed by Akeso that is currently approved for first line treatment of gastric cancer, first line treatment of cervical cancer, and second/third line treatment of cervical cancer. The study’s principal investigator, Professor Shen Lin from Peking University Cancer Hospital, will present the findings in an oral presentation.

Phase Ⅲ Study of lvonescimab plus chemotherapy versus Tislelizumab plus chemotherapy as Firstline Treatment for advanced squamous non-small cell lung cancer (HARMONi-6)

Speakers: Professor Shun Lu (Shanghai, China)
Session: Presidential Symposium 2 Proffered Paper session
Presentation Time: 16:30 -16:42 (CEST) Sun. 19.10.2025
Room: Berlin Auditorium – Hub 27
The upcoming detailed results from the HARMONi-6 study, to be presented at ESMO (Free ESMO Whitepaper) 2025, will provide a comprehensive overview of the exceptional efficacy and favorable safety profile of ivonescimab in combination with chemotherapy for the treatment of first line advanced squamous NSCLC. These findings will further underscore ivonescimab’s role in advancing treatment strategies beyond first-generation immuno-oncology therapies.

The HARMONi-6 study represents the third Phase III trial of ivonescimab in NSCLC, showing significant positive outcomes. This trial is particularly important as it introduces an antiangiogenic mechanism-based therapy for sq-NSCLC, a subtype previously lacking such therapeutic options. Notably, it is the second Phase III head-to-head trial where ivonescimab has outperformed a PD-1 inhibitor-based regimen, reinforcing its breakthrough clinical value.

The promising results thus far affirm that ivonescimab provides significant advancements in clinical treatment for NSCLC, whether compared to PD-1 monotherapy, PD-1 plus chemotherapy, or VEGF-targeted therapies. The consistent superiority observed in these comparisons highlights ivonescimab’s potential to redefine treatment paradigms in oncology.

In April 2025, Akeso announced that the topline results from the registrational Phase III study, HARMONi-6, met its primary endpoint of progression-free survival (PFS), as confirmed by the Independent Data Monitoring Committee (IDMC). The results showed statistically significant and clinically meaningful improvements in PFS for ivonescimab plus chemotherapy compared to tislelizumab plus chemotherapy. In the intent-to-treat (ITT) population, patients receiving ivonescimab plus chemotherapy showed significantly superior PFS benefits compared to the control group. This PFS improvement was consistently observed across all subgroups, regardless of PD-L1 expression status.

On July 28, 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) accepted the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as a first-line treatment for advanced sq-NSCLC.

Cadonilimab (Cado) plus chemotherapy (chemo) versus chemotherapy as first-line (1L) treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: final results of the Phase Ⅲ COMPASSION-15 trial
Speaker: Professor Shen Lin, Peking University Cancer Hospital
Presentation Format: Mini Oral Session
Abstract Number: 2098MO
Presentation Time: 10:45–10:50 AM (CEST) , Saturday, 18 October 2025
The final results of the COMPASSION-15 study, to be presented at ESMO (Free ESMO Whitepaper) 2025, will further validate the groundbreaking clinical value of the cadonilimab-based regimen, reinforcing its potential as a transformative therapeutic option for advanced gastric cancer.

Preliminary findings from the COMPASSION-15 study were first presented by Professor Ji Jiafu of Peking University Cancer Hospital at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These results garnered international recognition and were subsequently published in the esteemed Nature Medicine journal. Due to the positive clinical results, cadonilimab received approval from the NMPA in September 2024 for the first-line treatment of advanced gastric cancer. Furthermore, the regimen was included as the only immunotherapy strategy with a Category I Recommendation (Level IA Evidence) in the 2025 CSCO Gastric Cancer Guidelines, facilitating its widespread adoption in clinical practice.

On September 22, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that the Company received notice of an additional advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally (Press release, Plus Therapeutics, SEP 22, 2025, View Source;_hsenc=p2ANqtz-9FE0VkS0lXyVYLeYUX_e8OPwY_tMBw4qcG1ikTgGaPNR7TS1e_6ZHFTELAxFZVszjULgsem3LXhrctDaOQfJKZLO2kJw&_hsmi=381576755&utm_content=381576755&utm_source=hs_email [SID1234656154]). This $1.9 million payment is part of the Company’s previously awarded $17.6 million grant and is the second non-dilutive financing received from CPRIT following the $1.6 million receipt announced in July 2025.

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"Continued payments from CPRIT are supportive to our radiotherapeutic development initiatives, with a further $1.9 million in funding expected over the next 12 months, providing a steady source of significant non-dilutive financing," said Andrew Sims, Plus Therapeutics Chief Financial Officer. "The support from CPRIT builds on our active National Institutes of Health and Department of Defense grants, reflecting strong commitment for our clinical programs from strategic institutions. We continue to actively pursue additional grant opportunities to strengthen our capital position."

The funding supports and accelerates the Company’s clinical development of REYOBIQ for the ReSPECT-LM dose optimization trial and further develops the Company’s CNSide LM diagnostic test as a key pivotal trial endpoint.

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

On September 22, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that Dr Jeremy Graff, President and Chief Development Officer for Allarity Therapeutics, presented new and updated clinical data from the ongoing Phase 2 clinical trial in advanced ovarian cancer patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 7th Biennial Special Conference on Ovarian Cancer, held September 19–21, 2025, at the Grand Hyatt Denver in Denver, Colorado (Press release, Allarity Therapeutics, SEP 22, 2025, View Source [SID1234656153]). The poster is available via the Scientific Publications section of the Company’s website.

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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

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The presentation showcased the first Kaplan-Meier analysis for median Overall Survival (mOS) from the Company’s ongoing Phase 2 trial that enrolled patients with advanced ovarian cancer, all of whom had either platinum-resistant or refractory disease and had tumors showing a Stenoparib-specific Drug Response Predictor (DRP) score above 50. Notably, these data provide the first evidence that stenoparib, when given twice daily, may extend patient survival. The mOS has not been formally reached yet and now exceeds 25 months. Two patients actively remain on therapy now more than 24 months, with one of these two patients carrying a wild-type BRCA gene—a genetic background that typically precludes benefit from PARP inhibitors. Notably, one patient with primary platinum-refractory disease remains alive more than two years after enrollment—a clinical outcome that is highly uncommon in this population.

"These emerging clinical results presented at the AACR (Free AACR Whitepaper) Special Conference on Ovarian Cancer suggest that stenoparib may offer meaningful extended survival benefit for patients with advanced, platinum-resistant ovarian cancer (PROC)—a population with historically poor outcomes and limited treatment options," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "Importantly, the durability of clinical benefit—including in BRCA wild-type and heavily pre-treated patients—underscores stenoparib’s unique mechanism of action as a dual inhibitor of both PARP and the WNT pathway. Given the FDA’s recent proclamations emphasizing the need to assess Overall Survival, we are particularly excited that the median Overall Survival in this trial has not yet been reached and exceeds 25 months—that’s nearly 10 months longer than the mOS reported for the most recent FDA approvals and advances in therapy for PROC patients. We look forward to further exploring the game-changing potential of stenoparib through the ongoing enrollment of patients in our new Phase 2 trial protocol expressly enrolling PROC or platinum-ineligible patients. These data will help deepen and solidify the durable clinical benefit and extended overall survival stenoparib may provide and will support our attempts to accelerate stenoparib toward FDA approval."

A preliminary Kaplan-Meier (K-M) analysis of overall survival presented at this conference indicates that mOS has not yet been reached, with the current K-M estimate now exceeding 25 months, based on a median follow-up time of nearly 22 months. For context, the most recent clinical advances and FDA approved therapies for the treatment of PROC patients have shown mOS of approximately 16-16.5 months, an improvement versus the 11.5-13 months mOS of standard chemotherapy. This underscores stenoparib’s potential to meaningfully improve patient outcomes and dovetails with the FDA’s recently published draft guidance (Approaches to Assessment of Overall Survival in Oncology Clinical Trials, August 2025), which reaffirms overall survival as the most meaningful and objective endpoint for oncology drug approval.

The study population includes heavily pre-treated patients, many of whom had previously received PARP inhibitors, chemotherapy, immunotherapy, and antibody-drug conjugates (ADCs). Stenoparib continues to show a favorable safety profile, with significantly less myelotoxicity than typically observed with earlier-generation PARP inhibitors. This is especially relevant in light of the 2022 market withdrawal of first-generation PARP inhibitors in heavily pre-treated ovarian cancer, due to lack of demonstrated long-term survival benefit—emphasizing the need for therapies that may meaningfully extend overall survival. Moreover, the updated clinical data continue to show that stenoparib may provide clinical benefit in patients regardless of BRCA status, possibly reflecting the dual inhibition of PARP1/2 and the WNT pathway and distinguishing stenoparib from 1st generation PARP inhibitors.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

On September 22, 2025 Onconetix, Inc. (Nasdaq: ONCO) ("Onconetix" or the "Company") a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology, reported that its wholly owned subsidiary, Proteomedix AG ("Proteomedix") has signed a licensing agreement, with Immunovia AB, a pancreatic cancer diagnostics company based in Lund, Sweden (Press release, Onconetix, SEP 22, 2025, View Source [SID1234656152]).

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Under the terms of the agreement, Proteomedix will provide Immunovia with master cells required to produce antibodies related to three of the five biomarkers included in the PancreaSure test and a license for key intellectual property for the manufacturing of reagents used to measure these biomarkers, allowing Immunovia to purchase reagents directly from the supplier of Proteomedix.

In return, Immunovia will make payments totaling $700,000 to Proteomedix in 2025 and 2026, as well as pay a 3% royalty on net sales of PancreaSure and any other products incorporating the licensed intellectual property from 2026 to 2032.

"We are proud to have contributed to the development of PancreaSure and are excited to now support its manufacturing. Earlier detection of pancreatic cancer through PancreaSure gives patients real hope for better outcomes," said Beat Rheiner, PhD, CEO of Proteomedix." "At the same time, we remain focused on expanding the market penetration of our early prostate cancer detection test, Proclarix." said Karina Fedasz, Interim CEO of Onconetix.