On June 4, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the National Medical Products Administration (NMPA) has approved the company’s first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab (Press release, Akeso Biopharma, JUN 4, 2025, View Source [SID1234653721]). The NMPA approval marks the third approved indication for cadonilimab.

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With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.

The approval for cadonilimab’s use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer.

Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were presented as a Late-Breaking Abstract (LBA) at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and were subsequently published in The Lancet and later reported again in Nature Reviews Clinical Oncology.

Cervical cancer remains one of the most prevalent and deadly cancers among women, with a 5-year survival rate of approximately 17.0% for patients in the advanced stages. In 2022, China reported 150,700 new cervical cancer cases, resulting in the second-largest burden of cervical cancer worldwide.

Professor Wu Xiaohua, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center, stated, "COMPASSION-16 is the first Phase III study focused on first-line cervical cancer patients in China, with internationally recognized data. We’ve seen cadonilimab’s breakthrough efficacy in both recurrent and metastatic cervical cancer, showing high effectiveness, low toxicity, and strong anti-tumor activity regardless of PD-L1 expression. This first-line combination therapy sets a new standard in cancer treatment and is expected to accelerate the clinical adoption of cadonilimab, benefiting more patients."

Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, commented, "Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. For patients who respond to PD-1/L1 monotherapy, cadonilimab offers superior therapeutic outcomes over PD-1/PD-L1 therapies. For patients with low PD-L1 expression or those who are resistant to PD-1 monotherapy, cadonilimab provides significant clinical benefits over current treatment options. Cadonilimab takes advantage of the synergistic anti-tumor effect of two immune checkpoint targets, PD-1 and CTLA-4, while producing a meaningfully lower immune side effects than the combination of PD-1 and CTLA-4 antibody therapies. This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and in patient quality of life. This achievement reflects Akeso’s robust innovation capabilities and commitment to cancer patient outcomes, and it also aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide. "

Currently, cadonilimab is included in 16 authoritative clinical treatment guidelines and consensus documents across multiple oncology indications, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Beyond the three approved indications, cadonilimab is also currently in over 30 Phase II and III clinical trials for other cancer types, which includes different stages of disease progression as well as different cancer sub-types. These include clinical studies on gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer.

On June 4, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP) patient selection technology—reported a research collaboration with the Indiana Biosciences Research Institute (IBRI) (Press release, Allarity Therapeutics, JUN 4, 2025, View Source [SID1234653720]). The collaboration is aimed primarily at further deepening the Company’s mechanistic understanding of the dual mechanism of action of stenoparib.

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Stenoparib is a novel, orally available small-molecule inhibitor of PARP1/2 and tankyrase1/2. As such, stenoparib not only impairs DNA repair to selectively kill cancer cells but also inhibits the WNT signaling pathway—a cellular pathway commonly associated with chemoresistance and advanced-stage disease in multiple cancer types. This unique dual activity distinguishes stenoparib as a highly differentiated therapeutic candidate with the potential to address cancers that are resistant to standard-of-care therapies. Under the agreement, IBRI will conduct advanced molecular and cellular studies to clarify the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s observed anticancer effects.

"Understanding how stenoparib exerts its dual biological effects is central to our long-term clinical development strategy. It will enhance our ability to raise awareness of this molecule among leading oncologists and help us engage more effectively with sophisticated biotech investors," said Thomas Jensen, CEO of Allarity Therapeutics. "In addition to deepening our understanding of the foundational biology behind stenoparib’s differentiated profile, this research may further strengthen our DRP-based patient selection strategy and potentially open new opportunities for additional therapeutic combinations and indications, such as colorectal cancer, where WNT pathway activation is very common."

The collaboration is also expected to support Allarity in potential future efforts to pursue marketing approval for stenoparib, and to further clarify its mechanism of action in both the Company’s ongoing Phase 2 trial in advanced ovarian cancer and its recently announced combination trial evaluating stenoparib with temozolomide in recurrent small cell lung cancer (SCLC).

Furthermore, this collaboration underscores Allarity’s commitment to scientific excellence, translational research, and data-driven development, which form the foundation of its personalized oncology strategy.

On June 4, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported a poster presentation on its novel CAPTN-3 tri-specific antibody platform, will be featured at the Annual Congress of the European Association for Cancer Research (EACR) 2025, being held in Lisbon, Portugal from June 16 – 19, 2025 (Press release, Purple Biotech, JUN 4, 2025, View Source;id=351926&p=2377908&I=1206939-c7Z3G6f3m8 [SID1234653719]).

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EACR poster details are as follows:

Abstract #: EACR25-1964
Title: "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers"
Session Title: Immunotherapy
Session Date and Time: June 17, 2025, from 10:45 to 20:00
Presenting Author: Dr. Hadas Reuveni, Vice President of R&D, Purple Biotech

Abstracts related to the EACR meeting will be published online following the presentation. For more information, please visit the EACR 2025 website.

On June 4, 2025 Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, reported it has secured exclusive worldwide rights to develop and commercialize the clinical-stage Werner helicase (WRN) covalent inhibitor VVD-214 (RO7589831), strengthening and complementing its innovative oncology development pipeline (Press release, Vividion Therapeutics, JUN 4, 2025, View Source [SID1234653718]). VVD-214 was discovered and developed under an exclusive worldwide collaboration and license agreement initiated between Vividion and Roche in 2020. Vividon utilizes innovative discovery technologies to unlock difficult-to-drug targets with strong disease-links, and to develop small molecule precision therapeutics for devastating cancers and immune disorders.

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Preliminary data from a first-in-human study presented at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting showed that VVD-214 is well tolerated and has promising signs of activity. Vividion will continue the clinical development of VVD-214 within the company’s pipeline of innovative investigational therapeutics for cancers and immune disorders.

WRN is a DNA repair enzyme and a highly sought-after synthetic lethal target for treatment of cancers with microsatellite instability (MSI). By inhibiting WRN, VVD-214 aims to cause lethal DNA damage in cancers with high microsatellite instability while minimizing harm to healthy cells.

"Bringing VVD-214, the only clinical-stage covalent inhibitor of WRN in development worldwide, into our portfolio marks an incredibly exciting moment for Vividion," said Aleksandra Rizo, M.D., Ph.D., Chief Executive Officer of Vividion. "We are eager to progress development of this compound, building on the encouraging clinical data we’ve seen to date, as part of our mission to transform treatment for patients with cancer and other serious diseases."

The Phase I clinical trial (NCT06004245) is evaluating VVD-214 as a monotherapy and in combination with pembrolizumab as a treatment option for patients with solid tumors that display high MSI or deficient mismatch repair (dMMR) including but not limited to colorectal, endometrial, ovarian and gastric cancers. Treatment options for these patients today are limited, and a majority will relapse or become refractory to immune checkpoint inhibitors. The initial data, recently presented at AACR (Free AACR Whitepaper) by Timothy Yap, M.B.B.S., Ph.D., clinical investigator and professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, showed early signals of efficacy for VVD-214 in a range of solid tumor types with high MSI.1

"VVD-214 is showing promising potential to improve treatment options for patients suffering from MSI-high cancers, a population with high unmet medical need," said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division. "It underscores the ability of Vividion’s chemoproteomics technology to identify and advance new treatment opportunities for challenging and intractable diseases, and will be a valuable addition to the company’s portfolio."

Vividion also has ongoing Phase I trials evaluating an oral KEAP1 activator in solid tumors, an oral STAT3 inhibitor in solid and hematologic malignancies, and an oral RAS-PI3Kα inhibitor in advanced solid tumors. The company is advancing multiple innovative drug discovery programs toward the clinic and has a growing pipeline of opportunities emerging in early discovery in the fields of oncology and immunology leveraging its chemoproteomics platform.

On June 4, 2025 TOLREMO therapeutics AG (TOLREMO)), a clinical stage biotechnology company pioneering non-oncogene addiction in cancer, reported data from its ongoing Phase I study of TT125-802, a novel, orally administered bromodomain inhibitor of CBP/p300, for patients with advanced solid tumors who have relapsed or are refractory to standard-of-care therapies, including an abstract published at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, TOLREMO, JUN 4, 2025, View Source [SID1234653717]). Updated data from the study was discussed at TOLREMO’s SAB meeting during ASCO (Free ASCO Whitepaper) and recorded in a virtual ASCO (Free ASCO Whitepaper) data update.

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To date TT125-802 shows impressive anti-tumor activity in advanced solid tumors, including deep and durable responses in non-small cell lung cancer (NSCLC). In addition, TT125-802 demonstrates a best-in-class safety profile without thrombocytopenia, the primary toxicity associated with its class of inhibitors.

"Five out of seven NSCLC patients on this study experienced tumor shrinkage following progression on their prior therapy. The two patients with KRAS-G12C- or EGFR-mutant NSCLC – the two tumor types we had preclinically selected as target indications – each showed deep and durable responses to single agent TT125-802. There remains a large and urgent need for more effective and tolerable therapies, and TT125-802 has the potential to offer an improved therapeutic option through resistance-targeted combinations," said Florian Vogl, M.D., PhD, Chief Medical Officer at TOLREMO.

"EGFR- and KRAS-targeted therapies have historically been limited by intrinsic and acquired resistance. Inhibiting transcriptional mechanisms of resistance via CBP/p300 represents an exciting and much needed opportunity for more effective and tolerable therapies. TT125-802 has shown impressive activity in NSCLC even as a monotherapy, and I look forward to combining the drug with EGFR and KRAS-G12C inhibitors to provide better treatment options to my patients," added Pasi Jänne, M.D., PhD, Scientific Advisory Board member at TOLREMO and Senior Vice President for Translational Medicine and the Director of the Belfer Center for Applied Cancer Science at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School.

"The best-in-class safety and activity in solid tumors is particularly notable because we didn’t set out to develop a CBP/p300 inhibitor – initially, TT125-802 was developed phenotypically to inhibit non-oncogene addiction in cancer," said Stefanie Flückiger-Mangual, PhD, CEO and co-founder of TOLREMO. "By starting with the biology around transcriptional addiction, it led us to CBP/p300 as a novel target in this space and yielded best-in-class chemistry, enabling a wider therapeutic window and broadening the clinical potential of our asset both in hematological malignancies as well as in solid tumors."

Dr. Jänne and Dr. Omar Saveedra Santa Gadea, a medical oncologist at NEXT Oncology Hospital Quirónsalud in Barcelona, Spain also shared their perspective on the importance of these results, including specific review of clinical case studies as part of an ASCO (Free ASCO Whitepaper) video update at View Source