On July 31, 2025 Alphamab Oncology (stock code: 9966.HK) reported that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical study in the United States (study number: JSKN003-202) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels.

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JSKN003 is an anti-HER2 biparatopic ADC developed inhouse which can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated significant differentiated advantages including better serum stability and stronger bystander effect, which effectively expands the therapeutic window. In multiple clinical studies at various stages in China and Australia, JSKN003 has shown promising tolerability, safety, and significant antitumor activity.

In China, three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing breast cancer (BC), platinum-resistant ovarian cancer (PROC), and HER2-positive BC are currently undergoing smoothly. In March 2025, JSKN003 was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) for the treatment of PROC, not restricted to HER2 expression levels.

JSKN003-202 is a randomized, open-label, multi-center Phase II clinical study aimed at evaluating the safety and efficacy of JSKN003 in the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, and determine the recommended phase III dose (RP3D). The FDA approval of this U.S. Phase II trial marks a significant milestone in Alphamab Oncology’s global development strategy for its innovative pipeline, which will further strengthen the Company’s competitive edge in oncology therapeutics.

About JSKN003

JSKN003 is a bispecific ADC developed based on KN026 using Alphamab’s proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing breast cancer (BC), or high HER2-expressing solid tumors. JSKN003 was granted breakthrough therapy designation by CDE for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. It has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ). Three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing BC, PROC, and HER2-positive BC as well as multiple exploratory Phase II clinical studies are currently undergoing smoothly.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, JUL 31, 2025, View Source [SID1234657000])

On July 31, 2025 Kyowa Hakko Kirin reported consolidated Financial Summary (IFRS) Fiscal 2025 (Press release, Kyowa Hakko Kirin, JUL 31, 2025, View Source [SID1234656876]).

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On July 31, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported second quarter 2025 financial results and provided a corporate update (Press release, FibroBiologics, JUL 31, 2025, View Source [SID1234656320]).

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Recent Highlights

Successfully closed third $5 million tranche of a $25 million total financing, with proceeds used to advance research and development efforts and support the upcoming Phase 1/2 clinical trial in diabetic foot ulcers (DFUs).
Strengthened leadership team with the appointment of Jason D. Davis, CPA, as Chief Financial Officer, who brings over 25 years of experience in building and leading organizations.
Presented pre-clinical evidence at the Society for Investigative Dermatology Annual Meeting supporting the potential of fibroblast spheroids to reduce psoriasis severity. Findings showcased the fibroblast-based candidate’s ability to enable sustained remission and reduce relapse, accompanied by a significantly lower adverse side effects profile.
Highlighted potential of fibroblast-based therapies for chronic disease treatments at the BIO International Convention 2025.
Confirmed the use of the CYWC628 master cell bank for the manufacturing of CybroCell, FibroBiologics’ investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease.
Upcoming Milestones

Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients in the first quarter of 2026.
Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026.
Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, by the end of 2025.
Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics, said, "Backed by our strong research and development efforts, we are continuing to progress toward entering the clinic with our Phase 1/2 trial evaluating CYWC628 in diabetic foot ulcer patients, while simultaneously advancing IND-enabling studies for CYPS317 in psoriasis. Our robust intellectual property portfolio, which now includes more than 275 issued or pending patents, is reinforced by the growing pre-clinical evidence supporting the potential of our fibroblast-based therapies. We believe this expanding IP position enhances our competitive advantage and supports our long-term strategy for innovation. As always, we remain focused on executing our clinical milestones and delivering meaningful value to both patients and shareholders as we advance toward our goal of transforming chronic disease treatments."

Financial Highlights for the Six Months Ended June 30, 2025

Research and development expenses were approximately $3.8 million for the six months ended June 30, 2025, compared to approximately $1.9 million for the same period in 2024. The increase was primarily due to increased chemistry, manufacturing and control costs of $0.2 million for cell manufacturing activities; increased CRO costs of $0.9 million to prepare for a clinical trial; increased personnel related expenses of $0.3 million due to hiring additional research scientists; and increased research materials and supplies expenses of $0.5 million due to increased laboratory personnel and preclinical studies.
General and administrative expenses were approximately $5.2 million for the six months ended June 30, 2025, compared to approximately $4.7 million for the same period in 2024. The increase was primarily due to increased expenses of $0.5 million for added personnel in 2025, which includes stock-based compensation expense; increased professional fees of $0.3 million for accounting, legal and marketing expenses; increased travel expenses of $0.1 million; and decreased Direct Listing related expenses of $0.4 million.
For the six months ended June 30, 2025, FibroBiologics reported a net loss of approximately $9.6 million compared to a net loss of approximately $7.6 million for the same period in 2024. The net loss for the six months ended June 30, 2025, was primarily due to the increase in both research and development expenses and general and administrative expenses discussed above.
Cash and cash equivalents totaled approximately $8.8 million at June 30, 2025.
For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected].

On July 31, 2025 ImmuneOnco Biopharmaceuticals reported preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China (Press release, ImmuneOnco Biopharma, JUL 31, 2025, View Source [SID1234655712]).

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As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable). Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the IMM2510 chemotherapy combination trial in front-line NSCLC at a future medical conference.

The IMM2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events (TRAE) leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.

Professor Caicun Zhou, M.D., Ph.D., director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study of IMM2510 in 1L NSCLC said： "IMM2510 has demonstrated early but compelling activity in front-line NSCLC patients. The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with IMM2510 in this setting."

Dr. Wenzhi Tian, CEO of ImmuneOnco said: "We are delighted to witness the progress of IMM2510 in front-line non-small cell lung cancer (NSCLC). This data paves the way for its advancement into Phase 3 clinical studies and provides valuable insights to support further research across multiple indications."

Bronson Crouch, CEO of Instil said: "We are pleased with the preliminary clinical results of the combination of IMM2510/AXN-2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class. We look forward to further public updates from ImmuneOnco on these data, as well as the initiation of our previously announced US phase 1 clinical trial before the end of this year."

On July 31, 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 UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 31, 2025, View Source [SID1234655022]).

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"The randomized Phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe BriaCell’s Phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer," stated Kelly E. McCann, MD, PhD, Breast Medical Oncologist, and Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center. "We are excited to support this important study and anticipate strong patient enrollment through our large multi-center clinical site."

"The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrollment and execution," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We remain confident in our timeline for sharing top-line data in 2026."

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor against physician’s choice in patients with advanced metastatic breast cancer. This design builds upon maturing positive survival data from BriaCell’s Phase 2 study, most recently presented at ASCO (Free ASCO Whitepaper) 2025, which evaluated the same combination in a similar MBC patient population . Notably, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

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 .