On September 9, 2026 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101- EA-001) as "safe to proceed".

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The FDA determination enables a patient who experienced clinical benefit while receiving HCB101 in the Company’s Phase 1 study to continue treatment with HCB101 beyond the parent clinical trial. Expanded Access, or compassionate use, allows patients with serious or life-threatening diseases to receive investigational therapies outside standard clinical trials when specific regulatory criteria are met. In an individual-patient Expanded Access request, FDA considers the patient’s clinical circumstances, including whether the potential benefit justifies the potential risks and whether those risks are reasonable in the context of the disease.

"For us, this starts with the patient," said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. "When a patient is benefiting from an investigational therapy and has limited treatment options, we believe every appropriate avenue to continue access should be considered. HCB101 was created to make a meaningful difference, and this milestone reflects the patient-first principle guiding our FBDB platform."

FDA’s determination that HCB101-EA-001 is "safe to proceed" applies specifically to this individual-patient Expanded Access protocol and does not constitute approval of HCB101 or an FDA determination of efficacy.

"Working within the FDA framework, we translated an individual patient’s need into a practical solution allowing treatment to continue," said Alvin Luk, Ph.D., M.B.A., President and Chief Medical Officer (Group) and Chief Executive Officer (USA) of HanchorBio. "That is where clinical medicine, regulatory science, and drug development properly align."

A Potential First for the SIRPα-Fc Fusion Protein Class

While Expanded Access pathways have previously been utilized for the anti-CD47 monoclonal antibody, HCB101-EA-001 is clinically and structurally distinct:

Targeted Continuation: Unlike broad population access programs, HCB101-EA-001 was specifically established to extend treatment for an individual patient who determined clinical benefit during a Phase 1 clinical trial.

Novel Mechanism: HCB101 is an engineered SIRPα-Fc fusion protein designed to block the CD47-SIRPα "don’t eat me" signal and trigger macrophage-mediated tumor-cell phagocytosis.

Based on publicly available information, HanchorBio believes this is the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein, setting a significant precedent as HanchorBio continues to advance the program globally across multiple tumor types and combination strategies.

About HCB101

HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB platform. HCB101 blocks CD47–SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.

(Press release, Hanchor Bio, SEP 9, 2026, View Source [SID1234670690])

On September 9, 2026 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, and Servier, an independent international pharmaceutical group governed by a foundation, reported that the first patient has been dosed in OptimUM-11, a global Phase 3 registrational trial evaluating darovasertib, a first-in-class oral protein kinase C (PKC) inhibitor, in combination with crizotinib, an oral cMET inhibitor, as adjuvant therapy for patients with primary uveal melanoma who have completed local therapy and have an increased risk of developing metastatic disease. Currently, there are no approved adjuvant treatment options for patients with primary uveal melanoma.

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"Dosing the first patient in OptimUM-11 represents an important milestone in our strategy to advance darovasertib across the uveal melanoma patient journey," said Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. "Patients with primary uveal melanoma are commonly at risk for metastatic recurrence following treatment of their primary tumor, highlighting the need for an effective systemic therapy in the adjuvant setting to delay or prevent disease progression. We believe the darovasertib combination has the potential to address the principal pathways associated with the initiation and metastatic progression of uveal melanoma, and we look forward to working with our partner Servier and the global investigator community to advance this registrational trial."

"Preventing or delaying metastatic recurrence could fundamentally change the treatment journey for patients with high-risk primary uveal melanoma," said Arnaud Lallouette, Executive Vice President Global Medical & Patient Affairs at Servier. "Through OptimUM-11, Servier and IDEAYA are jointly advancing a global registrational study of the darovasertib combination with the goal of establishing a new adjuvant treatment option for patients worldwide."

OptimUM-11 is being conducted by IDEAYA in collaboration with its partner, Servier, to evaluate darovasertib in combination with crizotinib as an adjuvant therapy for patients with primary uveal melanoma. The trial is expected to enroll approximately 450 patients who have completed primary local therapy and have an increased risk of metastasis. Patients will be eligible irrespective of HLA status and will be randomized 1:1 to receive darovasertib in combination with crizotinib for 12 months or observation. The primary endpoint of the trial is relapse-free survival. IDEAYA retains regulatory and commercial rights to darovasertib in the United States, while Servier holds all such rights outside the United States. The companies will share the associated development costs of the trial.

About Darovasertib

Darovasertib is a potential first-in-class oral, small-molecule inhibitor of PKC. Darovasertib was designed to inhibit PKC isoforms downstream of the GNAQ and GNA11 oncogenic driver mutations that are present in nearly all uveal melanoma patients. Darovasertib is being evaluated in multiple clinical trials in uveal melanoma, including in patients with metastatic disease (OptimUM-01 and OptimUM-02), as well as in primary uveal melanoma as a neoadjuvant (OptimUM-09 and OptimUM-10) and adjuvant (OptimUM-11) therapy.

IDEAYA has initiated submission of a new drug application (NDA) for darovasertib in combination with crizotinib for patients with first line metastatic uveal melanoma (mUM) under the oncology center of excellence (OCE) real-time oncology review (RTOR) program and expects to complete the NDA submission in the second half of 2026. The U.S. Food and Drug Administration (FDA) has also granted darovasertib Fast Track designation for the treatment of mUM, Orphan Drug designation in primary uveal melanoma and Breakthrough Therapy Designation as a neoadjuvant therapy for patients with primary uveal melanoma for whom enucleation has been recommended. Darovasertib is an investigational product and has not been approved by the FDA or any other regulatory authority.

(Press release, Ideaya Biosciences, SEP 9, 2026, View Source [SID1234670689])

On September 9, 2026 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported that Solstice Oncology, its partner company, has launched with a $225 million Series A financing led by RA Capital Management, with participation from Canaan Partners, Forbion and other investors. Solstice is a clinical-stage immuno-oncology company focused on treating cancer earlier, in the neoadjuvant setting.

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Solstice is advancing its lead candidate porustobart, a differentiated, second-generation, Fc-enhanced cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, across two clinical indications, one in microsatellite-stable (MSS) colon cancer and a second, undisclosed indication. Its Phase 2 trial is evaluating porustobart in combination with pembrolizumab in the neoadjuvant setting for the treatment of MSS clinical stage II-III colon cancer, the indication with the largest segment of colon cancer patients, which has yet to benefit from immunotherapy.

Porustobart was discovered and developed by Harbour BioMed. In February 2026, Harbour BioMed entered into a license agreement and equity partnership with Solstice Oncology for the exclusive development and commercialization of porustobart (also known as HBM4003 in Harbour BioMed’s pipeline) outside Greater China, enabling the advancement of the program globally.

In a Phase 2 clinical study conducted by Harbour BioMed, porustobart in combination with tislelizumab, a PD-1 inhibitor, demonstrated a 30% objective response rate (7 of 23 patients) in late-line patients with MSS metastatic colorectal cancer without liver metastases, with responses showing encouraging durability. The median duration of response was 8.4 months, and porustobart demonstrated a favorable safety profile supporting its continued clinical development. These findings provide clinical support for further evaluating porustobart in combination with PD-(L)1 blockade and in earlier lines of treatment, including the neoadjuvant setting.

"We are pleased to see Solstice Oncology launch with strong support from leading investors and advance porustobart into the neoadjuvant setting," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "As the originator of porustobart and a partner of Solstice, we look forward to supporting the continued development of this differentiated CTLA-4 antibody and exploring its potential to benefit patients worldwide."

"We believe the greatest opportunity in oncology lies in treating disease earlier, in the neoadjuvant setting, when the tumor is still present, the immune system is still intact, and disease hasn’t yet hardened its resistance to treatment," said Caroline Loew, PhD, CEO of Solstice Oncology. "Treating patients early with an immuno-oncology combination therapy like the one we are evaluating in our Phase 2 trial could allow the immune response to act systemically, reaching micrometastatic disease well beyond the primary tumor, which is where we see the greatest opportunity to improve cure rates and long-term survival. Since founding the company in February, our team has moved with the speed and discipline this opportunity demands, filing and clearing an IND and now advancing directly into a Phase 2 trial, for which we anticipate data in the second half of 2027."

(Press release, Harbour BioMed, SEP 9, 2026, View Source [SID1234670688])

On September 9, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, reported that the first patient has been dosed in Arm A of PNOC035, a Phase 2 platform study evaluating paxalisib in combination with gemcitabine for patients ages 1 to 39 with recurrent or progressive atypical teratoid/rhabdoid tumor (AT/RT). AT/RT is widely recognized as one of the most aggressive forms of pediatric brain cancer.

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PNOC035 is conducted by the Pediatric Neuro-Oncology Consortium (PNOC), an open-label, multi-center platform study. In Arm A, patients receive oral, once-daily paxalisib in combination with intravenous gemcitabine on Days 1, 8 and 15 of each 28-day treatment cycle.

The combination increased median survival nearly four-fold (22 to 82.5 days; p<0.0001) in an orthotopic AT/RT preclinical model and demonstrated complementary anti-tumor activity across multiple AT/RT cell lines. These preclinical findings provided the rationale for advancement into the multicenter PNOC035 clinical study evaluating paxalisib plus gemcitabine in children and young adults with recurrent or progressive AT/RT. These findings, previously presented at ISPNO, AACR (Free AACR Whitepaper) and Neuro-Oncology meetings, provided the scientific rationale for PNOC035 and extend paxalisib’s pediatric neuro-oncology development beyond diffuse midline glioma into another area of significant unmet need.

Paxalisib has been granted both Orphan Drug Designation and Rare Pediatric Disease Designation by the U.S. Food and Drug Administration (FDA) for AT/RT. These designations do not constitute FDA approval or endorsement of any therapeutic claim. If paxalisib were to receive marketing approval for this indication, which would require successful completion of clinical development and FDA regulatory approval, Kazia could become eligible to receive a pediatric priority review voucher from the FDA.

"AT/RT typically affects infants and very young children, and families facing this devastating diagnosis have limited treatment options," said Dr. John Friend II, Chief Executive Officer of Kazia Therapeutics. "Despite decades of research, there are still no approved therapies for recurrent or progressive AT/RT, underscoring the urgent need for new treatment options. We’ve remained committed to pediatric brain cancer because this is an area where the need is especially great and the options are often fewest. Reaching this milestone with the PNOC035 team is a meaningful step forward, and we look forward to working closely with PNOC as enrollment progresses."

About PNOC035

PNOC035 is a Phase 2 platform trial conducted by the Pediatric Neuro-Oncology Consortium (PNOC) for patients ages 1 to 39 with recurrent or progressive AT/RT. The platform design allows multiple treatment arms to be evaluated within a shared trial infrastructure, with patients enrolling in an arm based on availability and arm-specific eligibility criteria. Arm A evaluates paxalisib in combination with gemcitabine. Additional information about the study is available on ClinicalTrials.gov (NCT07447076).

(Press release, Kazia Therapeutics, SEP 9, 2026, View Source [SID1234670687])

On September 9, 2026 Transcenta Therapeutics (HKEX: 06628), a global clinical-stage biopharmaceutical company with fully integrated capabilities in discovery, R&D and process development of antibody-based therapeutics, reported that it and its subsidiary, HJB, have entered into a technology licensing and strategic collaboration agreement with WuXi Biologics. Under the agreement, Transcenta will grant WuXi Biologics and its affiliates a non-exclusive license to certain technologies relating to Transcenta’s Highly Intensified Continuous Bioprocessing ("HiCB") platform and ExcelPro cell culture media. Transcenta will receive an upfront payment of RMB 10 million and will be eligible for milestone payments upon the achievement of specified conditions. Through this collaboration, WuXi Biologics will become Transcenta’s strategic partner for CMC development and supporting molecules across Transcenta’s development pipeline.

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HiCB platform integrates intensified continuous perfusion upstream processing with hybrid continuous downstream purification, enabling a step-change in productivity, achieving significant increase in productivity compared with conventional fed-batch processes, while maintaining superior product quality through shorter residence time and optimized culture conditions. HiCB can significantly reduce cost of goods, lower capital investment, and enable agile and just-in-time production. It also provides a solution for improving recovering yield and product quality for complex biologics.

This collaboration is part of Transcenta’s continued efforts to advance partnerships for its HiCB technology platform and broaden its application to address CMC challenges for complex biologic molecules. It also offers a flexible approach to rapidly expand production capacity. Transcenta plans to further unlock the commercial value of the HiCB platform through external licensing and industry partnerships.

(Press release, Transcenta, SEP 9, 2026, View Source [SID1234670686])