On November 7, 2025 SciBase Holding AB ("SciBase") (STO: SCIB), a leading developer of AI-based diagnostic solutions for skin disorders, reported that SciBase and Castle Biosciences ("Castle") (NASDAQ: CSTL) have expanded their collaboration and license agreement and entered into a separate loan agreement. The two companies first entered into the collaboration and license agreement in June 2025. The expanded agreement includes providing Castle increased autonomy over the manufacturing process. Under the separate loan agreement, Castle will provide SEK 20 million to SciBase.

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The goal of the first joint clinical study is to develop a test that predicts flares in patients diagnosed with atopic dermatitis (AD), with additional indications to potentially follow. The loan is based on market terms with a potential for Castle to request conversion of the loan into new shares.

"Our collaboration with Castle Biosciences is moving ahead at full speed," said Pia Renaudin, CEO of SciBase. "With this loan, we secure the resources needed to smoothly ramp up production and maintain uninterrupted growth. We expect the resulting improvements in product margins will create value across all markets and indications. This collaboration will also help us accelerate the adoption of Nevisense in skin barrier health and continue driving strong sales growth in skin cancer diagnostics."

The loan agreement is a five-year loan amounting to SEK 20 million. The interest rate on the loan amounts to STIBOR plus two (2) per cent per annum and shall be paid quarterly. However, the first interest payment date shall be 31 March 2026, and the final interest payment date shall be on the repayment date of the loan. The loan shall be repaid in cash no later than five years following the signing of the loan agreement or, if demanded by Castle, by way of conversion of the loan amount into new shares in SciBase. In case of conversion, the conversion price per share shall correspond to the volume weighted average price of the shares in SciBase during the 30 trading days preceding the repayment date. For the avoidance of doubt, repayment of the loan may be made in a combination of cash repayment and conversion repayment. The loan is secured by a share pledge over SciBase’s shares in SciBase AB.

This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CEST on November 7, 2025.

(Press release, Castle Biosciences, NOV 7, 2025, View Source [SID1234659654])

On November 7, 2025 Akeso, Inc. (HKEX: 9926.HK) reported the preclinical research data for its novel antagonistic monoclonal antibody targeting IL-1RAP, AK135, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held in National Harbor, Maryland.

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The results demonstrated that AK135 effectively targets IL-1RAP and blocks three key pro-inflammatory signaling pathways—IL-1, IL-33, and IL-36 at their source, thereby halting the transmission of inflammatory signals. In preclinical models, AK135 provided significant pain relief in neuropathy, exhibiting dose-dependent efficacy, while also showing good tolerability and safety profiles.

In vitro Results:

ELISA, Fortebio molecular interaction technology, and flow cytometry (FACS) results demonstrated that AK135 has high affinity for IL-1RAP, with binding activity comparable to or superior to that of the control antibody CAN04.
Reporter gene assays further confirmed that AK135 effectively inhibits the activation of IL-1, IL-33, and IL-36 signaling pathways, showing excellent half-maximal inhibitory concentration (IC50) values in each of the pathways.
In tumor cell models, AK135 significantly reduced the secretion of pro-inflammatory cytokines (such as IL-6 and IL-8) induced by IL-1, IL-33, and IL-36.
In vivo Results:

The in vitro experiments confirmed the high affinity and potent neutralizing activity of AK135. To further evaluate its in vivo efficacy, the research team established a Chemotherapy-induced peripheral neuropathy (CIPN) mouse model and assessed the pharmacological effects of AK135 through intermittent low-dose paclitaxel administration.
Following AK135 treatment, the paw withdrawal threshold (PWT) in the CIPN model was significantly increased, indicating that AK135 effectively alleviated mechanical allodynia, with a dose-dependent efficacy.
Throughout the treatment period, mice in all dose groups maintained stable body weight, with no significant signs of toxicity, demonstrating good tolerance.
CIPN is a prevalent and dose-limiting side effect of chemotherapy, affecting 50-90% of treated patients, of which 30-40% progressing to chronic neuropathic pain. Despite its clinical significance, effective treatment options remain limited, and the underlying mechanisms are not fully understood. Emerging evidence suggests that pro-inflammatory cytokines released by the damaged neurons play a key role in CIPN pathogenesis. IL-1 receptor accessory protein (IL-1RAP/IL-1RAcP) is a critical mediator of inflammatory signaling, amplifying responses through the interleukin-1 (IL-1), interleukin-33 (IL-33), and interleukin-36 (IL-36) pathways. Akeso developed AK135, a novel antagonistic monoclonal antibody targeting IL-1RAP, to alleviate the peripheral neuralgia by inhibiting these proinflammatory signaling pathways.

About AK135 (IL-1RAP Targeting Antibody)
AK135 is a novel antagonistic antibody targeting IL-1RAP, internally developed by Akeso, aimed at treating chemotherapy-induced peripheral neuropathy (CIPN). By precisely blocking IL-1RAP, this product simultaneously inhibits the three core inflammatory signaling pathways—IL-1, IL-33, and IL-36, providing relief from neuroinflammatory responses at their source. Preclinical studies have shown that AK135 significantly alleviates neuropathic pain in a dose-dependent manner, while also demonstrating good tolerance. Currently, AK135 is in Phase I clinical trials for the treatment of CIPN.

(Press release, Akeso Biopharma, NOV 7, 2025, View Source [SID1234659653])

On November 7, 2025 Akeso, Inc. (HKEX: 9926.HK) reported that the final Overall Survival (OS) analysis results from the HARMONi-A study, a Phase III study evaluating ivonescimab combined with chemotherapy for the treatment of EGFR-mutated non-squamous non-small cell lung cancer (nsq-NSCLC) following EGFR-TKI progression, were selected as a "Late-Breaking Abstract" (LBA) for the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held in National Harbor, Maryland, USA. Professor Xiuning Le from MD Anderson Cancer Center presented these findings to a global audience during an oral presentation session.

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HARMONi-A is the first global Phase III clinical trial of an immunotherapy in the EGFR-TKI resistant, EGFR-mutated nsq-NSCLC setting to demonstrate clinically meaningful and statistically significant benefits in both Progression-Free Survival (PFS) and Overall Survival (OS). This final OS analysis, the first from a Phase III trial of ivonescimab, confirms the breakthrough value of ivonescimab-based therapy in improving both PFS and OS. Historically, cancer immunotherapies have largely failed to demonstrate significant breakthroughs in this specific indication. Prior Phase III trials involving other regimens—such as PD-1 inhibitors combined with chemotherapy or immunotherapies combined with anti-angiogenic therapy, failed to show significant OS benefits. The significant positive outcomes in both PFS and OS in the HARMONi-A study underscore the substantial clinical benefit improvement of ivonescimab over PD-1 inhibitors.

Previously, the HARMONi-A study had already met its primary endpoint, demonstrating a statistically significant improvement in PFS at the interim analysis (PFS HR 0.46, P < 0.001). Previously, during the regulatory review for the approval of ivonescimab in first-line PD-L1-positive NSCLC in China, a descriptive analysis of OS from the HARMONi-A study was conducted in May 2024 at the request of the regulatory authorities. The final OS analysis results presented at SITC (Free SITC Whitepaper) 2025 represent the final and only pre-specified formal OS analysis for the HARMONi-A study, performed as a sequential test according to the pre-specified statistical analysis plan (SAP).

The final OS analysis, with a median follow-up period of 32.5 months, showed that the ivonescimab plus chemotherapy regimen provided a clinically meaningful and statistically significant improvement in OS compared to chemotherapy alone:

The median OS was 16.8 months in the ivonescimab treatment group compared to 14.1 months in the control group (OS HR=0.74, P=0.019), achieving statistical significance. The OS benefit increased with extended follow-up.
The ivonescimab combination regimen consistently demonstrated OS benefit over the control group across all subgroups:
In patients with brain metastases, OS HR=0.61;
In patients without brain metastases, OS HR=0.77;
In patients with EGFR 19Del mutations, OS HR=0.83;
In patients with EGFR L858R mutations, OS HR=0.60.
With a median follow-up of 32.5 months, the long-term safety profile of the ivonescimab combination therapy remained favorable, with no new safety signals identified. The incidence of common treatment-related adverse events (TRAEs) showed no significant difference between the two groups.

Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, Akeso announced that ivonescimab was successfully added to China’s National Reimbursement Drug List, effective January 1, 2025, ensuring widespread patient access to this life-saving treatment.

Additionally, Summit Therapeutics, Akeso’s global partner for ivonescimab, announced in October 2025 that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, seeking approval for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant, third-generation EGFR-TKI-resistant, non-squamous NSCLC.

(Press release, Akeso Biopharma, NOV 7, 2025, View Source;302608764.html [SID1234659652])

On November 7, 2025 CREATE Medicines Inc. (formerly Myeloid Therapeutics), a biotechnology company advancing in vivo immune-cell programming with mRNA-LNP therapeutics, reported first-in-human results from its Phase 1 MYE Symphony trial (NCT05969041) evaluating MT-302, an mRNA-LNP-encoded TROP2-targeted in vivo CAR therapy in patients with advanced solid tumors, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting.

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"These data provide important mechanistic insights into how in vivo programmed myeloid cells behave within the tumor microenvironment," said Rasha Cosman BSc (Med), MBBS, FRACP, Head of the Early Phase Clinical Trials Unit at The Kinghorn Cancer Centre, St. Vincents Hospital Sydney, "The degree of remodeling observed, combined with a manageable safety profile and repeat-dose feasibility, and early signal of anti-tumor activity in a heavily pre-treated population, is highly encouraging in tumor settings where immune infiltration has been historically limited. Seeing immune cells effectively reprogrammed inside the body to mount a targeted anti-tumor response represents a meaningful milestone and supports continued clinical advancement."

Results
27 patients with advanced TROP2-positive solid tumors were treated with MT-302 across seven dose cohorts.

Manageable safety profile consistent with immune cell activation.
Dose and tumor burden dependent low grade cytokine release syndrome observed in 51.9% of participants with kinetics consistent with tumor target engagement. There were no events of grade 3 or higher CRS.
Maximum tolerated dose: 0.10 mg/kg without steroid premedication. One Grade 4 ICANS event was observed at the highest dose tested (0.15 mg/kg).
Pharmacokinetics: terminal half-life of pegylated and ionizable lipids 45–50 hours.
Biological activity: CAR⁺ myeloid cells observed within tumors with T-cell infiltration and cytokine induction (IFNγ, CXCL9/10); the CXCL9:SPP1 ratio correlated with tumor-burden change, indicating pro-inflammatory tumor-microenvironment remodeling.
Clinical signal: one confirmed partial response in HR⁺ breast cancer in a patient on treatment for 16 months (20 doses) with pharmacological activity observed at 0.015 mg/kg.
"These data represent the first demonstration of an in vivo CAR therapy achieving tumor penetration and measurable biological activity in patients with solid tumors," said Matt Maurer, MD, Chief Medical Officer of CREATE Medicines. "MT-302 showed proof-of-mechanism while maintaining a manageable safety profile and repeat dosing without preconditioning or immunosuppression."

Conclusions
In this first-in-human study, MT-302 demonstrated tolerable repeat dosing, robust immunologic activity, direct tumor penetration by CAR myeloid cells and broad immune activation in heavily pre-treated patients. These results provide clear proof-of-mechanism for in vivo CAR therapies in solid tumors and support advancement of MT-302 for front-line use. Dosing with MT-302 was recently initiated in the first ever front-line solid tumor trial with an in vivo CAR combined with a standard frontline regimen in the SPaCE-MT trial (EUCT 2024-520213-45-00).

"This is a foundational moment for our platform and for the field of in vivo cell therapy," added Daniel Getts PhD, Chief Executive Officer and co-founder of CREATE Medicines. "We have clinical evidence demonstrating that immune cells can be reprogrammed inside the body to mount a targeted anti-tumor response, paving the way for a new, highly versatile modality in the fight against solid tumors."

Presentation Details:
SITC 40th Anniversary Annual Meeting

Title: First-in-Human Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of mRNA-LNP MT-302 In Vivo CAR Therapy in Solid Tumors
Presenting Author: Dr. Rasha Cosman, The Kinghorn Cancer Centre, St. Vincent’s Hospital Darlinghurst NSW Australia
Category: Clinical Oral Abstract Session 1
Publication Number: LBA 1342
Session Date & Time: Friday, November 7, 2025: 11:30 AM ET- 12:15 PM
Location: Gaylord National Resort & Convention Center, Potomac Ballroom, National Harbor, MD
About MT-302
MT-302 is an investigational mRNA-LNP in vivo CAR therapy designed to program immune cells inside the body. Delivered systemically, MT-302 recognizes and eliminates TROP2-expressing solid tumors by encoding a TROP2-specific chimeric antigen receptor to transiently reprogram immune cells. This approach eliminates the need for ex vivo manipulation or preconditioning, while achieving repeatable dosing and controllable anti-tumor activity.

(Press release, Create Medicines, NOV 7, 2025, View Source [SID1234659651])

On November 7, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported the presentation of two late-breaking abstracts on its lead asset, HCB101, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held November 5-9, 2025, in National Harbor, Maryland. Both datasets were accepted for late-breaking poster presentations, highlighting the program’s potential impact on innate immune checkpoint blockade.

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HCB101’s progress reflects its distinct engineering compared to earlier CD47-targeting approaches. First-generation CD47 antibodies, such as magrolimab and lemzoparlimab, demonstrated clinical activity but faced significant safety or efficacy challenges, leading to discontinuations or halted collaborations. Second-generation wild-type SIRPα fusions, such as maplirpacept (TTI-622), improved safety but did not deliver sufficient efficacy in solid tumors, limiting their adoption. IgG1-based fusions attempted to boost immune activation but triggered excessive Fcγ-mediated toxicity and poor tolerability, restricting their use mainly to hematologic malignancies. Third-generation engineered SIRPα fusions with inactivated IgG1 Fc improved safety in combinations but showed limited standalone efficacy.

"The acceptance of two late-breaking abstracts at SITC (Free SITC Whitepaper) for HCB101 monotherapy and combination therapy, along with our earlier preclinical abstract for HCB301, a tri-specific fusion targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ, reinforces the scientific breadth of our platform across innate and adaptive immunity," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "HCB101 was purposely engineered to overcome the cytopenias seen with first-generation anti-CD47 antibodies while maintaining potent immune activation. In second-line gastric cancer, the combination of HCB101 with standard-of-care therapy achieved a 100% confirmed response rate in the active-dose cohort, far exceeding the 28% ORR benchmark from the RAINBOW trial. These results position HCB101 not just as a safer SIRPα-CD47 backbone, but as a next-generation macrophage checkpoint immunotherapy with best-in-class potential."

Late-Breaking Abstract Highlights (Data as of August 2025)

1. HCB101-101 Monotherapy Study (NCT05892718)

Title: HCB101, a Next-Generation Fc-Engineered SIRPα-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers

In the ongoing Phase 1a dose-escalation, no dose-limiting toxicities (DLTs) have been observed at doses up to 24 mg/kg.
CD47 receptor occupancy ≥99% achieved at doses ≥5 mg/kg, with dose-proportional pharmacokinetics.
Confirmed partial responses seen in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma (MZL).
Several patients achieved stable disease, with progression-free survival up to 32 weeks.
2. HCB101-201 Combination Therapy Study (NCT06771622)

Title: Phase 1b/2a Study of HCB101 Combined with Standard Therapies Demonstrates Manageable Safety and Dose-Dependent Antitumor Activity in Immunologically Cold Advanced Solid Tumors

In second-line gastric cancer (GC):
100% confirmed partial response rate (6/6 evaluable patients) at active doses when combined with ramucirumab and paclitaxel.
Tumor shrinkage up to 78%, surpassing the ~26.5% ORR benchmark from RAINBOW.
In first-line triple-negative breast cancer (TNBC):
Confirmed partial response with 73% tumor reduction at the effective dose.
Safety was manageable and consistent with the cytopenia-sparing design, with only minimal hematologic effects observed.
Dr. Fangling Ning, Investigator from the Affiliated Hospital of Binzhou Medical University, commented, "What’s unique about HCB101 is that it avoids the cytopenias that plagued anti-CD47 antibodies by minimizing red blood cell binding, while still engaging CD47 strongly on tumor cells. In our gastric cancer cohort, the responses at active doses are encouraging in a patient population that historically has had limited options. These findings validate HCB101’s unique design and suggest meaningful potential in immunologically cold tumors."

About HCB101: A Differentiated CD47-SIRPα Blockade

HCB101 is a 3.5th-generation, affinity-optimized SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s proprietary FBDB platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging. Key differentiators of HCB101:

Enhanced safety: Cytopenia-sparing profile, with no DLTs observed up to 30 mg/kg and receptor occupancy >90% at ≥1.28 mg/kg, supporting a broad therapeutic window.
Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.
Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, TNBC, HNSCC, non-Hodgkin lymphoma, and ovarian cancer.
Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in 2L gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in 1L TNBC and 2L HNSCC, substantially exceeding historical benchmarks.

(Press release, Hanchor Bio, NOV 7, 2025, View Source [SID1234659650])