On October 17, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company’s human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) trastuzumab botidotin (also known as A166) was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have received one or more prior anti-HER2 therapy.

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The approval is based on a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study that evaluates the efficacy and safety profile of trastuzumab botidotin versus T-DM1 in patients with HER2-positive unresectable or metastatic BC who have received prior trastuzumab and taxane-containing regimens. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR) compared with T-DM1; the beneficial trend for overall survival (OS) of trastuzumab botidotin was also observed. Results from this study will be presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress held in Berlin, Germany (Presentation # LBA24, Proffered paper session 1: Breast cancer, metastatic).

The Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.

Dr. Michael Ge, CEO of Kelun-Biotech said, "We are thrilled to see our first HER2 ADC drug, trastuzumab botidotin, successfully approved for market. This marks a significant advancement in the treatment of HER2-positive breast cancer. As China’s first domestically developed HER2 ADC capable of broadly covering 2L+ HER2 BC patients, trastuzumab botidotin leverages its differentiated structural design to deliver superior efficacy while addressing unmet clinical needs in this population."

About HER2+ BC

Breast cancer, as the most common malignant tumor, poses a serious threat to women’s health. Among its subtypes, HER2-positive breast cancer accounts for approximately 15%–20% of all breast cancer cases[1], and is characterized by its aggressiveness and high malignancy. According to the 2025 CSCO guidelines, first-line treatment for HER2-positive breast cancer primarily consists of trastuzumab and pertuzumab in combination with taxane-based chemotherapeutic agents. Second-line treatment regimens comprise tyrosine kinase inhibitors (TKIs, such as pyrotinib) and antibody-drug conjugates (ADCs, such as T-DM1 and T-DXd). Following disease progression on second-line therapy, subsequent treatment strategies are determined based on prior second-line regimens, the patient’s tolerance to therapy, tumor burden, and other relevant factors. Despite recent advances in anti-HER2 therapeutics, a significant number of patients still experience drug resistance or severe adverse effects, highlighting an urgent need for agents with improved safety profiles to address the treatment requirements of patients with recurrent or drug-resistant HER2-positive breast cancer.

A bout trastuzumab botidotin

Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a drug-to-antibody-ratio (DAR) of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

(Press release, Kelun, OCT 17, 2025, View Source [SID1234656754])

On October 17, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), reported that it will host a webinar on Monday, October 20th at noon EDT to discuss its first-in-human, early feasibility clinical study for its Targeted Hyperthermia Therapy cancer treatment. Ten advanced stage melanoma patients who were failing to respond to standard immunotherapy treatment were recruited into this early feasibility study.

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Interested parties can register here: http://bit.ly/3JcFls5. A recording of the webinar will be made available following the webinar in the Investor Information section of the Company’s website.

(Press release, Sona Nanotech, OCT 17, 2025, View Source [SID1234656738])

On October 17, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported the two-year efficacy and safety results from its MOTION Phase 3 study of vimseltinib in patients with TGCT in cases where surgical removal of the tumor is not an option will be presented as a poster during the 2025 European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper), taking place October 17-21 in Berlin, Germany.

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"These long-term Phase 3 MOTION results add to the established body of evidence supporting vimseltinib as a best-in-class treatment for TGCT," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "TGCT often causes debilitating pain, stiffness and impaired mobility and these results demonstrate the durable benefit that vimseltinib can offer patients."

Summary of Data and Findings from the 2-year results of the MOTION Phase 3 Study

Methods

The global Phase 3 MOTION study (NCT05059262) aims to evaluate the efficacy and safety of vimseltinib for the treatment of TGCT in cases where surgical removal of the tumor is not an option.

The study consists of two parts. In Part 1, eligible study participants were assigned to receive either vimseltinib or matching placebo for 24 weeks. Participants assigned to placebo in Part 1 had the option to receive vimseltinib for Part 2. Part 2 was a long-term treatment phase in which all participants received open-label vimseltinib. Patients received vimseltinib 30 mg twice weekly in all periods. Objective response rate (ORR) based on best overall response was assessed by independent radiological review (IRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and per Tumor Volume Score (TVS). Duration of response (DOR) and safety were also evaluated.

Efficacy

In these two-year results from the MOTION Phase 3 trial, vimseltinib continued to demonstrate robust and durable antitumor efficacy with a manageable safety profile that was consistent with prior reports. These long-term results support vimseltinib as a treatment option for patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability, where it is approved. These results are reported with two years of follow-up in patients randomized to vimseltinib in Part 1 and crossed over from placebo to vimseltinib in Part 2. The data cutoff for this analysis was February 22, 2025.

In total, 118 patients received vimseltinib. At data cutoff, 51% (60/118) remained on treatment. With at least 2 years of follow-up, results demonstrate robust and durable antitumor activity with vimseltinib per RECIST v1.1 and per TVS, including in patients who crossed over to vimseltinib in Part 2.

Of 83 patients randomized to vimseltinib in Part 1, 73 continued open-label treatment in Part 2. Median (range) treatment duration was 23.6 months (2 to 36).
Of the 40 patients randomized to placebo in Part 1, 35 crossed over to vimseltinib in Part 2. Median treatment duration for this group was 19.1 months (1 to 30).
ORR on study per RECIST v1.1 was 48% (40/83) for patients randomized to vimseltinib and 54% (19/35) for those who crossed over to vimseltinib. ORR on study per TVS was 81% (67/83) for patients randomized to vimseltinib and 71% (25/35) for those who crossed over to vimseltinib.
The corresponding median DOR per RECIST v1.1 and per TVS was still not reached.
Safety

Vimseltinib continued to have a manageable safety profile that was consistent with prior reports with no new safety signals.

Most treatment-emergent adverse events (TEAEs) were grade 1/2, and grade 3/4 TEAEs were similar between randomized vimseltinib and crossover groups.
There were no new TEAEs in ≥15% of patients receiving vimseltinib and no new serious adverse events in more than one patient.
Serum enzyme elevations were consistent with the known mechanism of action of CSF1R inhibition, and there was no evidence of cholestatic hepatotoxicity or drug-induced liver injury.
About Vimseltinib

Vimseltinib is an oral, switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform. It has been approved in the United States for adult patients with symptomatic TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is caused by a dysregulation in colony-stimulating factor 1 (CSF1) gene leading to overproduction of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion.1 TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS). TGCT is a rare, locally aggressive neoplasm that can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients, surgical resection will potentially cause worsening functional limitation or severe morbidity. Systemic treatment options are limited and new therapeutic options are needed.

(Press release, Ono, OCT 17, 2025, View Source [SID1234656755])

On October 17, 2025 IDEAYA Biosciences, Inc. (the "Company") reported the first median overall survival ("OS") results from its Phase 1/2 clinical trial (OptimUM-01) evaluating darovasertib, the Company’s investigational oral protein kinase C ("PKC") inhibitor, in combination with Pfizer’s crizotinib, a c-MET inhibitor, as a first-line treatment for patients with metastatic uveal melanoma ("mUM"). The data will be presented on Sunday, October 26, 2025 by Dr. Justin Moser at the 2025 Society for Melanoma Research Congress ("SMR") taking place in Amsterdam, Netherlands.

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Data reported at SMR were from 44 first-line ("1L") mUM patients, including both HLA*A2:01-negative and HLA*A2:01-positive patients, in the single-arm Phase 1/2 OptimUM-01 trial with a median follow-up time of 25 months as of the cut-off date of May 28, 2025. Across all 44 patients treated with the darovasertib and crizotinib combination, a median OS of 21.1 months and a median progression free survival ("PFS") of 7.0 months was observed. In 41 efficacy-evaluable patients, the confirmed overall response rate by RECIST 1.1 was 34% (14/41) with a 9.0 month median duration of response. A disease control rate of 90% (37/41) was also observed, with 85% (35/41) of patients achieving ‘any reduction’ in target lesions. The combination continued to have manageable tolerability with the most common treatment-related adverse events ("TRAEs") (TRAEs >30%) of diarrhea, nausea, edema, vomiting, dermatitis, hypoalbuminemia, and fatigue. Grade ≥3 TRAEs were iron-deficiency anemia and pulmonary embolism (both 5%). The proportion of patients enrolled in the OptimUM-01 study that had baseline ECOG performance status scores ("PS") of 0 and 1 was 61% (27/44) and 39% (17/44), respectively. The proportion of patients with ECOG PS 1 in the OptimUM-01 study is approximately two times higher than an earlier published registrational study in mUM.

Metastatic uveal melanoma is a rare and aggressive form of ocular cancer with poor prognosis, where historical median OS reported in published meta-analysis from patients in the treatment naïve setting is approximately 12 months. The Company is conducting a registration-enabling Phase 2/3 trial (OptimUM-02) of the darovasertib and crizotinib combination in 1L HLA*A2:01-negative mUM and is targeting to report median PFS data from this trial by year-end 2025 to Q1 2026 to support a potential U.S. accelerated approval filing.

Pursuant to the Clinical Trial Collaboration and Supply Agreement with Pfizer to evaluate darovasertib and crizotinib as a combination therapy in mUM, Pfizer provided the Company with a defined quantity of crizotinib at no cost, as well as an additional defined quantity of crizotinib at a lump-sum cost.

A presentation summary of the SMR data will be available on the Investor Relations tab of the Company’s corporate website after the presentation.

Positive Phase 2 Data for Darovasertib in the Neoadjuvant Setting of Primary Uveal Melanoma

On October 20, 2025, the Company presented positive clinical data from its ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib in patients with primary uveal melanoma ("UM"). The data were presented in a Proffered Paper oral presentation by Dr. Marcus Butler, M.D., Associate Professor, Princess Margaret Cancer Center at the University of Toronto, at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") in Berlin, Germany.

Data presented at ESMO (Free ESMO Whitepaper) for neoadjuvant darovasertib were from a total of 95 patients with primary UM, including 56 patients recommended for enucleation ("EN") (surgical eye removal; Cohort 1) and 39 patients eligible for plaque brachytherapy ("PB") (Cohort 2) as of a data cut-off date of June 13, 2025. Patients were enrolled into Cohort 1 or Cohort 2 based on investigator recommended primary local therapy at baseline determined by tumor size and proximity to critical eye structures. All patients received neoadjuvant darovasertib for up to 12 cycles (or maximum benefit) prior to definitive primary local therapy. As of the cut-off date, only 94 patients were evaluable for efficacy, which reflects one patient in Cohort 2 that was excluded per protocol based on not yet receiving at least one dose of study drug and at least one post-baseline tumor assessment. Patients who derived benefit from darovasertib in the neoadjuvant setting were then eligible to receive darovasertib for up to six additional cycles as adjuvant therapy and monitored for disease recurrence and changes in visual acuity.

Key Findings from OptimUM-09

•
Tumor shrinkage and eye preservation

•
83% (78/94) of patients demonstrated ocular tumor shrinkage, with 54% (51/94) achieving ≥20% tumor shrinkage.

•
Patients recommended for EN (Cohort 1) demonstrated robust ocular tumor shrinkage following treatment with darovasertib, with approximately 84% (47/56) experiencing any reduction in tumor size by product of diameters, and 50% (28/56) and 37.5% (21/56) achieving a ≥20% and ≥30% reduction, respectively.

•
Similarly, among patients eligible for PB (Cohort 2), approximately 82% (31/38) achieved any reduction in ocular tumor size by product of diameters, with 60.5% (23/38) and 44.7% (17/38) demonstrating a ≥20% and ≥30% reduction, respectively.

•
Among 42 patients in Cohort 1 who had completed primary local therapy at the time of the data cut, a 57.1% (24/42) eye preservation rate was observed. Of these patients, 75% (18/24) received PB and 25% (6/24) received external beam radiation instead of the EN procedure.

•
Among patients in Cohort 1 with ≥20% tumor shrinkage prior to primary local therapy, the eye preservation rate jumped to 95% (19/20). Based in part on these data, and after discussions with the FDA, the Company has proposed ≥20% tumor shrinkage as the definition of response in primary UM for their ongoing Phase 3 trial (OptimUM-10) of darovasertib in the neoadjuvant setting.

•
Predicted radiation reduction and visual preservation

•
Among 37 evaluable patients with paired dosimetry in Cohort 2, approximately 70% (26/37) observed any reduction in the predicted dose of radiation to critical eye structures (fovea, disc, lens) compared to baseline following treatment with darovasertib in the neoadjuvant setting, with approximately 35-40% experiencing a ≥20% reduction. This magnitude of reduction is relevant since a similar decrease in radiation to the tumor apex is associated with improved visual outcomes.

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64.9% (24/37) of the evaluable patients in Cohort 2 had a reduced predicted risk of vision loss at 3-years post-PB based on a vision prognostic tool developed at the Cleveland Clinic that is used to predict the risk of developing 20/200 vision (legal blindness) or worse following radiation administered during PB.

•
Improved visual acuity during neoadjuvant treatment

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54.7% (29/53) of patients in Cohort 1 and 60.5% (23/38) of patients in Cohort 2 demonstrated an improvement in visual acuity scores ("VAS") during neoadjuvant darovasertib therapy, compared to baseline.

•
Patients in Cohort 1 with improved VAS scores from baseline had a mean gain of 17 letters on treatment, with ~72% (21/29) gaining ≥5 letters at 2 consecutive visits.

•
Similarly, patients in Cohort 2 with improved VAS scores from baseline had a mean gain of 10 letters while on treatment, with ~52% (12/23) gaining ≥5 letters at 2 consecutive visits.

•
Safety and Tolerability:

•
Darovasertib was generally well tolerated with manageable adverse events, which included low-grade diarrhea, nausea, vomiting, and fatigue.

•
Grade 3 or higher TRAEs occurred in 16.8% (16/95) of patients. Rates of treatment-related serious adverse events (5.3%) and treatment discontinuation due to adverse events (6.3%) were low.

Darovasertib has received U.S. Food and Drug Administration Breakthrough Therapy Designation in the neoadjuvant setting of primary uveal melanoma for EN eligible patients. The Company is currently conducting a Phase 3 trial (OptimUM-10) of darovasertib as a single-agent in the neoadjuvant setting of primary UM. The Company is also targeting to report topline median PFS data from its registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib in combination with crizotinib in first-line, HLA*A2:01-negative metastatic UM by the end of 2025 to Q1’26 to enable a potential accelerated approval filing in the United States.

(Press release, Ideaya Biosciences, OCT 17, 2025, View Source [SID1234656820])

On October 17, 2025 TOLREMO therapeutics AG (TOLREMO) reported encouraging clinical data from 34 patients with advanced solid tumors treated with TT125-802 in the dose escalation part of an ongoing first-in-human study (NCT06403436). The data will be presented on October 19 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany, and highlights TT125-802’s confirmed clinical activity and favorable safety profile.

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TT125-802 is an orally available small-molecule inhibitor that selectively blocks the bromodomains of CBP/p300, transcriptional co-activators implicated in non-oncogene addiction – a key driver of cancer and drug resistance that functions in parallel to oncogenic pathways. This update expands on initial data presented at ASCO (Free ASCO Whitepaper) earlier this year, establishing TT125-802 as the first CBP/p300 bromodomain inhibitor to report clinical activity across a variety of solid tumors, including durable confirmed responses in non-small cell lung cancer (NSCLC).

In the now completed dose escalation part of the study, 34 heavily pre-treated solid tumor patients received TT125-802 across 5 dose escalation cohorts (15 mg QD – 60 mg BID) and 2 cohorts examining the role of food on exposures. No MTD was reached and TT125-802 was safe and well tolerated. The most common drug-related AEs were dysgeusia and hyperglycemia. No thrombocytopenia was observed. The recommended dose was selected at 60 mg once a day on a continuous basis, without food restriction.

Suppression of CBP/p300 target pathways was confirmed in patient hair follicles by RNA-seq.

Anti-tumor activity was observed across all dose levels in this heavily pre-treated population. 4 patients stayed on study for over one year, including 3 patients with adenoid cystic carcinoma and one patient with a bulky dedifferentiated liposarcoma. 3 patients (EGFR exon 19 delta, KRAS-G12C, squamous NSCLC) achieved a deep confirmed partial response (PR). The EGFRmut and KRAS-G12Cmut patients had progressed on an EGFR inhibitor and KRAS-G12C inhibitor, respectively, in a prior line of therapy. Both had a rapid PR after 6 weeks of TT125-802 monotherapy and remained progression-free for almost 7 months. The squamous NSCLC patient had progressed on standard-of-care therapy and had a PR after 12 weeks of TT125-802. The patient was on study for 5.5 months until progression.

Dr. Omar Saavedra Santa Gadea at NEXT Oncology Hospital Quirónsalud in Barcelona, an investigator on the study said, "It is remarkable to see such rapid, deep and durable responses in NSCLC patients who had exhausted all prior treatments. TT125-802’s mechanism targeting non-oncogene addiction offers a novel approach to improving clinical outcomes for patients in this high-need setting."

"These results validate our approach to target epigenetic mechanisms driving cancer and drug resistance and support the continued clinical development of TT125-802 in patients with solid tumors and hematological malignancies," said Florian Vogl, CMO at TOLREMO. "The absence of thrombocytopenia, a common toxicity with bromodomain inhibitors, sets TT125-802 apart. The wide therapeutic window opens up clinical opportunities for TT125-802 which have so far been unattainable for this class of drugs."

"We will now initiate a combination study investigating the efficacy of TT125-802 in combination with an EGFR inhibitor and a KRAS-G12C inhibitor in the respective oncogene-driven NSCLC populations, and with docetaxel in squamous NSCLC patients. We look forward to demonstrating the full therapeutic potential of TT125-802 for patients in need," said Stefanie Flückiger-Mangual, Ph.D., CEO and co-founder of TOLREMO.

Details of the poster presentations are:

Abstract Title: Clinical activity of TT125-802, a highly selective bromodomain inhibitor of CBP/p300, in advanced solid tumors: update on the ongoing phase I study

Authors: O. Saavedra, E. Garralda, V. Boni, J. Fuentes Antrás, I. Colombo, M. Imbimbo, G. Molina, I. Braña, K. Homicsko, F.D. Vogl, D. Gruber, S. Costanzo, A. Cesano, S. Flückiger-Mangual

Category: Developmental Therapeutics

Presentation Number: 978P

Date/Time: 19 October 2025 / 12:00 – 12:45 CEST

TOLREMO is assessing TT125-802 in a first-in-human, multicenter Phase 1 trial (NCT06403436) to evaluate the safety, tolerability, pharmacokinetics, and efficacy in patients with advanced solid tumors. The company recently received two U.S. FDA Fast Track designations for the treatment of patients with advanced or metastatic EGFR-mutant or KRAS-G12C-mutant NSCLC with disease progression on at least one prior line of therapy.

(Press release, TOLREMO, OCT 17, 2025, View Source [SID1234656739])