WSD0922 / Wayshine Biopharm - LARVOL DELTA

Extended Survival In A Patient With Leptomeningeal Disease Related To EGFR Exon 19 Deletion Metastatic Non-small Cell Lung Cancer: A Case Report (SNO 2025) - "She was initiated on Osimertinib...Despite treatment with stereotactic radiosurgery, she had further LMD progression, and another surgical resection was performed at 55 months, yet LMD recurred at 62 months, and she was enrolled in phase-2 WSD0922 clinical trial utilizing an oral brain-penetrant non-competitive reversible EGFR inhibitor with complete radiological resolution of LMD. At 73 months, she had LMD relapse and was initiated on intrathecal pemetrexed and intravenous amivantamab, and has thus far received 11 doses of intrathecal pemetrexed and amivantamab every two weeks with complete radiological response. At last follow-up, the patient is alive 82 months from her LMD diagnosis with excellent functional status. our case highlights that leveraging different mechanisms of action to target EGFR mutation in sequential fashion along with consideration of intrathecal chemotherapy in patients with LMD related to metastatic EGFR-mutated NSCLC can potentially help..."

Case report • Clinical • Metastases • Cough • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR

WSD0922-Fu therapy in patients with EGFR mutant glioblastoma – Updates from the dose expansion cohorts of a first-in-human phase 1 clinical trial (MC1914) (SNO 2025) - P1 | "All patients received prior radiation and temozolomide. However, examples of clinical efficacy will be shown along with data on recurrence patterns. Phase 2 clinical trial development is in progress."

Clinical • First-in-human • P1 data • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Pruritus • Solid Tumor • EGFR

WAYWIN103: A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Wayshine Biopharm, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Extended Survival In A Patient With Leptomeningeal Disease Related To EGFR Exon 19 Deletion Metastatic Non-small Cell Lung Cancer: A Case Report (WFNOS 2025) - P2 | "She was initiated on Osimertinib...Despite treatment with stereotactic radiosurgery, she had further LMD progression, and another surgical resection was performed at 55 months, yet LMD recurred at 62 months, and she was enrolled in phase-2 WSD0922 clinical trial utilizing an oral brain-penetrant non-competitive reversible EGFR inhibitor with complete radiological resolution of LMD. At 73 months, she had LMD relapse and was initiated on intrathecal pemetrexed and intravenous amivantamab, and has thus far received 11 doses of intrathecal pemetrexed and amivantamab every two weeks with complete radiological response. At last follow-up, the patient is alive 82 months from her LMD diagnosis with excellent functional status. our case highlights that leveraging different mechanisms of action to target EGFR mutation in sequential fashion along with consideration of intrathecal chemotherapy in patients with LMD related to metastatic EGFR-mutated NSCLC can potentially help..."

Case report • Clinical • Metastases • Cough • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR

WSD0922-Fu therapy in patients with EGFR mutant glioblastoma – Updates from the dose expansion cohorts of a first-in-human phase 1 clinical trial (MC1914) (WFNOS 2025) - P1 | "All patients received prior radiation and temozolomide. However, examples of clinical efficacy will be shown along with data on recurrence patterns. Phase 2 clinical trial development is in progress."

Clinical • First-in-human • P1 data • Brain Cancer • Glioblastoma • Glioma • Lung Cancer • Non Small Cell Lung Cancer • Pruritus • Solid Tumor • EGFR

A Phase I/II Study to Evaluate EGFR-TKIs in the Treatment of Subjects with Non-Small Cell Lung Cancer (ChiCTR) - P1/2 | N=78 | Not yet recruiting | Sponsor: Shanghai East Hospital; Hangzhou Weiruibao Biopharm Co., LTD.

New P1/2 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase II, MRCT, open label, multicenter, single arm study to assess the efficacy of WSD0922-FU in NSCLC patients with EGFR C797S mutation (ESMO 2025) - P2 | "Background Although 3rd-generation EGFR TKI, such as Osimertinib is highly effective in front-line metastatic EGFR -mutated ( EGFR m+) NSCLC, treatment resistance ultimately occurs, including the emergence of the on-target C797S mutation for which there are no approved TKIs. Legal entity responsible for the study Wayshine Biopharm Inc. Funding Wayshine Biopharm Inc."

Clinical • P2 data • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

WAYWIN103: A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC (clinicaltrials.gov) - P1/2 | N=48 | Not yet recruiting | Sponsor: Wayshine Biopharm, Inc.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase I/II Study on WSD0922-FU in EGFR C797S+ NSCLC (IASLC-WCLC 2025) - P1, P1/2 | "In patients with EGFRm+ C797S advanced NSCLC who progress after 3rd generation EGFR-TKI treatment, WSD0922-FU provides a good efficacy and tolerability with an ORR of 63.2% at RP2D. This study supports further investigation of WSD0922 in extension cohort to potentially establish standard 2nd/3rd line for NSCLC patients progression after 1st line 3rd generation EGFR TKI treatment with C797S mutation."

P1/2 data • Alopecia • Anemia • Anorexia • Dyslipidemia • Hematological Disorders • Hypertriglyceridemia • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Wayshine Biopharm, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Wayshine Biopharm, Inc. | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A multicenter, open-label, single-arm phase I/II study to assess the efficacy and safety of WSD0922-FU in patients with EGFR C797Sm+ advanced non-small cell lung cancer (NSCLC) in China (NCT06631989). (ASCO 2025) - P1, P1/2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT06631989 Background: Although 3rd-generation EGFR TKIs, such as Osimertinib, Almonertinib, Furmonertinib, Befotertinib etc. are highly effective in front-line metastatic EGFR-mutated (EGFRm) NSCLC, treatment resistance ultimately occurs, including the emergence of the on-target C797S mutation for which there are no approved TKIs. Enrollment in this study for dose expansion cohorts is ongoing and 15 sites are open across China. Clinical trial information: NCT06631989."

Clinical • Metastases • P1/2 data • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study to Assess the Efficacy of WSD0922-FU in Patients with C797S+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Wayshine Biopharm, Inc.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients with EGFRm+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Wayshine Biopharm, Inc.

Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy of WSD0922-Fu in osimertinib-resistant NSCLC with central nervous system (CNS) metastases – Updates from the dose escalation cohort of a first-in-human phase 1 clinical trial (MC1914) (SNO 2023) - P1 | "All patients with HGA received prior radiation and temozolomide. Furthermore, prolonged stable disease (9 cycles) was observed in a patient with EGFRvIII mutant GBM. Expansion cohorts are in progress to optimize WSD0922-Fu dose and schedule for future phase 2 development."

Clinical • P1 data • Astrocytoma • Brain Cancer • Fatigue • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor

WSD-0922, a novel brain-penetrant inhibitor of epidermal growth factor receptor, promotes survival in glioblastoma mouse models. (PubMed, Neurooncol Adv) - "The present preclinical study evaluated the novel EGFR inhibitor WSD-0922. We employed flank and orthotopic patient-derived xenograft models to characterize WSD-0922 and compare its efficacy to erlotinib, a potent EGFR inhibitor that failed to provide benefit for GBM patients...WSD-0922 treatment preferentially inhibited phosphorylation of several proteins, including those associated with EGFR inhibitor resistance and cell metabolism. WSD-0922 is a highly potent inhibitor of EGFR in GBM, and warrants further evaluation in clinical studies."

Journal • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • EGFR

First-in-human phase 1 trial of the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of WSD0922-Fu: Initial report from dose escalation cohort. (ASCO 2023) - P1 | "For patients with HGA, all patients were previously treated with radiation and temozolomide; the median number of prior lines of systemic therapy was 1 (range 1-4). The MTD for WSD0922-Fu monotherapy is 160 mg BID. Preliminary efficacy was observed in patients with osimertinib-resistant NSCLC and EGFRvIII mutant HGA. Enrollment to expansion cohorts is ongoing."

Clinical • P1 data • PK/PD data • Astrocytoma • Brain Cancer • Fatigue • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Pruritus • Solid Tumor

WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Mayo Clinic | N=77 ➔ 51

Enrollment change • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov) - P1 | N=77 | Recruiting | Sponsor: Mayo Clinic | Suspended ➔ Recruiting

Enrollment open • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov) - P1 | N=77 | Suspended | Sponsor: Mayo Clinic | Recruiting ➔ Suspended

Trial suspension • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2024

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov) - P1; N=72; Not yet recruiting; Sponsor: Mayo Clinic

Clinical • New P1 trial

WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: Mayo Clinic; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

"#WayshineBiopharm holding limited Announces #ORPHANDRUGDESIGNATION GRANTED By The FDA For #WSD0922 IN #GLIOMA (including #GLIOBLASTOMA AND #ANAPLASTICASTROCYTOMA) https://t.co/i2qcPl3J2F" (@1stOncology)

Orphan drug