Aibining (geptanolimab) / Apollomics, Walvax - LARVOL DELTA

Efficacy and safety of Geptanolimab in previously treated PD-L1-Positive recurrent or metastatic cervical cancer: a multi-center openlabel, single-arm, phase Ⅱ study (Front Oncol) - P2 | N=169 | "169 patients were enrolled from May 2019 to Jan 2022. In 100 efficacy-evaluable patients, the ORR was 18%, the disease control rate was 41%. The median PFS was 1.91 months. The median overall survival was 16.69 months. Furthermore, for 123 safety-evaluable patients, 97(78.9%) patients experienced a treatment-related adverse event. The most frequent treatment-related adverse events were hypothyroidism (30[24.4%]), anaemia (26 [21.1%]) and hyperthyroidism (17 [13.8%])."

P2 data • Cervical Cancer

Immune Checkpoints and Their Inhibition in T-Cell Lymphomas. (PubMed, Folia Biol (Praha)) - "Despite initial promising results, further studies are necessary to define the most suitable clinical applications and ICI therapeutic combinations with other novel treatment approaches within TCL treatment. ICIs, and their combinations, might hopefully bring the long awaited improvement for the treatment of T-cell-derived malignancies."

Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Clinical predictive value of PD-1/PD-L1-induced electrocardiogram changes for cardiotoxicity (PubMed, Zhonghua Zhong Liu Za Zhi) - "Groups were divided according to immunotherapy regimen: Group A (drug code: 609A), 16 patients were given 1 mg/kg of the drug for 21 days; Group B (drug code: HX008), 23 patients were treated with 200mg for 21 days; Group C (drug code: GB226), 28 patients were treated with 3mg/kg for 14 days; Group D (drug code: LP002), 26 patients were treated with 900mg for 14 days. The high sensitivity of early ECG changes induced by immune checkpoint inhibitors enables early prediction of related cardiotoxicity. The presence or absence of comorbid underlying disease and drug dosage are correlated with the occurrence of adverse cardiac events, and these early changes provide a evidence for clinical treatment and prevention."

Journal • Cardiovascular • Oncology • Solid Tumor • PD-1 • PD-L1

NMPA granted Priority Review Status to Geptanolimab (GenorBio Press Release) - "Genor Biopharma...announced that National Medical Products Administration (NMPA) has granted priority review status to its new drug application (NDA) for Geptanolimab, a PD-1 mAb, on July 28, 7 days after the NDA acceptance."

Priority review • Peripheral T-cell Lymphoma

Genomic traits of therapeutic response to anti-PD-1 therapy in peripheral T cell lymphoma (ESMO 2023) - "Methods We enrolled 89 peripheral T cell lymphoma (PTCL) patients in phase II clinical trial of geptanolimab and performed targeted next-generation sequencing for 440 cancer-associated genes...Conclusions In this study we comprehensively depicted the pre-treatment mutation profiles of PTCL and identified genetic alterations with prognostic value for anti-PD-1 therapy. Notably, we found JAK3 mutations which are vital and prevalent in PTCL reduced PD-L1 levels in vivo and in vitro, which are of great clinical and biological sense."

IO biomarker • Tumor mutational burden • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • JAK3 • KMT2C • KMT2D • LRP1B • PI3K • SETD2 • TMB • TP53

Geptanolimab Elicits Durable Responses and Acceptable Safety in PD-L1+ Cervical Cancer (OncLive) - P2 | N=80 | NCT03808857 | Sponsor: Genor Biopharma Co., Ltd. | "The novel anti-PD-1 antibody geptanolimab (GB226) demonstrated durable antitumor activity and favorable tolerability in patients with recurrent or metastatic PD-L1–positive cervical cancer who previously progressed on a platinum-based regimen, according to initial findings from part 2 of the phase 2 Gxplore-008 trial (NCT03808857). Findings presented at the 2023 ASCO Annual Meeting showed that patients treated with geptanolimab (n = 100) experienced an overall response rate (ORR) of 18% (95% CI, 11.03%-26.95%) according to independent central review (IRC) assessment and RECIST v1.1 criteria. This consisted of 5 complete responses and 13 partial responses (PRs). Stable disease was achieved by 23% of patients, and 51% experienced disease progression; 8% of patients could not be assessed."

P2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

CXD101 in Immunotherapy-related Liver Cancer (clinicaltrials.gov) - P2 | N=44 | Recruiting | Sponsor: Stephen Chan Lam | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • Gastrointestinal Cancer • Gene Therapies • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

CXD101 in Immunotherapy-related Liver Cancer (clinicaltrials.gov) - P2 | N=44 | Not yet recruiting | Sponsor: Stephen Chan Lam

Checkpoint inhibition • New P2 trial • Gastrointestinal Cancer • Gene Therapies • Hepatocellular Cancer • Hepatology • Immune Modulation • Liver Cancer • Oncology • Solid Tumor

The first domestic PD-1 monoclonal antibody was not approved for marketing [Google translation] (STCN) - "On June 12, Hong Kong-listed biopharmaceutical research and development company Jiahe Biologics announced that the company has been notified by the State Drug Administration of China that genolimzumab (GB226) is used for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL). The new drug marketing application was not approved. 'The company expects that other clinical trials or the development progress of the company's other drug candidates will not be affected'...According to the information on the official website of the State Food and Drug Administration, Jiahe Biotech’s genolimzumab injection appeared on the drug notification waiting list on June 9, 2023, with the acceptance number 'CXSS2000042 Country' and no drug approval number."

Launch non-US • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Efficacy and safety of geptanolimab (GB226) for relapsed/refractory primary mediastinal large B-cell lymphoma: an open-label phase II study (Gxplore-003). (PubMed, Cancer Immunol Immunother) - P2 | "Geptanolimab (GB226) demonstrated promising efficacy and a manageable safety profile in Chinese patients with r/r PMBCL."

Journal • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A multicenter, open-label, single-arm, phase II trial to evaluate the efficacy and safety of geptanolimab (GB226) in the treatment of patients (pts) with programmed cell death ligand 1 (PD-L1)–positive recurrent or metastatic cervical cancer, for whom prior platinum-containing chemotherapy has failed. (ASCO 2023) - P2 | "Clinical benefit was observed across most patient subgroups, with a trend of higher ORR in pts with squamous cell carcinoma, no previous bevacizumab use and higher CPS. GB226 demonstrated durable antitumor activity and manageable safety profile in pts with recurrent or metastatic cervical cancer. Clinical trial information: NCT03808857."

Clinical • Metastases • P2 data • Anemia • Cervical Cancer • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-L1

[VIRTUAL] The efficacy and safety of Geptanolimab (GB226) in patients with recurrent/metastatic/unresectable alveolar soft part sarcoma (ASPS): A multicenter, open-label, single-arm, phase 2 trial (AACR-I 2020) - P2 | "The ORR was 33.3% (95%CI: 7.5%-70.1%) in patients with prior anlotinib therapy (n=9). Geptanolimab shows promising efficacy and acceptable safety profile for recurrent/metastatic/unresectable ASPS."

Clinical • P2 data • Oncology • Sarcoma • Solid Tumor • PD-L1

Is the Scope of Costs Considered in Budget Impact Analyses for Anticancer Drugs Rational? a Systematic Review and Comparative Study (ISPOR 2022) - "In addition, a budget impact model was developed for the introduction of geptanolimab to China’s National Reimbursement Drug List to enable a comparison of two cost-scope scenarios...Thus BIAs for anticancer drugs should consider a rational scope of costs that adheres to BIA guidelines. Researchers and decision-makers should pay more attention to the scope of costs to achieve better-quality BIAs for anticancer drugs and enhance reimbursement decision-making."

HEOR • Review • Oncology

APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Apollomics (Australia) Pty. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Feb 2022

Trial completion • Trial completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • MSI

APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC (clinicaltrials.gov) - P1/2 | N=20 | Terminated | Sponsor: Apollomics (Australia) Pty. Ltd. | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2021 ➔ Dec 2021; Study terminated due to administrative reasons.

Combination therapy • Trial primary completion date • Trial termination • Clear Cell Renal Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Cvl218,a second-generation selective parp inhibitors with strong clinical potential for breast cancer (SABCS 2021) - "PARP enzymes activity, selectivity and solubility CVL218 have a strong potency and better selectivity on PARP1/2 over PARP3/5/6compared with the first-generation PARPi Olaparib and second-generation AZD5305...in vitro efficacy of CVL218 combination on breast cancer cell lines In vitro cell-based studies implied that CVL218 could sensitizing the cell proliferation inhibition of chemotherapies including Taxol and Temozolomide (TMZ) on HRDnegative solid tumors such as breast cancer cell lines, indication the potential for combination use (Table 2)...WhenCVL218 in combination with geptanolimab, significate tumor growth inhibition was presented compared with PD-1 monotherapy (p<0.01)... CVL218 is a second-generation PARP1/2 inhibitor with strong potency, selectivity,outstanding drug-like properties and very promising safety profiles. In vivo data reveal optimistic expectations for the clinical development of combination usage of CVL218 with chemotherapy and checkpoint..."

Clinical • Brain Cancer • Breast Cancer • Glioma • Oncology • Solid Tumor

Is the Scope of Costs Considered in Budget Impact Analyses for Anticancer Drugs Rational? A Systematic Review and Comparative Study. (PubMed, Front Public Health) - "In addition, a budget impact model was developed for the introduction of geptanolimab to China's National Reimbursement Drug List to enable a comparison of two cost-scope scenarios...Thus, BIAs for anticancer drugs should consider a rational scope of costs that adheres to BIA guidelines. Researchers and decision-makers should pay more attention to the scope of costs to achieve better-quality BIAs for anticancer drugs and enhance reimbursement decision-making."

HEOR • Review • Oncology

[VIRTUAL] Geptanolimab in Chinese patients with relapsed or refractory primary mediastinal large B-cell lymphoma: Results from a multicenter, open-label, single-arm phase II trial (ESMO 2021) - P2 | "Geptanolimab showed good anti-tumor activity with ORR of 64% and manageable safety profile in Chinese patients with relapsed or refractory PMBCL."

Clinical • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] A phase I study of APL-501, an anti-PD-1 antibody, in patients with recurrent or advanced solid tumors. (ASCO 2020) - P1 | "Preliminary results indicate clinical activity of APL-501 in relapsed/refractory malignant disease with a generally tolerable safety profile. The PK and RO profile, across all doses evaluated, appears comparable to marketed PD-1 inhibitors. Continued exploration of APL-501 with the RP2D in CUP and MSI-H/dMMR tumors is being planned."

Clinical • IO Biomarker • P1 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Thoracic Cancer

[VIRTUAL] The efficacy and safety of Geptanolimab (GB226) in patients with relapsed/refractory peripheral T cell lymphoma (PTCL): A multicenter, open-label, single-arm, phase 2 trial (AACR-I 2020) - P2 | "Patients could benefit from Geptanolimab after failure of Chidamide (an oral histone deacetylase [HDAC] inhibitor) treatment with an ORR of 33.3% (8/24). Geptanolimab (GB226), an anti-PD-1 antibody, can be an effective treatment for R/R PTCL, with an acceptable safety profile."

Clinical • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • ALK

[VIRTUAL] A phase ib trial of assessing the safety and preliminary efficacy of a combination therapy of geptanolimab (GB 226) plus fruquintinib in patients with metastatic colorectal cancer (mCRC). (ASCO 2021) - P1 | "The combination of geptanolimab and fruquintinib had manageable safety profiles and encouraging anti-tumor activity in mCRC patients."

Clinical • Combination therapy • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hypertension • Oncology • Renal Disease • Solid Tumor • MSI

Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: Genor Biopharma Co., Ltd.; Trial primary completion date: Jun 2021 ➔ Jun 2022

Clinical • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor • IFNG

APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC (clinicaltrials.gov) - P1/2; N=20; Active, not recruiting; Sponsor: Apollomics (Australia) Pty. Ltd.; Recruiting ➔ Active, not recruiting; N=119 ➔ 20; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Sep 2020 ➔ Sep 2021

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Apollomics (Australia) Pty. Ltd.; Recruiting ➔ Active, not recruiting; N=45 ➔ 30; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • MSI

Genor Biopharma Releases Its Annual Results for 2020 (Taiwan News) - “Upcoming Milestones; GB261 (CD20/CD3) – First Patient Enrollment in Australia in Q321, and initial POC Data in 1H22. GB491 (Lerociclib) (cyclin-dependent kinase, CDK4/6) – First Patient Enrollment for Phase 3 trial for 1L /2L HR+/HER2- mBC in Q421, and Interim Analysis for 2L HR+/HER2- mBC in 2Q23. GB226 (Geptanolimab) – NDA approval for r/r PTCL, Q321…Genor Biopharma expects to launch Geptanolimab (GB226) at Q3 this year…we plan to file NDA to NMPA for Coprelotamab (GB221) in HER2+ breast cancer at Q4 of 2021.”

Enrollment status • IND • Launch non-US • Non-US regulatory • P1 data • P3 data • Breast Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma