IAP0971 / SunHo BioPharma - LARVOL DELTA

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2024 ➔ Dec 2024

Enrollment open • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=78 | Not yet recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

INTERIM RESULTS ANNOUNCEMENT FOR THE SIX MONTHS ENDED JUNE 30, 2024 (HKEXnews) - "Our Core Product IAH0968 is an internally developed...We entered a Phase IIb/III clinical trial for CRC in January 2024, and expect to complete the Phase IIb trial for CRC in the fourth quarter of 2024. We also expect to complete the Phase II clinical trial for BTC in the third quarter of 2025....We plan to initiate a Phase II clinical trial for IAP0971 in China in the third quarter of 2024."

New P2 trial • Trial status • Biliary Tract Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

"New Stock" Shenghe Biotechnology (02898.HK) opened in the dark market at 14.02 yuan, 3.8% higher than the listing price [Google translation] (iis.aastocks.com) - "Shenghe Biotech sold 34.1518 million shares globally, with Hong Kong public offering accounting for 10% and international offering accounting for 90%. The sole sponsor is CICC. This listing introduced ETD Future as a cornerstone investor, subscribing for US$5.4 million (approximately HK$42.2 million) of the company's shares. This listing is expected to raise net proceeds of approximately 392 million yuan, of which approximately 28.2% will be used for the ongoing and planned clinical trials of IAH0968 in China; 35.8% will be used for the ongoing and planned clinical trials of IAP0971 in China; 36% will For use in ongoing and planned clinical trials of IAE0972 in China. (mn/k)..."

Financing • Hematological Malignancies • Oncology • Solid Tumor

Shenghe Biotech-B (02898.HK) is expected to be listed on May 24th and will introduce EMD as the cornerstone. [Google translation] (Sina Corp) - "Based on the offer price of HK$13.50 per share, the company estimates that it will receive net proceeds from the global offering of approximately HK$391.6 million. The company plans to use 28.2% of the net proceeds from the global offering, or approximately HK$110.4 million, for the ongoing and planned clinical trials of IAH0968 in China (mainly including the costs of raw materials and consumables used in clinical trials...approximately HK$140.1 million will be used for ongoing and planned clinical trials of IAP0971 in China...approximately HK$141.1 million will be used for ongoing and planned clinical trials of IAE0972 in China..."

Financing • Biliary Tract Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Shenghe Biotech's Hong Kong stock IPO resubmission form: none of its products have been commercialized. Investors suddenly bought shares and attracted the attention of the China Securities Regulatory Commission. [Google translation] (Eastmoney.com) - "The prospectus shows that Shenghe Biotech’s current pipeline includes 9 products, mainly covering non-small cell lung cancer, head and neck squamous cell cancer, bladder cancer, biliary tract cancer, colorectal cancer, and hepatitis B virus. Among them, three are listed as the core products of Shenghe Biotech, namely IAP0971, IAE0972 and IAH0968....The reporter noticed that the above nine products under development are all in the preclinical and clinical trial stages. Among them, the one with the fastest progress is IAH0968, which is currently in the clinical phase II trial stage; the research on colorectal cancer indications in IAH0968 will enter the clinical phase III stage in the first quarter of 2024."

Clinical • New P3 trial • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=236 | Not yet recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

Metastases • New P1/2 trial • Oncology • Solid Tumor

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Oncology • Solid Tumor • PD-L1

IAP0971, A novel PD1/IL15 immunocytokine that binds specifically to PD1 and fuses IL15/IL15Rα complex (AACR 2023) - P1/2 | "The indications of IAP0971 include lung cancer, cervical cancer, head and neck squamous cell carcinoma, liver cancer, lymphoma, and other malignant tumors. A Phase I/IIa clinical trial to evaluate the safety, tolerability and preliminary efficacy of IAP0971 in patients with locally advanced or metastatic malignant tumors is currently on-going (NCT05396391)."

IO biomarker • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Liver Cancer • Lung Cancer • Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL15 • IL2 • PD-1

Preclinical evaluation of IAP0971, a novel immunocytokine that binds specifically to PD1 and fuses IL15/IL15Rα complex. (PubMed, Antib Ther) - P1/2 | "IAP0971 has demonstrated a favorable safety profile and potent anti-tumor activities in vivo. A Phase I/IIa clinical trial to evaluate the safety, tolerability and preliminary efficacy of IAP0971 in patients with advanced malignant tumors is on-going (NCT05396391)."

Journal • Preclinical • Oncology • Solid Tumor • CD8 • IL15 • IL2 • PD-1

SunHo Announces First Patient Dosed in Phase 1/2 Clinical Trial of Two First-in-class Immunocytokines: IAP0971 and IAE0972 (PRNewswire) - "SunHo BioPharmaceutical...announced that IAP0971 (PD1-IL15 immunocytokine) and IAE0972 (EGFR-IL10 immunocytokine), two first-in-class immunocytokines developed in-house for the treatment of locally-advanced or metastatic malignant tumors have entered Phase 1/2 clinical trials. The first patient has been dosed respectively in June."

Trial status • Oncology • Solid Tumor

A Phase I/IIa Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=140 | Not yet recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

New P1/2 trial • Hematological Malignancies • Oncology • Solid Tumor • PD-L1