IBI-363 / Innovent Biologics, Takeda - LARVOL DELTA

Innovent Biologics Announces Closing of Global Strategic Partnership with Takeda for Next-Generation IO and ADC Therapies (PRNewswire) - "Takeda will pay Innovent an upfront payment of US$1.2 billion, including a US$100 million equity investment in Innovent through new share issuance at premium, i.e., HK$112.56 per share. Furthermore, Innovent is eligible for development and sales milestone payments for IBI363, IBI343, and IBI3001 (if option exercised) totaling up to approximately $10.2 billion, for a total deal value of up to $11.4 billion. Innovent is also eligible to receive potential royalty payments for each molecule outside Greater China, except with respect to IBI363 in the U.S...."

Licensing / partnership • Solid Tumor

IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

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

MarsLight-11: IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Fortvita Biologics (USA)Inc.

New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

IBI363 (PD-1/IL-2α-bias): Global Joint Development and Commercialization Collaboration (PRNewswire) - "According to the agreement, Innovent and Takeda will co-develop IBI363 globally, sharing development costs 40/60 (Innovent/Takeda). In the U.S., Innovent and Takeda will co-commercialize IBI363, sharing the U.S. profit or loss 40/60. Takeda will lead the co-development and co-commercialization efforts under joint governance and aligned development plan. In addition, Innovent will grant Takeda commercialization rights outside Greater China and the U.S. Takeda will have global manufacturing rights to supply IBI363 outside of Greater China..."

Licensing / partnership • Colorectal Cancer • Non Small Cell Lung Cancer

Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer (PRNewswire) - "The upcoming study will be the first global Phase 3 trial of IBI363....This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting....Innovent has also received IND approval from China's National Medical Products Administration (NMPA) for this program."

IND • New P3 trial • Non Small Cell Lung Cancer

IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC). (ASCO 2025) - P1 | "IBI363 was well tolerated with encouraging and durable efficacy observed in pts with advanced NSCLC who progressed to PD-(L)1, especially in the squamous subtype."

Clinical • Metastases • Anemia • Lung Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • IL2 • PD-1

A multicenter, randomized, controlled, open-label, phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma. (ASCO 2025) - "Here, we present the trial in progress of a phase 2 study evaluating efficacy and safety of IBI363 monotherapy versus pembrolizumab in mucosal and acral melanoma. No interim analysis is planned. A total of 118 PFS events among 180 pts is estimated to demonstrate the superior efficacy of IBI363 compared to the control, with a power of 90% (α=0.025, one-sided)."

Clinical • P2 data • Melanoma • Oncology • Solid Tumor • PD-1

Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer. (ASCO 2025) - P1 | "IBI363 monotherapy demonstrated prolonged overall survival in pts with advanced CRC compared to historic data of standard of care. IBI363 plus beva showed even more encouraging efficacy with acceptable safety and warrants further development."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • Colorectal Cancer • Endocrine Disorders • Microsatellite Instability • Musculoskeletal Pain • Oncology • Solid Tumor • KRAS • MSI • NRAS

Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients (pts) with immunotherapy-treated, advanced acral and mucosal melanoma. (ASCO 2025) - P1, P2 | "IBI363 showed encouraging efficacy in pts with IO-treated advanced acral and mucosal melanoma. The safety profile was acceptable and manageable. Further global clinical development of IBI363 in melanoma is ongoing."

Clinical • Metastases • Anemia • Hematological Disorders • Infectious Disease • Melanoma • Mucosal Melanoma • Musculoskeletal Pain • Oncology • Septic Shock • Solid Tumor • IL2 • PD-1

Breakthrough efficacy of IBI363 monotherapy has been achieved in patients with "immune-cold" melanoma, with notable durable response and prolonged survival benefit (Yahoo Finance) - P1 | N=260 | NCT05460767 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "In patients with at least one post-baseline tumor assessment (n=30), the confirmed objective response rate (cORR) was 23.3%, including 25.0% for mucosal type and 20.0% for acral type. The disease control rate (DCR) reached 76.7%, with 85.0% in mucosal type and 60.0% in acral type. In patients treated with 1 mg/kg Q2W with confirmed responses (n=7), a durable response was observed with a median duration of response (DoR) of 14.0 months and events of 42.9%. In patients treated with 1 mg/kg Q2W (n = 31) had a median progression-free survival (PFS) of 5.7 (2.7, 6.8) months, which was significantly longer than data from previous studies (PFS less than 3 months[1] ). The median follow-up time was 14.7 months, the median overall survival (OS) was 14.8 (9.9, NC) months, and the median OS of patients with mucosal subtype was 19.3 (9.9, NC) months. The overall 12-month OS rate was 61.5%."

P1 data • Mucosal Melanoma

2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from the Phase 1 PoC Clinical Study in Advanced Non-small Cell Lung Cancer (PRNewswire) - P1a/1b | N=260 | NCT05460767 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "As of the data cutoff date, April 7, 2025, a total of 136 patients with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W)....In the 1/1.5 mg/kg dose group, promising ORR/DCR/PFS/OS were observed. Median OS achieved 15.3 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 1/1.5 mg/kg dose group, the 3 mg/kg Q3W dose group observed more prominent confirmed ORR (36.7%), DCR (90.0%), PFS (median PFS 9.3 months) and OS trends (median OS not reached, 12-month OS rate 70.9%)....Among the patients with PD-L1 TPS<1%, IBI363 demonstrated outstanding efficacy signals: in the 1/1.5 mg/kg group (N=10), the confirmed ORR was 30.0% and the DCR was 90.0%, while that of the 3 mg/kg group (N=13) were 46.2% and 92.3%, suggesting the potential advantage of IBI363 in the population with low expression of PD-L1."

P1 data • Non Small Cell Lung Cancer

ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α -bias Bispecific Antibody Fusion Protein) from Phase 1 and 2 Clinical Studies on Immunotherapy-treated Advanced Malignant Melanoma (Innovent Biologics Press Release) - P1 | N=260 | NCT05460767 | Sponsor: Innovent Biologics | P2 | N=150 | NCT06081920 | Sponsor: Innovent Biologics | "The data presented at this ASCO meeting are from two multi-center Phase 1 and 2 clinical studies...designed to evaluate the efficacy and safety of IBI363 monotherapy in the treatment of advanced melanoma....In patients with at least one post-baseline tumor assessment (n=30), the confirmed objective response rate (cORR) was 23.3%, including 25.0% for mucosal type and 20.0% for acral type. The disease control rate (DCR) reached 76.7%, with 85.0% in mucosal type and 60.0% in acral type....In patients treated with 1 mg/kg Q2W (n = 31) had a median progression-free survival (PFS) of 5.7 (2.7, 6.8) months, which was significantly longer than data from previous studies (PFS less than 3 months[1] ). The median follow-up time was 14.7 months, the median overall survival (OS) was 14.8 (9.9, NC) months, and the median OS of patients with mucosal subtype was 19.3 (9.9, NC) months."

P1 data • P2 data • Melanoma

A pivotal Phase 2 registrational study of IBI363 in the treatment of advanced acral and mucosal malignant melanoma has been initiated (Yahoo Finance) - "Innovent Biologics announced a trial in progress (TiP) . It is a randomized, open-label, multi-center Phase 2 study evaluating the efficacy and safety of IBI363 monotherapy compared to pembrolizumab (Keytruda) in patients with unresectable, locally advanced or metastatic mucosal and acral melanoma who have not received prior systemic treatment. As the first pivotal registration trial of IBI363, this study is designed to directly compare IBI363 monotherapy with pembrolizumab in this patient population. A total of 180 patients are planned to be enrolled and randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC)."

Trial status • Mucosal Melanoma

2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Date of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from Phase 1 Clinical Studies in Advanced Colorectal Cancer (PRNewswire) - P1 | N=260 | NCT05460767 | Sponsor: Innovent Biologics | P1 | N=260 | NCT06717880 | "IBI363 monotherapy has demonstrated breakthrough antitumor therapeutic potential, showing a significant extension of overall survival compared to data of standard-of-care therapies....Notably, among patients receiving monotherapy with IBI363 (n=68), with a median follow-up time of 20.1 months, the median overall survival (OS) reached 16.1 months, demonstrating a significant improvement compared to the historical data of standard treatments (ranging from 6.4 to 9.3 months1-3)....The combination of IBI363 and bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile, with excellent data on objective response rate and progression-free survival."

P1 data • Colorectal Cancer • Microsatellite Instability

Innovent's IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Receives Second NMPA Breakthrough Therapy Designation for Immuno-resistant Squamous Non-Small Cell Lung Cancer (PRNewswire) - "Innovent Biologics...announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy....The latest data from the Phase 1 clinical study of IBI363 in subjects with squamous non-small cell lung cancer (sqNSCLC) who previously received immunotherapy were reported in an oral presentation at the 2025 ASCO Annual Meeting."

Breakthrough therapy • Lung Non-Small Cell Squamous Cancer

Exploration of the Dynamic Changes and Mechanisms of the Immune Microenvironment in Advanced Colorectal Cancer Treated With IBI363 Combination Therapy (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: jianming xu

New trial • Colorectal Cancer • Oncology • Solid Tumor

Preclinical data of IAR037, a novel CD40/PD-L1 bispecific antibody for the treatment of advanced solid tumors resistant to immune checkpoint inhibitors (AACR 2025) - "It strongly synergized with IBI363, a clinical-stage PD-1/IL-2v bispecific fusion protein, and demonstrated superior tumor regression in highly PD-1-resistant tumor model. IAR037 could specifically activate immune responses in the tumor microenvironment and tumor-draining lymph node while minimizing systemic side effects, showing unique advantages over other CD40-targeting anti-tumor therapies. In summary, IAR037 presents a novel therapeutic approach for ICI-resistant advanced solid tumors and the IND enabling study of IAR037 is ongoing."

Checkpoint inhibition • IO biomarker • Late-breaking abstract • Metastases • Preclinical • Oncology • Solid Tumor • CD40

Seven Oral Presentations: Innovent to Present Breakthrough Clinical Data of IBI363（PD-1/IL-2α-bias）and Other Novel Drug Candidates at the 2025 ASCO Annual Meeting (PRNewswire) - "Innovent Biologics...announces that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S."

Clinical data • Trial status • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Mucosal Melanoma • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Melanoma • Oncology • Solid Tumor

Innovent Receives NMPA Breakthrough Therapy Designation for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Melanoma (PRNewswire) - "Innovent Biologics...announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy."

Breakthrough therapy • Mucosal Melanoma

HK-listed Innovent is said to consider licensing partnership for cancer drug (China Daily) - "Hong Kong-listed Innovent Biologics Inc is considering a licensing partnership to develop a cancer drug that’s showing promise in treating several types of tumor, according to people familiar with the situation...The Suzhou, Jiangsu province-based firm is working with an adviser to gauge interest from global pharmaceutical companies in its IBI363 drug...Innovent is conducting clinical studies in China, the US and Australia to explore the efficacy and safety of IBI363, which has also received fast-track designations from the US Food and Drug Administration."

Licensing / partnership • Oncology

Head-to-Head Against Pembrolizumab: Innovent Announces First Patient Dosed in the First Pivotal Study of IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Melanoma (PRNewswire) - "Innovent Biologics...announced that the first patient has been dosed in its registrational study evaluating IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy versus pembrolizumab (Keytruda) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy....This is a randomized, multicenter, pivotal study designed to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab monotherapy in patients with unresectable, locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy....Updated follow-up results...across two earlier clinical trials (Phase 1a/1b study NCT05460767 and Phase 2 study NCT06081920)...will be shared at international conferences in 2025."

P1 data • P2 data • Trial status • Lymphoma • Mucosal Melanoma

Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer (PRNewswire) - "Innovent Biologics...announced that its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, has received its second Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy....'Earlier, we reported that in an expanded cohort of sqNSCLC patients, IBI363 showed a trend toward improved ORR and DCR at higher doses, along with a manageable safety profile....We will present the relevant data at upcoming academic conferences this year'."

Fast track • P1 data • Lung Non-Small Cell Squamous Cancer