Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes

Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.
Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.
RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).
Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.
Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.
Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.
Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.
Treatment protocol:
All subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.
Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.
Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital

Start Date01 Jan 2023

Sponsor / Collaborator

Henan Cancer Hospital

NCT04162327 / CompletedPhase 1

A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors

Start Date26 Nov 2019

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20191677 / CompletedPhase 1

评估IBI315治疗晚期恶性肿瘤受试者的安全性和耐受性的开放性、多中心、Ia/Ib期研究

[Translation] An open-label, multicenter, Phase Ia/Ib study to evaluate the safety and tolerability of IBI315 in subjects with advanced malignancies

评估IBI315在晚期肿瘤受试者中的安全性和耐受性、药代动力学（PK）特征、药效动力学特征、免疫原性、晚期肿瘤受试者中的抗肿瘤活性及在II期研究中的推荐剂量（RP2D）。

[Translation]

To evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic characteristics, immunogenicity, anti-tumor activity in subjects with advanced tumors, and the recommended dose (RP2D) of IBI315 in Phase II studies.

Start Date26 Nov 2019

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Fidasimtamab

100 Translational Medicine associated with Fidasimtamab

100 Patents (Medical) associated with Fidasimtamab

Literatures (Medical) associated with Fidasimtamab

01 Oct 2023·Advanced science (Weinheim, Baden-Wurttemberg, Germany)

Anti-PD-1/Her2 Bispecific Antibody IBI315 Enhances the Treatment Effect of Her2-Positive Gastric Cancer through Gasdermin B-Cleavage Induced Pyroptosis.

Article

Author: Chen, Xiangliu ; Xu, Jinling ; Teng, Lisong ; Zhang, Yingzi ; Yu, Xiongfei ; Wang, Haiyong ; Zhu, Mengjia ; Wu, Weiwei ; Zhou, Quan ; Teng, Fei ; Wang, Haohao ; Lin, Wu ; Yang, Yan ; Liu, Jin ; Lu, Jun ; Chen, YiRan ; Chen, Bingliang ; Lin, Ben

The majority of patients with human epidermal growth factor receptor 2 (Her2)-positive gastric cancer develop refractory to Her2-targeted therapy, where upregulation of immune checkpoints plays an essential role. Herein, a recombinant fully human IgG1 bispecific antibody IBI315 targeting both PD-1 and Her2 is developed and its antitumor efficacy as well as the underlying mechanism is investigated. IBI315 crosslinks the physical interaction between Her2-positive tumor cells and PD-1-positive T cells, resulting in significantly enhanced antitumor effects compared to each parent antibody or their combination, both in vitro and in vivo mouse tumor models reconstituted with human immune cells using patient-derived xenografts and organoids. Moreover, IBI315 treatment also induces the recruitment and activation of immune cells in tumors. Mechanistically, IBI315 triggers gasdermin B (GSDMB)-mediated pyroptosis in tumor cells, leading to the activation and recruiments of T cells. The activated T cells secret IFNγ, enhancing GSDMB expression and establishing a positive feedback loop of T cell activation and tumor cell killing. Notably, GSDMB is found to be elevated in Her2-positive gastric cancer cells, providing a rationale for IBI315's efficacy. IBI315 is supported here as a promising bispecific antibody-based immunotherapy approach for Her2-positive gastric cancer in preclinical studies, broadening the therapeutic landscape of this patient population.

01 Dec 2017·Experimental hematology & oncologyQ3 · MEDICINE

Development and clinical application of anti-HER2 monoclonal and bispecific antibodies for cancer treatment

Q3 · MEDICINE

ReviewOA

Author: Han, Xinwei ; Yu, Shengnan ; Li, Anping ; Qin, Shuang ; Wu, Kongming ; Liu, Qian ; Zhao, Weiheng

HER2-targeted immunotherapy consists of monoclonal antibodies (e.g. trastuzumab, pertuzumab), bispecific antibodies (e.g. MM-111, ertumaxomab) and activated T cells armed with anti-HER2 bispecific antibody (HER2Bi-aATC). Trastuzumab is a classic drug for the treatment of HER2 positive metastatic breast cancer. The combined application of pertuzumab, trastuzumab and paclitaxel has been suggested as a standard therapy for HER2 positive advanced breast cancer. The resistance to anti-HER2 antibody has resulted in disease progression. HER2-directed bispecific antibody may be a promising therapeutic approach for these patients. Ertumaxomab enhanced the interaction of immune effector cells and tumor cells. MM-111 simultaneously binds to HER2 and HER3 and blocks downstream signaling. Besides, HER2Bi-aATC is also an alternative therapeutic approach for HER2 positive cancers. In this review, we summarized the recent advancement of HER2-targeted monoclonal antibodies (trastuzumab, pertuzumab and T-DM1) and bispecific antibodies (MM-111, ertumaxomab and HER2Bi-aATC), especially focus on clinical trial results.

01 May 1999·Molecular immunologyQ3 · MEDICINE

Isolation and characterization of an anti-CD16 single-chain Fv fragment and construction of an anti-HER2/neu/anti-CD16 bispecific scFv that triggers CD16-dependent tumor cytolysis

Q3 · MEDICINE

Article

Author: L Zhang ; J D Marks ; L M Weiner ; H Simmons ; U B Nielsen ; A R Amoroso ; E Horak ; A M McCall ; R Schier ; G P Adams

Bispecific antibody (bsAb)-based clinical trials of cancer have been conducted primarily using intact murine monoclonal antibody (mAb)-derived molecules. In some of these trials, toxicity resulting from the interactions of antibody Fc domains with cellular Fc receptors has limited the doses of antibody (Ab) that can be employed. Furthermore, human anti-mouse Ab responses prohibit multiple therapy courses. These factors have decreased the efficacy of the bsAb 2B1, which targets the extracellular domains (ECD) of the HER2/neu protooncogene product and the human FcgammaRIII (CD16). To address these obstacles, we have constructed and characterized a fully human gene-fused bsAb from single-chain Fv (scFv) molecules specific for HER2/neu and CD16. The human anti-CD16 scFv component, NM3E2, was isolated from a human scFv phage display library. As binding of NM3E2 to human neutrophil-associated CD16 decreased in the presence of plasma IgG, we have concluded that NM3E2 recognizes an epitope in the vicinity of the Fc binding pocket. Furthermore, the NM3E2 scFv was found by surface plasmon resonance-based epitope mapping to share an overlapping epitope with the Leu-11c mAb. The human anti-HER2/neu scFv component, C6.5, which was previously isolated from a human scFv phage display library, was employed as fusion partner for the creation of a bispecific scFv (bs-scFv). In the presence of the C6.5 x NM3E2 bs-scFv, peripheral blood lymphocytes promoted significant lysis of human SK-OV-3 ovarian cancer cells overexpressing HER2/neu. Biodistribution studies performed in SK-OV-3 tumor-bearing scid mice revealed that 1% ID/g of 125I-labeled C6.5 x NM3E2 bs-scFv was specifically retained in tumor at 23 h following injection. These results indicated that both scFv components of the bs-scFv retained their function in the fusion protein. This bsAb should overcome some of the problems associated with the 2B1 bsAb. C6.5 x NM3E2 bs-scFv offers promise as a platform for multifunctional binding proteins with potential clinical applications as a result of its human origin, lack of an Fc domain, ease of production, high level of in vitro tumor cell cytotoxicity and highly selective tumor targeting.

News (Medical) associated with Fidasimtamab

29 Mar 2024

·www.biospace.com

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue was approximately RMB1,503 million during 2023. The revenue from pharmaceutical products increased by approximately 58% compared to 2022. The sales revenue of TUOYI® (toripalimab) was approximately RMB919 million, representing an increase of approximately 25% compared to the previous year. Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022. The decrease in R&D expenses was mainly due to the strategic management of R&D investments in certain early-stage pipelines, while optimizing resource allocation and focusing on R&D pipelines with greater potential. Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year. BUSINESS HIGHLIGHTS During 2023, we continued to focus on “unmet medical needs” and have made original, innovative and breakthrough progress in discovery, R&D and commercialization of innovative therapies and novel drugs. Here are the notable achievements and milestones: Advancements in the pipeline: Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of more drug modalities, including small molecules drugs, polypeptide drugs, antibody-drug conjugates (ADCs), bi-specific or multi-specific antibodies and nucleic acid drugs, as well as the exploration of next-generation innovative therapies including cancer and autoimmune diseases. The product pipelines cover five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. A total of three drugs (TUOYI®, JUNMAIKANG and MINDEWEI) are being commercialized, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the preclinical drug development stage. In January 2023, the marketing of MINDEWEI (Deuremidevir Hydrobromide Tablets, code: JT001/VV116), an oral nucleoside analog anti-SARS-CoV-2 Category 1 innovative drug, was conditionally approved by the National Medical Products Administration of China (the “NMPA”) for the treatment of adult patients with mild to moderate COVID-19. In February 2023, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (the “MHRA”) accepted the the marketing authorization application (the “MAA”) for toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”), as well as toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”). In March 2023, the investigational new drug (“IND”) application for JS010 (a recombinant humanized anti-CGRP monoclonal antibody injection) was approved by the NMPA. In April 2023, the NMPA accepted the supplemental new drug application (“sNDA”) for TUOYI® in combination with chemotherapy as perioperative treatment and monotherapy as consolidation therapy after adjuvant therapy for the treatment of resectable stage III non-small cell lung cancer (“NSCLC”). This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically. In April 2023, the new drug application (“NDA”) for ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, code: JS002) was accepted by the NMPA. In April 2023, the IND application for JS401 (a small interfering RNA (“siRNA”) drug targeting angiopoietin-like protein 3 (“ANGPTL3”) messenger RNA (“mRNA”)) was approved by the NMPA. In May 2023, the NMPA accepted the sNDA for TUOYI® in combination with paclitaxel injection (albumin-bound) for the treatment of PD-L1 positive (CPS ≥ 1) untreated metastatic or recurrent metastatic triple-negative breast cancer. In June and August 2023, the IND application for a randomized, double-blind, placebo-controlled, international multi-center phase III clinical study of tifcemalimab (a recombinant humanized anti-BTLA monoclonal antibody, code: TAB004/JS004) in combination with toripalimab as consolidation therapy in patients with limited-stage small cell lung cancer (“LS-SCLC”) without disease progression following chemo-radiotherapy was approved by the U.S. Food and Drug Administration (the “FDA”) and the NMPA, respectively. In July 2023, the sNDA for TUOYI® in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (“RCC”) was accepted by the NMPA. In July 2023, the sNDA for TUOYI® in combination with etoposide plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”) was accepted by the NMPA, which marked the tenth marketing application submitted for TUOYI® in China. In August 2023, the IND application for JS207 (a recombinant humanized anti-PD-1/VEGF bispecific antibody) was approved by the NMPA. In September 2023, the primary endpoint of progression free survival (“PFS”, based on independent radiological review) of a randomized, controlled, multi-center phase III clinical study (NCT03430297) of toripalimab versus dacarbazine for the first-line treatment of unresectable or metastatic melanoma had met the pre-defined efficacy boundary. In October 2023, the FDA approved the Biologics License Application (the “BLA”) for toripalimab (U.S. trade name: LOQTORZI™), in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Toripalimab is the first and only drug approved in the United States for the treatment of NPC, and is also the first innovative biological drug independently developed and manufactured in China that was approved for marketing by the FDA. In December 2023, the Therapeutic Goods Administration (the “TGA”) of the Australian Government’s Department of Health and Aged Care accepted the New Chemical Entity (the “NCE”) application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Additionally, the TGA also granted an orphan drug designation to toripalimab for the treatment of NPC. In December 2023, TUOYI® and MINDEWEI were successfully added to Category B of the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2023) (the “NRDL”) upon negotiations. Notably, three new TUOYI® indications were added, bringing the total to six indications included in the NRDL. TUOYI® is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. The inclusion of the MINDEWEI indication for adult patients with mild to moderate COVID-19 marked its first official listing in the NRDL. Update on external collaborations In March 2023, the company entered into a shareholders agreement with Rxilient Biotech and its wholly-owned subsidiary, Excellmab. The company would subscribe to the newly issued shares of Excellmab by payment in kind to obtain 40% equity interest in Excellmab. Subject to the fulfillment of the conditions precedent as agreed under the Shareholders Agreement, the company would substantially perform its capital contribution obligations, and express its intention to enter into a license agreement with Excellmab in the form agreed upon by the parties at the time of entering into the Shareholders Agreement, thereby granting Excellmab an exclusive license and other relevant rights to develop and commercialize intravenous toripalimab in Thailand, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines and Vietnam. According to the R&D progress of toripalimab and other matters, Junshi Biosciences may receive a milestone payment of up to approximately US$4.52 million, plus a percentage of royalties on the net sales. In May 2023, Junshi Biosciences entered into an exclusive license and commercialization agreement with Dr. Reddy’s, pursuant to which the company agreed to grant Dr. Reddy’s a license to develop and exclusively commercialize toripalimab injection in Brazil, Mexico, Colombia, Argentina, Peru, Chile, Panama, Uruguay, India and South Africa. Dr. Reddy elected to expand the scope of the license to cover Australia, New Zealand and nine other countries. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in both China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-6105 8800 PR Team: Junshi Biosciences Zhi Li zhi_li@junshipharma.com + 86 021-6105 8800

License out/inDrug ApprovalOrphan DrugPhase 3Financial Statement

14 Mar 2023

·www.biospace.com

Incyte Announces Data from Across its Oncology Portfolio will be Presented at the AACR Annual Meeting 2023

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte Corporation (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida. “As Incyte continues to advance research in areas where we believe we can have the biggest impact for patients, we look forward to sharing new pre-clinical and clinical data from our expansive oncology portfolio at this year’s AACR,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “Notably, a plenary session will feature data on pemigatinib in previously-treated solid tumors with activating FGFR1–3 alterations, and five-year results from the L-MIND study of tafasitamab (Monjuvi®) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be highlighted in a late-breaking oral presentation.” Key abstracts from Incyte-sponsored and partner programs include: Oral Presentation in a Plenary Session Pemigatinib Clinical and Translational Findings of Pemigatinib in Previously Treated Solid Tumors with Activating FGFR1–3 Alterations in the FIGHT-207 Study (Abstract #CT016. Session: Novel Biomarker-Driven Molecularly Targeted Therapy Trials. Tuesday, April 18, 2023, 10:15 a.m. – 10:30 a.m. ET) Oral Presentation INCB123667 (CDK2) Development of a CDK2-Selective Small Molecule Inhibitor INCB123667 for the Treatment of CCNE1hi Breast Cancers (Abstract #1143. Session: Small Molecule Therapeutic Agents. Sunday, April 16, 2023, 3:52 p.m. – 4:07 p.m. ET) Tafasitamab Five-Year Safety and Efficacy of Tafasitamab in Patients with Relapsed or Refractory DLBCL: Final Results from the Phase 2 L-MIND Study1 (Abstract #CT022. Session: Novel Clinical Trials for Hematological Malignancies. Sunday, April 16, 2023, 3:20 p.m. – 3:30 p.m. ET) Poster Presentations INCA33890 (PD-1×TGFbR2) INCA33890, a Novel PD-1×TGFbR2 Bispecific Antibody Conditionally Antagonizes TGF Signaling in Primary Immune Cells Co-expressing PD-1 (Abstract #2936. Session: Therapeutic Antibodies 2. Monday, April 17, 2023, 1:30 p.m. – 5:00 p.m. ET) INCB098377 (PI3Kδ) Discovery of INCB098377: a Potent Inhibitor of Phosphoinositide 3-Kinase-Gamma (Abstract #5162. Session: Modifiers of the Tumor Microenvironment. Tuesday, April 18, 2023, 1:30 p.m. – 5:00 p.m. ET) LIMBER (MPN) A Phase 1 Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Abstract #CT242. Session: Phase 1 and First-in-Human Clinical Trials in Progress. Tuesday, April 18, 2023, 1:30 p.m. – 5:00 p.m. ET) Preclinical Characterization of the BET Inhibitor, INCB057643, in Combination with Ruxolitinib for Treatment of Myeloproliferative Neoplasms (MPN) (Abstract #6274. Session: Epigenetics. Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET) Pemigatinib Drug Combination Screen Identifies Pemigatinib, an FGFR Inhibitor, as a Mechanism to Overcome KRASG12C Inhibitor Resistance in Lung Cancer (Abstract #412. Session: Drug Resistance in Molecular Targeted Therapies 2. Sunday, April 16, 2023, 1:30 p.m. – 5:00 p.m. ET) Pemigatinib, an FGFR Inhibitor, Overcomes Resistance to KRASG12C Inhibitors in Mesenchymal-Like NSCLC Tumors (Abstract #430. Session: Drug Resistance in Molecular Targeted Therapies 2. Sunday, April 16, 2023, 1:30 p.m. – 5:00 p.m. ET) P-Selectin Glycoprotein Ligand-1 P-Selectin Glycoprotein Ligand-1 Modulates the Functions of Human T Cells and Macrophages in Vitro (Abstract #6373. Session: Immune Checkpoints. Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET) Tafasitamab Combination of BTK Inhibitor Orelabrutinib, Anti-CD19 Antibody Tafasitamab, and IMiD Lenalidomide for the Treatment of B Cell Malignancies2 (Abstract #4013. Session: Tyrosine Kinase and Phosphatase Inhibitors 1. Tuesday, April 18, 2023, 9:00 a.m. – 12:30 p.m. ET) Preclinical Study of CD19 Detection Methods Using Monoclonal Antibodies Post Tafasitamab Treatment1 (Abstract #6329. Session: Anticancer Immunotherapeutics. Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET) Zilurgisertib Clinical Trial Simulation to Inform Dose Selection of Zilurgisertib, an ALK2 inhibitor, in Patients with Anemia Due to Myelofibrosis (MF) (Abstract #CT243. Session: Phase 1 and First-in-Human Clinical Trials in Progress. Tuesday, April 18, 2023, 1:30 p.m. – 5:00 p.m. ET) For registered attendees, the virtual meeting platform and all on-demand sessions will be available through July 19, 2023. More information regarding the AACR Annual Meeting 2023 can be found at . About Pemazyre® (pemigatinib) Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test3. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre is a trademark of Incyte Corporation. About Tafasitamab (Monjuvi® / Minjuvi®) Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi® monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI® in the U.S., and marketed by Incyte under the brand name Minjuvi® in Europe and Canada. XmAb® is a registered trademark of Xencor, Inc. About Jakafi® (ruxolitinib) Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older3. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States. About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions and Incyte’s goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; the effects of the COVID-19 pandemic and measures to address the pandemic on Incyte and its partners’ clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the U.S. FDA and other regulatory authorities outside of the United States; the efficacy or safety of Incyte and its partners’ products; the acceptance of Incyte and its partners’ products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report for the year ending December 31, 2022. Incyte disclaims any intent or obligation to update these forward-looking statements. _______________________ 1 MorphoSys Sponsored Abstract 2 Innocare Sponsored Abstract 3 Jakafi (ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug Administration 3 Pemazyre (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.

ImmunotherapyPhase 1Drug ApprovalPhase 2License out/in

22 Nov 2021

·endpts.com

Two of China's top PD-(L)1 players team up on CTLA-4 in $200M deal

Now that the PD-(L)1 craze has (largely) swept through China, resulting in the approval of more than a dozen drugs with more to come, two of the top domestic oncology players are teaming up to go after the other checkpoint target. Hengrui is licensing exclusive China rights to CStone’s CTLA-4 inhibitor, CS1002, in a deal worth up to $200 million, which covers research, development, registration, manufacturing and commercialization. CStone is keeping the rest of world rights to itself — in this case meaning outside “Greater China.” Even though Chinese drug developers have been scouting global partners to co-develop and sell their homegrown drugs outside of China with fervor, tie-ups between local biopharma companies are still uncommon. The PD-(L)1 drugs from Hengrui and CStone have each earned the favor of US-based companies, with Incyte grabbing Hengrui’s camrelizumab as early as 2015 (before ultimately dropping it) and EQRx picking up CStone’s sugemalimab more recently. The new partners note that despite the early discovery of CTLA-4 — Jim Allison and Tasuku Honjo were awarded the Nobel Prize for it — and all the clinical validation of it as an I/O target, only one anti-CTLA-4 antibody has been approved globally (including in China). Without naming Yervoy, they added that the drug made $1.69 billion in 2020. “As a leading global China pharmaceutical company with an extensive oncology pipeline and strong integrated capabilities in commercialization, we are very confident that Hengrui will bring the full potentialities of CS1002 into the Greater China market,” CStone CEO Frank Jiang said in a statement. While CStone has a partnership with Blueprint Medicines to market two of its targeted cancer therapies in China, it does not have any commercial drug of its own. Citing results from an ongoing Phase Ia/Ib study, CStone touted how the combination of CS1002 and CS1003, a PD-1 blocker, was well-tolerated and demonstrated “very encouraging efficacy” in PD-(L)1-refractory melanoma and hepatocellular carcinoma, as well as PD-(L)1-naïve, pretreated microsatellite instability high/deficient mismatch repair (MSI-H/dMMR) tumors. While other CTLA-4 drugs have spurred concerns with toxicity or lack of efficacy, Lianshan Zhang, Hengrui’s president of R&D, expressed faith that CS1002’s “differentiated dosing schedules” will make it a backbone I/O asset.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastrooesophageal junction cancer	Phase 2	-	Henan Cancer Hospital	01 Jan 2023
Advanced Malignant Solid Neoplasm	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	26 Nov 2019
Solid tumor	Phase 1	CN	Hanmi Pharmaceutical Co., Ltd.	26 Nov 2019

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NCT04162327 (PRNewswire) Manual	Phase 1	Solid tumor	27	IBI315	eodzbrqney(ywgcqbrnmi) = ahtrkfligm emrcsjwzjq (pzzwkhexhg ) View more	Positive	28 Sep 2021

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