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Innovent and Lilly Jointly Announce Results of Seven Clinical Studies of TYVYT® (sintilimab injection) to Be Presented at the ESMO ASIA Congress 2020

On November 4, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly",NYSE: LLY) reported that results of seven clinical studies of TYVYT (sintilimab injection) will be presented during the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ASIA ("ESMO ASIA") Virtual Congress 2020 from November 20th to 22nd (Press release, Innovent Biologics, NOV 4, 2020, View Source [SID1234569889]).

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The seven studies of TYVYT (sintilimab injection) to be presented on ESMO (Free ESMO Whitepaper) ASIA include one Proffered Paper Oral Presentation (a Phase 3 study) and six e-posters, covering indications including lung cancer, liver cancer, gastric cancer, and esophageal cancer.

1．
Cancer Type：Liver cancer
Presentation Type：Proffered Paper Oral Presentation
Title: Sintilimab plus bevacizumab biosimilar vs. sorafenib as first-line treatment for advanced hepatocellular carcinoma (ORIENT-32)
Presentation #：523
Presenter：Professor Zhenggang Ren
Date of Presentation: 21 November 2020

2.
Cancer Type：Liver cancer
Presentation Type：E-poster
Title：Sintilimab plus anlotinib as first-line therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC)
Presentation #：170P
Leading PI：Professor Xiaofeng Chen

3.
Cancer Type：Non–Small Cell Lung Cancer
Presentation Type：E-poster
Title： Efficacy and Safety of Sintilimab Plus Docetaxel in Patients with Previously Treated Advanced Non–Small Cell Lung Cancer
Presentation #：402P
Leading PI：Professor Zhehai Wang

4.
Cancer Type：Non–Small Cell Lung Cancer
Presentation Type：E-poster
Title：A Single-Arm Phase Ib Study of Autologous Cytokine-Induced Killer (CIK) Cell Immunotherapy in Combination with Sintilimab plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer
Presentation #：386P
Leading PI：Professor Xiubao Ren

5.
Cancer Type：Esophageal cancer
Presentation Type：E-poster
Title：A study of neoadjuvant sintilimab combined with triplet chemotherapy of lipo-paclitaxel, cisplatin, and S-1 for resectable esophageal squamous cell carcinoma（ESCC）
Presentation #：175P
Leading PI：Professor Yanhong Gu

6.
Cancer Type：Gastric cancer
Presentation Type：E-poster
Title：Phase II study of sintilimab combined with FLOT regimen for neoadjuvant treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma
Presentation #：160P
Leading PI： Professor Suxia Luo, Ning Li

7.
Cancer Type：Gastric cancer
Presentation Type：E-poster
Title: Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma
Presentation #：196TiP
Leading PI： Professor Baorui Liu

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.

Gracell Biotechnologies Announces Two Oral Presentations at the ASH Annual Meeting and Exposition 2020

On November 4, 2020 Gracell Biotechnologies Inc. ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported two oral presentations at the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition in December (Press release, Gracell Biotechnologies, NOV 4, 2020, View Source [SID1234569888]).

The conference is regarded as the world’s most comprehensive hematology event, where new data will be presented highlighting updates on the most critical topics in hematology. Due to travel restrictions as a result of the COVID-19 pandemic, this year’ s meeting will be held entirely online.

Dr. William Wei Cao, CEO of Gracell noted, "We are pleased to present data at this year’s ASH (Free ASH Whitepaper) annual meeting demonstrating that our pioneering FasTCAR platform has the potential of transforming CAR-T therapy with higher potency of cell expansion and including substantial time and cost saving (next-day manufacturing)."

Dr. Martina Sersch, CMO of Gracell, pointed out, "We are truly excited to have two oral presentations at this year’s ASH (Free ASH Whitepaper) annual meeting with very promising new data on two dual-targeted FasTCAR-enabled autologous CAR-T product candidates currently in development for the treatment of Multiple Myeloma and B-ALL. The IIT clinical data generated on our novel technology platform may show promise to have the potential to transform CAR-T therapy for patients with high unmet medical need and unlock additional treatment approaches."

Oral presentations:
178 Clinical Results of a Multicenter Study of the First-in-Human Dual BCMA and CD19 Targeted Novel Platform FasT CAR-T Cell Therapy for Patients with Relapsed/Refractory Multiple Myeloma
Abstract # 138614
Session Name: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma
Session Date: Saturday, December 5, 2020
Presentation Time: 12:15 PM
View Source

159 Successful 24-Hours Manufacture of Anti-CD19/CD22 Dual Chimeric Antigen Receptor (CAR) T Cell Therapy for B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Abstract # 136866
Session Name: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Chimeric Antigen Receptor T Cell Therapy
Session Date: Saturday, December 5, 2020
Presentation Time: 12:00 PM
View Source

Updated Clinical Data From Phase 2 SPiReL Study Evaluating IMV’s T Cell Therapy in Combination With Merck’s Keytruda® in Patients With r/r DLBCL to Be Presented at The American Society of Hematology Annual Meeting

On November 4, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that updated clinical data from phase 2 SPiReL study evaluating IMV’s T cell therapy in combination with Merck’s Keytruda in patients with relapsed / refractory Diffuse Large B Cell Lymphoma (r/r DLBCL) will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held virtually on December 5-8, 2020 (Press release, IMV, NOV 4, 2020, View Source [SID1234569883]).

The final poster presentation will include additional data collected between the abstract submission date and the presentation itself. The poster will be made available under the Scientific Publications & Posters section on IMV’s website and will also be available on the ASH (Free ASH Whitepaper) meeting platform.

Biomarkers associated with clinical response will be discussed in a separate poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, to be held virtually Nov. 9-14, 2020 and during a webcast hosted by IMV on November 12, 2020.

Poster Presentation Details

Poster Title

Clinical effectiveness of combination immunotherapy with DPX-Survivac, Low Dose Cyclophosphamide, and Pembrolizumab in Recurrent/Refractory DLBCL: The SPiReL Study.

Presenter: Neil Berinstein, MD, FRCPC, ABIM
Hematologist at Sunnybrook Health Sciences Centre, Toronto

Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster II

Presentation date: December 6 – 7.00am PST/10.00am EST

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Treatments with the DPX-Survivac T cell therapy have demonstrated a favorable safety profile across all clinical studies.

IMV’s T cell therapy, DPX-Survivac, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX). IMV’s lead compound is designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as Orphan Drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

About the SPiReL Study

"SPiReL" is a Phase 2 non-randomized, open label, efficacy, and safety study of a novel immunotherapy combination with DPX-Survivac and pembrolizumab. Intermittent low dose cyclophosphamide is given as an immune modulator. Subjects with r/r incurable DLBCL and survivin expression are eligible for participation. The primary outcome is to document the objective response rate using modified Cheson criteria for the combination treatment. Secondary objectives include safety, duration of response and time to next treatment. Exploratory endpoints include T cell response, tumor immune cell infiltration, and biomarker analysis. To date, 24 subjects have been enrolled.

ImmunoGen Announces Webcast of Presentation at Upcoming Jefferies Virtual London Healthcare Conference

On November 4, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming Jefferies Virtual London Healthcare Conference (Press release, ImmunoGen, NOV 4, 2020, View Source [SID1234569882]). The presentation is scheduled for November 18, 2020 at 12:00pm ET.

A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

Humanigen Announces ZUMA-19 Abstract Accepted for Presentation at American Society of Hematology 2020 Annual Meeting

On November 4, 2020 Humanigen, Inc., (Nasdaq:HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF) with its lead therapeutic candidate lenzilumab, the company’s proprietary Humaneered anti-human-GM-CSF immunotherapy, reported the acceptance of an abstract describing the ongoing ZUMA-19 study for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, to be held virtually from December 5-8, 2020 (Press release, Humanigen, NOV 4, 2020, View Source [SID1234569881]).

"The rationale for GM-CSF neutralization with CAR-T cell therapy is appealing and well-understood and we look forward to discussing this ongoing trial at ASH (Free ASH Whitepaper) in collaboration with our research partners," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.

ZUMA-19 is a joint Humanigen/Kite, a Gilead Company, clinical study that is being conducted as part of a clinical collaboration in the US. The ongoing ZUMA-19 Phase 1b/2 multicenter study is evaluating lenzilumab in adults with relapsed/refractory large B-cell lymphoma (R/R LBCL) who are receiving CAR-T cell therapy with axicabtagene ciloleucel.

The abstract, titled "ZUMA-19: A Phase 1/2 Multicenter Study of Lenzilumab Use with Axicabtagene Ciloleucel (Axi Cel) in Patients (Pts) With Relapsed or Refractory Large B Cell Lymphoma (R/R LBCL)," will be presented as a Trials-in-Progress poster (Abstract #2103) on Sunday, December 6 at 10:00 a.m. ET.