On June 3, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the preliminary results of efficacy and safety of sintilimab, the anti-PD-1 antibody that co-developed with Eli Lilly and Company, in combination with CAPOX in first-line gastric or gastroesophageal junction carcinoma (GC/GEJC) (NCT02937116, cohort F) were presented by poster at the 55th annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #4042; Monday, June 3, 8:00 AM -11:00 AM CDT] (Press release, Innovent Biologics, JUN 3, 2019, View Source [SID1234536845]).

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As the top and most influential international oncology conference, ASCO (Free ASCO Whitepaper) Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient," 2019 ASCO (Free ASCO Whitepaper) Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO (Free ASCO Whitepaper), showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session, and key data from several other clinical studies will be presented by posters and other sessions.

Gastric cancer is the second most common malignant tumor in China. The development of new agents for the treatment of advanced gastric cancer has been stagnant and unmet clinical need is high. NCT02937116 is an open-label, multicenter, Phase Ib study in China. Cohort F of the study contains 20 patients, designed to evaluate the efficacy and safety of sintilimab in combination with CAPOX for GC/GEJC in the first-line setting.

At the data cutoff (15 Jan 2019), the median follow up was 5.8 months (range, 2.4 to 12.5).

The objective response rate (ORR) was 85.0% (95% CI, 62.1 to 96.8).
The disease control rate (DCR) was 100.0% (95% CI, 83.2 to 100.0).
The median duration of response (DOR) was 5.3 months (95% CI, 4.8 to 7.2) and median progression free survival (PFS) was 7.5 months (6.2-9.4). Sintilimab showed an acceptable safety profile during the study.
"Over the past decade, the treatment of various malignant tumors has progressed rapidly. From traditional chemotherapy to targeted molecular therapy and immunotherapy, the prognosis of cancer patients has been improved remarkably. However, breakthroughs in the treatment of gastric cancer have been few. The efficacy data in Phase Ib study of sintilimab in gastric cancer is encouraging. We hope to see more positive data in the phase III study and provide more effective treatments for patients through our efforts," said Professor Nong Xu, Director of the Department of Oncology of the First Affiliated Hospital of Zhejiang University.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. 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-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

On June 3, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the results of circulating tumor DNA (ctDNA) for predicting response and resistance by anti-PD-1 therapy in Chinese relapsed/refractory classical Hodgkin lymphoma (r/r cHL) were presented by poster at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #7534; Monday, June 3, 8:00 AM -11:00 AM CDT] (Press release, Innovent Biologics, JUN 3, 2019, View Source [SID1234536844]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As the top and most influential international oncology conference, ASCO (Free ASCO Whitepaper) Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient", 2019 ASCO (Free ASCO Whitepaper) Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO (Free ASCO Whitepaper), showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session, and key data from several other clinical studies will be presented by posters and other sessions.

Tyvyt (sintilimab injection), a type of immunoglobulin G4 monoclonal antibody, has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA") for the treatment of patients with relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) based on the clinical data from ORIENT-1 study. A total of 192 plasma samples were collected from 75 patients prior to treatment and during therapy for performing ctDNA extraction next-generation sequencing. To date, ORIENT-1 is the largest study for patients with r/r cHL in China.

This research, led by Professor Yuan-kai Shi, Associate Dean of the Cancer Hospital of the Chinese Academy of Medical Sciences and Director of the Department of Oncology, is based on ORIENT-1 study, investigates the predictive value of ctDNA from patients with r/r cHL. The study showed:

Prior to treatment, the genomic profiling of baseline ctDNA revealed a mean allele mutation frequency of 3.15% (range: 0.49 ~ 60.15). Truncating mutations of B2M, TNFRSF14 and KDM2B were found in patients with acquired resistance: TNFRSF14 and KDM2B have not been previously reported and need to be confirmed in further studies.
The baseline ctDNA level was significantly different between the objective response group (CR+PR, n=41) with median baseline ctDNA level of 8.72% and the non-responder group (SD+PD, n=9) (p=0.0070) with median baseline ctDNA level of 2.9%.
Patients with ctDNA high achieved first response earlier than others (p<0.05). Patients with ctDNA drop ≥40% after three cycles of therapy achieved first response significantly earlier (median=71 days) than others (median=216 days, p=0.0074).
From this study ctDNA could be a promising predictive biomarker for patients with r/r cHL in China.

Innovent intends to further investigate the clinical value of ctDNA in predicting response and resistance by anti-PD-1 therapy in Chinese r/r cHL. The study demonstrated the ctDNA could serve as valuable biomarker for prediction of r/r cHL patients’ response or resistance to anti-PD1 immunotherapy, and might be used to identify patients with genes related to early remission or acquired resistance.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. 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-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

On June 3, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the results of extended follow-up on sintilimab, the anti-PD-1 antibody that co-developed with Eli Lilly and Company, for relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL) (ORIENT-1) were presented by poster at the 55th annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #7533; Monday, June 3, 8:00 AM -11:00 AM CDT] (Press release, Innovent Biologics, JUN 3, 2019, View Source [SID1234536843]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As the top and most influential international oncology conference, ASCO (Free ASCO Whitepaper) Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient," 2019 ASCO (Free ASCO Whitepaper) Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO (Free ASCO Whitepaper), showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session, and key data from several other clinical studies will be presented by posters and other sessions.

ORIENT-1, led by Professor Yuan-kai Shi, Associate Dean of the Cancer Hospital of the Chinese Academy of Medical Sciences and Director of the Department of Oncology, is a multicenter, single-arm, Phase II study in China, evaluating the efficacy and safety of sintilimab for the treatment of patients with relapsed/refractory classical Hodgkin’s lymphoma. Currently, ORIENT-1 study has the largest cohort of cHL patients in China with a total of 96 patients involved.

The primary clinical endpoint is objective response rate (ORR) as assessed by an independent radiological review committee (IRRC) according to 2007 IWG criteria. Moreover, complete response rate (CRR) is a secondary endpoint.

As of the data cutoff on 16 Oct 2018, 72.9% of patients were continuing treatment with a median follow-up of 14 months. ORR was 85.4% (82/96, 95% CI: 76.7 ~ 91.8) based on IRRC review. Twenty-eight patients (29.2%) achieved complete response (CR) by PET scan. The median duration of response (DoR) and progression free survival (PFS) have not been reached. Sintilimab showed an acceptable safety profile during the study.

Based on the results of ORIENT-1 study, sintilimab was approved for treating patients with r/r cHL in China.

The extended follow-up shows that the primary endpoint, ORR, has increased to 85.4% and the secondary endpoint, CR by PET scan, has increased to 29.2 %. Innovent intends to continue updating the response and survival rate for patients who have received sintilimab in this clinical trial.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. 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-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

On June 3, 2019 Brooklyn ImmunoTherapeutics, a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported the presentation of an ongoing trial poster at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 – June 4, 2019 at the McCormick Place in Chicago, IL (Press release, Brooklyn ImmunoTherapeutics, JUN 3, 2019, View Source [SID1234536842]). The poster describes a Phase 1b study to evaluate the safety, determine the recommended Phase 2 dose and investigate the biologic and clinical activity of IRX-2 in combination with nivolumab in solid tumor indications (NCT03758781).

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IRX-2 is an allogeneic, cell-derived biologic with multiple active cytokine components, including IL-2, that act on various parts of the immune system associated with activation of the entire tumor microenvironment.

"Anti-PD-1 therapy in oncology has been demonstrated to be a safe and effective therapeutic approach in treating certain cancers and increased lymphocyte infiltration has been associated with improved patient outcomes," said Rohit K Jain, M.D. M.P.H., principal investigator on the Phase 1b trial and Assistant Member in Moffitt Cancer Center Department of Genitourinary Oncology. "In data collected to date, IRX-2 has demonstrated an increase immune activation in the tumor microenvironment and was correlated with greater progression free survival and overall survival in a Phase 2 study in head and neck cancer. This clinically observed increased immune activation suggests the combination of IRX-2 therapy with PD-1 blockade with nivolumab could enhance outcomes compared to PD-1 blockade alone. This robust Phase 1b trial in up to five different indications will help us better understand the potential role of IRX-2 in oncology immunotherapy."

The Phase 1b clinical trial is taking place at Moffitt Cancer Center in Tampa, Florida and is currently recruiting patients.

"IRX-2 has been well-tolerated to date in clinical trials while demonstrating encouraging activity in squamous cell cancer of the head and neck," said Mark Leuchtenberger, interim President and CEO of Brooklyn ImmunoTherapeutics. "We believe the mechanism of action as well as the safety and clinical activity shown to date provides a strong rationale for combining IRX-2 with checkpoint inhibitors such as nivolumab for the treatment of solid tumor cancers. We look forward to the results of this important trial as well as the results of other ongoing studies, including the Phase 2B INSPIRE trial and an investigator-sponsored trial in squamous cervical intraepithelial neoplasia 3 or vulvar intraepithelial neoplasia 3."

About the Phase 1b Trial
Patients with recurrent or metastatic renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, HNSCC and melanoma are eligible. Patients who have received prior anti-PD-1/PD-L1 antibodies are eligible. The IRX-2 regimen consists of cyclophosphamide 300mg/m2 (Day 1) and subcutaneous IRX-2 injections for 10 days every 3 months. Nivolumab is administered at 240 mg once every two weeks. Planned total enrollment of approximately 100 patients. The study will include cohorts of the 5 different diseases. Each cohort will include two groups: 1) anti-PD-1/PD-L1 antibody naïve tumors, and 2) progressed during or after anti-PD-1/PD-L1 antibodies.

The primary study objective is to determine safety and tolerability of combination therapy. Secondary objectives are to evaluate the objective response rate, progression-free survival, and overall survival. The study is actively accruing patients.

On June 3, 2019 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and other diseases, reported that the company’s t-haNK investigational new drug application (IND) has cleared FDA review and the program has now transitioned to a first-in-human clinical trial targeting CD19 t-haNK in advanced B-cell lymphoma (Press release, NantKwest, JUN 3, 2019, View Source [SID1234536841]).

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CD19 is a transmembrane protein expressed in B cells and overexpressed in a large percentage of advanced leukemia and lymphoma representing a well validated therapeutic target. The CD19 t-haNK cell therapy is a novel, NK cell based immuno-oncology therapy that includes a CD19-based Chimeric Antigen Receptor (CAR) that has been engineered to create an NK cell that includes the high affinity CD16 (Fc receptor), which enhances an NK cell’s ability to bind and enhance monoclonal antibody activity. Use of a targeted, bi-specific NK cell is intended to enhance the cancer cell killing ability of this novel NK cell therapy.

"Based on extensive and encouraging preclinical results, we have enhanced our ability to modularly combine this proprietary off-the-shelf t-haNK-based therapy with a wide range of monoclonal antibodies using this multi-targeted approach," commented Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. Dr. Soon-Shiong continued, "We are now ready to transition this innovation in NK cell based therapeutics to a Phase I human clinical trials designed to assess the safety, tolerability and efficacy of CD19 t-haNK cell therapy in advanced b-cell lymphoma. Upon completion of the safety phase, NantKwest intends to combine this CD19 t-haNK cell therapy with other synergistic, immunomodulatory agents as part of an integrative, combination therapy approach that we describe as the NANT Cancer Vaccine to further enhance the synergistic effectiveness of this novel therapeutic intervention."

CD19 t-haNK

NantKwest’s CD19-t-haNK cell therapy is designed to provide precise tumor-cell specificity through the use of a CAR construct that utilizes a CD19-specific scFv (single chain antibody fragment) engineered into the company’s proprietary NK cell that includes the CD16 (Fc high affinity receptor).

In pre-clinical studies, cytotoxicity of these GMP-grade, cryopreserved CD19 t-haNK cells were comprehensively evaluated against a panel of cancer cell lines with different levels of CD19 expression in vitro and in vivo, with these studies showing increased activity and selective cytotoxicity towards CD19-expressing tumor cells of various b-cell origins including leukemia.

To better inform routine patient care, these clinical trials will incorporate a state-of-the-art, biomarker analysis using GPS Cancer, which is an integrated, multi-omics, whole genome, transcriptomic platform, both provided by NantHealth, an affiliated company. These comprehensive molecular analysis tools are designed to provide critical information to the clinical study team regarding the unique molecular alterations associated with the patient’s cancer and response rates, potentially enhancing patient management.

Additional information regarding the CD19 t-haNK clinical study can be found at www.nantkwest.com or www.clinicaltrials.gov/.

About NantKwest

NantKwest, a member of the NantWorks ecosystem of companies, is an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer and virally induced infectious diseases.