On September 19, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, metabolic and other major diseases, reported that the results of efficacy and safety of IBI305 (bevacizumab biosimilar) versus bevacizumab, both in combination with paclitaxel/carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients in a randomized, double-blind Phase III clinical trial (CTR20160848), were presented in an oral session at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) [Thursday, September 19, 11:25 AM -11:30 AM BJT] (Press release, Innovent Biologics, SEP 19, 2019, View Source [SID1234539657]).

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450 patients were enrolled and randomized into IBI305 group (n = 224) and reference bevacizumab (RBv) group (n = 226). By the cut-off date of March 31, 2019, the IRRC-assessed overall response rates (ORR) were 47.1% and 46.8% in IBI305 and RBv in full analysis set, respectively. The ORR ratio (IBI305/RBv) was 1.01 (90% CI: 0.846, 1.181) within the predefined equivalence margin (0.75, 1.33). By the cut-off date of May 22, 2019, the results showed that the investigator-evaluated median progression-free survival (PFS) in IBI305 and RBv groups were 7.3 months and 7.5 months, respectively, with no statistical difference (p=0.893).

"Lung cancer is the highest incidence cancer in China, and bevacizumab is an important treatment for non-squamous non-small cell lung cancer patients. It shows desirable results of the randomized, double-blind Phase 3 study comparing the efficacy and safety of IBI305 and bevacizumab combined with paclitaxel/carboplatin for the first-line treatment of advanced or metastatic non-squamous cell lung cancer. We hope this drug can be launched on the market soon and provide more treatment options to patients," said Professor Li Zhang, Cancer Prevention and Treatment Center, Sun Yat-sen University.

"Lung cancer is the malignant tumors with the highest morbidity and mortality in China. Currently, we have eight registration trials in progress, four of which are for the treatment of lung cancer. We hope to bring more clinical benefits to patients through our efforts and address the significant unmet medical needs in China," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About Advanced Non-squamous Cell Lung Cancer (NSCLC)

Lung cancer is the most common malignant tumor with the highest morbidity and mortality in China. NSCLC accounts for about 80% to 85% of all lung cancer cases. About 70% of NSCLC patients are locally advanced or metastatic diseases that unsuitable for resection at diagnosis. Meanwhile, a considerable proportion of early NSCLC patients who received surgical treatment will have recurrence or distant metastasis, and then will die due to disease progresses. About 70% of NSCLC patients in China are non-squamous NSCLC, and the first-line treatment for the disease has huge unmet medical needs.

About IBI305

IBI305 is a biosimilar product candidate of bevacizumab and a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on January 29, 2019 and has been granted with priority review status.

On September 19, 2019 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that it will present seven abstracts describing new research at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019, September 27 to October 1, in Barcelona, Spain (Press release, Caris Life Sciences, SEP 19, 2019, View Source [SID1234539656]).

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Key data to be presented at ESMO (Free ESMO Whitepaper) include the first study to address transcriptomic therapeutic biomarkers in metastatic Leydig cell tumor, an extremely rare testicular cancer with limited therapeutic options, and an analysis of BRAF inhibitors in BRAFV600E colorectal cancer and BRAFV600E melanoma, including resistance mechanisms as well as molecular and biological differences between the tumor types that may explain differential clinical responses.

"Our research at ESMO (Free ESMO Whitepaper) 2019 demonstrates how Caris’ innovative technology is helping the oncology community gain a greater understanding of tumor biology and advance science to help determine optimal treatment approaches," said Michael Korn, M.D., Chief Medical Officer at Caris Life Sciences. "As the management of cancer continues to rapidly evolve, our ongoing research into therapy biomarkers is playing a key role in guiding personalized treatment decisions that hold the potential to transform care for patients living with this debilitating disease."

In addition to the presentations, Caris will exhibit at booth #407 from September 27 through September 30 during regular exhibit hours. Company executives will also be available for one-on-one meetings during the Congress.

Caris scientists and collaborators, including those from the Caris-led Precision Oncology Alliance, will present research and associated findings from seven studies across a broad range of tumor types, including gastric, cervical, colorectal, testicular, as well as melanoma cancers and Merkel cell carcinoma, a rare type of skin cancer. Research to be presented at ESMO (Free ESMO Whitepaper) includes:

Saturday, September 28

"Large-scale analysis of CDH1 mutations define a distinctive molecular subset in gastric cancer (GC)" (ID 3521)
Presentation Number: 679PD
Presenter: Jingyuan Wang (5:10 p.m. CEST)
Session: Poster Discussion – Gastrointestinal Tumours, Non-Colorectal (4:30-5:50 p.m. CEST)
Location: Tarragona Auditorium (Hall 7)
Authors: Jingyuan Wang, Hiroyuki Arai, Francesca Battaglin, Ryuma Tokunaga, Wu Zhang, Heinz-Josef Lenz, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California; Joanne Xiu, Kelsey Poorman, W. Michael Korn, Caris Life Sciences
Sunday, September 29

"Molecular profiling reveals novel targetable biomarkers in neuroendocrine carcinoma of the uterine cervix" (ID 1988)
Presentation Number: 1057P
Presenter: Semir Vranic (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4),
Authors: Semir Vranic, College of Medicine, QU Health, Qatar University; David Arguello, Elma Contreras, Zoran Gatalica, Caris Life Sciences; Adela Cimic, Maimonides Medical Center

"WRN mutated Colorectal Cancer (CRC) is characterized by a distinct molecular and immunological profile" (ID 5515)
Presentation Number: 645P
Presenter: Andreas Seeber (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Andreas Seeber, Gilbert Spizzo, Kai Zimmer, Florian Kocher, Tyrolean Cancer Research Institute, Innsbruck Medical University; Alberto Puccini, Heinz-Josef Lenz, Francesca Battaglin, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California; Joanne Xiu, Yasmine Baca, W. Michael Korn, Caris Life Sciences; Richard M. Goldberg, West Virginia University Cancer Institute; Axel Grothey, West Cancer Center; Anthony F. Shields, Karmanos Cancer Institute, Wayne State University; Mohamed E. Salem, Levine Cancer Institute, John L. Marshall, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Monday, September 30

"Comprehensive molecular characterization of brain metastases (BM) from colorectal cancer (CRC)" (ID 3707)
Presentation Number: 1882PD
Presenter: Francesca Battaglin (11:10 a.m. CEST)
Session: Poster Discussion 2 – Translational Research (10:30-11:30 a.m. CEST)
Location: Tarragona Auditorium (Hall 7)
Authors: Francesca Battaglin, Alberto Puccini, Ryuma Tokunaga, Madiha Naseem, Hiroyuki Arai, Jingyuan Wang, Martin D. Berger, Wu Zhang, Heinz-Josef Lenz, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California; Joanne Xiu, Yasmine Baca, W. Michael Korn, Caris Life Sciences; Richard M. Goldberg, West Virginia University Cancer Institute; Axel Grothey, West Cancer Center; Anthony F. Shields, Philip A. Philip, Karmanos Cancer Institute, Wayne State University; Andreas Seeber, Tyrolean Cancer Research Institute, Innsbruck Medical University; Mohamed E. Salem, Levine Cancer Institute; John L. Marshall, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

"TERT gene fusions characterize a subset of metastatic Leydig cell tumors" (ID 1541)
Presentation Number: 981P
Presenter: Božo Krušlin (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Božo Krušlin, Clinical Hospital Centre, Zagreb; Zoran Gatalica, Joanne Xiu, Elena Florento, Jeffrey Swensen, Caris Life Sciences; Ondrej Hes, Biopticka Laborator, Plzen

"Comparative molecular analyses between microsatellite stable BRAFV600E mutant colorectal cancers and BRAFV600E mutant melanomas" (ID 4634)
Presentation Number: 1957P
Presenter: Mohamed E. Salem (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Mohamed E. Salem, Jimmy Hwang, Levine Cancer Institute; Joanne Xiu, W. Michael Korn, Zoran Gatalica, Rebecca Feldman, Michelle Saul, Caris Life Sciences; Alberto Puccini, IRCCS AOU San Martino – IST-Istituto Nazionale per la Ricerca sul Cancro; Axel Grothey, Ari VanderWalde, West Cancer Center; Richard M. Goldberg, West Virginia University Cancer Institute; Michael Hall, Fox Chase Cancer Center; Wafik El-Deiry, Warren Alpert Medical School, Brown University; Anthony F. Shields, Karmanos Cancer Institute, Wayne State University; John L. Marshall, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center; Heinz-Josef Lenz, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California

"Immuno-oncology therapy biomarker differences between polyoma-virus positive and negative Merkel cell carcinomas" (ID 1540)
Presentation Number: 134P
Presenter: Zoran Gatalica (12:00 p.m. CEST)
Session: Poster Display Session (12:00-1:00 p.m. CEST)
Location: Poster Area (Hall 4)
Authors: Zoran Gatalica, Joanne Xiu, Elma Contreras, Jeffrey Swensen, Caris Life Sciences

On September 19, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, reported the promotion of Larry Zhang to President (Press release, CASI Pharmaceuticals, SEP 19, 2019, View Source [SID1234539655]).

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Wei-Wu He, Ph.D., Chairman and CEO of CASI, commented, "We are excited to have Larry assume this expanded role. His cross-functional and, in particular, commercial experience has been invaluable to CASI’s advancement and growth in China. He was instrumental with the successful launch of EVOMELA and we expect Larry to continue to have an immediate impact on the growth and commercialization of our current and future pipeline."

Mr. Zhang first joined CASI Pharmaceuticals in September 2018 as President of CASI Pharmaceuticals (Beijing) Co., Ltd., the China operating subsidiary of CASI.

Mr. Zhang possesses over 20 years of executive experience in commercial operations, regulatory affairs, sales and marketing, and business development within the healthcare and biopharmaceutical industries in the U.S., Asia Pacific and China. Prior to joining CASI’s Beijing office, Mr. Zhang was Vice President, Head of Public Affairs and Corporate Responsibility at Novartis Group (China) focusing on the public affairs and public relations strategy including initiating Novartis’ China policy focusing on China FDA (NMPA), new drug approval reform, intellectual property protection, generic quality consistency evaluation and new regulations on biosimilars. Prior to joining Novartis Group (China), he served as Chief Executive Officer of Sandoz (China) Pharmaceutical Co. Ltd, a Novartis Company, where he oversaw the successful launch of six new products. Mr. Zhang has also held executive leadership roles within Bayer Healthcare and Baxter International Corporation in the U.S. and Asia Pacific.

On September 19, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported progress in its ongoing Phase 1 clinical study evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, in a trial-in-progress poster at The Annual Global Meeting of the International Gynecologic Cancer Society (IGCS 2019) in Rio de Janeiro, Brazil (Press release, Compugen, SEP 19, 2019, View Source [SID1234539654]).

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In a poster titled "COM701 (A Novel Immune Checkpoint Inhibitor) in Patients with Advanced Solid Tumors," the Company reported that it has completed enrollment in the seventh dose level in the COM701 monotherapy (Arm A) and second dose level in the combination of COM701 with Opdivo (Nivolumab) (Arm B) and that no dose-limiting toxicities were observed in these and prior dose level cohorts. COM701 as a monotherapy and in combination with Opdivo has shown an acceptable safety and tolerability profile at all dose levels tested. Study enrollment is advancing on schedule for additional dose levels.

The poster is available on Compugen’s website at www.cgen.com.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial of COM701 is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as of combination administration with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. Additionally, secondary endpoints include preliminary antitumor activity, pharmacokinetics and pharmacodynamics of COM701 monotherapy as well as COM701 in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).

On September 19, 2019 Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Leukine (sargramostim), a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF), for the potential treatment of Stage IIb-IV melanoma (Press release, Partner Therapeutics, SEP 19, 2019, View Source [SID1234539653]).

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Melanoma is the most aggressive form of skin cancer and rates of melanoma have been rising for the past 30 years. The American Cancer Society estimates 96,480 new melanoma cases will be diagnosed in the US and 7,230 people will die from the disease in 2019. The FDA grants orphan drug designation to promote the development of promising treatments for conditions that affect 200,000 or fewer U.S. patients annually. If a product holding Orphan Drug Designation receives the first FDA approval for the disease in which it has such designation the company qualifies for, among other things, seven years of market exclusivity following marketing approval.

The Eastern Cooperative Oncology Group (ECOG) previously reported results of Study 1608, a Phase II study in which patients with advanced stage melanoma received a combination of sargramostim and ipilimumab or ipilimumab alone1. Among 245 patients, the addition of sargramostim led to longer survival (median 17.5 vs 12.7 months). The most common Grade 3-5 toxicities in patients treated with sargramostim and ipilimumab were diarrhea (12.7%) and rash (9.3%) and occurred at similar rate in patients receiving ipilimumab alone. Overall, severe toxicities occurred less frequently in patients treated with sargramostim plus ipilimumab vs ipilimumab alone (44.9% vs 58.3%, Grade 3-5); the most notable reductions were in gastrointestinal and pulmonary toxicities. The results of this study led to initiation of a larger Phase 2/3 study (ECOG 6141) evaluating sargramostim in combination with ipilimumab and nivolumab as initial treatment of advanced or metastatic melanoma. This ongoing study is being conducted by ECOG with support from the National Cancer Institute.2

"Leukine’s role as an immunomodulator was not the initial focus when it was first discovered decades ago. As we learn more about the immunologic effects of GM-CSF on antitumor immunity, we believe there is potential to develop Leukine to help more patients benefit from treatment with checkpoint inhibitors in melanoma and other difficult to treat cancers," said Bob Mulroy, PTx’s CEO. "This orphan designation is an important step in the development of Leukine. We are pleased FDA has programs such as Orphan Drug Designation to support research in rare diseases."

Leukine was initially approved in the United States in 1991 and has five hematologic oncologic indications. Leukine is currently not approved for the treatment of melanoma. The approval of an orphan drug designation request does not alter the standard regulatory requirements and processes for obtaining marketing approval of an investigational drug. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

Please see full Prescribing Information for LEUKINE at www.leukine.com

About Leukine (sargramostim)

Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity3.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE.
Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Permanently discontinue LEUKINE in patients with serious allergic reactions.
LEUKINE can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE administration. LEUKINE should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease.
If ANC > 20,000 cells/mm3 or if WBC counts > 50,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
LEUKINE therapy should be discontinued if disease progression is detected during treatment.
Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration required.
Liquid solutions containing benzyl alcohol (including LEUKINE Injection) or LEUKINE for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates and low birth weight infants.
Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE should be avoided.
Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
In Allogeneic BMT patients–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increase creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin
In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema
Please see full Prescribing Information for LEUKINE at www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin’s lymphoma (HL).
LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.
LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).