On February 12, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the availability of preliminary results from the Phase II CALYPSO study of the savolitinib / Imfinzi (durvalumab) combination in a cohort of patients with metastatic papillary renal cell carcinoma ("PRCC"), an investigator initiated study led by Professor Thomas Powles, Lead for Solid Tumour Research at Barts Cancer Institute, and sponsored by Queen Mary University of London (Press release, Hutchison China MediTech, FEB 12, 2019, View Source [SID1234533272]).

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Full data from the PRCC cohort of the CALYPSO study will be presented on Saturday, February 16, 2019, in oral and poster presentations at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU") in San Francisco, CA.

Further details from the presentation are as follows:

Presentation Title:

A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO)

First Author:

Thomas Powles, MD, PhD, FCRP

Abstract No:

545

Oral Presentation:

Oral Abstract Session C: Renal Cell Cancer

Date & Time:

Saturday, February 16: 2:00 PM-3:30 PM PST

Poster Presentation:

Session C: Renal Cell Cancer

Date & Time:

Saturday, February 16: 7:00 AM-7:55 AM and 12:30 PM-2:00 PM PST

About PRCC in the CALYPSO study

PRCC is a subtype of kidney cancer that is unusually difficult to treat, with low response rates from current treatment options and no treatments approved for this specific indication. The CALYPSO study is an independently sponsored open-label Phase II study of Imfinzi in combination with several drug candidates in the treatment of renal cell carcinoma in the U.K. and Spain. Several arms of CALYPSO are evaluating the treatment of PRCC and clear cell renal carcinoma (ccRCC) with savolitinib, a highly selective inhibitor of the c-MET receptor tyrosine kinase, both as a monotherapy and in combination with Imfinzi (durvalumab), AstraZeneca’s anti-programmed death-ligand 1 ("PD-L1") antibody. CALYPSO enrolls an all-comer PRCC population with planned retrospective molecular profiling. For further details, please refer to clinicaltrials.gov number NCT02819596.

About Savolitinib

Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 700 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in PRCC, NSCLC, colorectal cancer (CRC) and gastric cancer with an acceptable safety profile. Chi-Med is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.

On February 12, 2019 BioPharma (LSKB, Company) reported it has reached the pre-specified number of events required for unblinding and analysis of the primary endpoint of overall survival in the ANGEL study, a global Phase III clinical trial, which is evaluating the safety and efficacy of rivoceranib (also known as apatinib) in patients with advanced or metastatic gastric cancer (Press release, LSK BioPharma, FEB 12, 2019, View Source [SID1234533268]).

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"Reaching the primary completion date in our global pivotal trial is an important milestone in the development of rivoceranib" said Scott Houston, Vice President of Clinical Development, "Outside of China, where apatinib is marketed, there is no small-molecule angiogenesis inhibitor approved for gastric cancer. We believe it will be the first such drug available for these patients worldwide."

The Company, which has conducted pre-submission meetings with FDA and EMA in the last month, will now focus on completion of database lock activities and subsequent data analysis with an expectation that the top-line, unblinded safety and efficacy data will be reported in the middle of this year. LSKB further expects to complete preparations in the second half of this year for filing marketing authorizations applications in several territories worldwide, including the US.

About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

On February 12, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that will report its fourth quarter and full year 2018 financial results on Tuesday, February 26, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 12, 2019, View Source [SID1234533267]).

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Dynavax will host a conference call and live audio webcast on Tuesday, February 26, 2019, at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events &Presentations" page in the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial (877) 423-9813 (domestic) or (201) 689-8573 (international) and refer to conference ID 13687416.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

On February 12, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, has previously reported a 72% 2-year survival rate and a 54% 5-year survival rate in patients treated with its cancer stem cell-targeting immunotherapy, ROOT OF CANCER (Press release, AIVITA Biomedical, FEB 12, 2019, View Source [SID1234533264]). AIVITA announced new data indicating that non-responders to its immunotherapy had, on average, 150,000 times more pre-existing PD-1 proteins in their bloodstreams than responders. These findings suggest a means to optimize patient inclusion criteria in AIVITA’s trials evaluating ROOT OF CANCER. Further, these findings indicate that the use of anti-PD-1 checkpoint inhibitor drugs in combination with AIVITA’s cancer stem cell-targeting immunotherapy could improve outcomes in previously unresponsive patient populations.

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PD-1 is a protein on the surface of cells which regulates the immune response and suppresses T cell inflammatory activity. PD-1 levels were monitored in cancer patient samples obtained in a randomized Phase 2 clinical trial by observing concentrations of a plasma biomarker consisting of soluble fragments of the PD-1 checkpoint protein that are shed by the patient’s T cells. The biomarker can be used to predict immune response to AIVITA’s personalized cancer immunotherapy.

"Exorbitantly high levels of PD-1 appear to be interfering with T cell activation in the non-responsive 28% of our treated patients," said Dr. Gabriel Nistor, Chief Science Officer at AIVITA. "This suggests anti-PD-1 checkpoint inhibitors could be used to counter this inhibiting effect, and allow our immunotherapy to work in patient populations that would otherwise be unresponsive."

"These data underscore a natural partnership, in which a combination therapy would be greater than either of its parts," said Dr. Hans Keirstead, CEO of AIVITA.

AIVITA has recently received IND clearance to begin a Phase 1B clinical trial testing this combination approach. AIVITA’s open-label, single-arm, phase 1B treatment study will establish safety and track efficacy of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from purified autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with the cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On February 12, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2018 fourth quarter and full year financial results on Tuesday, February 26, 2019, after the close of the financial markets (Press release, Jazz Pharmaceuticals, FEB 12, 2019, View Source [SID1234533263]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EST/9:30 p.m. GMT to discuss fourth quarter and full year 2018 financial results and provide a business and financial update and guidance for 2019 financial results.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at View Source Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 7095707

A replay of the conference call will be available through March 5, 2019 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 7095707