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PharmaMar Will Present the Results of the Phase I/II Study With Lurbinectedin in Combination With Doxorubicin in Relapsed Small-cell Lung Cancer During the IASLC World Conference

On September 6, 2018 PharmaMar (MCE: PHM) reported that the International Association for the Study of Lung Cancer (IASLC) has released today the abstracts for presentation during the Conference that will take place from the 23rd to the 26th of September in Toronto (Canada) (Press release, PharmaMar, SEP 6, 2018, View Source [SID1234529320]). The abstract to be presented by PharmaMar shows Overall Survival (OS) data obtained from the Phase I/II Study of lurbinectedin in combination with doxorubicin for the treatment of relapsed small-cell lung cancer.

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In the study, PharmaMar observed Overall Survival (OS) of 10.2 months in patients treated with lurbinectedin in combination with doxorubicin, and OS of 11.5 months in platinum-sensitive patients (patients with a chemotherapy free interval (CTFI) of more than 90 days) in patients treated with lurbinectedin in combination with doxorubicin. We believe that the OS periods observed in this trial is are more favorable than those seen in historical trials of the primary treatments used for second line in small-cell lung cancer, as topotecan or the CAV combination (cyclophosphamide, adriamycin, vincristine).

This multicenter, Phase I/II Clinical Study enrolled patients with relapsed small-cell lung cancer (n=27) in cohort B, using the dose 2mg/m[2] of lurbinectedin + 40mg/m[2] of doxorubicin, the same dose that is being evaluated in the Phase III randomized ATLANTIS study in a similar population. In both cases the refractory patients are excluded, meaning those patients that have relapsed or have suffered a progression of the disease up to 30 days after first line treatment (CTFI <30 days).

Following the receipt of early data from this study in August 2016 PharmaMar initiated the pivotal Phase III ATLANTIS Study, that reached in July 2018 its recruitment objective of 600 patients. The trial recruited patients at 160 centers in 20 countries, and results are expected at the end of 2019.

The abstract with all this data is available on the Congress web page: View Source

Overall survival with lurbinectedin plus doxorubicin in relapsed SCLC. Results from an expansion cohort of a phase Ib trial.
Poster: P1.12-20. Monday, September 24th, 2018, from 16:45 to 18:00. Exhibit Hall.

Lead author: Martin Forster, MD. University College of London Hospital and UCL Cancer Institute, London, UK

About lurbinectedin

Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

RedHill Biopharma Announces Advancement to Second Stage of Phase IIa Study with YELIVA® for Cholangiocarcinoma

On September 6, 2018 RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported that the ongoing single-arm Phase IIa study with orally-administered YELIVA (opaganib, ABC294640)1 for the treatment of advanced cholangiocarcinoma (bile duct cancer) has achieved its pre-specified efficacy goal for the first stage of the two-stage study design, and as a result, the study will continue to its second stage, enrolling the full cohort of 39 evaluable patients (Press release, RedHill Biopharma, SEP 6, 2018, View Source;LNGID=1&TMID=178&FID=1384&PID=0&IID=9184 [SID1234529317])

The primary efficacy endpoint of the study is defined as either partial or complete response, or stable disease at four months treatment with YELIVA. Enrollment of all subjects is expected to be completed by mid-2019.

The single-arm Phase IIa study is evaluating the activity of YELIVA as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma. All subjects enrolled in the study have received up to two lines of other systemic therapy for advanced disease. The study is being conducted at renowned clinical institutions in the U.S.

YELIVA was granted FDA Orphan Drug designation for the treatment of cholangiocarcinoma, providing various development incentives to develop YELIVA for this indication and, if approved, a seven-year marketing exclusivity period for the treatment of cholangiocarcinoma.

Complete Response Achieved in Patient treated under RedHill’s Expanded Access Program:
Additionally, a patient in the U.S. with advanced gallbladder carcinoma, a condition closely related to cholangiocarcinoma, who had progressed following standard-of-care chemotherapy, received treatment with YELIVA as part of RedHill’s Expanded Access Program, which allows compassionate use for eligible patients, and achieved a confirmed complete response, as measured by RECIST criteria (i.e. disappearance of all target lesions and all non-target lesions).

About cholangiocarcinoma:
Cholangiocarcinoma (bile duct cancer) is a highly lethal malignancy for which there is an urgent need for more effective treatments. Approximately 8,000 people are diagnosed with intrahepatic and extrahepatic bile duct cancers annually in the U.S.2, with recent studies showing an increased incidence of cholangiocarcinoma, mainly attributed to recent advancements in the diagnosis of this disease3. Surgery with complete resection remains the only curative therapy for cholangiocarcinoma; however, only a minority of patients are classified as having a resectable tumor at the time of diagnosis4. Additional treatment options include radiation therapy and chemotherapy. Still, the efficacy of these treatments in cholangiocarcinoma patients is also limited and the prognosis for relapse patients who have failed initial chemotherapy is very poor with an overall median survival of approximately one year5. The 5-year relative survival rates of intrahepatic and extrahepatic cholangiocarcinoma patients range between 2% to 30%, depending on the tumor type and stage at diagnosis6.

About YELIVA (opaganib, ABC294640):
YELIVA (ABC294640), a new chemical entity, is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. YELIVA received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute.

The Phase IIa study in cholangiocarcinoma was initiated following an extensive pre-clinical program, and a Phase I clinical study with YELIVA in patients with advanced solid tumors which successfully met its primary and secondary endpoints, demonstrating that the drug is well tolerated and can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity. Of the three patients with cholangiocarcinoma treated in the Phase I study, all of whom had prior therapy, one subject achieved a sustained partial response (overall survival (OS) = 20.3 months) and the other two subjects had prolonged stable disease (OS = 17.6 and 16.3 months).

The ongoing studies with YELIVA (ABC294640) for cholangiocarcinoma, multiple myeloma and advanced hepatocellular carcinoma (HCC) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

ERYTECH to Host Second Quarter 2018 Conference Call and Business Update

On September 6, 2018 ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will host a second quarter 2018 conference call and webcast on Tuesday, September 11, 2018, at 2:30 PM CEST/8:30 AM EST to discuss operational highlights (Press release, ERYtech Pharma, SEP 6, 2018, View Source;p=RssLanding&cat=news&id=2366273 [SID1234529312]).

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 4983808#:

USA/Canada: +1 (833) 818-6807 France: +33 176748988
International Dial-In Number: +1 (409) 350-3501 United-Kingdom: +44 2031070289
The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 800 585 8367, Conference ID: 4983808#. An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at View Source

Aileron Therapeutics Announces the Appointment of Dr. Manuel Aivado as Chief Executive Officer

On September 6, 2018 Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stapled peptide therapeutics for cancers and other diseases, reported that Manuel Aivado, MD, PhD, has been named President and Chief Executive Officer and elected to its Board of Directors (Press release, Aileron Therapeutics, SEP 6, 2018, View Source;p=RssLanding&cat=news&id=2366358 [SID1234529310]). Since 2012, Dr. Aivado has served as Aileron’s Senior Vice President and Chief Medical and Scientific Officer. He succeeds John P. Longenecker, PhD, who was appointed interim CEO on May 15, 2018.

"We are very pleased to announce this well-deserved promotion for Dr. Aivado," said Aileron Chairman Jeff Bailey. "Manuel clearly best exemplifies the skill set and talent needed to lead the company through its next stage of development."

"I am very excited to take on this new responsibility at Aileron as we further expand the clinical development of our lead product candidate, ALRN-6924, into combination therapies. ALRN-6924 represents the proof-of-concept for Aileron’s stapled peptide technology, which I believe to be capable of producing additional novel drug candidates that address previously undruggable targets," said Dr. Aivado. "In the future, we plan to broaden the applicability of our technology and expand our external collaborations. I am pleased with the external recognition that ALRN-6924 and our stapled peptide technology have earned in the scientific community, and I look forward to additional collaborations translating this recognition into therapeutic and commercial success."

Dr. Aivado brings more than 20 years of scientific, medical, and executive leadership to this position. Most recently, Dr. Aivado led Aileron’s clinical testing of stapled peptides against intracellular targets and designed and implemented the ALRN-6924 first-in-human trial. ALRN-6924 was selected for the "Best of ASCO (Free ASCO Whitepaper) Meetings," which highlights the most cutting-edge science and education from the world’s premier oncology event. Prior to joining Aileron, Dr. Aivado served as Vice President of Clinical Development and Pharmacovigilance at Taiho Oncology, Inc. He previously served as a Senior Medical Director in clinical development at GlaxoSmithKline. In addition, Dr. Aivado was an Instructor in Medicine at Beth Israel Deaconess Medical Center/Harvard Medical School. Prior to his industry experience, Dr. Aivado practiced clinical medicine in Germany for nearly ten years, during which he was awarded the Dr. Mildred Scheel cancer research scholarship award in 2002. Dr. Aivado is a German board-certified physician in internal medicine, hematology and medical oncology. He received his MD and PhD degrees from the Medical School of the University of Dusseldorf, Germany.

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild-type p53 tumor suppression by disrupting the interactions between p53 and its two primary suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, the Company believes there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.

ZETAGEN THERAPEUTICS, INC. AWARDED $300,000 USD GRANT FROM THE NATIONAL CANCER INSTITUTE (NCI) FOR PHASE I STUDY OF NOVEL, ADJUVANT IMPLANT FOR POST-METASTATIC SKELETAL LESIONS

On September 5, 2018 Zetagen Therapeutics, Inc., a private, US-based biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported its award of a $300,000 (USD) grant from the National Cancer Institute of the National Institutes of Health (NIH) (Press release, Zetagen Therapeutics, SEP 5, 2018, View Source [SID1234643681]). The grant will be used for a Phase I validation study of the Company’s proprietary, drug-eluding implant called ZetaMet (Zeta-BC-003). ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic being developed to suspend tumor growth and regrow bone.

"We are pleased that the National Cancer Institute, through this award, has recognized the potential ZetaMet (Zeta-BC-003) may hold for treating metastatic bone lesions," said Nikhil Thakur, MD, CMO of Zetagen Therapeutics, Inc. "Osteolytic metastases are among the most challenging of cancers to treat as they both destroy bone and cause debilitating pain in patients."

The grant is part of the Small Business Innovation Research Program (SBIR), a three-phase award system created by the Federal Government for small businesses to engage in research and development that has the potential for commercialization and public benefit. Zetagen exclusively licensed its platform technology from the State University of New York in 2016. The Company’s Phase I validation study will begin in Q4 2018.