R&D

eTheRNA Completes Enrolment of Low Dose Cohort for Phase 1b Study of TriMix mRNA-Based Cancer Specific Immunotherapy (ECI-006) in Melanoma

May 24, 2018

NIEL, Belgium, May 24, 2018 /PRNewswire/ —   ECI-006 is safe and well tolerated   eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its unique mRNA-based TriMix platform, announces that it has completed enrolment of the low dose cohort in its Phase 1b study (E011-MEL) of ECI-006 as an adjuvant therapy in […]

Bicycle Therapeutics Expands Strategic Partnership with AstraZeneca

May 24, 2018

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, announced today that it is expanding its collaboration with AstraZeneca to include additional targets in respiratory and cardio-metabolic diseases.   “Our collaboration with Bicycle continues to be highly productive. By expanding […]

Splash Pharmaceuticals Announces Dose Escalation in Phase I Clinical Trial in Platinum-resistant Ovarian Cancer Patients

May 24, 2018

SAN DIEGO–(BUSINESS WIRE)–Splash Pharmaceuticals, Inc. (“Splash”), a closely held private biopharmaceutical company that develops novel cancer therapies, announced the successful completion of the first safety cohort of patients and initiation of dose escalation in its ongoing clinical trial in platinum-resistant ovarian cancer patients. The Phase I trial is being conducted at Rutgers Cancer Institute of […]

SOTIO Starts Phase I/II Trial of DCVAC in Combination with ONCOS-102: The Targovax Adenovirus Based Immunotherapy

May 24, 2018

Prague, Czech Republic, May 24, 2018 / B3C newswire / — SOTIO, a biotechnology company owned by the PPF Group, announces today that the first patient was enrolled to the SP015 clinical trial of a combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming engineered human serotype 5 adenovirus, for patients with prostate […]

Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors

May 24, 2018

UTRECHT, The Netherlands, May 24, 2018 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The […]

U.S. FDA Grants Fast Track Designation for Krystal Biotech’s KB103 for the Treatment of Dystrophic Epidermolysis Bullosa

May 24, 2018

PITTSBURGH, May 24, 2018 (GLOBE NEWSWIRE) — Krystal Biotech Inc., (“Krystal”) (NASDAQ:KRYS), a gene therapy company developing topical and intradermal “off-the-shelf” treatments for rare dermatological diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KB103 for the treatment of dystrophic epidermolysis bullosa (DEB). KB103 is the first-ever […]

Immune Design Announces Launch of Web Portal for SYNOVATE Phase 3 Study of CMB305 Immunotherapy in Synovial Sarcoma

May 24, 2018

SEATTLE and SOUTH SAN FRANCISCO, Calif., May 24, 2018 (GLOBE NEWSWIRE) — Immune Design (Nasdaq:IMDZ), an immunotherapy company focused on novel therapies in oncology, today announced the launch of the patient and healthcare provider websites for the SYNOVATE study – a pivotal trial to evaluate CMB305 immunotherapy in synovial sarcoma patients. Clinical sites will soon […]

Enrolment Completed in Cynata’s Phase 1 Clinical Trial of CYP-001 in GvHD

May 24, 2018

MELBOURNE, Australia, May 24, 2018 (GLOBE NEWSWIRE) — Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce that the final patient has been treated in Cohort B of its Phase 1 clinical trial of CYP-001, its Cymerus™ mesenchymal stem cell (MSC) product candidate, in steroid-resistant acute graft-versus-host disease (GvHD). […]

Adamas Announces Publication of Pharmacokinetic Data for GOCOVRI™ in Clinical Pharmacokinetics

May 24, 2018

EMERYVILLE, Calif., May 24, 2018 (GLOBE NEWSWIRE) — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that pharmacokinetic (PK) data regarding GOCOVRI™ (amantadine) extended release capsules were published online in Clinical Pharmacokinetics. The paper, entitled Pharmacokinetics of ADS-5102 (Amantadine) Extended Release Capsules Administered Once-Daily at Bedtime for the Treatment of Dyskinesia concluded that GOCOVRI demonstrated a slow […]

Merck’s Cancer Drug Keytruda Notches Another Trial Success

May 24, 2018

(Reuters) – Merck & Co said on Wednesday its drug Keytruda helped patients with a certain type of lung cancer live longer and prevented the disease from spreading, helping to solidify its position in the lucrative cancer market.   Keytruda, already approved for other types of cancer, is being studied in a late-stage trial as […]

Gene Therapies That Could Transform Diseases Get Easier FDA Path

May 24, 2018

New therapies that may cure diseases caused by defective genes will get a faster path to approval by U.S. regulators, part of an effort by the Food and Drug Administration to keep pace with one of biotechnology’s fastest-growing fields.   Unlike traditional drugs, gene therapies are intended to be given once, transform the inner workings […]

Elligo Health Research Announces Acquisition of ePatientFinder Clinical Trial Exchange Technology Platform and Practice Network

May 24, 2018

Austin, Texas, May 24, 2018 (Business Wire) — Elligo Health Research, which improves clinical trial access by engaging the 97 percent of physicians currently not offering clinical research to their patients, has acquired ePatientFinder’s Clinical Trial Exchange technology platform and referring practice network, which is the largest of its kind.   This acquisition will enhance […]

Genosco/Yuhan Announce Results from Phase 1/2 Study of YH25448, a 3rd-Generation EGFR-TKI, in Advanced NSCLC to be Presented at ASCO 2018

May 23, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Genosco, a clinical-stage biotechnology company focused in immunology and oncology, today announced that the abstract from a Phase 1/2 study evaluating YH25448 (GNS-1480) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) is now available on the website of the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. YH25448 (GNS-1480), Genosco’s 3rd-generation […]

Pierre Fabre and Array BioPharma Announce COLUMBUS Phase 3 Study Overall Survival Results in BRAF-Mutant Melanoma Will Be Presented at 2018 ASCO Annual Meeting

May 23, 2018

CASTRES, France–(BUSINESS WIRE)–Pierre Fabre with its partner Array BioPharma Inc. will present overall survival (OS) data from its late-stage candidates encorafenib, a BRAF inhibitor, and binimetinib, a MEK inhibitor, at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO), being held June 1-5, 2018 in Chicago, Illinois.   “We are delighted by […]

Alexo Therapeutics Initiates ALX148 Clinical Trial Combination Cohorts for the Treatment of Patients with Advanced Solid Tumors and Lymphoma

May 23, 2018

DUBLIN & BURLINGAME, Calif.–(BUSINESS WIRE)–Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced it has initiated ALX148 combination dosing with targeted antibody therapies in its Phase 1 clinical program in patients with advanced solid tumors and lymphoma. The Company will present updated data on ALX148 at the 2018 […]

preliminary DATA from a phase I dose escalation and expansion study of monalizumab and Imfinzi® (durvalumab) SHOW ANTI-TUMOR activity in COLORECTAL CANCER patients

May 23, 2018

Marseille, France, May 17, 2018, 07:00 AM CEST Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH) last night announced preliminary data from an ongoing Phase I dose escalation and expansion study evaluating the safety and efficacy of the combination of monalizumab, a first-in-class monoclonal antibody targeting NK- and T cell checkpoint receptor […]

BeiGene Initiates Phase 3 Trial of Pamiparib as Maintenance Therapy in Chinese Patients with Ovarian Cancer

May 23, 2018

BEIJING, China and CAMBRIDGE, Mass., May 17, 2018 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the first patient was enrolled in a Phase 3 clinical trial in China of pamiparib (BGB-290), an investigational PARP […]

Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab)

May 23, 2018

WALTHAM, Mass., May 17, 2018 /PRNewswire/ — Syndax Pharmaceuticals, Inc. (“Syndax,” the “Company” or “we”) (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated results from multiple cohorts of the ongoing Phase 2 ENCORE 601 trial of entinostat in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 (programmed death […]

BeyondSpring to Present Positive Data From Prospective Phase 2 Trial Comparing Plinabulin to Neulasta for the Prevention of Chemotherapy-Induced Neutropenia at 2018 ASCO Annual Meeting

May 23, 2018

NEW YORK, May 17, 2018 (GLOBE NEWSWIRE) — BeyondSpring Inc. (NASDAQ:BYSI), a global clinical-stage biopharmaceutical company focused on the development of transformative cancer therapies, today announced that the Company will present results of the Phase 2 portion of Study 105, a prospective Phase 2/3 trial of its lead asset, Plinabulin, during a poster presentation at […]

Oncolytics Biotech® Announces Collaboration with Merck and Northwestern University Combining Keytruda® and REOLYSIN® in a Phase 2 Second Line Pancreatic Cancer Study

May 23, 2018

CALGARY, Alberta and SAN DIEGO, May 17, 2018 (GLOBE NEWSWIRE) — Oncolytics Biotech® Inc. (TSX:ONC) (OTCQX:ONCYF), currently developing REOLYSIN® (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, today announced an investigator sponsored study (IST) supported by Merck Inc. (Merck), Northwestern University (Northwestern) and Oncolytics. This study is an extension of the previously reported […]

Intellia Therapeutics Announces WT1 as Its First Cell Therapy Target, Following Presentation of Early Data at the American Society of Gene and Cell Therapy 21st Annual Meeting

May 23, 2018

CAMBRIDGE, Mass., May 17, 2018 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology, and its research collaborator, Ospedale San Raffaele (OSR), presented at the 21st Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) the first update on their joint […]

Clinical phase II results indicate that PMZ-2010 (centhaquin) is a novel highly effective resuscitative agent for hypovolemic shock

May 23, 2018

NAPERVILLE, Ill., May 17, 2018 /PRNewswire/ — Pharmazz, Inc. is pleased to announce interim analysis of a prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study of PMZ-2010 (centhaquin) as a resuscitative agent for hypovolemic shock due to excessive blood loss (CTRI/2017/03/008184). A total of 23 subjects were screened, of which 19 subjects met […]

Abeona Reports Update from EB-101 Gene Therapy in Epidermolysis Bullosa at 21st Annual ASGCT Meeting

May 23, 2018

NEW YORK and CLEVELAND, May 17, 2018 — Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening, rare, genetic diseases, announced today updated clinical data from the Phase 1/2 trial for EB-101, the company’s gene-corrected skin graft cell therapy for patients suffering from recessive dystrophic […]

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