On March 10, 2017 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported an agreement with F. Hoffmann-La Roche Ltd (Roche) whereby Roche has agreed to supply their PD-L1 blocking antibody Tecentriq (atezolizumab) for a clinical study combining Bavarian Nordic’s cancer vaccine, CV301, and Tecentriq in patients with urothelial carcinoma, or bladder cancer (Press release, Bavarian Nordic, MAR 10, 2017, View Source [SID1234518061]). Schedule your 30 min Free 1stOncology Demo! Bavarian Nordic plans to conduct a phase 2 study in patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, a patient population where Tecentriq has accelerated approval in the U.S. CV301 is designed to generate a T cell response to both CEA and MUC1, two tumor antigens that are highly over expressed in bladder cancers. This study will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer vaccine such as CV301 could be synergistic by enhancing the immune response seen in this patient population to date. The study is anticipated to initiate around the end of 2017.
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"In keeping with our strategy to expand the potential of CV301, we are extremely pleased to enter into this collaboration with Roche. This represents our second collaboration in the advancement of CV301 as combination therapy in multiple cancers. We look forward to the initiation of this study and to explore the potential synergy of our programs for the benefit of patients with bladder cancer," said Paul Chaplin, President and CEO of Bavarian Nordic.
Under the terms of the agreement, Roche has committed to supplying Tecentriq to Bavarian Nordic during the phase 2 trial. Bavarian Nordic will be responsible for conducting the clinical trial, and both companies will share data from the trial. Bavarian Nordic continues to retain all commercial rights to CV301.
About CV301
CV301 is an immunotherapy candidate which is being developed under a CRADA with the National Cancer Institute (NCI). CV301 targets two tumor-associated antigens, CEA and MUC1, which are over-expressed in multiple solid tumors, including lung, bladder and colorectal cancer. Similar to PROSTVAC, CV301 uses a prime/boost dosing schedule. CV301 incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules. In December 2016, the MAGNI-lung-01 study was initiated. This Phase 1b/2 study evaluates the combination of CV301 and OPDIVO (nivolumab) from Bristol-Myers Squibb in patients with non-small cell lung cancer.
Month: March 2017
Xenetic Biosciences to Present at the 29th Annual ROTH Conference
On March 9, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that M. Scott Maguire, Xenetic’s Chief Executive Officer will present at the 29th Annual ROTH Conference on Tuesday, March 14th at 11:30 a.m. PT in Dana Point, CA (Press release, Xenetic Biosciences, MAR 9, 2017, View Source [SID1234537804]).
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During his presentation, Mr. Maguire will provide a corporate update and will discuss the Company’s license deal with Shire plc (LSE: SHP, NASDAQ: SHPG), a significant stockholder of the Company, along with the clinical status of the product candidate PSA-Recombinant SHP656 (Factor VIII) being developed as a long-acting therapeutic for the treatment of hemophilia utilizing Xenetic’s proprietary PolyXen platform technology. Xenetic has the potential to receive from Shire up to $100 million in cash milestones plus royalties linked to sales.
Mr. Maguire will also discuss the Company’s clinical and regulatory progress for its in-house product candidate, XBIO-101 (sodium cridanimod), currently in development for the treatment of progesterone resistant endometrial cancer.
A live webcast of the presentation will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.
FDA grants orphan drug designation to Boehringer Ingelheim’s investigational anti-CD33 monoclonal antibody BI 836858 for treatment of myelodysplastic syndromes
On March 9, 2017 Boehringer Ingelheim reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS) (Press release, Boehringer Ingelheim, MAR 9, 2017, View Source [SID1234535519]). Orphan drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people.
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MDS are a group of bone marrow disorders. The bone marrow produces blood cells. In MDS, the bone marrow is characterized by cell abnormalities and ineffective blood cell production. Various subtypes of the disease exist with variable prognoses and treatment options. In some cases, MDS can progress to acute myeloid leukemia (AML), an aggressive and devastating blood cancer. According to data from the National Cancer Institute, an estimated 15,000 new cases of MDS are identified each year.
"Preclinical studies with our anti-CD33 monoclonal antibody have shown promising therapeutic potential in myelodysplastic syndromes, a rare group of bone marrow disorders," said Martina Flammer, M.D., Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim. "Orphan drug designation for our investigational candidate in MDS is an important recognition of our ongoing research efforts and underscores Boehringer Ingelheim’s commitment to studying treatment options for rare cancers."
A Phase I/II multi-center, open-label, dose escalation and randomized trial (NCT02240706 (link is external)) evaluating BI 836858 in patients with MDS is ongoing. BI 836858 previously received orphan drug designation for the treatment of patients with AML and is currently being evaluated as part of the Leukemia & Lymphoma Society’s (LLS) groundbreaking, first-of-its-kind Beat AML Master trial program to advance treatment for patients with AML. Using the latest genomic technology, the trial finds and matches specific AML mutations in newly-diagnosed patients over the age of 60 with an investigational drug or drugs best suited to attack the specific genetic mutations found within the cancer.
About BI 836858
BI 836858 is a monoclonal antibody that targets a protein called CD33, which is expressed on the surface of certain cancerous cells. BI 836858 has been engineered for improved antibody-dependent cell-mediated cytotoxicity (ADCC), a type of immune reaction in which a target cell or microbe is coated with antibodies and killed by certain types of white blood cells. Preclinical studies with the compound have shown promising ADCC against malignant cells.
About Boehringer Ingelheim in Oncology
Boehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for NSCLC that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.
10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
Cascadian Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Cascadian Therapeutics, MAR 9, 2017, View Source [SID1234518058]).
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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
SciClone Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, SciClone Pharmaceuticals, MAR 9, 2017, View Source [SID1234518053]).
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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
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