An experimental cancer “vaccine” showed promising results in a small clinical trial of patients with lymphoma, Angelica LaVito of CNBC reports, citing a study published in the journal Nature Medicine. The results in 11 patients were successful enough to warrant another clinical trial in March on lymphoma patients as well as breast and head-and-neck cancer, reports LaVito. Celldex Therapeutics (CLDX) and Oncovir provided the materials for the clinical trial and the lab work, she adds. Shares of Celldex are up 12c to $4.46 in morning trading
Monday, April 8, 2019
Entegris ‘does not currently intend to propose to revise’ Versum merger terms
Entegris (ENTG) issued the following statement earlier regarding Versum Material’s (VSM) determination that Merck KGaA’s (MKGAY) revised proposal constitutes a “Superior Proposal” under the terms of the previously announced merger agreement with Entegris: “Entegris has considered its options and does not currently intend to propose to revise the terms of the Entegris-Versum merger of equals.”
GENFIT: Upcoming Presentations on NASH, PBC and Diagnostics
GENFIT (Nasdaq and Euronext: GNFT – ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced it will present new data at the International Liver Congress (ILC) 2019, which will take place April 10-14 in Vienna, Austria.
Abstracts are available for download and viewing through the International Liver Congress website.
Biomerica nabs new patent for IBS in U.S.
The USPTO has issued a Notice of Allowance for Biomerica’s (NASDAQ:BMRA) first U.S. patent pertaining to the Company’s InFoods family of products that allow for new treatment option for patients suffering from Irritable Bowel Syndrome (IBS) and other gastrointestinal diseases.
Specifically, this allowed application contains numerous claims that broadly cover a product that helps identify patient specific foods, that when removed, may alleviate or improve an individual’s IBS symptoms.
Immunomedics enters promotion agreement with Janssen for erdafitinib
Immunomedics (IMMU) announced that it has entered into a promotion agreement in which Immunomedics will provide detailing services to Janssen (JNJ), for erdafitinib in the U.S. Under the terms of the agreement, Immunomedics’ sales team will provide product detailing from the launch of erdafitinib until the end of the Q1 2020, but only requires Immunomedics to support the product in first position detail until the FDA approval of sacituzumab govitecan. Immunomedics is eligible to receive low double digit royalties and milestone payments based on U.S. sales throughout 2019 and 2020, subject to sales thresholds in each year, respectively. A new drug application, or NDA, for erdafitinib is currently under review by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor, or FGFR, genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, pan-FGFR kinase inhibitor that received breakthrough therapy designation from the FDA in March 2018.
Alnylam alliance with Regeneron a ‘clear positive,’ says Piper Jaffray
Alnylam Pharmaceuticals (ALNY) today concluded its 2014 RNAi discovery collaboration with Sanofi (SNY) and announced a new five-year RNAi drug discovery alliance with Regeneron Pharmaceuticals (REGN), Piper Jaffray analyst Edward Tenthoff tells investors in a research note. Alnylam will receive $400M in cash and Regeneron will make a $400M equity investment at $90 per Alnylam share, bringing its estimated pro forma cash to $2.3B, adds the analyst. He believes the alliance is a “clear positive for Alnylam “dramatically expanding” its RNAi drug discovery capabilities and strengthening its balance sheet to advance its own orphan disease programs. Tenthoff reiterates an Overweight rating on Alnylam with a $142 price target. The stock in early trading is down 3%, or $2.95, to $89.94.
Inovio Hits 3rd Cancer Indication Milestone for MEDI0457 Phase 2
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that it achieved a third indication milestone from AstraZeneca resulting from dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (formerly called INO-3112) in combination with durvalumab targeting cervical, anal, penile, and vulvar cancers associated with the human papilloma virus (HPV). The milestone achievement for this multi-indication trial is the third MEDI0457-related Phase 2 milestone from AstraZeneca; two previous milestone payments resulted from initiating Phase 2 combination trials targeting head and neck and cervical cancers. Financial arrangements were not disclosed.
Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “This Phase 2 milestone stresses the potential breadth of MEDI0457 in treating multiple HPV-associated cancers. Inovio’s goal is to lead the HPV-treatment market from pre-cancers with its lead product VGX-3100 to cancers with MEDI0457 along with our partner AstraZeneca.”
In several on-going Phase 2 cancer-indication trials, AstraZeneca is evaluating MEDI0457 in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with HPV-associated head and neck, cervical, anal, penile, and vulvar cancers. Inovio is developing its HPV monotherapy VGX-3100 for pre-cancerous indications in a Phase 3 trial for cervical dysplasia; and in Phase 2 trials for vulvar and anal dysplasia.
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