Mon, Aug. 24, 8:47 AM
- Peregrine Pharmaceuticals (NASDAQ:PPHM) and AstraZeneca (NYSE:AZN) announce plans for a cancer immunotherapy clinical trial collaboration to evaluate PPHM's investigational phosphatidylserine-signaling pathway inhibitor, bavituximab, in combination with AZN's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab.
- The companies say they will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumors.
- PPHM +5.2%, AZN -1.2% premarket.
Thu, Aug. 20, 10:57 AM
- Advaxis (ADXS -3.8%) and AstraZeneca's (AZN -1.3%) MedImmune announce the initiation of a Phase 1/2 clinical trial evaluating Advaxis' axalimogene filolisbac (ADXS-HPV) in combination with MedImmune's durvalumab (MEDI4736) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
- The two-part open label study will evaluate the safety and efficacy of axalimogene filolisbac as monotherapy and in combination with durvalumab in ~66 subjects. Phase 1 will establish the maximum tolerated dose while Phase 2 will randomize patients to receive axalimogene filolisbac as monotherapy, durvalumab as monotherapy or the combination. The primary endpoints include objective response rate and progression-free survival. The estimated study completion date is December 2019.
- Axalimogene filolisbac is an immunotherapy based on the Advaxis Lm Technology, which uses live attenuated bioengineered Listeria bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
- Durvalumab is a monoclonal antibody that binds to PD-L1 (programmed death- ligand 1), a transmembrane protein on cancer cells. PD-L1 suppresses the immune system by binding to the PD-1 receptor found on the surface of activated immune cells. Binding to PD-1 down-regulates the immune system by preventing the activation of T cells.
Thu, Aug. 20, 8:01 AM
- Top line results from a 7,000-subject clinical trial, called EMPA-REG OUTCOME, show that Jardiance (empagliflozin), when added to standard of care, was superior in lowering cardiovascular (CV) risk in type 2 diabetics. The primary endpoint was the time to first occurrence of either CV death, non-fatal myocardial infarction or non-fatal stroke. About half of the deaths of people with type 2 diabetes are caused by CV disease.
- Full results will be presented on September 17 at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.
- Jardiance, co-developed by Boehringer Ingelheim and Eli Lilly (NYSE:LLY), is the only glucose-lowering drug that has demonstrated CV risk reduction. It was cleared in Europe in May 2014 and in the U.S. in July 2014.
- Related tickers: (NYSE:SNY) (NYSE:NVO) (NYSE:AZN)
Thu, Aug. 13, 7:35 AM
- Data from a Phase 2a clinical trial assessing FibroGen's (NASDAQ:FGEN) lead product candidate, roxadustat, in patients with chronic kidney disease (CKD)-associated anemia show responder rates that increase in a dose-dependent way. The results were published in Nephrology Dialysis Transplantation.
- The study enrolled 116 subjects with CKD-associated anemia who were not undergoing dialysis. Of this group, 96 were evaluable for efficacy. Four doses of roxadustat were tested (0.7, 1.0, 1.5 and 2.0 mg/kg) compared to placebo. Baseline characteristics were similar between the test arms and control arm. The responder rates (increased hemoglobin levels) ranged from 30% in the 0.7 mg/kg arm to 100% in the 2.0 mg/kg arm. The median time to response ranged from 42 days (1 mg/kg) to 14 days (2 mg/kg).
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
Mon, Aug. 10, 5:30 AM
- AstraZeneca (NYSE:AZN) has landed its third deal in less than a week aimed at bolstering its cancer drug pipeline by signing up rights to an experimental immunotherapy from Inovio Pharmaceuticals (NASDAQ:INO).
- Depending on the success of INO-3112 (which targets cancers caused by human papillomavirus types 16 and 18), Inovio will get $27.5M upfront and potential future payments of up to $700M,
- The deal builds on last week's immuno-oncology tie-ups with Sosei subsidiary Heptares and Mirati.
- INO +9.4% premarket
Thu, Aug. 6, 7:18 AM
- AstraZeneca (NYSE:AZN) acquires the exclusive global rights to develop, manufacture and commercialize HTL-1071, a small molecule adenosine A2A receptor antagonist, from Heptares Therapeutics, a wholly-owned subsidiary of Japanese biopharmaceutical firm Sosei Group. The companies will also collaborate to discover additional A2A receptor-blocking compounds. AZN will evaluate the assets across a range of cancers, including combinations with its existing portfolio of immunotherapies.
- Under the terms of the agreement, Heptares is eligible to receive more that $500M including an upfront payment of $10M, development and commercialization milestones and up to double-digit royalties on net sales.
Mon, Aug. 3, 6:55 AM
- AstraZeneca (NYSE:AZN) and Isis Pharmaceuticals (NASDAQ:ISIS) build upon their existing partnership by establishing a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. Under the terms of the agreement, ISIS will receive an upfront fee of $65M, development and regulatory milestones and tiered double-digit royalties on net commercial sales.
- Antisense drugs are short, chemically modified, single-stranded nucleic acids that target RNA. They are designed to inhibit the production of disease-causing proteins.
Thu, Jul. 30, 9:00 AM
- AstraZeneca (NYSE:AZN) Q2 results ($M): Total Revenues: 6,307 (-6.7%); Product Sales: 5,836 (-9.6%); U.S.: 2,356 (-3.4%); Europe: 1,261 (-23.1%); Established ROW: 785 (-14.3%); Japan: 522 (-9.8%); China: 583 (+11.3%); Emerging Markets: 1,434 (-1.8%).
- Sales by segment: Cardiovascular & Metabolic: 2,452 (-4.4%); Oncology: 707 (-6.7%); Respiratory, Inflammation & Autoimmunity: 1,225 (+1.1%); Infection, Neuroscience & GI: 1,452 (-24.3%).
- Key Product Sales: Crestor: 1,310 (-9.7%); Symbicort: 842 (-9.3%); Nexium: 647 (-33.4%); Onglyza: 208 (-12.6%).
- Net Income: 696 (-9.1%); EPS: 0.55 (-10.0%); CF Ops: 1,080 (-48.1%).
- Shares are up 2% premarket on modest volume.
Thu, Jul. 30, 8:33 AM
Thu, Jul. 30, 7:57 AM
- Roche (OTCQX:RHHBY) submits its Premarket Approval (PMA) application to the FDA seeking clearance for its cobas EGFR Mutation v2, a companion diagnostic test for AstraZeneca's (NYSE:AZN) Orphan Drug-, Fast Track- and Breakthrough Therapy-tagged AZD9291.
- Patients with non-small cell lung cancer (NSCLC) who have adenocarcinoma with tumor containing an EGFR (epidermal growth factor receptor) sensitizing mutation respond initially to current EGFR TKI therapies. About 67% relapse and develop drug resistance due to, in large part, the acquisition of a mutation called T790M. Patients with this mutation will most likely benefit from treatment with AZD9291.
- Roche's second generation test is built upon its current FDA-cleared assay for EGFR mutations. It is designed to identify a broad spectrum of EGFR mutations in patients with NSCLC, including T790M.
Wed, Jul. 29, 5:30 PM
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Tue, Jul. 28, 12:57 PM
- Privately-held Boehringer Ingelheim (BI) enters into an exclusive license and collaboration agreement with Seoul, Korea-based Hanmi Pharmaceutical to develop and commercialize HM61713, a third generation epidermal growth factor receptor (EGFR)-targeted therapy for the treatment of EGFR mutation-positive lung cancer.
- Under the terms of the agreement, Hanmi will receive an upfront payment of $50M, milestones up to $680M and tiered double-digit royalties on net sales. BI will have exclusive global commercialization rights to HM61713 except South Korea, China and Hong Kong.
- HM61713 is an orally active, irreversible EGFR mutation-selective tyrosine kinase inhibitor (TKI). It is currently in Phase 2 development for the treatment of patients with non-small cell lung cancer with T790M mutations who have developed resistance to other EGFR-targeting agents. A Phase 3 study will commence next year.
- EGFR-related tickers: (AZN +0.3%)(OTCQX:RHHBY +1.3%)(OTCPK:ALPMY) (OTCPK:ALPMF) (BMY +0.1%)(LLY +1.4%)(GSK -0.1%)(AMGN +4.3%)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Mon, Jul. 27, 4:04 AM
- Boosting its rare disease medicine offerings, Sanofi (NYSE:SNY) has agreed to buy cancer drug Caprelsa from AstraZeneca (NYSE:AZN) for as much as $300M, including an upfront payment of $165M and sales milestone payments of up to $135M.
- Caprelsa is currently sold in 28 countries for treating medullary thyroid carcinoma and had sales last year of $48M.
Wed, Jul. 22, 8:16 AM
- A Phase 3 clinical trial (SUMIT) assessing AstraZeneca's (NYSE:AZN) Orphan Drug-tagged selumetinib in combination with dacarbazine for the treatment of uveal melanoma failed to achieve its primary endpoint of progression-free survival (PFS). The full analysis of the data is ongoing.
- Selumetinib, licensed from Array BioPharma (NASDAQ:ARRY) in 2003, is under development for the second-line treatment, in combination with docetaxel, of KRAS-positive advanced non-small cell lung cancer, differentiated thyroid cancer and neurofibromatosis Type 1. It inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumor from growing.
- Uveal melanoma (UM), comprising 5% of all melanoma cases, occurs when cancer cells grow in the tissues of the eye. No effective treatments for advanced UM exist.
- AZN shares are off a fraction premarket on light volume. ARRY is off 15% premarket on higher-than-normal volume.
Tue, Jul. 14, 6:51 AM
- The FDA approves AstraZeneca's (NYSE:AZN) Orphan Drug-tagged IRESSA (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
- IRESSA is an oral EGFR tyrosine kinase inhibitor which works by blocking the activity of the EGFR tyrosine kinase enzyme that plays a key role in the growth and survival of cancer cells.
- The Orphan Drug label provides IRESSA a seven-year period of market exclusivity for EGFR-mutation-positive NSCLC. It is approved in 91 countries for the indication. The companion diagnostic test used to determine mutation status was developed by Qiagen (NASDAQ:QGEN).
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