Gilead Sciences announced results from studies investigating Epclusa in chronic hepatitis C virus infected patients with severe renal impairment undergoing dialysis and Harvoni in pediatric HCV patients aged three to five years, adding to the efficacy and safety profile of sofosbuvir-based regimens across diverse patient populations. Results from an open-label Phase 2 study demonstrated that treatment with the once-daily single-tablet regimen of Epclusa for 12 weeks in patients with genotype 1, 2, 3, 4 or 6 HCV and severe renal impairment undergoing dialysis resulted in cure rates of 95 percent with only two patients experiencing virologic failure. The most common adverse events were headache, fatigue, nausea, vomiting and insomnia. No patients discontinued therapy due to an adverse event. In another open-label Phase 2 study, children aged three to five years old with genotype 1 or 4 HCV infection received weight-based oral dosing of ledipasvir/sofosbuvir granules 33.75 mg/150 mg if less than 17 kg or 45 mg/ 200 mg if greater than or equal to 17 kg once-daily for 12 weeks. Overall, 97 percent of the patients were cured, and none experienced virologic failure. The most common AEs were vomiting, cough, pyrexia, rhinorrhea and streptococcal pharyngitis. One patient discontinued treatment due to an adverse event of abnormal drug taste. The use of Epclusa and Harvoni, including granules formulation, in the aforementioned patient populations is investigational; their safety and efficacy have not been established. The granule formulation is not approved. Epclusa and Harvoni are both indicated in the US for the treatment of chronic HCV infection in patients with no cirrhosis or compensated cirrhosis: Epclusa for adults with genotypes 1-6; and Harvoni for patients 12 years and older with genotypes 1, 4, 5 and 6. The US product labels for Epclusa and Harvoni each contain a Boxed Warning for the risk of hepatitis B reactivation in HCV/HBV co-infected patients. See below for US Important Safety Information. Gilead is presenting data on GS-9688, an investigational, oral selective toll-like receptor 8 agonist, one of several compounds under investigation as part of Gilead’s HBV cure program. The data support continued development of GS-9688 as a potential therapeutic approach for achieving a functional cure for patients with chronic HBV infection. In the first-in-human, healthy volunteer safety study, GS-9688 was well-tolerated at single ascending doses up to 5mg and resulted in pharmacodynamic activity as demonstrated by the production of the systemic cytokines IL-1RA and IL-12p40 and by the activation of key relevant immune cells including natural killer cells and mucosal-associated invariant T cells. The most commonly reported AEs among people receiving doses up to and including 5 mg were nausea and vomiting. There were no reports of Grade 3 or higher AEs, laboratory AEs or serious adverse events and no discontinuations or deaths. In a Phase 1b safety and tolerability study of GS-9688 in HBV chronically infected patients, dose-dependent activation of the cytokines IL-12p40 and IL-1RA was demonstrated with once weekly dosing for up to 4 weeks in viremic and virally-suppressed patients. There were no reports of SAEs; the most common AEs were headache and nausea. Based on these data, GS-9688 is currently being evaluated in Phase 2 studies in patients with chronic hepatitis B. Presentations on Vemlidy add further evidence to its established safety and efficacy profile in adults with chronic HBV and compensated liver disease, including longer term data on the safety of Vemlidy in virologically suppressed HBV patients. Through three years of treatment, patients originally randomized to receive TAF continued to show an improved bone and renal safety profile compared to treatment with tenofovir disoproxil fumarate 300mg with maintained viral suppression. In a separate study in post-liver transplant patients virally suppressed on TDF-based regimens, switching to TAF maintained viral suppression in all TAF-treated patients with improvements in renal function and bone mineral density, after 48 weeks of treatment.
Friday, November 9, 2018
Mirati Therapeutics presents data from Phase 2 trial of sitravatinib/nivolumab
Mirati Therapeutics announced preliminary biomarker data from the ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab in non-small cell lung cancer patients at the Society for Immunotherapy of Cancer 33rd Annual Meeting in Washington, D.C. The data will be presented today in a poster and also in an oral presentation on Saturday, November 10th. The ongoing Phase 2 clinical trial is evaluating the safety and efficacy of sitravatinib in combination with an anti-PD-1 immune checkpoint inhibitor, in patients who have experienced documented disease progression following prior checkpoint inhibitor therapy. Efficacy data were recently presented at the October 2018 European Society for Medical Oncology Congress. The data demonstrated a higher rate of durable responses than would be expected from treatment with docetaxel, the standard of care. Today’s presentation, “Preliminary Biomarker Analysis of Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor”, highlighted an initial assessment of correlative biomarkers for the 56 evaluable patients from the on-going clinical trial. Exploratory baseline and dynamic biomarker endpoints were evaluated for correlation with clinical outcomes. The analysis demonstrated a CD8+ T effector cell response in patients who achieved a clinical benefit, suggesting a therapy-driven restoration of the anti-tumor immune response in patients who had become refractory to prior checkpoint inhibitor treatment. The data suggest that patients with high PD-L1 at baseline may be more likely to benefit from treatment with the combination although the difference was not statistically significant. There was no difference in treatment outcomes for patients based on their baseline tumor mutational burden or other baseline biomarkers.
https://thefly.com/landingPageNews.php?id=2821491
Cambrex upgraded to Strong Buy from Outperform at First Analysis
First Analysis analyst Steven Schwartz upgraded Cambrex to Strong Buy while lowering his price target for the shares to $63 from $73. The analyst views yesterday’s post-earnings selloff as overdone.The company is “roughly holding to the mid-points” of previously stated 2018 guidance for EBITDA and earnings despite lowering revenue growth guidance by 200 basis points with some production work being be pushed into 2019, Schwartz tells investors in a research note.
https://thefly.com/landingPageNews.php?id=2821499
Sangamo cut to Neutral after Hemophilia A ‘about-face’ at Guggenheim
Guggenheim analyst Whitney Ijem downgraded Sangamo to Neutral from Buy after the company reported Q3 earnings and announced that it will not present initial SB-525 in hemophilia A data at ASH in December. The company’s “about-face” on the SB-525 data disclosure is concerning and makes Ijem question the timelines around additional updates, she tells investors. While she understand the company’s desire to wait for a “complete clinical picture” before announcing data, she worries that it might be a moving target for hemophilia A and potentially other programs, Ijem added. She withdrew her prior $18 price target on Sangamo as she awaits more clarity on what can be expected from the company in 2019.
https://thefly.com/landingPageNews.php?id=2821515
Sangamo reports Q3 EPS (13c), consensus (16c)
Reports Q3 revenue $23.56M, consensus $26.95M. Sandy Macrae, CEO of Sangamo, said last night with the company’s earnings press release: “We’ve made strong progress across our clinical development programs and look forward to potential data readouts and updates from multiple clinical trials in coming months. We expect to complete the final steps of the acquisition of TxCell by year end, establishing our leadership in the promising field of CAR-Tregs for immunological and autoimmune diseases. Finally, we are continuing to strengthen the leadership team with the addition of Stephane Boissel as EVP of Corporate Strategy.” Sangamo expects to report a balance of cash, cash equivalents, marketable securities and interest receivable of at least $380M at December 31, 2018. This anticipated cash balance is inclusive of research funding from existing collaborators and recent financings and is expected to last approximately two years. Sangamo expects operating expense of $160M-$165M for the year ending December 31, 2018.
https://thefly.com/landingPageNews.php?id=2821549
Welltower & Hines acquire Manhattan site for seniors housing community
Welltower and the New York office of international real estate firm Hines have closed on the acquisition of a development site at 2330 Broadway at 85th Street on the Upper West Side of Manhattan. Existing commercial structures on the site will be demolished to make way for construction of a state of the art 140,000-sq.ft., 17-story senior living and memory care community. The site on the northeast corner of 85th Street and Broadway is the second Manhattan senior living development site for the joint venture partnership of Hines, Welltower, and a passive institutional investor.
https://thefly.com/landingPageNews.php?id=2821555
https://thefly.com/landingPageNews.php?id=2821555
Thursday, November 8, 2018
MEI Pharma Inks Cancer Drug Deal with Japan’s Kyowa Hakko Kirin
The second-most advanced investigational drug in MEI Pharma’s four-asset portfolio is drawing attention from overseas as a potential treatment for several leukemias and lymphomas.
Japanese life sciences company Kyowa Hakko Kirin has agreed to pay the San Diego company $10 million upfront for rights to develop and commercialize ME-401 in Japan. The Japanese company will pay MEI up to $87.5 million more if the drug, a PI3K delta inhibitor, meets a variety of milestones; plus royalties from sales if it reaches the market.
Targeted therapies with PI3K inhibitors aren’t new. But such compounds can cause side effects, including diarrhea, colitis, and pneumonia, that limit how long a patient can receive such drugs.
MEI president and CEO Dan Gold, however, says the pharmaceutical properties of ME-401 set it apart from competitors—–and that the drug may provoke fewer side effects while remaining effective through an intermittent, rather than continuous, dosing schedule of one week one, three weeks off. The company is planning a Phase 2 trial soon to evaluate such a schedule in patients with whose follicular lymphoma (FL) has relapsed or has not responded to earlier treatment.
Gold joined MEI in 2010 when the company relocated to San Diego from Australia. MEI acquired ME-401 (formerly PWT143) from San Francisco’s Pathway Therapeutics in 2013.
“Doctors are not excited to use (PI3K), especially in healthier patients,” Gold said. “If we can show that this intermittent schedule really solves the toxicity problem without sacrificing the activity, then we open the door to lots of interesting potential to expand our market.”
For years researchers have been studying immunotherapies—which essentially enable the body’s immune system to more effectively fight cancer—as potential alternatives or complements to chemotherapy.
Recently the FDA approved cemiplimab (Libtayo), a checkpoint inhibitor from Regeneron (NASDAQ: REGN) and Sanofi (NYSE: SNY). The drug is a checkpoint inhibitor, a type of cancer drug that blocks a tumor’s ability to hide from the immune system, and it’s the seventh one to receive approval from the agency. Shortly thereafter, the scientists credited with discovering checkpoint inhibition—James Allison of MD Anderson Cancer Center in Houston and Tasuku Honjo of Kyoto University in Japan—won this year’s Nobel Prize in physiology or medicine.
Around the time MEI acquired the rights to ME-401, companies were racing to develop inhibitors to target B cells.
Foster City, CA-based Gilead Sciences (NASDAQ: GILD) was the first to market with a PI3K drug, idelalisib (Zydelig) in 2014.
But Sunnyvale, CA-based Pharmacyclics and Johnson & Johnson (NYSE: JNJ) got the OK for ibrutinib (Imbruvica), a Btk inhibitor, in 2013, and AbbVie (NYSE: ticker[[ABBV]]) later bought Pharmacyclics—and ibrutinib—for $21 billion.
“When all was said and done, Pharmacyclics…won the race,” Gold said. “They didn’t win it so much on efficacy, because in fact the biology tells us that PI3 delta should be a superior target for B-cell malignancies. The problem was that the PI3 delta class had toxicities which made the Btk (class) much more attractive as therapeutics because their toxicity profile is much, much better.”
However, interest in PI3K seems to be undergoing a rebirth of sorts. Bayer’s copanlisib(Aliqopa), an intravenous option for patients with relapsed FL who had received at least two prior treatments, was approved about a year ago.
And Verastem’s duvelisib (Copiktra), a twice daily pill, was approved in September for patients whose FL or chronic lymphocytic lymphoma (CLL) has relapsed or has not responded to at least two prior treatments.
In June MEI reported data from an ongoing Phase 1b study of ME-401. In the 30-patient study, the once daily drug demonstrated a 90 percent response rate in those with FL, CLL and small lymphocytic lymphoma (SLL).
The results led to a $75 million investment, a private placement led by Vivo Capital and CAM Capital, slated to fund ME-401’s continued clinical development. New Enterprise Associates, Perceptive Advisors, the Biotechnology Value Fund, Boxer Capital of Tavistock Group, and Amzak Health also participated, as did other new and earlier investors, MEI Pharma said at the time.
As part of the trial, MEI Pharma is also testing ME-401 in combination with rituximab. (Nicknamed ‘Vitamin R’ because of its broad utility, rituximab—the first biotech drug approved for cancer—was invented by the former Idec Pharmaceuticals, now part of Cambridge, Mass.-based Biogen.)
A few weeks prior to today’s announcement, MEI Pharma announced a collaboration with Chinese biopharma BeiGene (NASDAQ: BGN) to test how patients would respond to a combination of ME-401 and BeiGene’s zanubrutinib, an investigational BTK inhibitor.
“There are published data that suggests that if you could interfere with the Btk pathway and the delta pathway you may actually get better responses than either of those agents independently,” Gold said.
At the time, Oppenheimer analyst Leah Rush Cann said in a research note that data from the collaboration with BeiGene—and the ongoing trial testing a rituximab combo, too—could expand ME-401’s potential use. The firm anticipates the drug will launch in 2022, and estimates sales of about $620 million by the following year.
MEI signed a similar deal in 2016 for pracinostat, another one of its investigational drugs. Swiss pharmaceutical group Helsinn has paid MEI $20 million to date; an additional $444 million is tied to regulatory and sales-based milestones for the drug, which is being evaluated in a Phase 3 trial for patients who are diagnosed with acute myeloid leukemia (AML) who are unfit to receive intensive chemotherapy.
This latest news from MEI Pharma comes a month before the annual American Society of Hematology (ASH) conference, taking place this year in San Diego. There, the company plans to present data from the Phase 1B trial as well as others in its pipeline.
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