The following is a roundup of some of this week’s non-coronavirus biopharma news.
The pharmaceutical industry has thrown its might against the spread of COVID-19 as companies race to develop treatment options and potential vaccines. While those companies fight the pandemic, they continue to take aim at other diseases. The following is a roundup of some of this week’s non-coronavirus biopharma news.
AstraZeneca – Not only did AstraZeneca halt a Phase III trial for chronic kidney disease early due to “overwhelming efficacy,” the company also won approval for Imfinzi as a first-line treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care chemotherapies, etoposide and either carboplatin or cisplatin (platinum-etoposide). The approval was based on positive results from the Phase III CASPIAN trial showing IMFINZI in combination with platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus the standard-of-care treatment alone. In the Imfinzi plus chemotherapy arm, the risk of death was reduced by 27% with median OS of 13 months versus 10.3 months for chemotherapy alone. Results also showed an increased confirmed objective response rate in the Imfinzi plus chemotherapy arm, 68% versus 58% respectively. The second experimental arm testing tremelimumab in combination with Imfinzi and chemotherapy read out but did not meet the primary endpoint. Details will be presented at a forthcoming medical meeting, AstraZeneca said.
Novartis – Swiss pharma giant Novartis announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class investigational treatment for hyperlipidemia in adults. Hyperlipidemia refers to the high level of lipids (fats, cholesterol, triglycerides), such as LDL-C, found in the blood that are either acquired or from genetic disorders3. LDL-C is the most readily modifiable risk factor for Atherosclerotic Cardiovascular Disease (ASCVD). The pooled analysis of the ORION-9, -10 and -11 Phase III trials showed a durable and potent reduction in LDL-C of 51% when used in addition to other lipid-lowering therapies (LLT) over 17 months of treatment. Inclisiran is currently under review by the FDA and European Medicines Agency for use in adults with ASCVD or heterozygous familial hypercholesterolemia (HeFH) who have elevated LDL-C while being on a maximum tolerated dose of a LLT. If approved, inclisiran will be the first and only LDL-C-lowering treatment in the siRNA class, Novartis said. Additionally, a prespecified exploratory analysis using the safety reporting from all three trials indicated fewer MACE (major adverse cardiovascular events) with inclisiran compared to placebo. The overall safety and tolerability profile was generally similar between the inclisiran and placebo groups, the company said.
ElevateBio – Less than one year after it launched, Cambridge, Mass.-based ElevateBio, an incubator focused on the development of startup cell and gene therapy companies, secured $170 million in a Series B financing round that will be used to support the company’s next phase of growth. The Series B proceeds will enable ElevateBio to be fully operational with cGMP manufacturing and advance clinical development of at least six cell and gene therapies from across its portfolio companies to enter clinical studies this year and into 2021. The financing round was supported by the Invus Group, Surveyor Capital, EDBI and Vertex Ventures F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, and Samsara BioCapital. ElevateBio launched in May 2019 with $150 million in financing.
Jazz Pharmaceuticals – The FDA accepted Jazz Pharmaceuticals’ New Drug Application for sleep disorder drug JZP-258 under priority review. Jazz is developing JZP-258 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. JZP-258 is a novel oxybate product candidate that has less sodium than Xyrem (sodium oxybate). Low sodium is crucial due to narcolepsy’s association with an increased risk of comorbid conditions, including hypertension and cardiovascular disease. Xyrem is the only available product approved to treat both cataplexy and EDS in patients with narcolepsy ages 7 years and older and is the standard of care for treatment of cataplexy. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is July 21. Jazz presented the late-stage data of the Phase III study in September at World Sleep 2019 in Vancouver.
ZOLL Medical – The FDA approved Zoll Medical Corporation’s second-generation TherOx System, which provides SuperSaturated Oxygen (SSO2) Therapy and reduces heart muscle damage in “widow maker” heart attack patients. SSO2 Therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization via angioplasty and stenting of the blocked coronary artery. It is indicated for patients who suffer the most serious kind of heart attack. SSO2 Therapy is the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to reduce muscle damage in heart attack patients, Zoll said in a statement.
Akron – Florida-based Akron Biotech announced its expansion to a second manufacturing facility in the United States. Akron acquired a state-of-the-art 60,000-square-foot biologics manufacturing site in Sarasota, Florida. The new site bolsters the company’s U.S. capacity and strengthening its position as the industry’s premier ancillary materials supplier. The site will be operational later this year, the company said. The new site will facilitate rapid growth in each of the company’s three main cGMP business verticals: cytokines and growth factors, growth and cryopreservation media, and viral inactivated human-derived media supplements, the company said. Akron will continue to manufacture its flagship cytokine product portfolio (IL-2, IL-7, IL-15, IL-21, and others) at large scale and under cGMP compliance at its pharmaceutical manufacturing facility overseas.
Nuvo Group – Israel’s Nuvo Group received clearance from the FDA to market INVU, prescription-initiated, protocol-driven remote monitoring platform that offers measurements of fetal and maternal heart rate via a wireless sensor band. The INVU platform will be available by prescription from a healthcare provider who will initiate and schedule remote monitoring sessions.
