Privately held, Seattle-based Silverback Therapeutics Inc. brought in an oversubscribed $78.5 million series B financing to help drive its anti-HER2 antibody conjugated to a TLR8 agonist into the clinic by year’s end. The compound, designed to treat moderate or high HER2-expressing tumors, is also being readied for an NDA this year, company officials said. Preclinical data show the company’s SBT-6050 mouse surrogate is curative as a single agent in a human xenograft model lacking T, B and NK cells, which demonstrated myeloid cells potential mediate antitumor activity.

Medday’s confirmatory phase III in MS missteps

In a second pivotal phase III trial for treating progressive forms of multiple sclerosis, designed confirm the successful first trial, Paris-based Medday Pharmaceuticals SAS’ investigational MD-1003 failed to hit its primary and secondary endpoints. The primary endpoint was reversing functional disability while secondary endpoints included the relative reduction of disability progression risks and the time taken by patients to walk 25 feet. MD-1003 is a neurometabolic modulator targeting neurodegenerative and demyelination. The 642 patients received three daily doses of 100 mg of MD-1003 or a placebo in the randomized, double-blind study.

FDA’s Hahn: need to deploy test for SARS-CoV-2 across platforms delayed development

FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings. Hahn was grilled about the fact that South Korea had deployed many more tests for the underlying pathogen, but he noted that U.S. tests have to operate on a wide range of testing platforms, which has complicated the task of test development in the U.S.

Australia’s Mesoblast plans to evaluate its stem cell therapy in patients infected with COVID-19

PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe. The company is in active discussions with various governments, regulatory authorities, medical institutions and pharmaceutical companies to implement these activities.

CROI 2020: With Uhambo’s and research lessons, once more unto the breach

Continuing improvements in HIV treatment and progress towards a cure notwithstanding, an effective vaccine will be necessary to gain the upper hand in the decades-long fight against the pandemic. The final day of the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) included both a look back on the failed HVTN702/UHAMBO trial, and a plenary talk on how future vaccination efforts might do better.

Bills to ensure safety, supply of drugs and devices begin journey to passage

Taking a step back from the political rhetoric that’s infused the U.S response to COVID-19 and delayed, if not derailed, legislation aimed at lowering drug prices, a House subcommittee today is marking up several bipartisan bills intended to improve the safety and ensure the supply of drugs and medical devices. Meanwhile, President Donald Trump weighed in on drug pricing, calling on Congress to finally pass a bill to rein in those prices. He laid out basic principles a bill must have to get his signature, first of which is that it has to be bipartisan.

Australian investors cough up AU$53M to tackle a different global pandemic

PERTH, Australia – While the coronavirus captures the world’s attention, another global pandemic is quietly killing 100 million people under the age of 60, and Australian investors are putting up AU$53 million (US$34.58 million) to back late-stage projects at the George Institute for Global Health. In one of the country’s largest-ever private-public health partnerships, George Health Enterprises will receive AU$33 million from Federation Asset Management and health care provider Bupa to accelerate development of an innovative drug and technology pipeline born from The George Institute’s research program.

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Airway, Aytu, Biosight, Brii, Bristol Myers Squibb, Burke, Can-Fite, Cannabics, Cocrystal, Creative Medical Technology, Forty Seven, Gilead, Hitgen, Ideaya, Innovate, Janssen, Kaken, Kala, Kamada, Lifesci, Mallinckrodt, Medday, Medigene, Mylan, Newron, Nicox, Ocumension, Oncosec, Oncternal, Paratek, Pascal, Phio, Redhill, Rocket, Sanofi, Seelos, Sophiris, Sōrse, Spero, Tiziana, Verrica, Vir