DUBLIN – Genentech has succeeded where Sanofi SA and its partner, Regeneron Pharmaceuticals Inc., have failed, in obtaining some sort of a positive signal from a clinical trial of an interleukin-6 (IL-6) inhibitor in COVID-19. Genentech, a subsidiary of Basel, Switzerland-based Roche Holding AG, reported Sept. 18 that hospitalized patients who received Actemra/RoActemra (tocilizumab) plus standard of care were 44% less likely to require mechanical ventilation than those on standard of care only. The treatment did not improve survival, however.

Athira, Compass and Humanigen enjoy a fabulous Friday with hot stock sales

Upsized IPOs for neurodegenerative specialist Athira Pharma Inc. and the high-profile psychedelics venture Compass Pathways plc burst onto Nasdaq Friday, climbing fast alongside a well-received follow-on offering from cytokine storm fighter Humanigen Inc. Athira (NASDAQ:ATHA) raised $204 million, while Compass Pathways (NASDAQ:CMPS) brought in $127.5 million. Humanigen (NASDAQ:HGEN) raised $68 million.

New medicines in the pipeline to treat sickle cell disease

The CDC estimates that sickle cell disease affects well over 100,000 Americans with the disease occurring most often in African Americans. September has been designated as National Sickle Cell Awareness month designed to focus attention on the ongoing research in this field and the need for new treatments. The sector can certainly point to the significant progress that has taken place during the past few years, with new medicines reaching the market and several novel therapeutics with new mechanisms of action advancing in the pipeline.

Astrazeneca, Innate revise phase III milestone terms; ‘not as bad as it looks’?

The move to retool Innate Pharma SA’s deal for monalizumab with Astrazeneca plc put the jitters into some investors. A first-in-class antibody that targets an inhibitory receptor, NKG2A, expressed by natural killer cells and cytotoxic T lymphocytes, monalizumab is set to enter a phase III combo study with cetuximab in the second half of this year. Under the previous terms, Innate was set to collect a $100 milestone payment when the trial starts; the parties have agreed that Astrazeneca will pay $50 million instead, with the another $50 million potentially coming if monalizumab reaches an interim clinical threshold. Wainwright analyst Swayampakula Ramakanth said the switch is “not as bad as it looks,” but others are less optimistic.

Amytrx launches and puts its anti-inflammatory peptide into the clinic

Amytrx Therapeutics Inc., of Nashville, Tenn., founded in 2014 but launching now, is developing a therapeutic that could possibly be used to treat multiple inflammatory, autoimmune and metabolic diseases. Amytrx acquired AMTX-100 from Vanderbilt University and then brought in an $11 million series A fundraiser to bolster its pipeline. AMTX-100, bioengineered from human protein sequences, is a cell-penetrating anti-inflammatory peptide that targets importins. The peptide is in a phase I/IIb trial for treating moderate atopic dermatitis. The company’s preclinical program includes developing AMTX-100 into injectable, oral, eye drop and nasal spray versions.

Cuba works to develop SARS-CoV-2 vaccine shrouded in secrecy

CAJICA, Colombia - The Cuban government announced the successful development of a COVID-19 vaccine but little is known about it beyond announcements that it has already started phase I trials. Cuba’s ruling regime appears confident of the outcomes of the trials that started in August and that aim to demonstrate the vaccine´s safety and efficacy in preventing the new coronavirus. The island nation is looking for partners, but for now, little information on the vaccine has been released to the international community.

FDA approvals on par with last year; regulatory news slower in August

While COVID-19 is responsible for about 14% of the regulatory data collected by BioWorld in 2020 and even though numerous clinical trials have suffered delays, the pandemic does not appear to have slowed the pace of the FDA’s approval process.

Also in the news

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