More evidence of interest by major players in the microbiome came as Second Genome Inc. (SG) sealed a deal with Gilead Sciences Inc. valued at potentially more than $1.5 billion. The arrangement brought $38 million up front for SG and involves as many as five of Gilead’s pipeline compounds against inflammation, fibrosis and other diseases. The term sheet also includes efforts to identify potential new targets and candidates in inflammatory bowel disease. Gilead will pay as much as $300 million or so if preclinical, clinical, regulatory and commercial milestones are met in each of the five target discovery programs, plus low double-digit royalties for any approved products.

Immunomedics stock soars as efficacy signal prompts early halt of phase III TNBC trial

DUBLIN – Immunomedics Inc. is stopping the phase III Ascent trial of its antibody-drug conjugate, sacituzumab govitecan, in triple-negative breast cancer (TNBC) on the unanimous recommendation of the study’s independent data safety monitoring committee, after a scheduled look at the study data uncovered what the company called “compelling efficacy.” The move triggered an investor frenzy Monday, which propelled the Morris Plains, N.J.-based company’s stock (NASDAQ:IMMU) up by 179% during premarket trading to a new one-year high of $26.25.

Biopharmas keep cash rolling in despite decline in financial markets 

Although public offerings slowed considerably in March as a result of the steepest stock market declines in history during that period, global biopharmaceutical companies managed to collectively generate just over $16 billion in the first quarter from a record number public and private transactions. Only the first quarter of 2018 saw more cash raised in the past decade, according to BioWorld data.

Millendo quits Prader-Willi syndrome program after pivotal miss

Shares of Millendo Therapeutics Inc. (NASDAQ:MLND) fell nearly 68% by midday after a pivotal study of its experimental Prader-Willi syndrome (PWS) therapy, livoletide, failed to show a statistically significant improvement in hyperphagia and food-related behaviors vs. placebo. As it discontinues livoletide's development in PWS over the outcome, the Ann Arbor, Mich.-based company said it would turn its attention to developing nevanimibe for congenital adrenal hyperplasia and MLE-301 for menopausal vasomotor symptoms.

Izana’s namilumab joins testing for COVID-19 arsenal as data point to GM-CSF as target for severe disease

LONDON – Izana Biosciences Ltd. has become the third company to supply an anti-GM-CSF antibody for compassionate use against COVID-19, announcing namilumab, currently in phase IIb testing in the treatment of rheumatoid arthritis and ankylosing spondylitis, will be used to treat 20 patients with severe respiratory symptoms. The trial, at two centers in Italy, shows how increased understanding of the pathology is shifting the focus of clinical development in COVID-19. Following the first rush to test approved and advanced-stage antiviral drugs against the coronavirus infection, a second wave of trials is being set up, with the aim of blocking the immune cascade that is now known to cause severe respiratory failure in patients with advanced disease.

Menlo's serlopitant whiffs in two phase III studies 

Shares of Menlo Therapeutics Inc. are down 47% in midday trading after serlopitant failed two phase III trials testing the drug as a treatment for pruritus (itch) associated with prurigo nodularis. In both studies, serlopitant performed better than placebo, but the differences weren't statistically significant. Menlo is turning its focus to Amzeeq (minocycline), its acne medication that was launched at the beginning of 2020, and FMX-103, which is under FDA review with a PDUFA date of June 2, as a treatment for papulopustular rosacea.

In a second successful phase III, Axsome’s oral migraine treatment hits primary endpoints

Axsome Therapeutics Inc. said the INTERCEPT phase III top-line data for its oral migraine candidate, AXS-07, hit both co-primary endpoints, freedom from migraine pain and freedom from the most bothersome symptoms as compared to placebo, in early acute treatment. The company said ANX-07’s NDA for acute treatment of migraine is still on track for the fourth quarter of this year. The company stock (NASDAQ:AXSM) did little better than shrug, climbing a modest 3% to $56.74 per share in midday trading. Those shares had plenty of momentum already behind them in the past 12 months, having risen from a low of $13.25 nearly a year ago, then dramatically surging in late December to $103.83 when AXS-07 hit its co-primary and key secondary endpoints in the phase III MOMENTUM trail in migraine patients with a history of inadequate response.

Ansun Biopharma reveals positive results for novel COVID-19 candidate

HONG KONG – Another promising candidate has emerged in the race to find a treatment for the COVID-19 coronavirus. San Diego-based Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection. The clinical-stage recombinant biologic was evaluated as a 10-day treatment regimen of nebulized DAS-181 administered to four patients with severe bilateral viral pneumonia and hypoxemia. It seems that it may help reduce or eliminate some of the most significant symptoms associated with COVID-19.

India looks to cut reliance on China for APIs

NEW DELHI – In a bid to limit what is seen as excessive dependence on active pharmaceutical ingredients (APIs) from China, the Indian government has announced a $394 million scheme to promote the development of three bulk drug parks. The government would use the funds to finance infrastructure construction over the next five years at the three industrial parks focused on the manufacturing of APIs and bulk drugs. For India, the concern is that continuing to depend on China for the vast majority of APIs could impact drug manufacturing. Efforts to battle COVID-19 have brought those fears to the forefront.

Free access to BioWorld coronavirus articles

The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. Note that we have added three critical tables which are constantly updated:

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