Respiratory syncytial virus (RSV) continues to be a tough indication to make progress in. Enanta Pharmaceuticals Inc.’s phase IIb study of otherwise healthy adults treated with EDP-938, an N-protein inhibitor, missed its primary endpoint of reduction in total symptom score compared to placebo. It also missed the study’s secondary antiviral endpoints. Buoying Enanta’s hopes for the candidate was finding a statistically significant number of participants with undetectable RSV RNA compared to placebo. EDP-938 has plenty of work lined up for it as it’s in a phase II study of pediatric RSV patients and a phase IIb study of adult hematopoietic cell transplant recipients with RSV. The Watertown, Mass.-based company’s stock (NASDAQ:ENTA) had dropped about 10% soon after the market open; it had recovered about half the losses by midday.
Inceptor Bio raises $37M to advance triplet of CAR therapies
Inceptor Bio LLC, a company developing cell therapies for difficult-to-treat cancers, has closed a $37 million series A financing led by Kineticos Ventures, a fund founded by Inceptor CEO, Shailesh Maingi. Altogether, about 40 investors have committed to supporting the company's ongoing progress, he told BioWorld. Proceeds from the round, which follows a $26 million seed financing in 2021, will support moving Inceptor's lead CAR T program into phase I testing and continued development of a rare CAR-macrophage program and a CAR-natural killer cell program.
Shares in Bavarian Nordic pop following monkeypox vaccine order
Shares in Bavarian Nordic A/S jumped after the company received an order of its monkeypox vaccine from an “undisclosed European country.” The order comes amid a small but growing number of cases of monkeypox in Europe, with nine reported in the U.K. and further cases in Portugal and Spain bringing the total in the continent to more than 20. Shares in the company (CPH:BAVA) closed up more than 29% in afternoon trading to DKK183 (US$26.04), recovering from a bad day earlier this month when Johnson & Johnson terminated deals for HBV and HPV vaccines.
Almirall taps into Evotec discovery platform in dermatology alliance
Evotec AG and Almirall SA have entered a multitarget drug discovery alliance focused on severe skin disease, from which Evotec could earn up to €230 million (US$243.5 million) in per-program milestones. It is also receiving an undisclosed up-front payment, research funding and, should any products reach the market, it would also bank sales royalties in the high-single-digit percentage range. Hamburg, Germany-based Evotec is responsible for drug discovery and preclinical development, while Barcelona, Spain-based Almirall will handle clinical development and commercialization. The companies have not disclosed the drug targets they will focus on, but have identified atopic dermatitis and non-melanoma skin cancers, such as basal cell carcinoma, as examples of the conditions they will address.
New findings help to identify those most at risk for developing severe COVID-19 complications
Findings from three recent studies are shedding light on the pathways that are activated in severe cases of COVID-19, paving the way for earlier diagnosis and more targeted treatments.
ACIP considers whether to give US kids a boost
The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) started its meeting today on a somber note as CDC and committee officials recognized the 1 million Americans who have died from COVID-19 over the past two years. That number is continuing to climb, as another surge of infections is washing over the country, CDC Director Rochelle Walensky said, especially among older people and those who are immunocompromised. Over the past few weeks, the country has seen a steep increase in hospitalizations of older Americans, she noted, adding that many of those being hospitalized haven’t received a booster within the past six months. But today, ACIP is focused on younger Americans, as the committee decides whether to recommend boosters for children 5 to 11 years old following the FDA’s authorization Tuesday of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for that age group.
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