The July 25 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) could impact the future development of immune checkpoint inhibitors, such as Astrazeneca plc’s Imfinzi, to treat patients with non-small-cell lung cancer (NSCLC) both before and after surgery. Although much of the discussion will focus on an sBLA for Imfinzi (durvalumab), the committee will be asked to vote on whether the FDA should require that new trial design proposals for perioperative regimens for resectable NSCLC include adequate within-trial assessment of the contribution of the treatment phase to efficacy results.
Increased life expectancy also comes with age-related diseases. But what causes one to age? Although there is no single answer, scientists at Duke-National University of Singapore (NUS) have shown in mice that interleukin-11 (IL-11) promoted aging. Blocking it improved health and lifespan.
After reaching a height in 2021, seed and series A rounds have fallen in recent years, and 2024 is no exception, although amounts raised are tracking slightly ahead of last year. On July 23, the numbers were given a boost when two new companies – namely Dover, Del.-based Brenig Therapeutics Inc. and Boston-based Third Arc Bio Inc. – raised $65 million and $165 million, respectively, in series A financings. A third new company, Abiologics Inc., also received $50 million in initial funding.
The 2024 meeting of the International AIDS Society (IAS), which is being held in Munich this week, began with the announcement of another curative bone marrow transplant. The new case brings the total number of patients cured of HIV via a bone marrow transplant up to 7 since “Berlin patient” Timothy Ray Brown became the first such person in 2007.
The U.S. FDA advised Agenus Inc. to conduct a phase III trial for its immunotherapy combination, botensilimab (bot) and balstilimab (bal), instead of seeking accelerated approval based on phase II data, sending company shares plunging by 58.8% July 18.
Scinai Immunotherapeutics Ltd. has reported successful in vivo preclinical study results for its anti-IL-17A/F VHH antibody fragment (NanoAb) as a local intralesional biological treatment for mild to moderate plaque psoriasis. The NanoAb targets the two isoforms of the cytokine IL-17 (A and F) implicated in plaque psoriasis.
Lotte Biologics Co. Ltd. broke ground on its contract development and manufacturing organization (CDMO) plant at its Songdo Bio Campus in Incheon, South Korea, on July 3 to grow its production capacity and set “a new standard” for Korean CDMOs in the global market.
Lotte Biologics Co. Ltd. broke ground on its contract development and manufacturing organization (CDMO) plant at its Songdo Bio Campus in Incheon, South Korea, on July 3 to grow its production capacity and set “a new standard” for Korean CDMOs in the global market.
Glycoprotein VI (GPVI) is a platelet collagen receptor involved in platelet activation and an emerging target for treating thrombotic disorders such as ischemic stroke. Data have been presented by University of Würzburg scientists regarding a humanized anti-GPVI Fab antibody, EMA-601, with unprecedented potency in vitro and in vivo.
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