Those affected by primary biliary cholangitis (PBC) are fighting back against the recommendation by the EMA that the marketing authorization for Ocaliva (obeticholic acid), a second line treatment used by 7,000 patients in Europe, be withdrawn. Earlier today, patients and their supporters staged a protest outside the European Commission building in Brussels to oppose the EMA’s position that Ocaliva’s conditional license should be revoked. Adding to the pressure, the PBC Foundation, based in Edinburgh, U.K., and representing 16,000 patients with the rare, progressive liver disease, now has over 2,000 signatures on a petition calling for the voice of patients to be factored into regulators’ decisions.
FDA pushes to up the ante for NSCLC perioperative add-ons
“We are not a victim of our past actions. That was then,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, told the Oncologic Drugs Advisory Committee today as he explained why the FDA raised a flag on Astrazeneca plc’s use of a two-arm trial to support an sBLA for its PD-L1 immunotherapy Imfinzi (durvalumab) as an add-on perioperative regimen to treat resectable non-small-cell lung cancer (NSCLC). Yes, a similar drug was approved for perioperative use based on a two-arm trial. But more is known now, Pazdur said. The major reason the FDA convened the adcom is because it doesn’t want to perpetuate the use of two-arm trials for other perioperative regimens, one official said, noting the number of similar trial designs the agency is receiving. Two-arm trials are appropriate for either neoadjuvant or adjuvant add-ons, but not for regimens including both, agency reviewers said.
Viking presses obesity programs forward and investors like it
Viking Therapeutics Inc. is diving more deeply into developing obesity treatments and investors like an accelerated timetable the company has proposed. At midday, Viking shares (NASDAQ:VKTX) had catapulted 38% to $69.55 each. Viking said it is placing injectable VK-2735, a glucagon-like peptide 1 receptor and glucose-dependent insulinotropic polypeptide receptor agonist, into a phase III study of obesity while a phase II of an oral dose is expected to begin in the fourth quarter of 2024. Viking reported 14.7% weight reduction at 13 weeks in phase II testing, with solid phase I results from an oral version reported in March 2024. Viking also plans to file an IND for its amylin agonist candidate in obesity near year.
SK Bioscience invests SAFE-ly in Sunflower
SK Bioscience Co. Ltd. signed a simple agreement for future equity (SAFE) deal totaling $2 million with Hingham, Mass.-based Sunflower Therapeutics PBC on July 25 to secure both Sunflower’s equity and its yeast-based protein manufacturing technology. The conditional agreement will grant SK Bioscience future equity rights in Sunflower without the need for immediate valuation, allowing for minimal investment. Popular among startups, SAFE agreements are usually triggered at the occurrence of a priced investment or funding round, or a liquidity event. The investment pathway was first offered in 2013 and introduced in Korea in 2020.
Alkira Bio exits stealth via seed round to develop GPCR-targeting antibodies
Alkira Bio, a new spinout from Australia’s Florey Institute of Neuroscience and Mental Health, has emerged from stealth mode thanks to seed funding from Curie.bio. Although the amount of funding is not disclosed, Curie.bio typically invests $5 million to $10 million in a founder company and then co-pilots the drug discovery program, deploying drug development experts to its portfolio companies to help navigate decision-making as part of the deal, Florey researcher turned Alkira Bio CEO Daniel Scott told BioWorld.
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