Idrx Inc. launched with a $122 million oversubscribed series A round to boost precision drug combinations in cancer, with a first focus on non-PDGFR-driven gastrointestinal stromal tumors (GIST). The Plymouth, Mass.-based firm aims to develop a pairing, potentially with add-ons, powerful enough to handle existing mutations and those that turn up during treatment. Combo therapy attacks “not just the driver mutations, but also the key secondary mutations,” co-founder and CEO Ben Auspitz told BioWorld, and thereby “block every escape route the cancer has.” Read More
Beta-site APP-cleaving enzyme 1 (BACE1) inhibitors have a long history of failure in patients with Alzheimer’s disease. Clinical development of verubecestat, elenbecestat, lanabecestat, umibecestat, atabecestat and LY-3202626 were all discontinued. The drugs largely showed that inhibiting BACE1 reduced amyloid beta (AB) in both cerebrospinal fluid and plasma, reduced AB plaques on PET scans and reduced phosphorylated tau. Unfortunately, patients had early cognitive worsening, and there were signs of lowering of brain volume and increases in psychiatric adverse events. Read More
Lepu Biopharma Co. Ltd. has been given conditional approval by China’s NMPA for its anti-PD-1 monoclonal antibody, Puyouheng (pucotenlimab injection), based on data from a phase II study. The drug was conditionally greenlighted for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors. Read More
As omicron subvariants of the SARS-CoV-2 virus take hold, global cases began to rise in the past month, just as the U.S. authorized its fourth COVID-19 vaccine and developers continue their work on a fall booster targeting BA.4 and BA.5. Worldwide deaths have remained lower than each of the last two pandemic years, signaling that the worst is over. It is clear, however, that as current treatments lose their effectiveness and the virus continues to evolve, efforts to contain the virus will be ongoing. Read More
Big pharma is increasingly turning to Taiwan to leverage the power of the country’s data and computing power as precision medicine takes center stage in drug development, speakers said during the recent BIO Asia-Taiwan conference in Taipei. Read More
How many patents does it take to violate U.S. antitrust law? That question isn’t a lead-in to a lame joke. Neither is it a valid question for a patent challenge, according to the U.S. Court of Appeals for the Seventh Circuit, which Aug. 1 affirmed the dismissal of a payer suit against Abbvie Inc. that claimed the North Chicago drug company violated the Sherman Antitrust Act when it obtained 132 patents on Humira (adalimumab) and then invoked them against biosimilars. Read More
In the biopharma industry, the sirtuins have been a cautionary tale of some of the challenges in translating aging research. Research in the early aughts suggested that activating them could extend lifespan, and the spectacular rise of sirtuin activators crested in 2008, when GSK plc bought preclinical startup Sirtris Pharmaceuticals Inc. to the tune of $720 million, only to shutter it a few years later. But the hopes attached to sirtuin activators have not panned out. Read more in part seven of BioWorld’s multipart series on extending the human lifespan. Read More
In Extending the human lifespan, a BioWorld special report, the team examined the latest science, the key biological drivers that can be targeted pharmacologically and the companies developing potential “Fountain of Youth” candidate drugs. In this episode of the BioWorld Insider Podcast, the team discussed the report’s highlights and key takeaways.
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Aileron, Amphera, Bioinvent, Concert, Cymabay, Evofem, Eyepoint, Hutchmed, Immutep, Innate, Innovent, Syneurx, Verrica, Vivoryon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Greenlight, Qualigen, Scisparc, Stealth, VBL. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Arcutis, Armata, Beam, Biosight, Celyad, Eccogene, Eledon, Gamida, Janssen, Krystal, Pharming, Scynexis, Veru, Zenas. Read More
