Phase 1
Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
Bristol Myers Squibb acquired the degrader-antibody conjugate from Orum Therapeutics in 2023 for $100 million upfront and the possibility of up to $80 million more in milestones.
Structure Therapeutics’ oral GLP-1 candidate aleniglipron showed 72-week efficacy “in line” with Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote in a note to investors. Meanwhile, Structure’s amylin and calcitonin receptor agonist ACCG-2671 showed “impressive” target engagement in a Phase 1 trial of healthy volunteers, according to Leerink Partners.
The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.
Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
Not much is known about Boehringer Ingelheim’s drug candidate, dubbed BI 3031185, though the asset has completed at least two other Phase 1 studies this year.
Touting an “exceptional” gastrointestinal safety profile for its oral obesity drug candidate in a study of healthy volunteers, Enveda plans to test the asset in people stopping GLP-1 treatment.
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.
Just weeks after Pfizer’s Seagen-acquired antibody-drug conjugate sigvotatug vedotin failed a Phase 3 non-small cell lung cancer study, the big pharma has quietly culled another program being developed by the ADC specialist.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
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