Chidamide

HUYABIO eyes frontline melanoma with Phase III winWith its focus on ivonescimab, Summit sells antibiotic to BiossilLyora raises $2.5M for retinal gene therapies HUYABIO eyes frontline melanoma with Phase III winHUYABIO International said its global Phase III trial of HBI-8000 in combination with Bristol Myers Squibb's anti–PD-1 antibody Opdivo (nivolumab) met its primary endpoint in patients with advanced melanoma, possibly putting a first-line indication within reach.In the 404-patient study, those receiving the combo achieved median progression-free survival of 11.7 months, compared to 7.4 months for Opdivo plus placebo, translating to a 58% benefit in favour of the HBI-8000 arm. Overall survival data weren't disclosed; additional analyses are underway and detailed results will be presented at a future medical meeting.HBI-8000 is an oral histone deacetylase (HDAC) inhibitor already approved for certain lymphoma indications in China and Japan, where HUYABIO says it has been used in more than 90,000 patients. "We believe HBI-8000 will become an important addition to the standard of care [in melanoma]," said CEO Mireille Gillings.-Anna BratulicWith its focus on ivonescimab, Summit sells antibiotic to BiossilSummit Therapeutics said Tuesday it has sold the late-stage antibiotic ridinilazole to Biossil for $500,000 upfront. The drugmaker, which is working towards the US approval of PD-1/VEGF bispecific ivonescimab for lung cancer, is also eligible for up to $104.5 million in regulatory and commercial milestones, plus tiered royalties.Prior to the sale, Summit completed the Phase III Ri-CoDIFy study of ridinilazole in patients with a C. difficile infection. The company reported in late 2021 that ridinilazole had a higher observed sustained clinical response rate than vancomycin, but did not meet the study’s primary endpoint for superiority within the established time boundaries. "Recurrent C. difficile infection, selection of antibiotic-resistant genes, and gut dysbiosis are common, burdensome, and in need of new approaches," said Biossil Chief Science Officer Alexander Mosa. "We thank Summit for entrusting us with continued development of ridinilazole, and we will advance this programme with urgency and focus."-Elizabeth EatonLyora raises $2.5M for retinal gene therapiesLyora Therapeutics launched on Tuesday with $2.5 million in pre-seed funding to advance its in-licensed portfolio of preclinical-stage genetic medicines for inherited retinal diseases. Each of the biotech's assets are intended to be "one-and-done" therapies. LYA-101 is designed to treat retinitis pigmentosa caused by pathogenic variants in the PRPF31 gene, and LYA-102 is a CRISPR-based therapy aimed at addressing mutations in exon 13 of the USH2A gene to treat Usher Syndrome Type 2. The startup has an exclusive option to license from Editas Medicine certain rights applicable to USH2A gene editing.Lyora plans to submit an IND for LYA-101 within the next 18 months, with an application for LYA-102 shortly after.-Elizabeth Eaton