Resolution Therapeutics Ltd. is preparing for a phase I/II trial of its autologous engineered macrophage cell therapy, RTX-001, in the treatment of end-stage liver disease and has raised £63.5 million (US$83.3 million) to complete the study and to add further fibrotic and inflammatory disease programs to its portfolio. Recruitment to the study, to be conducted at 15 sites in Spain and the U.K., is due to start before the end of 2024, with the monocyte-derived patient macrophages being processed and modified at a facility in Edinburgh.

Enara’s ‘dark antigen’ work draws more pharma backing in series B

Dark genome miner Enara Bio Ltd. has closed a $32.5 million series B that will see the lead program targeting the first of a novel class of cancer antigens it has discovered through to the clinic. Enara calls these cancer antigens “dark antigens.” It says they can be found in solid tumors irrespective of the immune phenotype, and are often expressed at high prevalence across multiple different tumors.

Engene, CG, J&J bids in bladder cancer weighed

Developers continue their march toward new drugs for non-muscle invasive bladder cancer, with Engene Holdings Inc. the latest to offer news. The firm rolled out pivotal phase II data with non-viral gene therapy detalimogene voraplasmid (also known as detalimogene, and previously as EG-70), along with a planned protocol refinement. Detalimogene is in an ongoing study in patients who have high-risk, Bacillus Calmette-Guérin-unresponsive disease with carcinoma in situ. Other names prominent in the space include CG Oncology Inc. and Johnson & Johnson.

US CMS sets playing field for next round of Rx price negotiations

Round 2 of the U.S. Medicare price negotiations officially began late yesterday with CMS’ release of its final playbook and timeline, which build on lessons learned from the first round and comments on a draft guidance that was published in May. In response to the feedback CMS received, the second round will allow for more patient-focused sessions and offer increased engagement with the makers of the drugs selected for negotiations. The second round is intended to be more expansive, with the selection of up to 15 sole-source Part D drugs that account for some of the largest Medicare expenditures. However, since CMS considers drugs with the same moiety as one drug for the sake of the negotiations, more than 15 drugs actually could be forced into the negotiation process.

Septerna joins IPO queue; 23 biopharma debuts reach $5.9B

South San Francisco-based Septerna Inc. filed an S-1 with the U.S. SEC to conduct an IPO on Nasdaq about two years and eight months after launching operations with a $100 million series A led by Third Rock Ventures. Upon pricing and closing of the IPO, shares will list under the ticker symbol SEPN. The company is focused on G protein-coupled receptor (GPCR) oral small molecules derived from its Native Complex Platform. The filing comes on the heels of Bioage Labs Inc., of Richmond, Calif., closing its $227.7 million IPO and concurrent $10.6 million private placement on Oct. 1. Bioage’s IPO is the 23rd biopharma company debut completed this year, according to BioWorld data, bringing the total amount raised to $5.9 billion.

BioWorld Insider podcast: Capricor’s CEO pursues a BLA and talks rare disease

Capricor Therapeutics Inc. just wrapped up a visit with the U.S. FDA and is prepping to file a BLA in October for its Duchenne muscular dystrophy treatment. Linda Marbán, Capricor’s CEO, is the guest on the newest BioWorld Insider podcast and she talks about deramiocel (CAP-1002), the company’s allogeneic cardiac-derived cell therapy, for treating the rare disease and how the FDA has made strong efforts in helping lay the groundwork for deramiocel. Marbán has been working on the Duchenne treatment for many years and she has strong insights into how to tackle a rare disease development program and how the FDA has changed its ways over time to help out. She has been in the biopharma space for more than 20 years and also is a co-founder of Capricor.

Also in the news

AAX, Allarity, Atai, Atyr, Bioage, Biotheus, Briacell, Codexis, Eliem, Emergent, Emergex, Frazier, Gilead, Hemogenyx, Immunoprecise, Intelgenx, Johnson & Johnson, Kazia, Laboratoires Théa, Mithradote, Mitorx, Novaliq, Organogenesis, Orum, PDS, Spyre, TNF, Triveni, Verrica, Volastra