GENENTECH, INC.

Genprex completed Phase 1 of Acclaim-3 trial, showing REQORSA and Tecentriq safe for ES-SCLC patients. The Safety Review Committee approved Phase 2 expansion, with REQORSA's Recommended Phase 2 Dose set at 0.12 mg/kg. The trial aims to determine 18-week progression-free survival rates.

Genprex completed Phase 1 of Acclaim-3 trial, showing REQORSA and Tecentriq safe for ES-SCLC patients. The Safety Review Committee approved Phase 2 expansion with a recommended dose of 0.12 mg/kg. The trial aims to determine 18-week progression-free survival rates.

At the 2024 San Antonio Breast Cancer Symposium, experts discussed FDA approvals for ribociclib and inavolisib in HR+/HER2- BC, emphasizing treatment optimization, clinical trial design, and addressing ovarian/reproductive toxicities. Ribociclib's approval was based on NATALEE trial data showing improved invasive disease-free survival (iDFS) with safety concerns. Inavolisib, targeting PIK3CA mutations, showed improved progression-free survival (PFS) with post-marketing commitments for further evaluation. The session highlighted the need for comprehensive data analysis and monitoring of fertility impacts.

VEGF-A therapy has revolutionized nAMD treatment, but real-world outcomes often differ from clinical trial results. Newer agents like sozinibercept aim to improve VA beyond current standards, with ongoing phase 3 studies (ShORe and COAST) evaluating its efficacy.

The global spinal muscular atrophy market is projected to grow from USD 2,013.5 million in 2024 to USD 4,823.9 million by 2031, at a CAGR of 13.3%. Key drivers include FDA approvals for drugs like Zolgensma and Evrysdi, rising awareness, and increasing gene therapies. North America is expected to dominate due to its established healthcare infrastructure.

R.C.P. consults for Roche, Genentech, Eli Lilly, Eisai, and Novo Nordisk; receives royalties from Oxford and UpToDate; and provides educational support for Medscape.

The 42nd anniversary of FDA approval for human insulin synthesized via genetic engineering marks a pivotal moment in biotechnology, launching a revolutionary era in drug development. This milestone, covered extensively in the press, addressed a critical need for diabetes treatment, transitioning from animal-derived insulin to human-identical insulin produced in bacteria. The rapid approval process, despite initial bureaucratic hesitations, demonstrated the scientific and commercial viability of recombinant DNA technology, significantly impacting the biotechnology industry. However, the current drug approval process remains lengthy and costly, highlighting the need for regulatory improvements.

Global Personalized Medicines Market to grow from USD 588.31 Million in 2023 to USD 1,007.05 Million by 2031, driven by advancements in genetic technology and rising prevalence of rare diseases. North America leads in demand due to high healthcare expenditure, while Asia-Pacific shows the fastest growth. Market segments include diagnostics, genetic testing, and end-uses like hospitals and diagnostic centers. Key players are investing in R&D and collaborations, and insurance coverage and healthcare budgets are expanding.

An 1800 mg dose of MTPS9579A, an anti-tryptase antibody, did not inhibit high tryptase levels in bronchial lining fluid (BLF) in uncontrolled asthma patients, according to studies published in *Allergy*. The phase 2a study, conducted from October 2019 to May 2022, did not achieve its primary endpoint of reducing exacerbation events. The phase 1c trial found MTPS9579A concentrations in BLF were 6.8-fold lower than in nasal lining fluid (NLF), and no correlations were found between NLF and BLF samples for active or total tryptase. The researchers concluded that tryptase remains an important target for asthma treatment despite the negative results.

Positive phase 3 results for obinutuzumab in lupus nephritis showed higher complete renal response rates compared to standard therapy alone, with no new safety concerns.