GILEAD SCIENCES SL

Gilead and Tubulis enter exclusive license deal to develop ADC candidate for solid tumor target, with $20M upfront, $30M option fee, and up to $415M in milestone payments. The partnership leverages Tubulis' Tubutecan and Alco5 platforms to enhance ADC stability and reduce toxicity.

The global HIV clinical trials market is projected to grow from USD 1.30 billion in 2024 to USD 2.42 billion by 2034, at a CAGR of 6.4%. Key factors driving growth include increasing HIV infections, R&D investments, drug approvals, and HIV vaccine trials. Phase I trials held the largest revenue share in 2024, while the Asia Pacific region is expected to register the fastest growth. Major companies like Gilead Sciences and Janssen Global Services are significant contributors to the market.

Lenacapavir injections, given every six months, were 96% effective in preventing HIV infection in a clinical trial, outperforming daily oral PrEP medications. The study involved diverse at-risk populations and showed high adherence rates with lenacapavir, though some participants developed resistance. Future research is needed to address resistance and ensure broader access, especially in low- and middle-income countries.

Gilead Sciences invested $20 million in an exclusive option and license agreement with Tubulis to develop novel antibody-drug conjugate therapies for solid tumors, potentially totaling up to $415 million. The partnership aims to leverage Tubulis' Tubutecan platform for ultra-stable ADCs, following Gilead's recent setbacks with Trodelvy in bladder and lung cancer trials.

The pandemic accelerated the shift to decentralized clinical trials (CTs), making them more accessible and inclusive. The FDA issued guidance supporting decentralized elements in CTs, but industry adoption lags. Geographic disparities in CT participation persist, with 50% of trials in less than 2% of U.S. ZIP codes. Technology and community engagement are key to overcoming these barriers, ensuring equitable participation and better patient outcomes.

The Red Biotechnology Market, valued at USD 492.71 billion in 2023, is projected to reach USD 997.42 billion by 2032, driven by increasing R&D spending and advancements in genomics. Key players include Merck, F. Hoffmann-La Roche AG, and Pfizer. The market focuses on medical and pharmaceutical applications, including drug discovery and genetic modification, with growth opportunities in personalized medicine and AI integration. Challenges include regulatory and ethical concerns.

Abingworth seeks to raise up to $1.5 billion for biopharma clinical development in return for royalties, aiming to support up to eight late-stage trials. This follows earlier deals with Gilead and Teva, where Abingworth funded clinical studies in exchange for fixed payments and royalties on sales.

HepB-CpG vaccine (2 or 3 doses) achieved superior HBV seroprotection in HIV-positive individuals with prior nonresponse to hepatitis B vaccine, compared to conventional HepB-alum vaccine (3 doses).

Research in HIV is shifting towards PrEP therapies due to vaccine failures; Dr. Jonathan Weber highlights the challenges in HIV vaccine development, including lack of animal models and natural immunity, and predicts future investment will focus on long-acting PrEP due to its cost-effectiveness and transformative potential in preventing transmission.

Gilead Sciences announces 100% effective twice-yearly HIV prevention shot for women, with promising results in men. Controversy arises over exclusion of Latin American countries from generic distribution, despite rising HIV rates, prompting calls for equitable access to combat the AIDS epidemic.