Gilead Sciences

Sonoma Biotherapeutics Strengthens Leadership Team with Appointment of Rajesh Krishnan as Chief Technical Officer

9 days ago

• Sonoma Biotherapeutics has appointed Rajesh Krishnan, Ph.D., as Chief Technical Officer to advance their engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. • Dr. Krishnan brings over 25 years of industry experience in process development and manufacturing, most recently serving as CTO and CSO at Oncternal Therapeutics with previous leadership roles at Dynavax, Gilead, Merck, Amgen, and Pfizer. • The strategic appointment comes at a crucial time for the clinical-stage biotech company as they continue developing novel treatments aimed at restoring immune system balance through proprietary Treg cell therapy platforms.

Sylvester Comprehensive Cancer Center to Present Groundbreaking Research at ASCO 2025 Annual Meeting

a month ago

• Researchers from Sylvester Comprehensive Cancer Center will deliver 9 oral presentations, 4 rapid oral presentations, and 51 poster presentations at the upcoming ASCO 2025 Annual Meeting, showcasing significant advances across multiple cancer types. • Highlighted studies include the ADVANCE clinical trial examining novel multiple myeloma treatments, innovative virtual reality interventions for stem cell transplant patients, and groundbreaking research on alcohol-related cancer mortality in the US. • The extensive research portfolio demonstrates Sylvester's leadership in developing cutting-edge cancer therapies, addressing health disparities, and improving supportive care for diverse patient populations.

Trodelvy-Keytruda Combination Shows Promising Results in First-Line Treatment for Triple-Negative Breast Cancer

a month ago

• Gilead Sciences and Merck's phase 3 ASCENT-04/KEYNOTE-D19 trial demonstrated statistically significant improvement in progression-free survival with Trodelvy plus Keytruda compared to Keytruda with chemotherapy in metastatic TNBC patients. • The novel combination of antibody-drug conjugate (Trodelvy) with immunotherapy (Keytruda) represents a potential paradigm shift in treatment approach for aggressive triple-negative breast cancer, potentially displacing conventional chemotherapy. • Early data shows a positive trend toward improved overall survival, with detailed results to be presented at upcoming medical meetings and discussed with regulatory authorities.

Structure Therapeutics Advances Oral Obesity Drug Programs with Completed Enrollment in Key Aleniglipron Trials

3 months ago

• Structure Therapeutics has completed enrollment for ACCESS and ACCESS II trials evaluating aleniglipron in obesity treatment, with topline data expected by end of 2025. • The company's oral amylin receptor agonist ACCG-2671 is advancing toward Phase 1 trials, expanding their portfolio of oral small molecule therapeutics for metabolic diseases. • With $883.5 million in cash reserves, Structure Therapeutics is well-positioned to fund operations through 2027, supporting development of their innovative obesity treatment pipeline.

AstraZeneca Acquires FibroGen China for $160 Million, Strengthening Roxadustat Position

3 months ago

• FibroGen has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million, comprising $85 million in enterprise value plus an estimated $75 million in net cash holdings. • The strategic sale will extend FibroGen's cash runway into 2027 and enable continued development of its oncology pipeline, including the Phase 2 trial of FG-3246 for metastatic prostate cancer. • Upon closing in mid-2025, AstraZeneca will acquire all rights to roxadustat in China, where it leads the market for chronic kidney disease anemia treatment.

Xilio Therapeutics' Vilastobart Shows Promise in Metastatic MSS Colorectal Cancer

4 months ago

• Xilio Therapeutics reports a 27% preliminary response rate in heavily pre-treated MSS CRC patients without liver metastases using vilastobart and atezolizumab. • The combination therapy led to decreases in tumor biomarkers like CEA and ctDNA, along with improvements in clinical symptoms. • Vilastobart, a tumor-activated anti-CTLA-4, shows a differentiated safety profile with a low incidence of immune-related adverse events. • Xilio plans to present updated Phase 2 data later in 2025 and explore partnership opportunities to expand development beyond MSS CRC.

Nurix Therapeutics' BTK Degrader NX-5948 Shows Promise in B-Cell Malignancies and Autoimmune Diseases

4 months ago

• Nurix Therapeutics' NX-5948 demonstrates a 75.5% objective response rate in relapsed/refractory CLL/SLL patients in Phase 1 study. • NX-5948 receives PRIME designation from EMA for CLL and Fast Track designation from FDA for Waldenstrom's Macroglobulinemia. • Nurix plans to initiate pivotal trials for NX-5948 in CLL and expand development into autoimmune diseases in 2025. • The company's strong financial position, with $609.6 million in cash, supports aggressive development of its pipeline.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

IDEAYA Advances Oncology Pipeline with Novel Inhibitors and Gilead Collaboration

5 months ago

• IDEAYA Biosciences nominated IDE251, a first-in-class dual KAT6/KAT7 inhibitor, for cancer treatment, with IND submission planned for 2025, targeting breast and NSCLC. • The company is collaborating with Gilead Sciences to evaluate IDE397, a MAT2A inhibitor, with Trodelvy in MTAP-deletion NSCLC, addressing a significant unmet need. • IDEAYA nominated IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, with IND filing expected in mid-2025, enhancing its precision medicine oncology pipeline.

FDA Accepts Gilead's Lenacapavir for HIV Prevention with Priority Review

6 months ago

• The FDA has accepted Gilead's NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP). • Lenacapavir demonstrated 100% risk reduction in cisgender women and 96% risk reduction in a diverse population, compared to background HIV incidence. • The FDA has granted priority review with a target action date of June 19, 2025, potentially making it the first twice-yearly HIV prevention option. • Gilead is also pursuing global access, including submissions to the EMA and voluntary licensing agreements to facilitate availability in low- and middle-income countries.

Lupin Gains FDA Approvals for HIV, Cystic Fibrosis, and Heart Failure Generics

6 months ago

• Lupin receives FDA approval for generic Sacubitril/Valsartan tablets, a heart failure therapy, targeting a $6.06 billion market. • Tentative FDA approval granted to Lupin for generic Abacavir/Dolutegravir/Lamivudine tablets, an HIV treatment for pediatric patients. • Lupin's Ivacaftor oral granules, a generic for cystic fibrosis, also receive tentative FDA approval with potential for 180-day exclusivity.

Gilead to Withdraw U.S. Approval for Trodelvy in Metastatic Urothelial Cancer After TROPiCS-04 Failure

7 months ago

• Gilead Sciences will voluntarily withdraw the U.S. accelerated approval for Trodelvy in metastatic urothelial cancer following consultation with the FDA. • The decision is based on the TROPiCS-04 study failing to meet its primary endpoint of overall survival in the intention-to-treat population. • This withdrawal does not affect other approved Trodelvy indications, including those for metastatic TNBC and HR+/HER2- metastatic breast cancer. • Healthcare providers are being notified, and patients receiving Trodelvy for metastatic urothelial cancer should discuss alternative treatment options.

Gilead's Lenacapavir Shows Promise in HIV Prevention and Treatment

8 months ago

• Gilead's twice-yearly injectable lenacapavir reduced HIV infections by 96% in a Phase 3 trial, demonstrating superiority to daily oral Truvada for PrEP. • The PURPOSE 2 trial included cisgender men, transgender individuals, and gender non-binary people, showing broad efficacy across diverse populations. • Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024, with potential launch in 2025, prioritizing access in high-incidence, resource-limited countries. • A Phase 2 trial of once-weekly oral islatravir and lenacapavir maintained viral suppression in adults with HIV, paving the way for Phase 3 trials.