Search Results for “Gilead Sciences” – Page 2 – media

Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
- Source: drugdu
- 94
- April 3, 2024
FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

Don Tracy, Associate Editor Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy. The FDA has approved an expanded indication for Gilead’s Vemlidy (tenofovir alafenamide), to treat chronic hepatitis B virus (HBV) infection in pediatric patients aged six years and older who weigh at least 25 kg and have compensated liver disease. In 2016, the medication was initially approved for adults with chronic HBV and compensated liver disease, with an extended use approved in 2022 for children aged 12 years and above. Approval for the expanded indication was based on positive results stemming from Gilead’s Phase II clinical trial (Trial 1092) after 96 weeks, showing safety and efficacy in younger children. According to the study data, participants experienced progressive increases in the rates of virological suppression compared to those administered a placebo.1 “Chronic hepatitis B ...
- Source: drugdu
- 88
- April 2, 2024
Gilead and Merus enter trispecific antibody discovery deal

The agreement outlines the potential for Merus to earn up to $1.5bn payments from Gilead. Merus will head the early-stage research works for two programmes, with the option to expand to a third asset. Credit: aslysun / Shutterstock.com. Gilead Sciences has entered a research partnership, option and licence agreement with Merus for the discovery of dual tumour-associated antigens targeting trispecific antibodies. The partnership will leverage Merus’ Triclonics technology and Gilead’s capabilities in the oncology field. The aim is to advance multiple preclinical research programmes that could potentially transform cancer treatment. Merus focuses on the development of full-length, multispecific antibodies named Biclonics and Triclonics, referred to collectively as Multiclonics. These antibodies are created by a common light chain technology. The Triclonics trispecific platform creates antibodies that can target three different antigens simultaneously. Merus will spearhead the early-stage research works for two programmes, with the option to expand to a third asset. ...
- Source: drugdu
- 106
- March 9, 2024
Gilead signs antibody deal with Biocytogen amid ADC buzz

Biocytogen Pharmaceuticals shared plans for its new antibody evaluation and option agreement with Gilead Sciences. In the deal, Gilead will gain access to Biocytogen’s fully human antibody library. The agreement gives Gilead a three-year nomination period to choose its targets of interest and assess the selected antibodies, with the option of acquiring selected antibodies for worldwide therapeutic development. Biocytogen owns four genetically engineered RenMice platforms for the discovery of multiple antibody types. This includes bispecific antibody-drug conjugates (ADC), TCR-mimic antibodies and more. As of June 2023, the China-based company was part of 50 therapeutic antibody and multiple clinical asset co-development, out-licensing and transfer agreements. Earlier this year, Biocytogen partnered with Radiance Biopharma to share its bispecific ADC expertise. The company also signed deals with Ona Therapeutics in December 2023 and Myricx Bio in September 2023 to develop ADCs. This correlates with an uptick in high-value deals recently seen in the ...
- Source: drugdu
- 85
- February 21, 2024
Yet another clinical hold for Gilead’s magrolimab trials

Gilead Sciences had paused enrolment in the magrolimab solid tumour trials, with the FDA requesting a partial clinical hold on these studies. Earlier this month, the US regulatory agency placed a full clinical hold on all the clinical trials of magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). “Gilead will likely decide to deprioritise the magrolimab programme entirely,” said Sakis Paliouras, associate director for oncology research and analysis at GlobalData. Adding: “it is less likely, but still possible, that the company will come back from the clinical hold and continue the programme.” The latest partial clinical hold affects the Phase II trials of magrolimabin multiple solid tumour conditions such as head and neck squamous cell carcinoma (NCT04854499), triple-negative breast cancer (NCT04958785), and colorectal cancer (NCT05330429). In addition to Gilead-sponsored trials, the partial clinical also applies to Investigator Sponsored Studies with magrolimab in solid tumours. Paliouras said the blood ...
- Source: drugdu
- 155
- February 21, 2024
Dragonfly and Gilead enter partnership for cancer therapy

Dragonfly Therapeutics has entered a clinical collaboration with Gilead Sciences to assess the potential of its investigational drug candidate DF1001 with the latter’s Trodelvy for two cancer indications. The study of the combination regimen will focus on metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC). DF1001 is designed to act on natural killer (NK) cells and T-cell activation signals, leveraging co-stimulation of NK receptor NKG2D and CD16 for NK cell activation. Trodelvy is a Trophoblast cell-surface antigen 2-directed antibody-drug conjugate. Dragonfly will maintain operational control of the trial, with the first patients receiving the combination treatment in the second quarter of 2024. Study sites are already operational in the US, Belgium, France, Denmark and the Netherlands. The study is set to expand, with additional sites in Europe, North America and Asia Pacific. Developed using Dragonfly’s TriNKET platform, DF1001 is being evaluated in adult patients for the treatment of ...
- Source: drugdu
- 171
- February 19, 2024
Gilead’s Tecartus gets revised safety demand amid FDA’s push for CAR-T boxed warnings

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, the agency has adjusted the wording of a proposed boxed warning. In a revised letter (PDF) dated Jan. 23, the FDA is still pressing Gilead’s cell therapy unit Kite Pharma to include new language about the risk of T-cell malignancies in the black-box warning section of Tecartus’ label. But unlike its proposed boxed warning for other commercial CAR-T therapies, the FDA’s updated letter for Tecartus no longer names Tecartus patients specifically as having experienced T-cell malignancies. The FDA apparently took some time before uploading the new letter after taking down the original one, dated Jan. 19. The missing letter for Tecartus caused a brief period of confusion because the FDA says in all letters to ...
- Source: drugdu
- 90
- January 26, 2024
Gilead’s Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
- Source: drugdu
- 90
- January 25, 2024
Gilead Drug Fails Pivotal Lung Cancer Study, But Still Might Have Path Forward

Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients. By FRANK VINLUAN Sales for Gilead Sciences cancer drug Trodelvy are growing, but the company is counting on additional approvals to boost the product to blockbuster status and justify the premium price it paid to acquire the therapy. The drug’s failure in a pivotal lung cancer study is a setback to that strategy. Treatment with Trodelvy, an antibody drug conjugate (ADC), fell short of a Phase 3 study’s main goal of showing statistically significant improvement in overall survival in patients with advanced cases of non-small cell lung cancer (NSCLC), Gilead announced Monday. Nevertheless, the company pointed to numerical ...
- Source: https://medcitynews.com/author/fvinluan/
- 194
- January 24, 2024
Gilead calls off Oceanside manufacturing expansion, uproots biologics development team

Gilead Sciences is halting the expansion of its biologics site in Oceanside, California, and is moving the existing team’s responsibilities to its Foster City campus in the same state, a spokesperson confirmed. The move is based on Gilead’s desire to bring members of the biologics development and manufacturing team closer to the company’s R&D unit, which is based in the Bay Area in Foster City, the spokesperson said. “Over the next few years, the majority of our Gilead Biologics teams in our Pharmaceutical Development & Manufacturing organization, most of whom are currently in Oceanside, CA, will transition to Foster City,” the spokesperson said. The move will begin this year and conclude by 2027 “at the latest,” according to Gilead, with business operations continuing “as usual” for the time being. Oceanside and Foster City are about an 8-hour drive apart. The company did not specify how many employees, if any, would ...
- Source: drugdu
- 188
- January 18, 2024

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