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 ...
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 ...
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 ...
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 ...
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 ...
Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company’s recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of “all future products,” a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. “With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients,” the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson ...
Gilead Sciences has announced that its COVID-19 treatment, Veklury (remdesivir), has been approved by the US Food and Drug Administration (FDA) to treat patients with severe renal impairment, including those on dialysis. The drug is already approved in the US to treat COVID-19 in adults and paediatric patients who are hospitalised or have mild-to-moderate COVID-19 and are at high risk for progression to severe illness. However, its use has previously been limited among patients with severe renal impairment due to insufficient data. The FDA’s latest decision makes Veklury the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. Gilead’s supplemental new drug application was supported by positive results from a phase 1 study as well as data from the phase 3 REDPINE trial that demonstrated the efficacy and safety profile of Veklury among patients with moderately and severely ...
Gilead Sciences has shared positive results from a late-stage study of its chronic hepatitis D virus (HDV) treatment, Hepcludex (bulevirtide). Gilead said the new 96-week data from the phase 3 MYR301 trial, which was presented at this year’s European Association for the Study of the Liver Congress, “reinforces the role of Hepcludex as an efficacious and well-tolerated treatment for the management of chronic HDV”. Data shows that the combined virological and biochemical response rates continued to increase through week 96, with response rates of 55% and 56% at the 2mg and 10mg dose levels, respectively. An additional analysis from the trial, presented in a late-breaker, also showed that study participants who appeared to not respond or only partially respond to the antiviral at week 24 went on to achieve a virological response at 96 weeks. The safety profile at week 96 was consistent with what was observed at week 48, ...
Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal. In a letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, more than 30 organizations said they “commend the decision” by the Department of Justice (DOJ) to keep fighting in the case. After the recent trial went in Gilead’s favor on May 9, the DOJ is seeking a new trial, according to the letter. The groups said they “strongly support HHS’s and DOJ’s decision to contest the surprising verdict,” arguing that the government’s case remains “fundamentally strong.” The U.S. first sued Gilead in 2019, saying that taxpayers funded research in the early 2000s that eventually went into the company’s lucrative HIV prevention medicines. U.S. officials said they sought to license the patented technology to Gilead for many years ...
Right before opening arguments were set to begin in Gilead Sciences and Teva’s HIV antitrust trial, the two came to a last-minute settlement with some of the plaintiff groups. Both companies settled with the pharmacy plaintiffs, a group that includes CVS Pharmacy, Rite Aid and Walgreens, while Gilead made a deal with the direct purchasers. Now, indirect purchasers and others involved in the suit can take their claims to a California federal jury. Gilead and Teva confirmed the settlements, and Gilead noted that the lawsuit with the other parties is ongoing. “The claims against Gilead in this lawsuit lack merit, do not accurately reflect antitrust laws, and ignore Gilead’s history of innovation and scientific advancements to help address the pressing challenges of the HIV epidemic,” a Gilead spokesperson said over email. The deals mark an eleventh hour end to a sprawling case that dates back to 2019, when plaintiffs including ...
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