As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they’ve occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call. Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership. Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to ...
By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is laying off 113 employees from Reata Pharmaceuticals’ Plano, Texas site, according to a Worker Adjustment and Retraining Notification notice. The layoffs, set to take effect in late November, come just months after Reata was acquired by Biogen for $7.3 billion in July 2023. At the time, Biogen had just launched a sweeping cost-reduction program which involved terminating around 1,000 employees in an effort to save $1 billion in operating expenses by 2025. Late last month, Biogen completed the acquisition of Reata. In an emailed statement to Endpoints News, a Biogen spokesperson confirmed the job cuts which will mostly affect “roles where there are existing synergies at Biogen.” The positions include general and administrative services, as well as some development-focused jobs. “We are retaining those colleagues who have been essential to the launch of Skyclarys to ensure ...
By Kate Goodwin Pictured: Roche Building in Pleasanton/iStock, JHVEPhoto Roche’s Genentech claimed victory for the subcutaneous formulation of its multiple sclerosis blockbuster Ocrevus on Wednesday, with plans to submit Phase III data for regulatory approval. In the OCARINA II study, twice-yearly, 10-minute subcutaneous injections of Ocrevus were pitted against the currently approved IV formulation for multiple sclerosis (MS). The subcutaneous dosing proved as effective in patients with relapsing or primary progressive MS over a 24-week period as the IV version on pharmacokinetic, biomarker and MRI measures. Ocrevus works by targeting and removing a type of B cells that attack the myelin covering around the brain and spinal cord nerve cells. In the Phase III study, the subcutaneous injection provided rapid and sustained B-cell depletion similar to the IV infusion—97% and 98%, respectively, had levels of 5 cells/µL or less at two weeks, which was sustained over 24 weeks. Both formulations ...
Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024. By FRANK VINLUAN Drug discovery isn’t only about finding new targets. There’s still plenty of opportunity to find better ways to hit targets that are already drugged, according to Tom Miller, CEO of startup Iambic Therapeutics. Understanding how a molecule interacts with a known disease target enables drug hunters to design molecules that could be superior alternatives for patients. Miller notes that a molecule’s ability to bind to a target protein while leaving related proteins unaffected improves its safety. It’s also important to understand how the distribution of a molecule across tissues in the body affect efficacy. Iambic’s drug discovery research employs ...
Seven months after Travere Therapeutics’ flagship drug received accelerated FDA approval in a rare kidney disease, the molecule has fallen short of the key goal of its confirmatory test. It’s the small molecule’s second Phase 3 failure this year. By FRANK VINLUAN A Travere Therapeutics drug that won speedy approval early this year for a rare autoimmune kidney disorder has failed to meet the key goal of its confirmatory study. Still, the biotech points to data trends favoring patients treated with its drug, Filspari, and it aims to seek full approval. But even if the FDA permits the drug to remain on the market, the disappointing trial results reported Thursday call into question the commercial prospects of a product once projected to become a blockbuster seller. Filspari was developed to treat immunoglobulin A nephropathy (IgAN), in which the buildup of antibodies in the kidneys damages these organs. The FDA awarded ...
By Kate Goodwin Pictured: Businessmen shaking hands/iStock, Tippapatt Japanese biopharma PeptiDream on Wednesday announced yet another licensing agreement with Roche’s Genentech, this time worth up to $1 billion. The latest deal builds on previous partnerships between the two companies starting in December 2015 with licensing in 2016 and an expansion deal in 2018. PeptiDream will receive $40 million upfront for R&D of its macrocyclic peptide-radioisotope drug conjugates. Going forward, another $1 billion is on the line in milestones plus tiered royalties of product sales to markets outside of Japan. PeptiDream will oversee preclinical activities to develop a peptide-RI drug conjugate and retain rights in Japan for any products developed. While a particular target was not disclosed, PeptiDream CEO Patrick Reid said in a statement that the company hopes to “bring innovative first-in-class peptide radiopharmaceuticals to patients worldwide.” The peptide-RI drug conjugates in the deal with Genentech are designed to use ...
After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines. First up, the companies need to tell CMS by Sunday whether they’ll participate in the process or exit the Medicare and Medicaid programs entirely. In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access. BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid,” the spokesperson said. “That is ...
By Tristan Manalac Pictured: Illustration of a blood clot in a blood vessel/iStock, libre de droit Anthos Therapeutics is ending the Phase II AZALEA-TIMI 71 study ahead of schedule after its investigational monoclonal antibody abelacimab demonstrated an “overwhelming reduction” in bleeding compared to Bayer and Johnson & Johnson’s Xarelto (rivaroxaban), the company announced Monday. Patients treated with abelacimab saw a sharp reduction in the composite endpoint of major and clinically relevant non-major bleeding events compared with counterparts given rivaroxaban, the current standard-of-care oral anticoagulant. The Massachusetts-based biopharma did not provide specific data in Monday’s announcement but said that the Data Monitoring Committee stopped the study early following these data. Anthos will share the full results and analysis of the trial in an upcoming medical meeting. Due to the “overwhelming reduction in bleeding” reported in AZALEA-TIMI 71, abelacimab may represent a “paradigm shift” in atrial fibrillation care particularly in the prevention ...
By Connor Lynch Pictured: Bristol Myers Squibb in New Jersey/iStock, arlutz73 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons. Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease. In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than ...
CancerVAX has announced the development of a universal chimeric antigen receptor (CAR) T-cell platform in partnership with a research team from the University of California, Los Angeles (UCLA). The company plans to adapt the nanoparticle technology developed by the UCLA team, which is currently being used for a universal cancer vaccine project to target T cells. The nanoparticle technology is inspired by the lipid nanoparticle and messenger RNA (mRNA) technology used to develop Covid-19 vaccines. Conventional CAR-T therapies rely on gene editing performed in the laboratory to transform the allogeneic T cells to induce CAR protein expression before reinfusion of these calls back into the patient. The universal CAR-T cell therapy would use injectable smart nanoparticles, which would be loaded with genetic information for specific cancer cell targeting. These nanoparticles would attach to the patient’s T cells and reprogram them to target specific cancer cells. CancerVAX has reported that preliminary ...
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