Legend Biotech Nanjing

2Seventy bio, the cancer-focused drugmaker spun out of Bluebird bio, has decided to stop enrolling a key study thats been evaluating its multiple myeloma therapy Abecma earlier in the treatment process.The decision announced Wednesday was made, in part, to help ensure 2Seventy breaks even financially next year. The biotechnology company expects ending the trial will save $80 million in the near term. 2Seventy recorded a $27 million loss from operations in the second quarter and, as of June 30, had about $200 million in cash, cash equivalents and marketable securities.First approved in 2021 for a narrower group of patients, Abecma this spring got cleared for use in hard-to-treat multiple myeloma cases that arent adequately controlled after two or more prior lines of therapy. The now-scrapped study was testing whether the drug benefits newly diagnosed patients who have less than optimal responses to a certain kind of stem cell transplant.Positive results may have helped 2Seventy and Bristol Myers Squibb, which co-developed the drug, compete in a market that has grown in size and intensity over the past few years. Partners Johnson & Johnson and Legend Bio have a rival cell therapy, Carvykti, that in April gained approval as a so-called second-line treatment for adults with relapsed or refractory multiple myeloma.Meanwhile, Gilead Sciences and the biotech Arcellx have been advancing a newer medicine they claim could be the best cell therapy in its class. A late-stage study of the medicine, known as anito-cel, began last month, and should produce data by 2028. The study is assessing anito-cel in participants whove already received between one and three types of treatments for their multiple myeloma.Against this background, 2Seventy and Bristol Myers acknowledged that their choice to discontinue enrollment was influenced by the greatly improved treatment landscape for newly diagnosed multiple myeloma patients. In a statement, Anna Truppel-Hartmann, 2Seventys chief medical officer, noted how this changing landscape has resulted in considerably fewer patients who are eligible for a study like the one evaluating Abecma.2Seventys CEO Chip Baird said Abecma is still showing encouraging signs of growth. U.S. revenue from the drug totaled $54 million between April and June, and 2Seventy anticipates that number rising around 30% in the third quarter. The company also anticipates patient demand for the drug to increase by double-digits compared to the second quarter.Wednesdays announcement follows a couple other moves 2Seventy made this year to tailor the business and hasten it toward profitability. In January, the company sold its pipeline of cell therapy research to Regeneron for $5 million. Then in June, it handed off a hemophilia A research program to Novo Nordisk in exchange for $38 million.Shares of 2Seventy were down 8% Wednesday, to hover around $4.40 apiece. The biotechs stock has lost more than 80% of its value since it began trading on the Nasdaq in late 2021. '

Amgen has a new top scientist, announcing Thursday the appointment of Novartis veteran and prolific biotechnology startup founder Jay Bradner alongside another change to its leadership team.Bradner led the Novartis Institutes of BioMedical Research the Swiss pharmaceutical giants Cambridge, Massachusetts-based research hub from 2016 until last year. Now at Amgen, hes serving as both chief scientific officer and executive vice president of research and development. He succeeds David Reese, who is switching from head scientist to chief technology officer.“The steps we are announcing today reflect our conviction that the rapid convergence of 'biotech' and 'tech' will unlock the next frontier of innovation in biotechnology, said Robert Bradway, Amgens CEO, in a statement.Bradner was an associate professor at Harvard Medical School and a laboratory head at the Dana-Farber Cancer Institute. He co-founded several biotech startups before he joined NIBR, which doubled down in cancer research during his tenure.Hes also credited with helping Novartis branch deeper into more cutting-edge areas of drug development like cell and gene therapy, as well as reshaping how the company works with smaller biotechnology firms. That cultural shift appears to have remained following Bradners departure in October 2022. This year, the company entered a partnership with Bicycle Therapeutics, bought a gene therapy from Avrobio, and licensed genetic medicines from Legend Bio and Voyager Therapeutics.The executive change-ups come about two months after Amgen completed the largest acquisition, by dollar amount, in its history. The $28 billion purchase of Horizon Therapeutics stocked Amgens portfolio with a dozen products that collectively brought in $1.8 billion over the first six months of this year.Amgens top-selling drug, the inflammatory disease treatment Enbrel, is set to lose market exclusivity by the end of the decade. So the company has turned to dealmaking to offset the expected revenue loss.From July through September, Amgen recorded $6.5 billion in product sales, a 5% increase from the same three-month period in 2022. The leukemia therapy Blincyto and the osteoporosis drug Evenity hit record highs, while sales of the cholesterol-lowering medicine Repatha rose 31% year over year, to $406 million.Amgen says its focus is on four areas of drug research: oncology, inflammation, general medicine and rare disease. The company also develops biosimilars, and early this year launched a copycat version of AbbVies blockbuster Humira in the U.S. '

LB2102 will mark the first time Novartis has turned the power of its T-Charge platform to a solid-tumor-focused cell therapy. Novartis will give a solid-tumor-focused cell therapy the T-Charge treatment, after paying $100 million upfront to Legend Biosciences for a selection of CAR-T candidates. The therapies in question all target Delta-like ligand protein 3 (DLL3), including an autologous CAR-T dubbed LB2102 that Legend has taken into the clinic for lung cancer. What makes this deal especially noteworthy is Novartis’ decision to incorporate its T-Charge platform in the manufacturing process of these therapies. The T-Charge process involves a significant portion of CAR T-cell expansion taking place within the patient’s body. By minimizing the time the cells spend outside the body (ex vivo), it aims to preserve naive and stem cell memory T cells. According to the theory, this preservation may result in better responses, improved long-term outcomes and a reduced risk of severe adverse events. Last year, Jennifer Brogdon, Ph.D., head of cell therapy research in the Department of Exploratory Immuno-Oncology of the Novartis Institutes for BioMedical Research, told Fierce Biotech that CAR-T-focused biotechs had already been in contact with the Swiss pharma to explore the possibility of giving their own candidates the T-Charge treatment. LB2102 will mark not only the first time Novartis has turned the power of its T-Charge platform onto an externally-developed CAR-T but also the first time it has been used on a solid-tumor-focused cell therapy, the Big Pharma said. Legend will oversee a phase 1 trial of LB2102 in the U.S., before Novartis takes over all further development. "We have explored CAR-T in solid tumors previously and believe that our T-Charge platform coupled with Legend Biotech’s unique CAR design may add a level of potency and persistence needed to provide transformative benefit for patients," Brogdon told Fierce Biotech via email this morning. Beyond the hefty $100 million upfront payment, the New Jersey-based biotech is also in line for over $1 billion in potential milestone payments as well as tiered royalties. “We believe LB2102 has an innovative CAR design and armor mechanism that increases its anti-tumor activity,” Legend’s chief scientific officer Guowei Fang, Ph.D., said in the release. “We are excited that a major pharmaceutical company with deep roots in oncology and cell therapy has chosen to further this product candidate in the clinic.” Novartis already has two homegrown CAR-T therapies in the clinic that were produced by the T-Charge platform. Rapcabtagene autoleucel, also known as YTB323, has been shown to produce a 63% complete response rate after three months among 26 patients with relapsed/refractory diffuse large B-cell lymphoma in a phase 1 trial. The other asset, PHE885, has demonstrated a 96% overall response rate among the 23 patients with relapsed/refractory multiple myeloma. Since then, Novartis has remained loyal to the platform’s potential. T-Charge can only be used for autologous therapies, and Novartis has so far resisted the hype around so-called "off-the-shelf" CAR-Ts.