The subtype accounts for 20% of all T-cell leukaemias, a rare form of blood cancer which produces too many abnormal T-cells OneChain Immunotherapeutics (OCI), a biotechnology company that specialises in developing CAR T cell therapies for oncological diseases, has announced that the CARxALL clinical trial has dosed its first cortical T-cell acute lymphoblastic leukaemia (coT-ALL) patient with OC-1, a CAR T therapy. Being conducted at Hospital Clínic and Hospital Sant Joan de Déu in Barcelona, the trial is open to both paediatric and adult patients worldwide. T-cell leukaemia is a rare form of blood cancer that occurs when the bone marrow produces too many abnormal T-cells, a type of white blood cell that protects the body from infections. The subtype, coT-ALL, accounts for 20% of T-cell leukaemias and is characterised by a poor prognosis in patients who do not respond to existing therapies. CAR T therapies are a form of ...
The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
Recently, Legend Biotech announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of relapsed or refractory multiple myeloid(RRMM) patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and are resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies and antibody-drug conjugates (ADCs). The FDA’s approval is based on positive results from the CARTITUDE-4 study, which showed that compared with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (PVd), DPd) these two standard treatment regimens, CARVYKTI® can significantly improve the progression-free survival (PFS) of adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received first- to third-line treatment. This result has statistical and clinical significance. The approval ...
SHANGHAI and NANJING, China and SAN JOSE, Calif., March 29, 2024 /PRNewswire/ — IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the ...
The annual meeting of the American Association for Cancer Research (AACR) will be held on April 5-10, 2024, local time in San Diego, USA. As one of the world’s most influential academic events in the field of oncology, the AACR Annual Meeting focuses on all aspects of oncology research and innovation, and releases cutting-edge research results in the field of global oncology. Recently, AACR officially released the information of selected studies, and five studies of two innovative drugs, namely, Anrotinib (small molecule multi-targeted receptor tyrosine kinase inhibitor) and TQB2916 (CD40 agonist) from Chiatai Tianqing Pharmaceutical Group, have been selected. Clinical Studies ALTER-G-001 A Multicohort, Multicenter, Phase II Study – Cohort C Results Update: Anlotinib in Combination with Chemotherapy for First-Line Treatment of Digestive Tract Tumors with Unresectable Liver Metastases CT213/13 – Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Updated results from a multi-cohort, ...
Astellas subsidiary Xyphos Biosciences has entered a research partnership and licence agreement with Kelonia Therapeutics aimed at developing new immuno-oncology therapeutics in an $875m deal. The alliance will merge Xyphos’ ACCEL technology with Kelonia’s in vivo gene placement system to develop universal, off-the-shelf in vivo chimeric antigen receptor (CAR) T-cell therapies for up to two programmes. Kelonia focuses on genetic medicine innovation and utilises its in vivo gene placement system to precisely deliver genetic material to the target cells within the patient’s body. This system employs lentiviral particles for efficient delivery. Xyphos’ ACCEL technology platform features the convertible CAR used on immune cells. Xyphos will oversee the development and marketing of the products resulting from the joint research. Kelonia is entitled to an upfront payment of $40m for the first programme. If Xyphos opts for the second programme, an additional $35m will be paid to Kelonia. The deal also includes ...
In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a period filled with patent cliffs and new government-mandated pricing pressure in the latter half of the decade. Bristol Myers will have a relatively stable business through 2025 as large legacy products, though declining, continue to generate sizable chunks of revenue. Still, the company’s focus will center on a growth portfolio that includes 11 key brands and about three dozen clinical candidates. Besides commercialization and R&D efforts, the company remains interested in dealmaking, Boerner said. “This, along with pipeline execution, can best position the company into the transition period,” the CEO told analysts Friday. Bristol Myers has “some clear strengths” compared with other companies that have successfully navigated similar periods of patent losses in the past, Boerner figures. The CEO touted the company’s “expanding growth portfolio across multiple ...
January 25, 2024, Nanjing, Shanghai, China, and San Jose, California, USA – IASO Bio, a biopharmaceutical company dedicated to the development, production and sales of innovative cell-based drugs, announced the National Medical Products Administration (NMPA) Review Center (CDE) has officially approved its fully human BCMA-targeted chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel Injection, R&D code: CT103A) for the new expanded indication of refractory generalized myasthenia gravis (Myasthenia gravis, MG). ) clinical trial application (IND) (acceptance number: CXSL2300759). Equecabtagene Autoleucel Injection (trade name: Equecabtagene Autoleucel®) has been approved for marketing by the State Food and Drug Administration on June 30, 2023, for the treatment of relapsed and refractory multiple myeloma. The approval of this IND for myasthenia gravis further expands This is the second autoimmune indication approved for IND after Neuromyelitis Optica Spectrum Disease (NMOSD). IASO Bio is the first company in China to use CAR-T products for autoimmune ...
For more than 2 years, Johnson & Johnson has been plotting its future as a two-sector company. In the wake of the company’s consumer healthcare spinoff last summer, the company’s fourth-quarter results offer plenty of signs of life from the new-look J&J.After wrapping up 2023 with a total haul of $85.2 billion, the company is heading into 2024 with “multiple catalysts for growth,” CEO Joaquin Duato said on J&J’s fourth-quarter and full-year earnings conference call. Across J&J’s innovative medicines portfolio, the company’s oncology and immunology medicines generated the lion’s share of sales in 2023’s fourth quarter, helping the unit achieve operational growth in the U.S. of 9.5% during the period. Worldwide, J&J’s pharma business reeled in $13.72 billion during the fourth quarter, a 4% increase from the same period in 2022.On the immunology front, J&J’s antibody blockbuster Stelara grew its market share and demonstrated continued strength in inflammatory bowel disease (IBD), J&J said in ...
By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
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