Afamitresgene Autoleucel

Today, a brief rundown of news involving Evotec, Bluebird bio and the company formerly known as BeiGene, as well as updates from Leerink Partners and Abeona Therapeutics that you may have missed.Halozyme Therapeutics has made an unsolicited bid to buydrug discovery specialist Evotec for 11 euros per share in cash, an offer worth some 2 billion euros in total. In a press release, Halozyme said the combined company could offer increased scale and become a highly attractive strategic partner to the drug industry. Evotec, in its own statement, said it would carefully analyze this expression of interest. Ned PagliaruloBluebird bio has recorded its first revenue from sales of Lyfgenia, the companys gene therapy for sickle cell disease that won U.S. approval late last year. The process to prepare and receive Lyfgenia is lengthy, so only recently did the first patient actually get an infusion, at which point Bluebird books revenue for the $3.1 million therapy.Another 16 patients have started the process to receive treatment. The company is counting on climbing demand for Lyfgenia and its two other gene therapies, Zynteglo and Skysona, as it works to break even. Currently, it has enough cash to fund operations into the first quarter. Ned PagliaruloCancer drugmaker BeiGene will now operate under the name BeOne Medicines, a change that it says reflects its commitment to oncology research. The name also distances the company from its roots in China, a connection that may be less helpful as lawmakers in the U.S. increasingly view such ties as a national security risk. BeOne, which trades on the Hong Kong and Shanghai stock exchanges as well as the Nasdaq, is headquartered in California and in Switzerland. Ned PagliaruloAdaptimmune will lay off a third of its workforce in a bid to save about $300 million and break even financially in 2027, the company said Wednesday. Adaptimmune in August won U.S. clearance for its first product, a cell therapy called Tecelra for a type of soft tissue cancer. Going forward, the company will focus resources on that launch and another program in development for similar cancers, while partnering off two unrelated projects in preclinical testing. Its also shutting down a Phase 2 study in ovarian tumors.Ben FidlerLeerink Partnershas named two senior managing directors, Grant Curry and Jason Truman, to join its biopharma M&A team. Truman previously worked in a similar role at Guggenheim Securities, while Curry was a managing director at Gordon Dyal & Co. Leerink, which reemerged via a management buy-out after the collapse of SVB Financial Group,hopes to grow its M&A business. Outside of the big banks, Centerview Partners, Lazard and PJT Partners currently win the most deal business from drugmakers, according to BioPharma Dive data. Ned PagliaruloBy the end of next April, Abeona Therapeutics should know whether the Food and Drug Administration will approve its gene therapy pz-cel for a rare wound healing condition known as recessive dystrophic epidermolysis bullosa. The agency rejected pz-cel this past April, asking Abeona for more information on how its produced.The company then resubmitted its application with new information and, on Thursday, secured a target decision date of April 29, 2025 from the agency. Ned Pagliarulo '

The primary analysis of the IGNYTE-ESO trial comprises data from 64 patients with either synovial sarcoma or myxoid/round cell liposarcoma (MRCLS). Credit: Nadiia Lapshynska via Shutterstock. Adaptimmune ’s pivotal Phase II trial of its investigational T cell therapy lete-cel has met its primary endpoint, with the company now eyeing up its second sarcoma approval. UK-based Adaptimmune will submit a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lete-cel for the treatment of advanced or metastatic synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) by the end of 2025. Data from the Phase II IGNYTE-ESO trial (NCT03967223) showed that 42% of patients treated with lete-cel achieved a response. In synovial sarcoma, the median response lasted for 18.3 months, while in MRCLS, the median response was 12.2 months. All patients experienced treatment-emergent adverse events (TEAEs), including cytopenia, cytokine release syndrome and rash. Adaptimmune said that safety findings were consistent with previous data, showing no unexpected adverse events. The primary analysis of the IGNYTE-ESO trial comprises data from 64 patients with either synovial sarcoma or MRCLS. Investigators will share detailed results from the trial on 16 November at the Connective Tissue Oncology Society (CTOS) 2024 annual meeting in San Diego, US. Synovial sarcoma and MRCLS are rare and often aggressive cancers with limited treatment options. Synovial sarcoma is a soft tissue cancer that arises in the limbs, primarily affecting young adults. MRCLS is a subtype of liposarcoma that can spread quickly and prove challenging to treat with conventional methods like surgery, chemotherapy, and radiotherapy. Adaptimmune is on its way to building a portfolio of sarcoma treatments. The company achieved its first FDA approval in August 2024 for Tecelra (afami-cel), a T cell receptor (TCR) therapy for adults with metastatic synovial sarcoma. This approval marked several firsts, including the first engineered cell therapy for solid tumours, and the first new therapy for synovial sarcoma in over a decade. According to a GlobalData analyst , the approval of lete-cel would multiply the US addressable market by 2.5 times, from 400 patients annually with Tecelra to 1,000. The treatments could be combined or administered sequentially, as lete-cel targets another antigen. GlobalData is the parent company of Pharmaceutical Technology. Adaptimmune has actively engaged in several partnerships to bolster its position in the cell therapy space. In 2021, the company teamed up with Roche’s subsidiary Genentech on T cell therapy development – a five-year agreement with a potential value exceeding $3bn. However, Genentech walked away from the partnership in April 2024 for reasons that were not disclosed. The cell therapy company quickly pivoted, securing a $665m deal with Galapagos just seven weeks later. This deal, including a $100m upfront payment, granted Adaptimmune rights to uza-cel, a MAGE-A4 T cell therapy. The company has further partnered with Agilent Technologies to develop the MAGE-A4 ICH 1F9 pharmDx companion diagnostic, which won FDA approval in August, as well as with Thermo Fisher Scientific to include Tecelra in the labelling for their SeCore CDx HLA-A Locus Sequencing System.