Iovance Biotherapeutics Inc. has received IND clearance from the FDA for IOV-5001, a next-generation interleukin-12 (IL-12)-tethered tumor-infiltrating lymphocyte (TIL) therapy.
Drug developer stocks rebounded over July and August, with 23 companies on the BioWorld Drug Developers Index posting gains and only seven declining. The two-month upswing marks a reversal from the February-through-June period, when the index remained in the negative.
Drug developer stocks rebounded over July and August, with 23 companies on the BioWorld Drug Developers Index posting gains and only seven declining. The two-month upswing marks a reversal from the February-through-June period, when the index remained in the negative.
Immatics NV’s IMA-203 “looks like a melanoma drug,” said Cantor Fitzgerald analyst Eric Schmidt after he took a peek at the latest data, prepared as part of an upcoming meeting with the U.S. FDA. The candidate emerged from Immatics’ Actengine platform, set up to formulate a personalized therapy in which a patient’s own T cells are collected, genetically modified and then reinfused. Immatics offered data with IMA-203 as a monotherapy that targets preferentially expressed antigen in melanoma from an ongoing phase I trial testing what’s been established as the recommended phase II dose of 1-10x109 TCR-T cells in 30 heavily pretreated metastatic melanoma patients who were evaluable for efficacy.
Though down nearly 6% in January, the BioWorld Drug Developers Index (BDDI) rebounded in February, finishing the month with a 4.41% increase and outperforming both the Nasdaq Biotechnology Index (NBI; up 1.33%) and the Dow Jones Industrial Average (DJIA; up 3.47%). In 2023, BDDI concluded the year down 11.35%, trailing behind the NBI and DJIA.
Roughly 35 years after early patient data suggested the potential of tumor-infiltrating lymphocytes (TIL) in cancer, Iovance Biotherapeutics Inc. received U.S. FDA approval for lifileucel, marking both the first autologous TIL cell therapy for commercial use and the first one-time cell therapy for a solid tumor cancer. Branded Amtagvi, lifileucel is cleared for use in patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor
Iovance Biotherapeutics Inc.’s faith in tumor-infiltrating lymphocyte (TIL) therapy lifileucel was further proven by the Jan. 23 acquisition of worldwide rights from Clinigen Ltd. to Proleukin (aldesleukin), an IL-2 product used to promote T-cell activity after infusion of TILs. Terms call for San Carlos, Calif.-based Iovance to pay Clinigen, of Burton Upon Kent, U.K., £166.7 million (US$$206.1 million) right away and a £41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, plus double-digit global royalties for Clinigen.
Phase II melanoma data characterized by Iovance Biotherapeutics Inc. as positive failed to excite Wall Street, which took away 53.6% of the company’s share value (NASDAQ:IOVA), or $8.10, and pushed the closing price to $7.02 on May 27. The San Carlos, Calif.-based firm offered results from registrational cohort 4 (n=87) of the C-144-01 study testing lifileucel (LN-144, autologous tumor infiltrating lymphocytes) in advanced melanoma.
Phase II data from Iovance Biotherapeutics Inc. in advanced melanoma at the recent meeting of the American Society of Clinical Oncology turned up an important relationship between previous anti-PD-1 therapy exposure and the durability of treatment response. Findings added weight to the idea that tumor-infiltrating lymphocytes (TILs) should be deployed earlier in therapy.
Public biopharmaceutical companies did manage to attract some investors off the sidelines in May with medical conference season getting into full gear. However, it was generally another lackluster month, with the Nasdaq Biotech index dropping 2% in the period in contrast to the broader markets with the Dow Jones Industrial Average growing by 2%. The sector, however, could get a significant boost in the next few days if the FDA gives the green light to Biogen Inc. and Eisai Co. Ltd.’s experimental Alzheimer’s disease therapy, aducanumab, a recombinant chimeric human IgG1 monoclonal antibody targeting beta-amyloid, that could be the first disease-modifying therapy for an indication that has seen no novel therapies approved in more than 15 years.
