Orange County Bio’s Post

Tumor infiltrating lymphocytes: complex science, but maybe even more complex launch. At 515K$ per treatment, Iovance will face challenges. TIL therapy originated from research at the National Institutes of Health in the 1980s. It took decades to fine-tune, and Iovance had to overcome multiple regulatory delays bringing the therapy, formerly known as lifileucel, to market. Its clearance is the “culmination of scientific and clinical research efforts,” https://lnkd.in/ebbBwVr3

Last month, the FDA announced that BCMA- or CD19-directed autologous CAR T cell therapies were under review after the agency received reports of several secondary blood cancers in patients who have been treated with them. But leading oncologists say the cancers appear to be rare and the therapy is lifesaving in the context of deadly malignancies that have already outwitted chemotherapy and radiation. This perhaps raises more questions than distinct next steps... - Should treatment regimens change in light of this FDA review? - How should providers, insurance, regulatory agencies and patients balance the risks? - Should "immortal time bias" be factored in? How should we consider the real benefits of CAR-T therapy? Curious to get your thoughts... #cartcelltherapy #fda #cancertreatment https://lnkd.in/eKujDimC.

🚀 Breaking News in the Cell Therapy World! 🚀 CAR therapy is making groundbreaking strides by extending its scope beyond hematological malignancies to tackle solid tumors and even autoimmune diseases. FDA's approval of Nkarta, Inc.’s investigational new drug application marked a significant milestone. This green light opens the gateway to a clinical trial utilizing CAR-NK cells for the treatment of lupus nephritis, underscoring the potential of cellular therapies in addressing complex autoimmune conditions. Read more about this significant breakthrough: https://lnkd.in/dPsE6q2e   #OrangeCountyBio, #OCBio, #CellTherapy, #CARtherapy, #CGT, #CARNK, #autoimmunedisease, #lupus

Johnson & Johnson announced that #FDA has granted full approval to #Balversa, marking a landmark development in targeted therapy for advanced #bladdercancer. This approval establishes Balversa (#erdafitinib) as the first and only treatment for adult patients with locally advanced or metastatic #urothelialcarcinoma (mUC) and susceptible #FGFR3 #genetic alterations. The Phase 3 THOR study demonstrated that Balversa® reduces the risk of death by 36% compared to #chemotherapy, marking a significant advancement for patients with limited options.  https://lnkd.in/d5v5M2wM

At Theragent Inc, we constantly are researching and testing new methods to help deliver the therapeutics of tomorrow to patients in need of them today. Download our latest white paper to see how we are driving new methods to generate NK cells using a feeder-free platform with reduced risks. #NKcells #CGT #CDMO #whitepaper

Feeder-free Natural Killer (NK) cell expansion systems are a desirable choice for clinical applications due to reduced safety risks. However, historically lower expansion rates of these systems present a challenge to widespread clinical adoption and are a key reason why feeder-based expansion systems are still frequently used, despite safety and regulatory risks. Check out Theragent's latest research, led by Raymond Wu Ph.D., on an innovative NK cell therapy solution that can help overcome this barrier. https://lnkd.in/gYQj2mDJ #CAGT #NKCELL #THERAGENT

“Regorafenib in Patients With Solid Tumors With BRAF Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.” There are more than 150 active INDs associated with BRAF targeted and combination therapy across all indications. This is the second largest sub population solid tumor active efforts in precision medicine in R/R groups. Combinations are increasing along T & B cell combination targets.

One of the taglines on the newly designed EpicentRx website is, “Enter the Epicenter,” which lead EpicentRx therapy, RRx-001 (nibrozetone), takes literally because it causes cells in the center of tumors to enter highly immunogenic cell death (ICD), a special type of cellular demise. ICD gooses the dysfunctional immune system with the release of danger signals or DAMPs and causes it, like a bloodhound, to sniff out, track down, and eliminate the tumor cells, wherever they are. Read more here https://bit.ly/4cvqi6w.

It can be quite a challenge to make significant changes and pivot during ongoing trials, especially when a substantial amount of time, money, and resources have already been invested. Nevertheless, it is essential to make necessary adjustments to ensure that your drug candidate successfully reaches the finish line and fulfills its potential to save lives. These strategic moves aim to enhance the identification of targeted patients with MRD using advanced diagnostic tools, alleviate patient enrollment challenges, and set the candidate apart from other autologous cell therapies.

The findings in the peer-reviewed research published by JAMA Oncology signify a major advancement in the ability to make highly accurate, comprehensive and personalized predictions about the risk of clinically significant #prostatecancer. As Lynx Dx Chief Medical and Commercial Officer, Spencer Heaton, notes: “The research findings demonstrate the potential of MPS2 to facilitate more informed decision-making about a patient’s best course of treatment by shedding new light on a serious condition that is notoriously difficult to diagnose.” Read the full announcement: https://lnkd.in/gwKU_Tun #ProstateCancer #Innovation #CancerResearch