Ribrecabtagene autoleucel

BENGALURU, India & HYDERABAD, India--(BUSINESS WIRE)-- #AurigeneOncology --Aurigene Oncology Limited, a wholly-owned subsidiary of Dr. Reddy’s Laboratories Limited and a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment of cancer, has announced the Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study – India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma. The study reported initial results from the first 8 patients. All patients were heavily pre-treated with median of 5.5 previous lines of treatment. Most patients had also received transplant in the past and had disease progression post-transplant. All 8 patients (100%) achieved clinical response, with 5/8 (62.5%) having achieved stringent complete response. With respect to safety, there were no high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity, in any of the patients. After reviewing the Phase 1 data, the Indian Regulatory Agency i.e., Drugs Controller General of India (DCGI), has given the nod to commence Phase 2 part of the trial. These results of Phase 1 were presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently. “The results from the trial in heavily pre-treated relapsed refractory myeloma patients are very exciting for us in India. We are thrilled with the data, as the drug could be transformative for Indian patients with myeloma,” commented Dr. Murali Ramachandra, CEO, Aurigene Oncology Limited . Ribrecabtagene autoleucel is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. DRL-1801 for the clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology Limited, Bangalore. About Aurigene Oncology Limited: Aurigene Oncology Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY), is a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment of cancer. Founded in 2002, Aurigene has contributed to the discovery of 20 novel chemical entities for clinical development. Some of these molecules were in collaboration with global Pharma and biotech companies while remaining were developed on its own. Aurigene has out-licensed several assets and is now engaged in clinical development of 10 assets. Aurigene’s clinical pipeline includes first- in-class oral inhibitor of immune checkpoint protein CD47, first-in-class inhibitor fatty-acid binding protein FABP5 and best-in-class inhibitor of acetyl transferases CBP and p300. Aurigene also has a strong pre-clinical pipeline, including advanced programs based on selective degradation of SMRACA2, first-in class CBP, p300 and pan-KRAS degraders. Contacts MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM

Shenzhen Pregene Biopharma, a clinical-stage biopharmaceutical company engaged in discovering, developing, manufacturing and commercializes innovative medicines and CellPoint, a cell therapy company developing CAR-T therapeutics for use at the point-of-care (POC), today announce an exclusive license agreement for the development and commercialization of PRG-1801, Pregene's single domain antibody-based anti-BCMA chimeric antigen receptor T cell (CAR-T) program, for the treatment of hematological indications in Europe and the United States. PRG-1801 is a single domain antibody anti-BCMA CAR-T cell therapy in development for the treatment of relapsed/refractory multiple myeloma that has demonstrated strong signs of efficacy and an excellent safety pro its initial investigator-initiated trial and Phase I/II clinical trials. Under the terms of the collaboration, Pregene will receive over €20 million of upfront and near-term consideration, and is eligible to receive additional development, commercial milestone and royalty payments. CellPoint will be responsible for the development and commercialization of the anti-BCMA CAR-T therapy in Europe and the US. As part of this partnership, Pregene will also provide translational and lentivirus manufacturing services to be reimbursed by Cellpoint. "We are excited to partner with Cellpoint to develop CAR-T cell therapies via a POC platform," said Jishuai Zhang, Chief Technology Officer and Co-founder of Pregene. "The potential of our single domain antibody fully human BCMA CAR-T to treat patients with relapsed/refractory multiple myeloma has been validated in clinical trials of our BCMA autologous CAR-T product candidate. We expect the POC modality to enable faster treatment for broader patients using our differentiated CAR-T therapy, and we look forward to working with the team at CellPoint as they seek to develop and commercialize PRG-1801." Tol Trimborn, Chief Executive Officer of CellPoint, said: "We are very pleased to add Pregene's novel anti-BCMA CAR-T therapy to our CAR-T portfolio and look forward to develop it using our decentralised, POC manufacturing model. This is our second clinical stage program and we have demonstrated we can provide cell therapy to cancer patients in only 6 days vein-to-vein, from apheresis to infusion. We are excited to work closely alongside Pregene to bring this to patients with a convenient, readily available treatment alternative."