Vusolimogene oderparepvec

Plus, news about Kanglin Biotechnology, Seelos, Orbus and Sonata: Replimune’s $125M offering: The biotech announced the offering four days after it submitted an FDA application for RP1, or vusolimogene oderparepvec. It is administered in combination with Bristol Myers Squibb’s Opdivo for patients with advanced melanoma who have already undergone treatment with a PD1. — Jaimy Lee Otsuka, Ionis ink deal for experimental ALS drug: The Japanese drugmaker is paying Ionis $10 million upfront, plus undisclosed milestones, to make and market ulefnersen, an antisense oligonucleotide. The companies are already working together on Ionis’ donidalorsen in Europe and Asia. — Jaimy Lee Chinese gene therapy company raises $20M in Series A: Kanglin Biotechnology plans to use the funds to support the development of its lead asset, dubbed KL003, for beta thalassemia and sickle cell disease. The treatment is set to enter a Phase 2 trial next year. — Ayisha Sharma Seelos Therapeutics files for bankruptcy: The biotech’s filing comes after its ALS drug failed a platform trial earlier this year. — Kyle LaHucik Orbus Therapeutics’ rare brain tumor drug passes Phase 3 test: The biotech’s eflornithine in combination with standard chemotherapy achieved a “clinically meaningful improvement” in overall survival (OS) and progression-free survival in patients with grade 3 IDH mutant astrocytoma. The median OS was 34.9 months for treatment versus 23.5 months for chemotherapy alone. — Ayisha Sharma More layoffs at Sonata Therapeutics: The Flagship-founded startup is conducting a second round of layoffs this year. It’s letting go of 20 employees, plus CEO Volker Herrmann has stepped down and Sonata chair David Khougazian is now acting CEO, a Flagship spokesperson confirmed. Fierce Biotech first reported the news. — Kyle LaHucik

Nov. 21, 2024 -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting. Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious diseases when preliminary clinical evidence indicates that the therapy may provide substantial improvement over existing available therapies on one or more clinically significant endpoints. This Breakthrough Therapy designation is based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. “Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens,” said Sushil Patel, Ph.D., CEO of Replimune. The confirmatory Phase 3 IGNYTE-3 trial of RP1 in combination with nivolumab in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment is currently enrolling patients. For more information, visit https://replimune.com/clinical-trials/ignyte-3/. RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. The content above comes from the network. if any infringement, please contact us to modify.