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Replimune Group, Inc. (NASDAQ: REPL) is a clinical-stage biotechnology company committed to advancing cancer treatment through innovative oncolytic immune-gene therapies. Founded in 2015 and headquartered in Woburn, Massachusetts, Replimune leverages its proprietary Immulytic™ platform to develop product candidates aimed at activating the immune system against solid tumors.
The core of Replimune’s portfolio includes RP1, RP2, and RP3, all based on genetically-engineered strains of herpes simplex virus 1 (HSV-1). These strains are modified to maximize tumor killing and stimulate a systemic anti-tumor immune response. RP1, the company’s lead product, is designed for enhanced tumor killing and has shown promising results in combination with anti-PD1 therapies. It is currently undergoing clinical trials for anti-PD1 failed melanoma and other skin cancers, with plans to submit a Biologics License Application (BLA) in 2H 2024.
Another notable candidate is RP2, which expresses an anti-CTLA-4 antibody-like protein to further enhance immune response. RP2 has demonstrated durable response rates in advanced uveal melanoma patients, a particularly challenging cancer type with limited treatment options. RP3, the third candidate in the pipeline, is engineered to express multiple immune-activating proteins, though its development has currently been paused to focus on higher priority programs.
Replimune's recent achievements include favorable safety profiles and substantial response rates in clinical trials. For instance, RP2 in combination with nivolumab showed a durable overall response rate of nearly 30% in patients with metastatic uveal melanoma. Additionally, RP1 has demonstrated significant anti-tumor activity in organ transplant recipients who typically cannot undergo systemic immunotherapy.
The company has established alliances with major pharmaceutical entities, such as Regeneron Pharmaceuticals, to further its clinical trials and explore combination therapies. Financially, Replimune is robust, with a cash runway extending into early 2026, thanks to strategic reprioritization and successful capital management.
Replimune is dedicated to evolving its portfolio and optimizing its RPx platform. The dual local and systemic mechanism of action of its therapies offers a versatile approach that can be combined with various other cancer treatment modalities, thus holding significant promise for the future of oncology.
Replimune Group, Inc. (Nasdaq: REPL) announced updates on its CERPASS and IGNYTE clinical trials. The Phase 2 CERPASS trial of RP1 with Libtayo for cutaneous squamous cell carcinoma will now include complete response (CR) rate as a primary endpoint, reducing target enrollment from 240 to 180 patients. Initial data is expected in 2022. Additionally, Replimune had a Type B meeting with the FDA regarding the IGNYTE trial for anti-PD1 failed melanoma, indicating a potential path for accelerated approval if data is compelling.
Replimune Group Inc. (NASDAQ: REPL) will host an investor event on June 3, 2021, at 8:00 AM ET, to discuss data from its Phase 2 skin cancer studies involving RP1 combined with Opdivo and Phase 1 results of RP2. Presentations will be made by leading experts, including CEO Philip Astley-Sparke and Robert Coffin, Ph.D., President of R&D. Attendees can access the live webcast on the company's website, with a replay available afterwards. Replimune focuses on developing innovative oncolytic immuno-gene therapies through its Immulytic® platform.
Replimune Group, Inc. (Nasdaq: REPL) announced the appointment of Sushil Patel, Ph.D. as Chief Commercial Officer, effective May 3, 2021. Patel, formerly with Genentech, brings over 20 years of oncology experience and will lead Replimune's commercial team. Notably, he was responsible for significant successful drug launches, generating over $3.5 billion in annual sales. The company plans to grant him stock options and restricted stock units upon his employment start date. This strategic leadership move aims to bolster the development and commercialization of Replimune’s oncolytic immuno-gene therapies.
Replimune Group announced promising data on its oncolytic immuno-gene therapies RP1 and RP2 at the AACR 2021 Annual Meeting. Key findings include increased infiltration of CD8+ T cells and PD-L1 expression in patients treated with RP1 and RP2, suggesting robust systemic immune activation. Pre-clinical studies also indicated potent anti-tumor activity driven by GALV-GP R- expression. The data support RP1 and RP2's potential as effective treatment options, particularly in hard-to-treat cancers, enhancing tumor destruction while minimizing off-target effects.
Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company focused on oncolytic immuno-gene therapies, will present two posters at the AACR Annual Meeting 2021, held virtually from April 10-15 and May 17-21, 2021. The presentations include:
- LB180: Clinical biomarker studies on oncolytic HSV (RP1 and RP2) combined with nivolumab, scheduled for April 10 at 8:30 am EDT.
- 1917: Immunomodulatory effects of a novel herpes simplex virus platform with anti PD-1 therapy, also on April 10 at 8:30 am EDT.
Both posters will be available on-demand from April 10.
Replimune Group, Inc. (Nasdaq: REPL) announced participation in three upcoming virtual investor conferences. The H.C. Wainwright Global Life Sciences Conference will be held on March 9-10, 2021, featuring a live presentation on March 9 at 7:00 am ET. The Barclays Global Healthcare Conference takes place on March 11, 2021, with a fireside chat scheduled for 9:10 am ET. Lastly, the 33rd Annual Roth Conference is set for March 17, 2021, at 1:30 pm ET. A webcast of the Barclays presentation will be available for replay on Replimune's website for 90 days.
Replimune Group, Inc. (NASDAQ: REPL) announced that CEO Philip Astley-Sparke will present at the SVB Leerink 10th Annual Global Healthcare Conference on February 24, 2021, at 8:40 AM ET. The presentation will be available via webcast on Replimune's website, with a replay accessible for 90 days post-conference.
Founded in 2015 and based in Woburn, Massachusetts, Replimune is developing oncolytic immuno-gene therapies using its proprietary Immulytic™ platform, aiming to enhance immune responses to cancer treatments.
Replimune Group (NASDAQ: REPL) reported its fiscal third quarter results for 2020, revealing a net loss of $21.8 million, up from $16.2 million a year prior. The company highlighted its progress in advancing its clinical candidates, particularly RP1, RP2, and RP3, with several studies ongoing and initial data expected throughout 2021. Additionally, Replimune's cash position stands at $493.3 million, extending its runway through the second half of 2024. However, the company noted that COVID-19 has impeded patient enrollment in clinical trials.
Replimune Group Inc. (NASDAQ: REPL) announced significant progress in its oncolytic immuno-gene therapy programs. Key developments include ongoing trials for RP1 in combination with Opdivo for anti-PD1 failed melanoma and NSCLC. RP3 dosing has commenced, and new data is expected in 2021. The company has successfully established a commercial-scale GMP manufacturing facility. Despite delays in patient enrollment due to COVID-19, Replimune maintains a strong cash position of $493 million, expected to fund operations through mid-2024.
Replimune Group, Inc. (NASDAQ: REPL) announced that CEO Philip Astley-Sparke will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 5:20 PM ET. The event will be held virtually, with a simultaneous webcast available on Replimune’s website. The presentation will focus on their innovative oncolytic immuno-gene therapies developed from the Immulytic™ platform, which aims to enhance cancer treatment by boosting immune responses to tumor antigens. A replay of the conference will be accessible for 30 days afterwards.
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