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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 (NASDAQ: REPL) announced that its management will present at two upcoming virtual conferences. The BTIG Virtual Biotechnology Conference is scheduled for August 9, 2021, at 11:00 am ET. The second event, the 2021 Wedbush PacGrow Healthcare Virtual Conference, will include a panel discussion on immuno-oncology challenges on August 11, 2021, at 12:35 pm ET. Replimune is focused on developing oncolytic immune-gene therapies to enhance cancer treatment effectiveness through its Immulytic® platform.
Replimune Group, Inc. (NASDAQ: REPL) announced that Dr. Robert Coffin, its President and Chief R&D Officer, will speak at the William Blair Biotech Focus Conference 2021. This virtual event is scheduled for July 14, 2021, at 4:20 PM ET, focusing on addressing PD-(L)1 refractory tumors. A webcast will be available on Replimune's website, with a replay accessible for 90 days. Replimune specializes in oncolytic immuno-gene therapies, leveraging its Immulytic® platform to enhance cancer treatment through improved immune responses and viral-mediated tumor cell killing.
Replimune Group announces encouraging interim results from its Phase 2 clinical trials involving RP1 combined with Opdivo for skin cancer treatments and RP2 for anti-PD1 failed cancers. The results highlight a high rate of complete responses, particularly in cutaneous squamous cell carcinoma, with a current complete response rate of 46%. Replimune plans to initiate a Phase 2 study targeting tumors with liver metastases, a critical unmet need. The virtual investor event is set for today at 8:00 am ET to discuss these findings and future plans.
Replimune Group, Inc. (NASDAQ: REPL) reported fiscal year 2021 financial results, ending with approximately $476 million in cash, projected to fund operations into the second half of 2024. The company announced the addition of a complete response endpoint in the CERPASS clinical trial for non-melanoma skin cancer, aiming to enhance regulatory approval prospects. Additionally, they dosed the first patient in a new NSCLC cohort and strengthened the management team with key hires for commercial preparation.
Replimune Group, Inc. (Nasdaq: REPL) has appointed Tanya Lewis as Chief Development Operations Officer, effective May 10, 2021. Previously a board member, Lewis brings extensive experience from her roles at Karyopharm Therapeutics and other biopharmaceutical firms. She will focus on executing clinical and regulatory strategies for BLA filings and product registrations. CEO Philip Astley-Sparke highlighted her potential to enhance the company’s ambition to broaden its immuno-oncology treatments. Replimune is committed to advancing its oncolytic immuno-gene therapies to address various cancer types.
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.
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