Full-Time
Senior Analyst
Quality Control
Posted on 9/10/2025
Replimune
201-500 employees
Develops oncolytic immunotherapies for cancer
No salary listed
Oxford, UK
In Person
 Biology & Biotech (2) |
|---|
| , |
- Degree in Chemistry or Biochemistry or other related science.
- Three years or more of laboratory-based experience working in a similar environment.
- Competent analytical skills and attention to detail.
- Understanding of Good Manufacturing Practices.
- Computer literacy including Microsoft Word and Excel, good communication and organizational skills.
- Ability to work independently and with others in a team.
- Perform QC testing of various routine and non-routine samples according to Standard Operating Procedures (SOPs).
- Maintain various cell lines on a regular basis by revival and passaging at set intervals.
- Perform QC sample and material receipt and maintain inventory.
- Routine equipment maintenance and troubleshooting as required.
- Lead introduction of new equipment and participate in validation activities.
- Write, update or review SOPs, protocols, forms and update as required.
- Participate in QC method transfers, validation, and stability activities.
- Adhere to current Good Manufacturing Practices (cGMP) and Good Documentation practices (GDP).
- General lab tasks such as housekeeping, inventory of supplies, order supplies etc.
- Write deviations/Corrective and Preventive Actions/Change controls related to QC and assist with investigations related to Out Of Specification and Out Of Trend results.
- Become a trainer in method as processes and train junior member of the team as required.
- Assist with internal and regulatory agency audits/ inspections.
- Ensure training is kept in GMP compliant state.
Replimune focuses on developing oncolytic immunotherapies for cancer. Its therapies use engineered viruses to selectively infect and kill tumor cells while stimulating an immune response, aiming to enhance the activity of immune checkpoint inhibitors. The treatments work by a combination of direct oncolysis and immune system activation to attack tumors, potentially across multiple cancer types. The company differentiates itself by combining multiple mechanisms of action and pursuing partnerships and licensing to bring therapies to market, rather than relying on a single modality. Its goal is to validate safety and efficacy through clinical trials and to commercialization through collaborations and eventual approval of its oncology therapies.
Company Size
201-500
Company Stage
IPO
Headquarters
Woburn, Massachusetts
Founded
2015
Simplify's Take
What believers are saying
- IGNYTE-3 phase 3 trial recruits for RP1 plus nivolumab versus physician's choice.
- RP2 advances in phase 2/3 for uveal melanoma and phase 2 for hepatocellular carcinoma.
- 44% ORR in acral melanoma cohort addresses rare aggressive subtype per ESMO 2025.
What critics are saying
- FDA's April 10, 2026 CRL rejects RP1 BLA citing insufficient IGNYTE trial evidence.
- 224 Massachusetts layoffs in April 2026 deplete $269 million cash by late 2026.
- Class actions by Bragar Eagel and Bleichmar drain funds via 2027 settlements.
What makes Replimune unique
- RPx platform uses HSV-1 backbone with GALV-GP R– and GM-CSF for immunogenic cell death.
- RP1 reverses PD-1 resistance via T-cell infiltration and antigen presentation upregulation per SITC 2025.
- IGNYTE trial shows 33.6% ORR and 24.8-month median DOR in anti-PD-1 failed melanoma.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Wellness Program
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 5%2 year growth
↑ 0%Replimune Group received a complete response letter from the FDA rejecting its biologics licence application for RP1 combined with nivolumab to treat advanced melanoma. The FDA questioned whether the data supporting breakthrough therapy designation was sufficient for approval. In the IGNYTE trial, patients who had progressed on anti-PD-1 therapy achieved a 34% response rate with a median duration of 24.8 months when treated with RP1 plus nivolumab, showing a favourable safety profile. CEO Sushil Patel criticised inconsistent FDA communication and a fragmented regulatory process, noting a different review team was appointed for resubmission. The company stated that without timely accelerated approval, RP1 development would not be viable and announced substantial job cuts, including scaling back US manufacturing operations.
Replimune presents late-breaking abstract and additional posters on RP1 at 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025). Replimune (NASDAQ: REPL) presented late-breaking biomarker and updated clinical data for RP1 plus nivolumab at SITC 2025 on Nov 7, 2025. The IGNYTE trial update (abstract #1327) reported that RP1 appears to reverse multiple mechanisms of resistance to PD-1 blockade and upregulates gene signatures linked to PD-1 responsiveness. With an additional 7 months follow-up, the combination showed an objective response rate (ORR) of 33.6% and a median duration of response of 24.8 months. Consistent durability was observed across PD-L1 - positive and PD-L1 - negative tumors and in primary and secondary resistance settings. Two additional posters (abstracts 611 and 600) reported comparable efficacy by BRAF status and tolerability with extended RP1 dosing. * ORR 33.6% reported with RP1 plus nivolumab * Median duration of response 24.8 months with additional 7-month follow-up * Durability consistent across PD-L1 - positive and PD-L1 - negative tumors * Biomarker data showing RP1 reverses multiple PD-1 resistance mechanisms WOBURN, Mass., Nov. 07, 2025 (GLOBE NEWSWIRE) - Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that biomarker data and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab was presented as a late-breaking abstract during an oral session at the 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025) in National Harbor, Maryland. Two additional posters on RP1 are also being presented. "These data are important because they demonstrate that RP1 plus nivolumab can potentially reprogram the tumor microenvironment and reverse mechanisms of resistance to immune checkpoint blockade," said Kostas Xynos, M.D., Ph.D., Chief Medical Officer of Replimune. "Low T cell levels in tumors, tumor PD-L1 expression, T-cell activation and IFNy gene signature expression, as well as the loss of antigen presentation machinery are well known mechanisms of resistance to immune checkpoint blockade." Data from the late-breaking abstract (#1327) presented by Trisha Wise-Draper, M.D., Ph.D., show: * Pharmacodynamic changes that were not achieved during prolonged prior anti - PD-1 therapy demonstrate that the addition of RP1 reverses multiple resistance mechanisms to PD-1 blockade and highlights the contribution of RP1 in melanoma patients who previously failed such treatment. * Treatment with RP1 plus nivolumab led to upregulation of gene signatures associated with responsiveness to PD-1 blockade. * With additional follow-up (7 months), RP1 combined with nivolumab continues to demonstrate a clinically meaningful response rate (ORR: 33.6%) and durability (median duration of response: 24.8 months). * Consistent duration of response was observed across PD-L1 - positive and negative tumors, as well as in both primary and secondary resistance settings. Median duration of response for PD-L1-negative patients was 24.8 months and for patients with primary resistance was 22.6 months. Additional posters being presented at the meeting include: * Abstract 611: RP1 plus nivolumab in patients with and without prior BRAF-directed therapy: A subgroup analysis of patients with anti-PD-1 failed BRAF-mutant melanoma from the IGNYTE clinical trial (Katy Tsai, M.D.) * RP1 plus nivolumab demonstrated comparable efficacy in BRAF-mutant and BRAF - wild-type advanced melanoma. * Greater activity was observed in BRAF-naïve patients - similar to findings from the SECOMBIT and DREAMseq trials. * Abstract 600: Retreatment with RP1 in combination with nivolumab in patients with advanced anti-PD-1- failed melanoma (Gino K. In, M.D.) * Extended RP1 treatment beyond 8 doses was well tolerated providing clinical benefit in a majority of patients. About IGNYTE The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma and confirmed progression on anti-PD1- based therapy for > 8 weeks as the last prior treatment. RP1 was administered intratumorally into superficial and/or deep/visceral tumors once every 2 weeks for up to 8 doses (<=10 mL per cycle) with intravenous nivolumab (240 mg); nivolumab was then given alone (240 mg every 2 weeks or 480 mg every 4 weeks) for up to 2 years, with further RP1 allowed if indicated. About RP1 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. About Replimune 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 intended to ignite local 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 then activate 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. Forward Looking Statements This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and sufficiency of our clinical trials and outcomes, the potential applicability of our product candidates to treat certain indications, the proposed mechanism of action of our product candidates and biologic effect, and other statements identified by words such as "could," "expects," "intends," "hope," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and sufficient continuous operation of our in-house manufacturing facility to produce the necessary quality and quantity of our product candidates for continuous clinical trial supply, the timing and scope of regulatory approvals, if any, our ability to resolve the issues identified in the CRL and the Type A meeting in a manner satisfactory to the FDA and to us and the timing thereof, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Media Inquiries Arleen Goldenberg Replimune 917.548.1582 [email protected] What did Replimune announce about RP1 plus nivolumab at SITC 2025 (Nov 7, 2025)? Replimune presented late-breaking IGNYTE data showing RP1 plus nivolumab reverses multiple PD-1 resistance mechanisms and reports an ORR of 33.6% with a median DOR of 24.8 months. What is the objective response rate (ORR) for REPL's RP1 plus nivolumab in the IGNYTE trial? The reported ORR for RP1 plus nivolumab in the IGNYTE update is 33.6%. How durable are responses for REPL (RP1) plus nivolumab in anti - PD-1 failed melanoma? Median duration of response was reported as 24.8 months, with consistent durability across PD-L1 status and resistance settings. Did the IGNYTE biomarker data for REPL show reversal of PD-1 resistance mechanisms? Yes. The late-breaking biomarker data showed RP1 upregulated gene signatures linked to PD-1 responsiveness and reversed multiple resistance mechanisms. How did RP1 plus nivolumab perform in BRAF-mutant versus BRAF - wild-type patients (REPL)? A subgroup poster (abstract 611) reported comparable efficacy between BRAF-mutant and BRAF - wild-type patients, with greater activity in BRAF-naïve patients. Is extended RP1 dosing beyond 8 doses safe and beneficial according to Replimune's SITC 2025 posters? Abstract 600 reported that extended RP1 treatment beyond 8 doses was well tolerated and provided clinical benefit for a majority of patients.
Replimune highlights acral melanoma data for RP1 plus nivolumab at the ESMO Congress 2025. Replimune (NASDAQ: REPL) presented an ad hoc analysis from the IGNYTE phase 2 cohort at ESMO Congress 2025 showing activity of RP1 plus nivolumab in acral melanoma (Poster 1644P). The cohort had an objective response rate (ORR) of 44% (8/18) and a median duration of response of 11.9 months (95% CI lower bound 3.9 months, upper bound not reached). Safety was described as favorable with mostly transient grade 1 - 2 treatment-related adverse events. The company noted ongoing phase 3 IGNYTE-3 enrollment in post-anti-PD1/CTLA-4 progressed melanoma and an additional NMSC poster (1661P) at ESMO. * ORR 44% in acral melanoma (8/18 patients) * Median duration of response 11.9 months * Safety: mainly transient grade 1 - 2 treatment-related adverse events * Phase 3 IGNYTE-3 randomized trial is currently recruiting * Small sample size: only 18 acral melanoma patients * Result reported as an ad hoc (post-hoc) analysis, limiting robustness * Lower bound of DOR CI is 3.9 months; upper bound not reached Phase 2 ad hoc data show promising activity of RP1+nivolumab in acral melanoma but sample size and post-hoc nature limit conclusions. RP1 combined with nivolumab produced an objective response rate of 44% (8/18) in an ad hoc cohort of acral melanoma, with a median duration of response of 11.9 months. Acral melanoma is described as a rare, aggressive subtype (2-3% of cases) that often responds poorly to standard immune checkpoint inhibitors, so a single-arm signal of this magnitude in a difficult-to-treat subgroup warrants attention. Key dependencies and risks include the small sample size (n=18), the ad hoc nature of the analysis, and the lack of a randomized control within this subgroup. Safety is reported as mainly transient grade 1 - 2 events, but no detailed adverse event rates or long-term follow-up are provided here. These factors limit confidence in how reproducible or clinically durable the benefit will be. Concrete items to watch are the enrollment and results from the randomized IGNYTE-3 phase 3 trial comparing RP1+nivolumab versus physician's choice in PD-1/CTLA-4 progressed melanoma, the publication of full safety and efficacy tables for the acral cohort, and any prespecified subgroup analyses or confirmatory data at future conferences. Expect meaningful intermediate updates over the next 6 - 24 months as the phase 3 trial matures. 10/19/2025 - 08:00 AM WOBURN, Mass., Oct. 19, 2025 (GLOBE NEWSWIRE) - Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced data from a new ad hoc analysis from the IGNYTE phase 2 cohort of RP1 plus nivolumab was presented by Caroline Robert, M.D., Ph.D., at the European Society for Medical Oncology (ESMO) Congress 2025 being held in Berlin (Poster 1644P). The analysis of acral melanoma patients from the IGNYTE clinical trial showed treatment with RP1 combined with nivolumab resulted in an objective response rate of 44% (8/18) with a median duration of response of 11.9 months (3.9, not reached). The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events. Acral melanoma is a rare and aggressive type of cutaneous melanoma (2-3% of all melanoma cases) that frequently occurs on the palms of the hands, soles of the feet, and nailbeds, and often has poor outcomes with many patients presenting with in-transit metastases. Acral melanoma does not typically respond well to available therapies, such as immune checkpoint inhibitors. Following progression on first-line therapy, aside from targeted therapy for a subset of patients with BRAF mutation-positive tumors, few viable treatment options exist. The IGNYTE-3 randomized controlled phase 3 trial evaluating RP1 plus nivolumab versus physician's choice of treatment in melanoma that has progressed on anti-PD1 and anti-CTLA-4 therapy is currently recruiting. An additional poster titled, "Efficacy and safety of RP1 + nivolumab in patients with non-melanoma skin cancers (NMSC)" is also being presented at ESMO by Dirk Schadendorf, M.D. (Poster 1661P). About IGNYTE The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma and confirmed progression on anti-PD1- based therapy for > 8 weeks as the last prior treatment. RP1 was administered intratumorally into superficial and/or deep/visceral tumors once every 2 weeks for up to 8 doses (<=10 mL per cycle) with intravenous nivolumab (240 mg); nivolumab was then given alone (240 mg every 2 weeks or 480 mg every 4 weeks) for up to 2 years, with further RP1 allowed if indicated. About RP1 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. About Replimune 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 intended to ignite local 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 then activate 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. Forward Looking Statements This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and sufficiency of our clinical trials and outcomes, the potential applicability of our product candidates to treat certain indications, and other statements identified by words such as "could," "expects," "intends," "hope," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and sufficient continuous operation of our in-house manufacturing facility to produce the necessary quality and quantity of our product candidates for continuous clinical trial supply, the timing and scope of regulatory approvals, if any, our ability to resolve the issues identified in the CRL and the Type A meeting in a manner satisfactory to the FDA and to us and the timing thereof, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Media Inquiries Arleen Goldenberg Replimune 917.548.1582 [email protected] What were the RP1 plus nivolumab results in acral melanoma presented at ESMO 2025 for REPL? The ad hoc IGNYTE phase 2 analysis reported an ORR of 44% (8/18) and a median DOR of 11.9 months. When and where did Replimune present RP1 acral melanoma data for REPL? Data were presented at ESMO Congress 2025 in Berlin (Poster 1644P) on Oct. 19, 2025. What safety profile was reported for RP1 plus nivolumab in the IGNYTE acral melanoma cohort? Safety was described as favorable with generally transient grade 1 - 2 treatment-related adverse events. Is there a phase 3 trial for RP1 plus nivolumab for REPL and what is its status? Yes, the randomized phase 3 IGNYTE-3 trial evaluating RP1 plus nivolumab versus physician's choice is currently recruiting. How many acral melanoma patients were included in the REPL IGNYTE analysis and why does that matter? The analysis included 18 patients; the small sample size limits statistical confidence and generalizability.
NEW YORK, Sept. 11, 2025 (GLOBE NEWSWIRE) - Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ:REPL) in the United States District Court District Of Massachusetts on behalf of all persons and entities who purchased or otherwise acquired Replimune securities between November 22, 2024 and July 21, 2025, both dates inclusive (the "Class Period").
NEW YORK, July 26, 2025 (GLOBE NEWSWIRE) - Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Replimune Group, Inc. (NASDAQ: REPL) and certain of the Company's senior executives for potential violations of the federal securities laws.