RP1

Replimune Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 3, 2023
Bevacizumab, Radiation, CRC, Skin, Roche, Clinical trial, Merkel-cell carcinoma, SCCHN, Data collection, Uveal melanoma, RP3, Incyte, SOC, Cisplatin, RP1, ASCO, ORR, CSCC, American Society of Clinical Oncology, Cytokine release syndrome, Patient, Standard of care, Melanoma, Carcinoma, CPS, Annual general meeting, Liver, Nivolumab, ATC, RP2, Kinetics, BLA, PD-L1, Society, Safety, Fatigue, Pharmaceutical industry, Vaccine, Medical imaging, Nursing

“It was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO.

Key Points: 
  • “It was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO.
  • S,G&A Expenses: Selling, general and administrative expenses were $15.2 million for the first quarter ended June 30, 2023, as compared to $11.4 million for the first quarter ended June 30, 2022.
  • Selling, general and administrative expenses included $5.5 million in stock-based compensation expenses for the first quarter ended June 30, 2023.
  • Net Loss: Net loss was $49.6 million for the first quarter ended June 30, 2023, as compared to a net loss of $42.3 million for the first quarter ended June 30, 2022.

Replimune and Incyte Enter into Clinical Trial Collaboration and Supply Agreement to Evaluate RP1 and INCB99280 in Patients with Cutaneous Squamous Cell Carcinoma

Retrieved on: 
Monday, July 31, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Learning, Hematology, Clinical trial, Multimedia, RPX, RP1, Development, CSCC, Patient, Carcinoma, PD-L1, Safety, Pharmaceutical industry, Incyte

Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, and Incyte (NASDAQ:INCY), a global biopharmaceutical company, today announced a clinical trial collaboration and supply agreement to study RP1, Replimune’s lead product candidate, in combination with INCB99280, Incyte’s small molecule oral PD-L1 inhibitor.

Key Points: 
  • Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, and Incyte (NASDAQ:INCY), a global biopharmaceutical company, today announced a clinical trial collaboration and supply agreement to study RP1, Replimune’s lead product candidate, in combination with INCB99280, Incyte’s small molecule oral PD-L1 inhibitor.
  • This press release features multimedia.
  • Under the terms of the agreement, Incyte will initiate and sponsor the clinical trial of INCB99280 and RP1 in patients with high risk, resectable cutaneous squamous cell carcinoma (CSCC), with the clinical trial expected to initiate in early 2024.
  • Replimune will supply Incyte with RP1 for the study and share equally in the costs of the study.

RP1 Shatters Metaverse Limits: Showcases Technology Platform Capable of Scaling to Billions of People

Retrieved on: 
Wednesday, June 14, 2023
Data Management, Technology, Software, Metaverse, Networks, Internet, Linda, Meta, AWE, Augmented World Expo, Web browser, Virtual, Central processing unit, PC, HTC, RP1, DATA, VR, CPU, Apple, Ecosystem, Imagination, AR, Tourism, Video game, Online shopping

RP1 offers the industry's first software solution to tackle this problem, unlocking the power of the largest hardware and chipset manufacturers.

Key Points: 
  • RP1 offers the industry's first software solution to tackle this problem, unlocking the power of the largest hardware and chipset manufacturers.
  • RP1 has paved the way for the Metaverse to become a reality today by building a new foundational standard on top of current Internet protocols.
  • On-Demand: No more App stores; on-demand content without the need for pre-installed downloads, accessible via web browser or native app.
  • “The Metaverse will be a new way for anyone to express themselves using tools as simple as TikTok and Instagram.

Replimune Presents Initial RP1 Data from the ARTACUS Clinical Trial at the 2023 American Transplant Congress (ATC) Meeting

Retrieved on: 
Tuesday, June 6, 2023
Heart, Clinical trial, Merkel-cell carcinoma, RP1, Lung, Development, Patient, Lymph, Kidney, CR, Liver, Immunodeficiency, ATC, Death, ORR, Pneumonia, Skin, Pharmaceutical industry, Dentistry

This data from the ARTACUS trial will be presented at the ATC 2023 Meeting being held in San Diego.

Key Points: 
  • This data from the ARTACUS trial will be presented at the ATC 2023 Meeting being held in San Diego.
  • “Cutaneous cancer represents the most common post-transplant malignancy in highly immuno-compromised solid organ transplant patients.
  • The challenge treating this high-risk population is that the use of anti-PD1 therapies can lead to organ transplant rejection in these patients,” said Robert Coffin, President and Chief Research & Development Officer of Replimune.
  • This is the first clinical trial assessing single-agent RP1 in immunocompromised patients.

Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Saturday, June 3, 2023
Abstract, Radiation, Progression-free survival, Neoplasm, Clinical trial, OS, SCCHN, BRAF, Uveal melanoma, RP3, Bristol Myers Squibb, SOC, RP1, PFS, ASCO, Development, Patient, Cytokine release syndrome, Standard of care, Melanoma, CPS, GM-CSF, Liver, RP2, Kinetics, ORR, Safety, Fatigue, Nivolumab, Medical imaging, Pharmaceutical industry, Nursing, Vaccine

WOBURN, Mass., June 03, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced updated data from the first 75 patients in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial along with data from the ongoing Phase 1 trial of RP2 combined with nivolumab in patients with uveal melanoma are being presented at the ASCO annual meeting. The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab is registration-directed.

Key Points: 
  • The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab is registration-directed.
  • The anti-PD1 failed melanoma cohort is registration-directed and completed enrollment earlier in the year with 141 patients enrolled.
  • These updated data include the first 75 patients from the anti-PD1 failed melanoma cohort combined with the 16 anti-PD1 failed melanoma patients from the prior all comers 30 patient melanoma cohort (n=91 in total).
  • Data in uveal melanoma patients from the Phase 1 clinical trial evaluating RP2 in combination with nivolumab was presented.

Replimune to Present at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
McCormick Place, REPL, Uveal melanoma, RP1, ASCO, American Society of Clinical Oncology, Patient, Melanoma, RP2, Society, Nivolumab, Pharmaceutical industry

WOBURN, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced multiple presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from June 2-6, 2023.

Key Points: 
  • WOBURN, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced multiple presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from June 2-6, 2023.
  • Replimune has one abstract selected for a poster discussion session that will include updated results from the first 75 patients treated with RP1 combined with nivolumab from the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial.
  • In addition, the Company will also present data from the Phase 1 trial of RP2 combined with nivolumab in uveal melanoma, and trial-in-progress posters from the RP2/3 programs.
  • Abstract Title: Preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of RP2 as a single agent and in combination with nivolumab in a cohort of patients with uveal melanoma

Replimune Reports Fiscal Fourth Quarter and Year Ended 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 18, 2023
Bevacizumab, Radiation, CRC, Skin, Roche, Clinical trial, SCCHN, RP3, SOC, RP1, ASCO, CSCC, Patient, Standard of care, Melanoma, CPS, RP2, BLA, HCC, Nivolumab, Pharmaceutical industry

WOBURN, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2023 and provided a business update.

Key Points: 
  • R&D Expenses: Research and development expenses were $37.9 million for the fourth quarter and $126.5 million for the fiscal year ended March 31, 2023, as compared to $21.7 million for the fourth quarter and $79.5 million for the fiscal year ended March 31, 2022.
  • Research and development expenses included $2.3 million in stock-based compensation expenses for the fourth quarter and $10.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.
  • Selling, general and administrative expenses included $4.6 million in stock-based compensation expenses for the fourth quarter and $18.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.
  • Net Loss: Net loss was $49.2 million for the fourth quarter and $174.3 million for the fiscal year ended March 31, 2023, as compared to a net loss of $31.7 million for the fourth quarter and $118.0 million for the fiscal year ended March 31, 2022.

Replimune Reports Fiscal Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 9, 2023
Osteosarcoma, Sarcoma, Liver, Standard of care, Breast cancer, Skin cancer, Melanoma, GI, RP2, SCCHN, Bevacizumab, HCC, Skin, Roche, Patient, Uveal melanoma, CPS, RP1, Colorectal cancer, ORR, CSCC, Clinical trial, Epithelioid, Lung cancer, Nivolumab, RP3, SOC, Investment, CRC, Head, Radiation, Chondrosarcoma, Exercise, Hepatocellular carcinoma, Pharmaceutical industry, Medical imaging, Leiomyosarcoma

WOBURN, Mass., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2022 and provided a business update.

Key Points: 
  • Research and development expenses included $2.6 million in stock-based compensation expenses for the third quarter ended December 31, 2022.
  • S,G&A Expenses: Selling, general and administrative expenses were $11.4 million for the third quarter ended December 31, 2022, as compared to $10.3 million for the third quarter ended December 31, 2021.
  • Selling, general and administrative expenses included $4.4 million in stock-based compensation expenses for the third quarter ended December 31, 2022.
  • Net Loss: Net loss was $39.7 million for the third quarter ended December 31, 2022, as compared to a net loss of $29.7 million for the third quarter ended December 31, 2021.

Replimune Appoints Former Sanofi U.S. Commercial Oncology Head, Chris Sarchi, as Chief Commercial Officer and Sushil Patel as Chief Strategy Officer

Retrieved on: 
Wednesday, January 4, 2023
Hoffmann-La Roche, IMS Health, Boehringer Ingelheim, Head, Genentech, University of London, Squamous cell carcinoma, RP1, RP2, Health, GSK, Skin, CSCC, RP3, University, Imperial College London, Center for Study of Science, Technology and Policy (CSTEP), Nursing, BCC, Marketing, Molecular biology, Management, Fine chemical, Sanofi, Biotechnology, Science, Medicine, Vismodegib, Biosimilar

“These leadership appointments provide broad strategic and operational commercial acumen as we ramp up our commercial planning ahead of the potential 2024 commercial launch of RP1,” said Philip Astley-Sparke, Chief Executive Officer of Replimune.

Key Points: 
  • “These leadership appointments provide broad strategic and operational commercial acumen as we ramp up our commercial planning ahead of the potential 2024 commercial launch of RP1,” said Philip Astley-Sparke, Chief Executive Officer of Replimune.
  • “Chris led the launch of Libtayo in cutaneous squamous cell carcinoma (CSCC) at Sanofi, and was also involved with the launch of Erivedge in basal cell carcinoma (BCC) when at Genentech.
  • Sush will partner with Chris on our go-to-market strategy in the U.S. with RP1 and also in defining our commercialization strategy for the rest of the world.
  • Chris began his career with GSK where he held several sales and marketing leadership roles of increasing responsibility.

Replimune Announces Positive Initial Data from the Anti-PD1 Failed Melanoma Cohort of the IGNYTE Clinical Trial & an RP2/3 Program Update

Retrieved on: 
Wednesday, December 7, 2022
Roche, Bristol Myers Squibb, University, Immunotherapy, Liver, Colorectal cancer, Head, Melanoma, Sarcoma, Clinical trial, CPS, CD40L, RP1, Osteosarcoma, CRC, Hepatocellular carcinoma, SCCHN, SOC, RP2, Uveal melanoma, Chondrosarcoma, Principal investigator, Skin cancer, Neck, CR, ORR, GM-CSF, Radiation, Department of Oncology, University of Cambridge, Bevacizumab, Nivolumab, Disease, Safety, Cancer, RP3, Liver disease, PR, CSCC, Patient, HCC, Medical imaging, Pharmaceutical industry, Vaccine

WOBURN, Mass., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced an initial data snapshot from the first 75 patients from the anti-PD1 failed cutaneous melanoma cohort of the IGNYTE clinical. The IGNYTE clinical trial is evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab, with the anti-PD1 failed melanoma cohort being conducted with registrational intent. The Company also provided new data from the ongoing Phase 1 clinical trials evaluating RP2 and RP3, as well as a detailed overview of its RP2/3 Phase 2 development plans. A virtual investor event will be held today at 8:00 a.m. ET to discuss the new data. The data from this update can be found in the presentation for today’s investor event, linked here.

Key Points: 
  • The IGNYTE clinical trial is evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab, with the anti-PD1 failed melanoma cohort being conducted with registrational intent.
  • The Company is today presenting new data from the first 75 patients from the 125 patient anti-PD1 failed melanoma cohort, which has registrational intent.
  • The IGNYTE clinical trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb, with the anti-PD1 failed melanoma cohort expected to complete enrollment by around the end of this year.
  • This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma.