RP3

Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

Retrieved on: 
Tuesday, December 5, 2023
Chills, CRS, Melanoma, RP1, CRC, Food, Melanoma Research, RECIST, NMSC, Transplant, Diarrhea, FDA, Cytokine release syndrome, Colorectal cancer, SCCHN, Type, RP3, CRR, Fatigue, Headache, Nausea, Itch, Myocarditis, Incidence, Nivolumab, Influenza-like illness, Research, Clinical trial, Injection site reaction, Myalgia, CSCC, Skin cancer, HCC, Weakness, Society, Head, Appetite, RP2, Regeneron Pharmaceuticals, Carcinoma, Investment, Webcast, Patient, Lipase, Angiosarcoma, MCC, Vomiting, Neck, Uveal melanoma, Rash, BLA, Pharmaceutical industry

The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.

Key Points: 
  • The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.
  • The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692).
  • The registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients and completed enrollment earlier this year.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

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

Retrieved on: 
Tuesday, November 7, 2023
Bevacizumab, Patient, FDA, Research, Carboplatin, RP1, NMSC, Biologics license application, Nivolumab, Biotechnology, Financial management, Carcinoma, Cisplatin, Data collection, Disclosure, SITC, Immunotherapy, 8th Plenary Session of the Central Committee of the League of Communists of Serbia, Initiation, RP3, Clinical trial, Marketing, Melanoma, Skin, Annual general meeting, RP2, PTC, CFO, Roche, Society, CSCC, PTC Therapeutics, Therapy, Investment, Calendar, BLA, D, Merkel-cell carcinoma, Pharmaceutical industry, Nursing, Cryptocurrency

WOBURN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • R&D Expenses: Research and development expenses were $49.1 million for the second quarter ended September 30, 2023, as compared to $28.8 million for the second quarter ended September 30, 2022.
  • S,G&A Expenses: Selling, general and administrative expenses were $14.7 million for the second quarter ended September 30, 2023, as compared to $12.7 million for the second quarter ended September 30, 2022.
  • Selling, general and administrative expenses included $4.7 million in stock-based compensation expenses for the second quarter ended September 30, 2023.
  • Net Loss: Net loss was $60.0 million for the second quarter ended September 30, 2023, as compared to a net loss of $43.1 million for the second quarter ended September 30, 2022.

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 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 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.

Giant Food Debuts New Campaign Focused on Local Impact

Retrieved on: 
Wednesday, January 4, 2023
CityCenterDC, SOCOM U.S. Navy SEALs: Confrontation, Social media, Metro, NCPA, Social equality, Pleasure, Transport, Norfolk Southern Railway, City centre, University, ABC Fine Wine & Spirits, Supermarket, Healthy Living, Workforce, Starbucks, RP3, Education, Multimedia, American Association of Colleges of Pharmacy, Giant Food, Travel, Neighbor, Hay–Adams Hotel, University of Maryland, College Park, Nutritional rating systems, AACP, Research, Food, Radio, Grocery store, Health care, Giant, DMV, Marketing, D.C

LANDOVER, Md., Jan. 4, 2023 /PRNewswire/ -- Today, Giant Food, the leading greater Washington D.C. regional grocery chain, announces its new brand campaign, "Find Your Local." Dedicated to all things local, the campaign theme calls attention to Giant's longtime commitment to the communities it serves across areas of educational programs, partnerships, and product offerings.

Key Points: 
  • LANDOVER, Md., Jan. 4, 2023 /PRNewswire/ -- Today, Giant Food , the leading greater Washington D.C. regional grocery chain, announces its new brand campaign, "Find Your Local."
  • Giant Food offers over 1,000 items from more than 100 local vendors.
  • All commercials were shot locally and produced using local businesses and a workforce that was over 85% from the DMV region.
  • No other grocer knows the local unique tastes and traditions as well as Giant and this campaign is a perfect reflection of that," said RP3 Founder-CEO Beth Johnson.

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.

Replimune Enters into Clinical Collaboration Agreement with Roche for the Development of RP3 In Colorectal Cancer and Hepatocellular Carcinoma

Retrieved on: 
Wednesday, December 7, 2022
Roche, Bristol Myers Squibb, MOA, Colorectal cancer, Head, Protein, Neoplasm, Coronavirus, Clinical trial, Tumor microenvironment, RP1, Security (finance), CRC, FDA, TME, SCCHN, Hepatocellular carcinoma, Safety, CD40L, HSV, RP2, RPX, Lymph, Regeneron Pharmaceuticals, Immunogenic cell death, GI, Neck, Drug Quality and Security Act, GM-CSF, Toxicity, Bevacizumab, Antigen, RP3, Philosophy, Patient, HCC, 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 that the Company has entered into a Master Clinical Trial Collaboration and Supply Agreement in relation to Replimune’s RP2/3 program in colorectal cancer (CRC) and hepatocellular carcinoma (HCC). Specifically, the companies will collaborate in third-line (3L) CRC and in first- and second-line (1L & 2L) HCC. Under the terms of the agreement, the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab for 2L HCC and 3L CRC combined with RP3. Roche will also supply atezolizumab and bevacizumab for 1L HCC combined with RP3, and for 3L CRC combined with RP2. Approximately 30 patients will be enrolled within each cohort. Replimune will have responsibility for operationalizing the clinical trial.

Key Points: 
  • Specifically, the companies will collaborate in third-line (3L) CRC and in first- and second-line (1L & 2L) HCC.
  • Under the terms of the agreement, the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab for 2L HCC and 3L CRC combined with RP3.
  • Roche will also supply atezolizumab and bevacizumab for 1L HCC combined with RP3, and for 3L CRC combined with RP2.
  • Replimune will have responsibility for operationalizing the clinical trial.