CSCC

Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers Presented During Oral Presentation at the American Association of Cancer Research (AACR) 2024 Annual Meeting

Retrieved on: 
Sunday, April 7, 2024
Skin cancer, Immunotherapy, Risk, Patient, SAN, RP1, University, MD Anderson Cancer Center, Society, AACR, Carcinoma, CSCC, SITC, PD-L1, Skin, Pharmaceutical industry

The results were initially presented late last year at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).

Key Points: 
  • The results were initially presented late last year at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
  • In the evaluable patient population (n=23), 20 had cutaneous squamous cell carcinoma (CSCC) and three had merkel cell carcinoma.
  • Of note, a patient treated with RP1 for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers.

GENESIS Pharma Announces an Exclusive Distribution Agreement With Regeneron Pharmaceuticals to Commercialize cemiplimab in Greece, Cyprus and Malta

Retrieved on: 
Friday, March 1, 2024
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, NSCLC, European, Cemiplimab, BCC, Patient, CSCC, Pharmaceutical industry

GENESIS Pharma, a regional biopharma company specialized in the commercialization of innovative medicines targeting severe and rare diseases in Central and Eastern Europe, announces an exclusive distribution agreement for the cancer medicine cemiplimab in Greece, Cyprus and Malta with Regeneron Ireland DAC.

Key Points: 
  • GENESIS Pharma, a regional biopharma company specialized in the commercialization of innovative medicines targeting severe and rare diseases in Central and Eastern Europe, announces an exclusive distribution agreement for the cancer medicine cemiplimab in Greece, Cyprus and Malta with Regeneron Ireland DAC.
  • Regeneron Ireland DAC is a wholly owned subsidiary of Regeneron, a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases.
  • Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology.
  • The two companies will work to seamlessly complete the transition of all relevant commercialization activities by the second quarter of 2024.

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

Retrieved on: 
Thursday, February 8, 2024
Carcinoma, Neoplasm, Melanoma, NMSC, Merkel-cell carcinoma, REPL, Angiosarcoma, SITC, PFS, Clinical trial, Research, RECIST, Society, Hercules, Patient, CSCC, Type, FDA, Marketing, Investment, RP1, Food, MCC, Immunotherapy, Skin, Nivolumab, Uveal melanoma, Annual general meeting, BLA, RP2, Pharmaceutical industry

WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.

Key Points: 
  • WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.
  • We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024.
  • Selling, general and administrative expenses included $4.5 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
  • Net Loss: Net loss was $51.1 million for the third quarter ended December 31, 2023, as compared to a net loss of $39.7 million for the third quarter ended December 31, 2022.

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.

Ankyra Therapeutics Announces Clinical Trial Supply Agreement with Regeneron to Evaluate ANK-101 in Combination with Libtayo® (cemiplimab) in Patients with Cutaneous Squamous Cell Carcinoma

Retrieved on: 
Monday, November 13, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, PD-L1, Clinical trial, CSCC, PD-1, Neoplasm, Skin, Patient, Tumor microenvironment, Therapy, Toxicity, Pharmaceutical industry, Regeneron Pharmaceuticals

Ankyra Therapeutics, a clinical stage biotechnology company developing a new form of local immunotherapy termed “anchored immunotherapy,” today announced a clinical trial supply agreement with Regeneron to evaluate ANK-101 in combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab).

Key Points: 
  • Ankyra Therapeutics, a clinical stage biotechnology company developing a new form of local immunotherapy termed “anchored immunotherapy,” today announced a clinical trial supply agreement with Regeneron to evaluate ANK-101 in combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab).
  • The Ankyra platform uses an inert aluminum hydroxide scaffolding to link to bioactive immuno-oncology agents.
  • Significant monotherapy anti-tumor activity has been seen in multiple murine tumor models and in a Phase I clinical trial of canine melanoma.
  • “We are excited to expand our clinical collaborations to evaluate the combination of ANK-101 with cemiplimab in cutaneous squamous cell carcinoma (CSCC),” said Dr. Joe Elassal, Chief Medical Officer at Ankyra.

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.

Medicenna Announces Promising Single-Agent Response and Durability of MDNA11 in the Phase 1/2 ABILITY Study During Dose Escalation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Monday, November 6, 2023
Hypertelorism, PD, VLS, Trae tha Truth, BCC, MSI-H, MDNA, MCC, Poster, Pharmacodynamics, SITC, Immunotherapy, Radiation, SD, RDE, PK, DLT, Safety, Society, CSCC, PDAC, Patient, Combination therapy, Toxicity, TSX, LFT, Nevus, Medical imaging, Pharmaceutical industry, Vaccine

MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.

Key Points: 
  • MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.
  • Following return from a 7 week vacation, a single new lesion was observed and MDNA11 treatment was resumed.
  • Monotherapy expansion part of ABILITY-1 is enrolling patients with metastatic melanoma, non-melanoma skin cancers (CSCC, MCC, and BCC) and MSI-H/dMMR tumors.
  • A copy of the poster and a related slide deck have been posted to the “ Events and Presentations ” page of Medicenna’s website.

Replimune Presents Updated Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers During Oral Presentation at the 38th Annual Meeting of the Society for Immunotherap

Retrieved on: 
Friday, November 3, 2023
RP1, Carcinoma, MD Anderson Cancer Center, MCC, Development, SITC, Immunotherapy, Skin, ORR, University, Society, CSCC, Patient, Skin cancer, Abstract, Transplant, Pharmaceutical industry

Treatment with RP1 monotherapy led to an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses).

Key Points: 
  • Treatment with RP1 monotherapy led to an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses).
  • One patient treated for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline that was treated with RP1.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers.
  • “Patients receiving organ transplants are highly susceptible to skin cancer at a rate which is far higher than in the general population.

Regeneron Reports Third Quarter 2023 Financial and Operating Results

Retrieved on: 
Thursday, November 2, 2023
CSU, DLBCL, Bispecific monoclonal antibody, FDA, Adolescence, American College, Ageing, CD3, ESMO, Food, Multiple myeloma, CD20, Fast Track, ACG, Congress, European Society for Medical Oncology, DME, Symantec Endpoint Protection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American College of Gastroenterology, The Lancet, Ministry, Ministry of Health (Kuwait), CRL, MHLW, Ministry of Health, Labour and Welfare, Oncology, Sanofi, Safety, Atopic dermatitis, CSCC, European, Patient, BCMA, Chronic obstructive pulmonary disease, COPD, Dupilumab, BLA, Pharmaceutical industry, Medical device, Vaccine, C5, Regeneron Pharmaceuticals, Health, EU

"Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.

Key Points: 
  • "Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.
  • These results were also presented at the 23rd EURETINA Congress in October 2023.
  • The Company announced that Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron, will retire in February 2024.
  • Christopher Fenimore, current Senior Vice President, Head of Accounting and Controller at Regeneron, will succeed Mr. Landry as Chief Financial Officer upon his retirement.

Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC)

Retrieved on: 
Saturday, October 21, 2023
Clinical Science (journal), MPR, Hypophysitis, ESMO, MD Anderson Cancer Center, Clinical research, Regeneron Pharmaceuticals, Carcinoma, Lymph, Congress, European Society for Medical Oncology, PCR, PD-1, The Lancet, Observation, Senior, Quality of life, Radiation, Risk, Recurrence, The New England Journal of Medicine, Oncology, University, Safety, Cancer, CSCC, AE, Patient, Translation, Death, Heart failure, Pharmaceutical industry, Medical imaging, Gasoline, Cemiplimab

TARRYTOWN, N.Y., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.

Key Points: 
  • “Advanced, resectable cutaneous squamous cell carcinoma can lead to reduced patient function and quality of life following the cumulative effects of treatment, typically surgery and radiation.
  • “Results from both the single-institution pilot trial and the multi-center Phase 2 trial found neoadjuvant cemiplimab was highly active in patients with resectable cutaneous squamous cell carcinoma.
  • These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years.”
    The multicenter, single-arm Phase 2 trial included two parts.
  • In Part 1, patients (n=79) received Libtayo 350 mg every three weeks for up to four doses, followed by curative-intent surgery.