Mucosal melanoma

Mural Oncology Launches to Advance Pipeline of Novel Engineered Cytokine Immunotherapies

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Wednesday, November 15, 2023
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DUBLIN, Ireland, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA) today launched as an independent, publicly traded, clinical-stage immuno-oncology company leveraging its core competencies in immune cell modulation and protein engineering to develop novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers. Mural’s ordinary shares will begin trading on the Nasdaq Global Market tomorrow, November 16th, under the ticker symbol “MURA”.

Key Points: 
  • “Immunotherapies have made a tremendous impact on the treatment of cancers over the past decade,” said Caroline Loew, Ph.D., the Company’s chief executive officer.
  • We believe Mural Oncology can lead the future of immunotherapies for patients.
  • Our protein engineering expertise allows us to reimagine the development of pro-inflammatory cytokine-based therapeutics that could address the key limitations with current cancer immunotherapies.
  • Goodwin Procter LLP and Arthur Cox LLP are serving as legal counsel to Mural Oncology.

Iovance Biotherapeutics Announces Clinical Data for Lifileucel in Advanced Mucosal Melanoma at the European Society for Medical Oncology (ESMO) Congress

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Monday, October 16, 2023
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The abstract reports outcomes of a subset of 12 patients with advanced mucosal melanoma treated with lifileucel in the pooled consecutive cohorts from the C-144-01 trial.

Key Points: 
  • The abstract reports outcomes of a subset of 12 patients with advanced mucosal melanoma treated with lifileucel in the pooled consecutive cohorts from the C-144-01 trial.
  • Patients with mucosal melanoma, which is rare and difficult to treat, have worse outcomes after anti–PD-1 therapy compared to patients with other melanoma subtypes.
  • The ORR assessed by an independent review committee (IRC) using RECIST v1.1 was 50% (95% CI: 21%–79%).
  • Treatment emergent adverse events (TEAEs) were consistent with known safety profiles of lymphodepleting chemotherapy and interleukin-2 (IL-2).

Ankyra Therapeutics Presents Preliminary Canine Clinical Data with cANK-101 Supporting Therapeutic Potential of Anchored Immunotherapy

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Wednesday, April 19, 2023
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Ankyra Therapeutics has developed an anchored drug-delivery platform based on linking immunotherapy drugs to aluminum hydroxide.

Key Points: 
  • Ankyra Therapeutics has developed an anchored drug-delivery platform based on linking immunotherapy drugs to aluminum hydroxide.
  • The linked compounds are delivered locally to the tumor, where they are retained for several weeks promoting anti-tumor activity while preventing systemic toxicity.
  • cANK-101 is a novel agent comprised of canine interleukin-12 complexed with aluminum hydroxide using the Ankyra platform.
  • Fan on bringing a potentially new immuno-oncology drug to dogs with malignant melanoma who have few other effective therapeutic options,” stated Howard L. Kaufman, MD, CEO of Ankyra Therapeutics.

Junshi Biosciences Announces NMPA Accepted supplemental New Drug Application for Toripalimab in Combination with Chemotherapy as First-Line Treatment of Advanced NSCLC

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Friday, December 10, 2021
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The study enrolled 465 NSCLC patients in 63 centers in China, among which 220 were squamous NSCLC patients and 245 were non-squamous NSCLC patients.

Key Points: 
  • The study enrolled 465 NSCLC patients in 63 centers in China, among which 220 were squamous NSCLC patients and 245 were non-squamous NSCLC patients.
  • Existing domestic and overseas studies have shown that monotherapy or combination chemotherapy of anti-PD-(L)1 monoclonal antibody has already become new standard for the first-line treatment of NSCLC.
  • Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.
  • Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

Junshi Biosciences Announces Two Additional Indications for Toripalimab Included in China’s National Reimbursement Drug List

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Friday, December 3, 2021
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Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma and nasopharyngeal carcinoma.

Key Points: 
  • Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma and nasopharyngeal carcinoma.
  • InDecember 2020, toripalimab was successfully included in the updated National Reimbursement Drug List for the indication of the second-line treatment of unresectable or metastatic melanoma.
  • Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.
  • Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

Junshi Biosciences Announces Approval of Supplemental New Drug Application by NMPA for Toripalimab in Combination with Cisplatin and Gemcitabine as First-Line Treatment for Patients with Locally Recurrent or Metastatic Nasopharyngeal Carcinoma

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Tuesday, November 30, 2021
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In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma.

Key Points: 
  • In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma.
  • In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy.
  • This study is the worlds largest Phase III clinical study for a checkpoint inhibitor in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC.
  • Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

Junshi Biosciences and Coherus Announce Toripalimab Granted Orphan Drug Designation in the United States for Esophageal Cancer

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Monday, November 15, 2021
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SHANGHAI, China and REDWOOD CITY, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc.(Coherus, Nasdaq: CHRS) announced today that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer.

Key Points: 
  • SHANGHAI, China and REDWOOD CITY, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc.(Coherus, Nasdaq: CHRS) announced today that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer.
  • Orphan drug designation is granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S.
  • Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma.
  • Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa in Combination With Pembrolizumab for the Treatment of Platinum-Resistant Ovarian Cancer

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Monday, October 25, 2021
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DUBLIN, Oct. 25, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer.

Key Points: 
  • DUBLIN, Oct. 25, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer.
  • The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.
  • Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need.
  • For more information on Fast Track designation, please visit the FDA's website, available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated... .

Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa in Combination With Pembrolizumab for the Treatment of Platinum-Resistant Ovarian Cancer

Retrieved on: 
Monday, October 25, 2021
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DUBLIN, Oct. 25, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer. The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.

Key Points: 
  • DUBLIN, Oct. 25, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer.
  • The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.
  • Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need.
  • For more information on Fast Track designation, please visit the FDA's website, available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated... .

Alkermes to Present Two Posters on Investigational Immuno-oncology Candidate, Nemvaleukin Alfa, at the 2021 European Society for Medical Oncology (ESMO) Virtual Congress

Retrieved on: 
Monday, September 13, 2021
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DUBLIN, Sept. 13, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced two poster presentations related to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the 2021 European Society for Medical Oncology (ESMO) Virtual Congress, taking place Sept. 16-21, 2021.

Key Points: 
  • DUBLIN, Sept. 13, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced two poster presentations related to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the 2021 European Society for Medical Oncology (ESMO) Virtual Congress, taking place Sept. 16-21, 2021.
  • "We're pleased to share updates from the nemvaleukin development program with the scientific and medical community at ESMO.
  • Details of the presentations are as follows:
    Presentation Date: The poster presentation will be available on demand to attendees beginning Sept. 16, 2021.
  • The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.