Merkel-cell carcinoma

Kymera Therapeutics to Present New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

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четверг, мая 23, 2024

WATERTOWN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced new clinical data for KT-253, a first-in-class MDM2 degrader, from its ongoing Phase 1 dose escalation trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 – June 4, 2024, in Chicago, Illinois. Results released in an ASCO abstract today include a data cut-off of January 26, 2024.

Key Points: 
  • Results released in an ASCO abstract today include a data cut-off of January 26, 2024.
  • “We continue to see encouraging data from the trial’s dose escalation phase demonstrating potent upregulation of p53 biomarkers and signs of antitumor activity in patients.
  • The Company expects to complete the study and share additional clinical data to inform the program’s next development steps in 2024 at an upcoming medical meeting.
  • Kymera is also developing a biomarker-based patient selection strategy for subsequent development beyond Phase 1a and is expected to present data at a medical meeting this year.

Phio Pharmaceuticals Announces Completion of Dosing in First Patient Cohort in PH-762 Phase 1b Dose-Escalation Study

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среда, мая 15, 2024

MARLBOROUGH, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced progress on its Phase 1b clinical study for their lead compound PH-762.   Dosing of the first cohort of patients was completed and screening for the next dose cohort is on-going.

Key Points: 
  • Dosing of the first cohort of patients was completed and screening for the next dose cohort is on-going.
  • Phio’s Phase 1b study (NCT 06014086) is a multi-center, dose-escalating clinical trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.
  • This study will assess the tumor response, and determine the recommended dose for further study of PH-762.
  • “This is exciting news for Phio and our lead compound PH-762 with the dosing of the 1st cohort completed, we look forward to advancing the study to bring an innovative treatment option to patients with skin carcinomas,” said Robert Bitterman, CEO of Phio Pharmaceuticals.

SOTIO Presents Overview of DUET-01 Phase 1/2 Study at ASCO Annual Meeting

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четверг, мая 23, 2024

SOTIO Biotech , a clinical-stage immuno-oncology company owned by PPF Group, will present on June 1, 2024 (Developmental Therapeutics—Immunotherapy session) a Trial-in-Progress poster on the first-in-human DUET-01 Phase 1/2 study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • SOTIO Biotech , a clinical-stage immuno-oncology company owned by PPF Group, will present on June 1, 2024 (Developmental Therapeutics—Immunotherapy session) a Trial-in-Progress poster on the first-in-human DUET-01 Phase 1/2 study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • The study is evaluating the use of BOXR1030, a metabolically enhanced CAR T-cell therapy, for the treatment of patients with solid tumors.
  • GPC3 is a clinically validated tumor-restricted target with a high prevalence in several solid tumor indications with unmet medical need.
  • The trial will enroll up to 98 patients with advanced, unresectable hepatocellular carcinoma, squamous cell lung cancer, myxoid/round cell liposarcoma, and Merkel cell carcinoma.

Phio Pharmaceuticals Reports Q1 2024 Results and Provides Business Update

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четверг, мая 9, 2024

MARLBOROUGH, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today reported its Q1 2024 financial results and provided a business update.

Key Points: 
  • MARLBOROUGH, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today reported its Q1 2024 financial results and provided a business update.
  • At March 31, 2024, we had cash of $6.5 million as compared with $8.5 million at December 31, 2023.
  • Net loss was $2.2 million for the three months ended March 31, 2024 as compared with $3.6 million for the three months ended March 31, 2023.
  • The decrease in net loss was primarily due to the changes in research and development expenses, as described above.

SOTIO to Present Poster on DUET-01 Clinical Trial at 2024 ASCO Annual Meeting

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среда, апреля 24, 2024

SOTIO Biotech , a clinical-stage immuno-oncology company owned by PPF Group, today announced it will present a Trial-in-Progress poster on the DUET-01 Phase 1/2 study of BOXR1030 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, 2024, in Chicago, IL.

Key Points: 
  • SOTIO Biotech , a clinical-stage immuno-oncology company owned by PPF Group, today announced it will present a Trial-in-Progress poster on the DUET-01 Phase 1/2 study of BOXR1030 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, 2024, in Chicago, IL.
  • BOXR1030 is a next-generation GPC3-targeted CAR T-cell therapy enhanced with a transgene encoding GOT2, a critical enzyme involved in cellular metabolism.
  • It is the most advanced therapeutic candidate from SOTIO’s BOXR platform of enhanced cell therapies for the treatment of solid tumors.
  • The trial will enroll up to 98 patients with advanced, unresectable hepatocellular carcinoma, squamous cell lung cancer, myxoid/round cell liposarcoma, and Merkel cell carcinoma.

Phio Pharmaceuticals Announces Addition of Clinical Trial Sites at Banner MD Anderson Cancer Center, The George Washington University, and Integrity Research

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среда, марта 13, 2024

Banner MD Anderson Cancer Center in Gilbert, Arizona

Key Points: 
  • Banner MD Anderson Cancer Center in Gilbert, Arizona
    Integrity Research Clinical Associates in Delray Beach, Florida
    These sites join Centricity Research in Dublin, Ohio, which enrolled the study’s first patient in November.
  • The principal investigator at the George Washington University trial is Vishal Patel, M.D.
  • at the Banner MD Anderson Cancer Center trial site.
  • More information about this clinical trial is available at clinicaltrials.gov (identifier: NCT06014086 ).

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

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четверг, февраля 8, 2024

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.

Acrivon Therapeutics Appoints Jean-Marie Cuillerot, M.D., as Chief Medical Officer

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среда, января 3, 2024

WATERTOWN, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics or AP3, today announced the appointment of Jean-Marie Cuillerot, M.D., as chief medical officer.

Key Points: 
  • WATERTOWN, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics or AP3, today announced the appointment of Jean-Marie Cuillerot, M.D., as chief medical officer.
  • “Jean-Marie has over twenty years of successful experience in oncology drug development, and we are delighted to have him join Acrivon,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics.
  • “During his impressive career, he has effectively executed on advancing drugs from early development through regulatory approval, at both pharma and biotech companies.
  • Prior to Dragonfly, Dr. Cuillerot was the chief medical officer of Agenus, where he led development activities for five investigational therapies.

Phio Pharmaceuticals Announces First US Patient Enrolled in Phase 1B Clinical Trial with Intratumoral PH-762 anti-PD-1 Therapy for Treatment of Skin Carcinomas

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четверг, ноября 9, 2023

“The initiation of enrollment in this trial represents a milestone as we develop PH-762 for the treatment of squamous cell and other skin cancers,” said Phio’s President and CEO Robert Bitterman.

Key Points: 
  • “The initiation of enrollment in this trial represents a milestone as we develop PH-762 for the treatment of squamous cell and other skin cancers,” said Phio’s President and CEO Robert Bitterman.
  • The study treatment consists of four intratumoral injections of PH-762 at weekly intervals within a single tumor lesion.
  • Excision of the tumor occurs approximately two weeks following the fourth intratumoral dose of PH-762.
  • The clinical study is expected to enroll up to 30 patients and will be conducted across 4 to 6 centers in the United States.

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

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вторник, ноября 7, 2023

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.