ASCO

Tempest Reports New Preclinical Data for TPST-1120 in RCC at the AACR Annual Meeting

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화요일, 4월 9, 2024

These new data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.

Key Points: 
  • These new data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.
  • “Preclinical data presented at AACR further demonstrate that TPST-1120 has the potential to positively transform the tumor microenvironment and expand the activity of anti-tumor immunity in kidney cancer,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest.
  • In preclinical models of renal cell carcinoma (RCC), treatment with TPST-1120 reduced tumor growth by 52%-56% as monotherapy.
  • Additional improvement in anti-cancer activity was demonstrated in combination treatment with standard first-line RCC cabozantinib or anti-PD1 therapy, where tumor inhibition was 81% and 74%, respectively.

Syncromune® Inc. Presents Positive Results from SYNC-T™ SV-102 Phase 1 Trial at AACR Annual Meeting 2024

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월요일, 4월 8, 2024

FORT LAUDERDALE, Fla., April 08, 2024 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company focused on the development of SYNC-T™, an in situ personalized therapy optimized for solid tumor cancers, today announced the presentation of positive results from the SV-102 Phase 1 trial at the American Association for Cancer Research (AACR) Annual Meeting 2024. The trial, involving patients with metastatic castrate-resistant prostate cancer (mCRPC), showed an overall response rate (ORR) of 85%.        

Key Points: 
  • FORT LAUDERDALE, Fla., April 08, 2024 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company focused on the development of SYNC-T™, an in situ personalized therapy optimized for solid tumor cancers, today announced the presentation of positive results from the SV-102 Phase 1 trial at the American Association for Cancer Research (AACR) Annual Meeting 2024.
  • The trial, involving patients with metastatic castrate-resistant prostate cancer (mCRPC), showed an overall response rate (ORR) of 85%.
  • The Phase 1 trial enrolled 15 mCRPC subjects, most of whom had diffuse bone metastases and had experienced failure with prior therapies.
  • The trial is ongoing, with results expected in the second half of 2024.

Lipella Pharmaceuticals to Publish Abstract Detailing Compelling Preclinical Support for New Product Candidate at ASCO 2024

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금요일, 4월 5, 2024

Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .

Key Points: 
  • Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .
  • Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, said, “ASCO’s 2024 meeting is the ideal venue for dissemination of our recent progress in the treatment of bladder cancer.
  • Lipella’s new product candidate, LP-50 (intravesical pembrolizumab), is intended to be indicated for non-muscle invasive bladder cancer (NMIBC).
  • Dr. Michael Chancellor, Lipella’s Chief Medical Officer, emphasized the significance of this milestone for advancing the company’s LP-50 program.

MacroGenics Provides Phase 2 TAMARACK Study Early Interim Safety Data and Plans for Future Disclosures

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수요일, 4월 3, 2024

As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31.

Key Points: 
  • As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31.
  • The abstract containing this early interim data, based on a January 4, 2024 data cut-off, was not accepted.
  • TAMARACK is an ongoing randomized, open-label, Phase 2 dose selection study assessing the efficacy, safety, and tolerability of two dose levels of vobra duo (2.0 mg/kg and 2.7 mg/kg IV Q4W).
  • At data cutoff (Jan 4, 2024), 182 pts with mCRPC enrolled on TAMARACK, of which 177 received vobra duo.

FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer

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화요일, 4월 2, 2024

“We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.

Key Points: 
  • “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression.
  • The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts.
  • These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with CD46 positive prostate cancer.

MediciNova Announces Abstract Regarding Results of a Clinical Trial of MN-166 (ibudilast) in Glioblastoma Accepted for Presentation at the 2024 American Society of Clinical Oncology Annual Meeting (2024 ASCO)

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수요일, 4월 3, 2024

LA JOLLA, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that an abstract regarding results of a clinical trial of MN-166 (ibudilast) in glioblastoma (GBM) has been selected for an oral presentation at the American Society of Clinical Oncology (2024 ASCO) Annual Meeting to be held May 31 – June 4, 2024 in Chicago.

Key Points: 
  • LA JOLLA, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that an abstract regarding results of a clinical trial of MN-166 (ibudilast) in glioblastoma (GBM) has been selected for an oral presentation at the American Society of Clinical Oncology (2024 ASCO) Annual Meeting to be held May 31 – June 4, 2024 in Chicago.
  • The oral presentation will be presented by one of the investigators of this clinical trial, Gilbert Youssef, M.D., Attending Physician at Harvard Medical School, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women's Hospital.
  • The presentation details are as follows:

Cyclacel Pharmaceuticals to Present New Clinical Data at 2024 ASCO Annual Meeting Highlighting Fadraciclib’s Potential as a Precision Medicine for Cancer

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월요일, 4월 1, 2024

BERKELEY HEIGHTS, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that new clinical, pharmacokinetic (PK) and pharmacodynamic (PD) data from the CYC065-101 study of fadraciclib as monotherapy was selected by the Scientific Program Committee for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31-June 4, 2024 in Chicago.

Key Points: 
  • BERKELEY HEIGHTS, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that new clinical, pharmacokinetic (PK) and pharmacodynamic (PD) data from the CYC065-101 study of fadraciclib as monotherapy was selected by the Scientific Program Committee for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31-June 4, 2024 in Chicago.
  • Details of the presentations are as follows:
    A phase 1 study evaluating the safety, pharmacokinetics, and efficacy of fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

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금요일, 3월 29, 2024

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Erasca Reports Fourth Quarter 2023 and Full Year 2023 Business Updates and Financial Results

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수요일, 3월 27, 2024

SAN DIEGO, March 27, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today provided business updates and reported financial results for the fiscal quarter and full year ended December 31, 2023.

Key Points: 
  • In addition, a strategic pipeline prioritization sharpened Erasca’s focus on existing programs that we believe have the highest probability of success for patients.
  • Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the quarter ended December 31, 2023, compared to $29.4 million for the quarter ended December 31, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $9.1 million for the quarter ended December 31, 2023, compared to $8.7 million for the quarter ended December 31, 2022.
  • Erasca will hold a conference call and webcast on Thursday, March 28, 2024 at 8:30 am ET.

Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025

Retrieved on: 
수요일, 3월 27, 2024

Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.

Key Points: 
  • Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.
  • “During 2023 Transgene continued to make significant progress, delivering compelling data that confirm the value of our approach to treating cancer using our novel immunotherapies” commented Dr. Alessandro Riva, MD, Chairman and CEO of Transgene.
  • As announced on May 5, 2023, AstraZeneca terminated its oncolytic virus research and development collaboration with Transgene following a strategic review of its pipeline.
  • In 2024, Transgene expects to communicate progress and significant results and readout on all of its clinical stage assets.