CDK9

MEI Pharma and Infinity Pharmaceuticals Host Video Webcast Providing Overview and Update on Pending Merger to Advance Three Promising Clinical Oncology Candidates

Retrieved on: 
Thursday, June 15, 2023
Oncology, Health, Communications, General Health, Pharmaceutical, Biotechnology, Public Relations, Investor Relations, Bevacizumab, Venetoclax, SCCHN, Cancer, OXPHOS, Head, Eganelisib, Associate, Patient, Division, Colorectal cancer, Moores Cancer Center, Infinity, Wells Fargo, HNSCC, Webcast, Bone marrow, Neoplasm, MEI, PD-1, CDK9, Pharmaceutical industry

On the webcast Mr. David Urso will provide an update on the pending merger and an overview of the combined company, which joins the expertise and resources of MEI and Infinity to advance a robust pipeline of three clinical-stage oncology drug candidates.

Key Points: 
  • On the webcast Mr. David Urso will provide an update on the pending merger and an overview of the combined company, which joins the expertise and resources of MEI and Infinity to advance a robust pipeline of three clinical-stage oncology drug candidates.
  • The combined company’s development pipeline consists of three differentiated programs.
  • You can access the video webcast under the investor relations section of MEI's website on the "Events and Presentation" page at www.meipharma.com , or under the investor relations page of Infinity’s website on its “Events and Presentation” page at www.infi.com .
  • The pre-recorded video webcast will be archived for at least 30 days after the conclusion of the event.

SELLAS Life Sciences to Host Virtual Expert Panel Discussion on GFH009 in Acute Myeloid Leukemia

Retrieved on: 
Tuesday, May 16, 2023
University, University of North Carolina, EST, Acute myeloid leukemia, MD Anderson Cancer Center, AML, Azacitidine, SLS, Patient, Bone marrow, CDK9, Venetoclax, Pharmaceutical industry, MD

NEW YORK, May 16, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced it will host a virtual panel discussion on Tuesday, May 30, 2023 at 8:00 a.m. EST.

Key Points: 
  • NEW YORK, May 16, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced it will host a virtual panel discussion on Tuesday, May 30, 2023 at 8:00 a.m. EST.
  • GFH009 is a clinical stage small molecule, highly selective CDK9 inhibitor that SELLAS is investigating for treatment of patients with hematologic malignancies and solid tumors.
  • SELLAS plans to commence a Phase 2a clinical trial during the second quarter of 2023 with GFH009 in combination with venetoclax and azacitidine in AML patients.
  • A live question and answer session will follow the formal discussion and a replay of the event will be available on SELLAS’s website .

MEI Pharma Reports Third Quarter Fiscal Year 2023 Results and Operational Highlights

Retrieved on: 
Thursday, May 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Workforce, Commercialization, Lymphoid leukemia, Venetoclax, Calendar, Cancer, Acute myeloid leukemia, Kyowa Kirin, Development, AML, Patient, Investment, PMDA, Colorectal cancer, Infinity, Cell cycle, Bone marrow, Neoplasm, MEI, Research, CDK9, Cyclin-dependent kinase 9, Safety, Pharmaceutical industry, Cryptocurrency

MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for the quarter ended March 31, 2023, and highlighted recent corporate events.

Key Points: 
  • MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for the quarter ended March 31, 2023, and highlighted recent corporate events.
  • In February 2023, MEI Pharma and Infinity Pharmaceuticals announced a definitive merger agreement for an all-stock transaction pursuant to which Infinity will become a wholly owned subsidiary of MEI Pharma.
  • Research and development expenses were $15.1 million for the quarter ended March 31, 2023, compared to $22.3 million for the quarter ended March 31, 2022.
  • MEI recognized revenue of $5.9 million for the quarter ended March 31, 2023, compared to $9.7 million for the quarter ended March 31, 2022.

Prelude Therapeutics Announces First Quarter 2023 Financial Results and Operations Update

Retrieved on: 
Monday, May 8, 2023
Neutropenia, KRAS, Hepatotoxicity, Differentiable function, MYC, SMARCA2, AACR, Diarrhea, Half-life, HER2, Bone marrow, Cancer, Trae Waynes, G&A, Toxicity, Brain, Vomiting, Patient, Security (finance), Administration, Nausea, Research and development, R, Research, Cardiotoxicity, CDK9, Safety, Pharmaceutical industry, Vaccine

WILMINGTON, Del., May 08, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2023, and provided an update on recent clinical and development pipeline progress.

Key Points: 
  • WILMINGTON, Del., May 08, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2023, and provided an update on recent clinical and development pipeline progress.
  • 2023 AACR Annual Meeting: Prelude participated in the 2023 American Association for Cancer Research Annual Meeting, presenting two clinical and six preclinical poster presentations.
  • Prelude anticipates that its existing cash, cash equivalents and marketable securities will fund the Company’s operations into the fourth quarter of 2024.
  • We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

SELLAS Announces Positive Topline Data from GFH009 Phase 1 Dose-Escalation Trial in Acute Myeloid Leukemia Cohort Supporting Advancement to Phase 2 Clinical Study

Retrieved on: 
Thursday, May 4, 2023
Pharmacodynamics, Lymphoma, MYC, University, PD, BMB, Leukemia Research, Therapeutic index, Survival, Bone marrow, Associate, Acute myeloid leukemia, MRD, AML, Azacitidine, Hematological Cancer Research Investment and Education Act, Doctor of Science, SLS, MD, Patient, Cure, MCL1, CR, Toxic leukoencephalopathy, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Leukemia, CDK9, BIW, Food, Pharmaceutical industry, Vaccine, Hematology

NEW YORK, May 04, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced positive topline data for the cohort of patients with acute myeloid leukemia (AML) from its Phase 1 dose-escalation trial in relapsed/refractory (r/r) myeloid malignancies for GFH009, its CDK9 inhibitor. Dose escalation continues in the lymphoma cohort with the last dose level of 75 mg weekly. Clinical activity observed in the lymphoma group will be announced after completion of the last dose level and is expected by the end of the second quarter or early third quarter of 2023.

Key Points: 
  • Dose escalation continues in the lymphoma cohort with the last dose level of 75 mg weekly.
  • In the cohort of patients with AML, GFH009 treatment showed evidence of anti-tumor activity increasing with higher doses and no significant safety issues, including at the highest dose levels.
  • The recommended Phase 2 dose (RP2D) for AML has been established and submitted to the U.S. Food and Drug Administration (FDA).
  • SELLAS plans to commence a Phase 2a trial with GFH009 in combination with venetoclax and azacitidine (aza/ven) in patients with AML during the second quarter of 2023 with topline data expected by the end of the year.

SELLAS Life Sciences Successfully Completes Phase I Trial Dose Escalation of Novel, Highly Selective CDK9 Inhibitor GFH009 in Acute Myeloid Leukemia

Retrieved on: 
Thursday, April 20, 2023
CRC, PK, MYC, Venetoclax, DOR, Malignancy, Survival, Research, Acute myeloid leukemia, Bone marrow, AML, Azacitidine, BCL2, Data analysis, SLS, Patient, MCL1, EFS, Toxic leukoencephalopathy, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CDK9, Food, Safety, Pharmaceutical industry, MD

NEW YORK, April 20, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced completion of the safety evaluation stage of the highest dose cohort of patients with acute myeloid leukemia (AML) who relapsed after or were refractory to available antileukemic therapies in its Phase 1 dose escalation clinical trial of GFH009. No further dose escalations are planned in the AML group, while dose escalation continues in the lymphoma group with the addition of a 75 mg once-a-week dose cohort, which is planned to be the highest dose level for that group.

Key Points: 
  • “We are very encouraged by the strong efficacy signals and safety profile of our highly selective CDK9 inhibitor, GFH009, observed in this positive Phase 1 trial.
  • The trial will be a single arm open label dose ranging study with one dose level at the RP2D and one dose below RP2D.
  • GFH009 continued to be safe and well tolerated at all dose levels, with no dose limiting toxicities and no significant off target toxicities observed.
  • Based on the available Phase 1 data, the Phase 2a trial design will be submitted to the FDA by the end of the month.

Monte Rosa Therapeutics Presents Preclinical Data from GSPT1 Degrader Program Focused on MYC-Driven Cancers at AACR 2023

Retrieved on: 
Monday, April 17, 2023
Carcinoma, MYC, Index, AACR, PD, DLBCL, Survival, Disclosure, Clinical trial, Cancer, Lung cancer, American Association for Cancer Research, NSCLC, Treatment of lung cancer, SCLC, Patient, MTD, Growth, Trial of the century, AI, Therapy, Horizon, CDK9, GSPT1, MGD, Safety, Medical imaging, Pharmaceutical industry, Fine chemical, PDX

The data were presented at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, FL.

Key Points: 
  • The data were presented at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, FL.
  • “Our extensive preclinical work on MRT-2359 forms a strong basis for our ongoing clinical trial by providing insight into the effects of GSPT1 degradation on the MYC pathway in cancer.
  • We look forward to reporting initial data from the Phase 1 arm of the trial later this year,” said Owen Wallace, Ph.D., Chief Scientific Officer of Monte Rosa.
  • The preclinical data were presented as follows:
    Title: New Drugs on the Horizon - Discovery of MRT-2359, an orally bioavailable GSPT1 molecular glue degrader, for MYC-driven cancers
    Session: New Drugs on the Horizon: Part 3
    Title: Development of MRT-2359, an orally bioavailable GSPT1 molecular glue degrader, for the treatment of lung cancers with MYC-induced translational addiction

Infinity Pharmaceuticals Reports Full Year 2022 Financial Results

Retrieved on: 
Tuesday, March 28, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TNBC, Bevacizumab, CPI, Information technology, Progression-free survival, Pembrolizumab, DCR, Survival, Overalls, Food and Drug Administration, Macrophage, Pharmacokinetics, Lead, OXPHOS, Head, G&A, Bankruptcy, Eganelisib, Cetuximab, Wind, Trial of the century, ORR, Carcinoma, Patient, Colorectal cancer, Randomized controlled trial, Bone marrow, Neoplasm, MEI, PD-1, Research, FDA, Breast cancer, CDK9, Venetoclax, Food, Safety, Financial toxicity, Nivolumab, Pharmaceutical industry, Cryptocurrency, Infinity, HNSCC

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the “Company”), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its full year 2022 financial results.

Key Points: 
  • Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the “Company”), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its full year 2022 financial results.
  • Infinity’s Full Year 2022 Financial Results:
    At December 31, 2022, Infinity had total cash and cash equivalents of $38.3 million, compared to $80.7 million at December 31, 2021.
  • Research and development expenses for 2022 were $32.4 million, compared to $31.6 million in 2021.
  • General and administrative expenses were $13.5 million for 2022, compared to $14.2 million for 2021.

SELLAS Life Sciences Reports Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 16, 2023
MSD, Multiple myeloma, CDK9, Advanced Materials and Processes Research Institute, MPM, Clinical trial, Financial toxicity, Neoplasm, Acquisition, Lymphoma, Merck & Co., Venetoclax, Acute myeloid leukemia, GPS, Doctor of Science, WT1, NCI, Merck, MYC, Research, Mesothelioma, PD, CR2, MD, Medication, Biomarker, Patient, Protocol, Bristol Myers Squibb, Bone marrow, SLS, D, National Cancer Institute, Azacitidine, Merck Sharp & Dohme Federal Credit Union, Ovarian cancer, AML, Pharmacokinetics, IND, Nivolumab, Cryptocurrency, Pharmaceutical industry, Greater China

NEW YORK, March 16, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today reported financial results for the full year ended December 31, 2022 and provided a business update.

Key Points: 
  • This participation will trigger milestone payments totaling $13 million to SELLAS, which are expected during the first half of 2023.
  • Patient enrollment was completed at the end of 2022 and SELLAS expects to report topline data during the first half of 2023.
  • Opdivo® is a registered trademark of Bristol-Myers Squibb Company, New York, NY, USA and is not a trademark of SELLAS.
  • The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

Prelude Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 15, 2023
Research, AACR, Glioma, SMARCA2, CDK9, Lung cancer, CDK4, Venetoclax, Head, File, Patient, Toxicity, BTK, SMARCA4, Breast, Azacitidine, Bone marrow, Safety, Cyclin-dependent kinase 9, Hematological Cancer Research Investment and Education Act, BeiGene, Pharmaceutical industry, Beauty salon

WILMINGTON, Del., March 15, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the fiscal year ended December 31, 2022, and provided a corporate update.   

Key Points: 
  • Cash balance of $201.7 million as of December 31, 2022; runway remains unchanged through Q4 2024
    WILMINGTON, Del., March 15, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the fiscal year ended December 31, 2022, and provided a corporate update.
  • “We made considerable progress in 2022, including the filing and acceptance of two new INDs for our next generation CDK4/6 inhibitor and our first-in-class, highly selective SMARCA2 degrader.
  • Initial data from PRT2527 and PRT1419 demonstrate encouraging safety, favorable pharmacokinetic and pharmacodynamic profiles in solid tumors, and support continued advancement in hematological cancers.
  • Title: A phase 1, open-label, multicenter, dose-escalation study of PRT2527, a cyclin-dependent kinase 9 (CDK9) inhibitor, in adult patients (pts) with advanced solid tumors.