CDK9

SELLAS Life Sciences Provides Business Update and Reports Second Quarter 2022 Financial Results

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Giovedì, Agosto 11, 2022
Acute myeloid leukemia, Immortalised cell line, Advanced Materials and Processes Research Institute, WT1, SPD, GLOBE, NEW, Clinical trial, CT, IND, Research, AML, MPM, CDK9, Patient, Cancer, Pembrolizumab, Company, COVID-19, Lymphoma, D, Acquisition, NMPA, SD, Nivolumab, Safety, GPS, NASDAQ, Payment, Second, Ovarian cancer, Toxic epidermal necrolysis, Mesothelioma, SLS, Pharmaceutical industry

NEW YORK, Aug. 11, 2022 (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 provided a business update and reported its financial results for the quarter ended June 30, 2022.

Key Points: 
  • Financial Results for the Second Quarter 2022:
    Licensing revenue: There was no licensing revenue for the second quarter of 2022 and $1.0 million for the first half of 2022, which related to Chinas NMPA approval of an IND application by 3D Medicines.
  • This compares to $1.9 million for the second quarter of 2021 and $7.6 million for the first half of 2021.
  • R&D Expenses: Research and development expenses for the second quarter of 2022 were $5.5 million, compared to $3.5 million for the same period in 2021.
  • Acquired In-Process Research and Development: There was no acquired in-process research and development for the second quarter of 2022.

Vincerx Pharma Reports Second Quarter 2022 Financial Results and Provides a Corporate Update

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Giovedì, Agosto 11, 2022
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PALO ALTO, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the second quarter ended June 30, 2022 and provided a corporate update.

Key Points: 
  • We shared key updates last quarter that are intended to strategically position Vincerx to aggressively advance our pipeline programs while optimizing our cash runway, said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx.
  • The Vincerx team remains focused on our prioritized studies and look forward to providing additional progress updates in the coming months.
  • Based on its current business plans and assumptions, Vincerx believes its available cash will be sufficient to meet its operating requirements into late 2024.
  • Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

Cyclacel Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update

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Mercoledì, Agosto 10, 2022
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- Oral fadraciclib demonstrated good tolerability with continuous dosing;

Key Points: 
  • - Oral fadraciclib demonstrated good tolerability with continuous dosing;
    - Conference call scheduled for August 10, 2022 at 4:30 pm ET -
    BERKELEY HEIGHTS, N.J., Aug. 10, 2022 (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 second quarter 2022 financial results and provided a business update.
  • In the second half of 2022 we are optimizing the dosing schedule to maximize target coverage and determine recommended Phase 2 dose (RP2D).
  • Tax credit receipts of $3.3 million in respect of the financial year ended December 31, 2021, were received in April 2022.
  • The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.

SELLAS Life Sciences’ GFH009 Demonstrates Cancer Cell Growth Inhibition in Preclinical In Vitro Studies in Solid Cancer and Acute Myeloid Leukemia Cell Lines

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Martedì, Agosto 9, 2022
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NEW YORK, Aug. 09, 2022 (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 results from preclinical in vitro studies for its highly selective CDK9 inhibitor, GFH009, in solid cancer and acute myeloid leukemia (AML) cell lines. The data shows that GFH009 demonstrated significant anti-tumor effects in all four selected cell lines. In three out of the four cell lines, GFH009 inhibited cancer cell growth by 90 to 100 percent.

Key Points: 
  • - In Three of the Four Cell Lines, GFH009 Inhibited Cancer Growth by 90 to 100 Percent -
    NEW YORK, Aug. 09, 2022 (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 results from preclinical in vitro studies for its highly selective CDK9 inhibitor, GFH009, in solid cancer and acute myeloid leukemia (AML) cell lines.
  • In three out of the four cell lines, GFH009 inhibited cancer cell growth by 90 to 100 percent.
  • NCI-H209: a small cell lung cancer cell line characterized by the loss of function of two major tumor suppressor genes, RB1 and TP53.

Prelude Therapeutics Announces Second Quarter 2022 Financial Results and Business Update

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Martedì, Agosto 9, 2022
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WILMINGTON, Del., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2022 and provided an update on recent clinical and development pipeline progress.

Key Points: 
  • Prelude will complete data analyses of the ongoing expansion cohorts and expects to announce next steps for the PRMT5 program in the second half of 2022.
  • MCL1 Inhibitor Program: Prelude remains on track to begin evaluating combinations with PRT1419 and report early findings by the end of 2022.
  • SMARCA2/BRM Protein Degrader Program: Prelude remains on track to complete IND-enabling studies and submit an IND application by year-end 2022.
  • Prelude anticipates that its existing cash, cash equivalents and marketable securities will fund Preludes operations into the second half of 2024.

Kronos Bio Reports Recent Business Progress and Second-Quarter 2022 Financial Results

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Giovedì, Agosto 4, 2022
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SAN MATEO, Calif. and CAMBRIDGE, Mass., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, today reported recent business progress and second-quarter 2022 financial results.

Key Points: 
  • Data are anticipated in the second half of 2023 with a primary endpoint of measurable residual disease negative complete response.
  • Kronos Bio opened additional sites for its planned Phase 1b/2 clinical trial of lanraplenib, the companys next generation SYK inhibitor, in combination with gilteritinib in patients with FLT3-mutated AML.
  • Kronos Bio is continuing to enroll patients in the dose escalation stage of the Phase 1/2 study of KB-0742 in solid tumors.
  • Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass.

SELLAS Life Sciences Adds Once-a-Week Dose Cohort in Ongoing Phase 1 Clinical Trial with its Highly Selective CDK9 Inhibitor GFH009

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Giovedì, Luglio 7, 2022
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The patients in the AML arm of the clinical trial have entered the last twice-a-week 30mg planned dose level.

Key Points: 
  • The patients in the AML arm of the clinical trial have entered the last twice-a-week 30mg planned dose level.
  • Additionally, enrollment for lymphoma patients at the twice-a-week 15mg dose level cohort has been completed and safety assessments are underway.
  • The twice-a-week dose regimens for both groups will proceed as planned and are on target for completion this year.
  • About SELLAS Life Sciences Group, Inc.
    SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications.

Cyclacel Pharmaceuticals Achieves Key Business Objectives in First Half of 2022 and Continues to Advance Clinical Pipeline

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Giovedì, Giugno 30, 2022
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Data collected to date in fifteen patients suggest that fadraciclib may have activity across a range of solid tumors and lymphomas.

Key Points: 
  • Data collected to date in fifteen patients suggest that fadraciclib may have activity across a range of solid tumors and lymphomas.
  • We look forward to reporting additional data at our R&D Day in the fall of 2022.
  • The Company is planning an R&D Day in the fall of 2022 to present updated data from the 065-101 and 140-101 clinical trials.
  • The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.

SELLAS Life Sciences Provides Clinical Update for GFH009 Ongoing Phase 1 Clinical Trial

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Lunedì, Giugno 27, 2022
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NEW YORK, June 27, 2022 (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 provided a clinical update on the ongoing Phase 1 dose-escalating clinical trial of GFH009, its novel and highly selective CDK9 inhibitor, in advanced relapsed and refractory lymphoma and acute myeloid leukemia (AML).

Key Points: 
  • We continue to see positive results in our clinical efforts for GFH009, especially in assessing the safety in patients with lymphoma and AML, said Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS.
  • The clinical process for safety is to determine the highest dose level patients can tolerate without experiencing adverse events or side effects.
  • About SELLAS Life Sciences Group, Inc.
    SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications.
  • These statements include, without limitation, statements related to the clinical data for GFH009, plans for further development of GFH009, and the potential for GFH009 as a drug development candidate.

Vincerx Pharma Presents Preclinical and Clinical Data on PTEFb/CDK9 Inhibitor VIP152 in Lymphoma at the European Hematology Association 2022 Congress

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Venerdì, Giugno 10, 2022
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PALO ALTO, Calif., June 10, 2022 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced a poster presentation of preclinical and clinical data on VIP152, the Company’s PTEFb/CDK9 inhibitor, at the European Hematology Association (EHA) 2022 Congress, being held virtually and in Vienna, Austria from June 9-12, 2022.

Key Points: 
  • Compared with other CDK9 inhibitors, VIP152 was the most selective CDK9 inhibitor and had the most robust MYC mRNA downregulation.
  • Additionally, our data showed reproducible reductions in MYC, MCL1, and PCNA mRNA in the blood of patients with various types of lymphoma after VIP152 treatment.
  • These data support the utility of a selective CDK9 inhibitor for the treatment of patients with hematologic malignancies, added Dr. Hamdy.
  • Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.