Cyclin

Aprea Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, March 26, 2024
Ovarian cancer, Cyclin, IND, Therapy, Anemia, Research, University, Cell cycle, MD Anderson Cancer Center, PLK1, DDR, Investigational New Drug, Safety, Pharmacokinetics, Synthetic lethality, WEE1, U.S. FDA, Mutation, Acceleration, Part, HERG, ATR, KOL, Acquisition, Cancer, AACR, Research and development, Poster, FDA, Cyclin E, Toxicity, Aplastic anemia, Administration, Conference, APRE, PLK3, PLK2, Division, Data, Cardiotoxicity, Pharmaceutical industry

DOYLESTOWN, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • “Aprea had a very productive 2023 with significant progress across our diversified pipeline of synthetic lethality-based cancer therapeutics.
  • An update from Part 1 of the trial was featured in a poster presentation at the AACR-NCI-EORTC International Conference in October 2023.
  • Select Financial Results for the Fourth Quarter ended December 31, 2023
    As of December 31, 2023, Aprea reported cash and cash equivalents of $21.6 million.
  • Research and Development (R&D) expenses were $2.0 million for the quarter ended December 31, 2023, compared to $0.5 million for the fourth quarter of 2022.

Aprea Therapeutics Announces Private Placement Financing of up to $34.0 Million

Retrieved on: 
Monday, March 11, 2024
Cyclin, Exchange, Prospectus, APRE, DNA, Cyclin E, Sale, Breast, WEE1, DDR, Therapy, Patient, United, Security (finance), IND, Synthetic lethality, ATR, VWAP

DOYLESTOWN, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that it has entered into a securities purchase agreement with new and existing healthcare focused institutional investors and certain Company insiders to raise up to $34.0 million in gross proceeds, including initial upfront funding of $16.0 million and up to an additional $18.0 million upon cash exercise of accompanying warrants at the election of the investors.

Key Points: 
  • “This meaningful financing led by high quality healthcare institutions will support Aprea in our goal to be a leader in the field of Synthetic Lethality (SL) and DNA Damage and Response (DDR),” said Dr. Oren Gilad, President and CEO of Aprea.
  • The private placement is expected to close on or about March 13, 2024 subject to satisfaction of customary closing conditions.
  • Aprea intends to use the upfront net proceeds from the private placement for general corporate purposes and to fund clinical development of APR-1051, the Company’s WEE1 inhibitor product candidate which recently received IND clearance.
  • Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Zentalis Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Wednesday, August 9, 2023
Amgen, DNA, ZymoGenetics, AACR, Drug development, Therapy, DDR, Neoplasm, Uterine serous carcinoma, Paclitaxel, American Association for Cancer Research, Coronavirus Scientific Advisory Board, Woman, Outer ring road, Medication, Cyclin E1, Biomarker, Bayer, USC, Carboplatin, Carcinoma, MD Anderson Cancer Center, ASCO, Development, State Administrative Expenses, American Society of Clinical Oncology, Patient, Homologous recombination, SAN, University, Administration, Annual general meeting, Cancer, Clinical Ovarian Cancer & Other Gynecologic Malignancies, R, Research, Ovarian cancer, Society, ORR, Safety, Pharmaceutical industry, Cryptocurrency, Cyclin

NEW YORK and SAN DIEGO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the quarter ended June 30, 2023, and highlighted recent corporate accomplishments.

Key Points: 
  • Azenosertib plus chemotherapy combinations also demonstrated positive results in women facing heavily pretreated ovarian cancer.
  • Presented positive azenosertib + chemotherapy combination data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • Zentalis is preparing for a Phase 3 trial of azenosertib using intermittent dosing in combination with chemotherapy in Cyclin E1+ platinum-sensitive ovarian cancer.
  • Cash and Marketable Securities Position: As of June 30, 2023, Zentalis had cash, cash equivalents and marketable securities of $553.0 million.

Zentalis Pharmaceuticals Appoints Kimberly Freeman as Chief Strategy Officer

Retrieved on: 
Tuesday, August 1, 2023
DNA, GSK plc, Drug development, Cyclin, Female, Therapy, University, DDR, ARM, Cancer, Medication, Postgraduate education, Weill Cornell Medical Center, AstraZeneca, Marketing, Reliance Institute of Life Sciences, Boehringer Ingelheim, Regenerative medicine, Wharton School of the University of Pennsylvania, Graduate, Patient, SAN, State University of New York Upstate Medical University, Cell, Clinical Ovarian Cancer & Other Gynecologic Malignancies, Commodity, Research, FDA, Woman, Cornell University, Widener University Commonwealth Law School, Pharmaceutical industry, Medical imaging, Science, Biology

NEW YORK and SAN DIEGO, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced the appointment of Kimberly Freeman as Chief Strategy Officer.

Key Points: 
  • NEW YORK and SAN DIEGO, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced the appointment of Kimberly Freeman as Chief Strategy Officer.
  • In this role, she will support and implement Zentalis’ long-term portfolio strategy.
  • Ms. Freeman joins Zentalis with over 25 years of clinical development and strategic leadership experience, including deep expertise in oncology, particularly in gynecologic malignancies and the DNA damage response (DDR) pathway.
  • “Kimberly brings an outstanding track record of building and executing drug development and franchise strategies that will be invaluable to Zentalis as we seek to capitalize on the significant opportunity we see with azenosertib across a broad array of tumor types,” said Dr. Kimberly Blackwell, Chief Executive Officer of Zentalis.

Circle Pharma Achieves Major Milestone with the Selection of a Clinical Development Candidate Directly Inhibiting Cyclins A and B

Retrieved on: 
Wednesday, July 19, 2023
Oncology, Professional Services, Health, Venture Capital, Clinical Trials, Pharmaceutical, Biotechnology, Pancreatic cancer, Pharma, AACR, Cancer, Hope, Lung cancer, PDX, SCLC, Cyclin, American Association for Cancer Research, Patient, Cell cycle, Annual general meeting, Ovarian cancer, Carcinoma, Stomach, Cyclin-dependent kinase 7, Breast cancer, Pharmaceutical industry

Circle Pharma, a biopharmaceutical company advancing the discovery and development of intrinsically cell-permeable macrocycles, announced today the selection of CID-078 for its first clinical development program.

Key Points: 
  • Circle Pharma, a biopharmaceutical company advancing the discovery and development of intrinsically cell-permeable macrocycles, announced today the selection of CID-078 for its first clinical development program.
  • CID-078 is the first-and-only-in-class dual inhibitor of Cyclins A and B, which play essential roles in regulating cell cycle progression.
  • Inhibiting Cyclins A and B selectively induces synthetic lethality in certain cancers exhibiting cell cycle dysregulation while sparing healthy cells.
  • Circle Pharma recently presented pre-clinical data for its dual Cyclin A/B inhibitors at this year’s American Association for Cancer Research (AACR) Annual Meeting.

Zentalis Announces Presentation of Positive Phase 1b Data Demonstrating Durable Responses and Favorable Safety Profile of Azenosertib in Combination with Chemotherapy at the 2023 ASCO Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
Neutropenia, Obstetrics, Therapy, Neoplasm, Paclitaxel, Outer ring road, Gynecologic Oncology (journal), Medication, PLD, Carboplatin, Associate, IHC, Cyclin E1, Dana–Farber Cancer Institute, ASCO, WEE1, Patient, Division, SAN, Anemia, Cancer, HR, Washington University School of Medicine, Gynaecology, Immunohistochemistry, Poster, Ovarian cancer, Abstract, Thrombocytopenia, ORR, Pharmacology, Safety, Fatigue, Platinum, Pharmaceutical industry, Cyclin

Results will be presented in a poster discussion session at the 2023 ASCO Annual Meeting on June 5th (Abstract #5513).

Key Points: 
  • Results will be presented in a poster discussion session at the 2023 ASCO Annual Meeting on June 5th (Abstract #5513).
  • “The addition of azenosertib increased ORRs and mPFS over those observed historically with chemotherapy alone, or compared to adavosertib in combination with chemotherapy.
  • We are very encouraged by our robust chemotherapy combination data, particularly the strong efficacy and tolerability results when dosing azenosertib intermittently.
  • These data provide a compelling rationale to advance azenosertib into a registrational study in combination with either carboplatin or paclitaxel in Cyclin E1+ ovarian cancer.

Zentalis Pharmaceuticals Reports First Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Wednesday, May 10, 2023
ZymoGenetics, G&A, Development, Gene amplification, Patient, Roche, R, Amgen, Therapy, American Board of Obstetrics and Gynecology, Coronavirus Scientific Advisory Board, Bayer, WEE1, CCNE1, AACR, Cancer, American Association for Cancer Research, BRAF, Cyclin E1, Biomarker, Acute myeloid leukemia, MD Anderson Cancer Center, AL, Administration, SAN, University, Amyloidosis, Research, Ovarian cancer, Partnership, Drug development, Clinical trial, Pfizer, Medication, Cetuximab, Trial of the century, ASCO, State Administrative Expenses, AML, Foundation Medicine, Pharmaceutical industry, Medical device, Cyclin

“I share Zentalis’ passion and commitment to developing therapeutics for difficult-to-treat cancers,” said Dr. Hausman.

Key Points: 
  • “I share Zentalis’ passion and commitment to developing therapeutics for difficult-to-treat cancers,” said Dr. Hausman.
  • The Company remains on track to provide an update on azenosertib monotherapy dosing in the first half of 2023.
  • Cash and Marketable Securities Position: As of March 31, 2023, Zentalis had cash, cash equivalents and marketable securities of $392 million.
  • General and Administrative Expenses: General and administrative (G&A) expenses for the quarter ended March 31, 2023 were $16.4 million, compared to $11.8 million during the three months ended March 31, 2022.

Zentalis to present positive clinical data in ovarian cancer combining azenosertib and chemotherapy, including clinical support for Cyclin E1 expression as predictive marker for clinical benefit from azenosertib at the 2023 ASCO Annual Meeting

Retrieved on: 
Wednesday, April 26, 2023
Partnership, Therapy, American Society of Clinical Oncology, Fallopian tube cancer, Medication, ASCO, Malignancy, Patient, SAN, Roche, Cancer, Poster, Foundation Medicine, Ovarian cancer, Society, Pharmaceutical industry, Medical imaging, Cyclin

NEW YORK and SAN DIEGO, April 26, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, announced today that it will present positive clinical data from its Phase 1b trial investigating azenosertib in combination with chemotherapy in patients with advanced platinum-resistant ovarian cancer in a poster at the American Society of Clinical Oncology (ASCO) Meeting in Chicago, June 2-6, 2023. Azenosertib is the Company's potentially first-in-class Wee1 inhibitor currently being investigated in multiple clinical trials as a monotherapy and in combination.

Key Points: 
  • Azenosertib is the Company's potentially first-in-class Wee1 inhibitor currently being investigated in multiple clinical trials as a monotherapy and in combination.
  • These encouraging clinical data, together with the preclinical data we recently presented at the 2023 AACR Annual Meeting, provide clear support for the use of Cyclin E1 expression as a predictive marker to identify patients who may significantly benefit from treatment with azenosertib,” said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis.
  • The current Foundation Medicine partnership involves global prospective genomic profiling for potential patient enrollment in Zentalis’ Phase 2 clinical trial of azenosertib in Cyclin E1 driven high-grade serous ovarian cancer.
  • The companies are also exploring opportunities to develop Foundation Medicine’s tissue-based next generation sequencing assay as a companion diagnostic for azenosertib.

Circle Pharma’s first-in-class orally bioavailable macrocyclic cyclin A/B inhibitors highlighted in poster presentations at American Association for Cancer Research Annual Meeting

Retrieved on: 
Thursday, April 20, 2023
Oncology, Professional Services, Health, Venture Capital, Clinical Trials, Pharmaceutical, Biotechnology, Neutropenia, DNA, CRISPR, AACR, Cyclin, Dana–Farber Cancer Institute, DFCI, Bone marrow, American Association for Cancer Research, Gene expression, Cell, Cyclin B, RB, Cyclin A, CDK2, DNA repair, Apoptosis, Cancer, Mouse, Carcinoma, Ovarian cancer, SAC, IND, Circle, Genome, Pharmaceutical industry, SCLC

Circle Pharma announced today that two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting held April 14-19, in Orlando, Florida, highlight promising pre-clinical data of its first-in-class orally bioavailable macrocyclic cyclin A/B inhibitors targeting intractable cancers.

Key Points: 
  • Circle Pharma announced today that two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting held April 14-19, in Orlando, Florida, highlight promising pre-clinical data of its first-in-class orally bioavailable macrocyclic cyclin A/B inhibitors targeting intractable cancers.
  • Circle expects to advance its cyclin A/B inhibitor program into IND-enabling studies later this year and subsequently into clinical development for testing in a range of cancer types, including SCLC.
  • The data presented by Circle Pharma shows activity across a wide range of human tumor cell lines and tumor regression in xenograft models of small cell lung carcinoma (SCLC) and ovarian cancer.
  • Pre-clinical development of orally bioavailable macrocycles with dual cyclin A and B inhibitory activity drive synthetic lethality in multiple tumor types.

Zentalis Announces Preclinical Data Supporting Cyclin E1 As A Predictive Marker For Azenosertib Treatment At AACR Annual Meeting 2023

Retrieved on: 
Monday, April 17, 2023
DNA, AACR, Therapy, Pharmacodynamics, Clinical trial, Development of the human body, Research, Cyclin E1, Cell, Biomarker, Barrow Neurological Institute, CDK2, Gene amplification, Oregon Health & Science University School of Dentistry, Patient, Pharmacokinetics, SAN, Cancer, Annual general meeting, CCNE1, Growth, Poster, Ovarian cancer, DNA repair, Pharmaceutical industry, Vaccine, Glioblastoma, Cyclin

NEW YORK and SAN DIEGO, April 17, 2023 (GLOBE NEWSWIRE) -- ZentalisTM Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announces preclinical data that supports CCNE1 amplification and / or Cyclin E1 expression as a potential marker for the enrichment of patient populations for treatment with azenosertib, the Company’s potentially first-in-class Wee1 inhibitor product candidate. These new preclinical data demonstrate that azenosertib drives cancer cell death in Cyclin E1-high tumor cells in vitro and substantially inhibits the growth of Cyclin E1-high, patient-derived, in vivo tumor models.

Key Points: 
  • These new preclinical data demonstrate that azenosertib drives cancer cell death in Cyclin E1-high tumor cells in vitro and substantially inhibits the growth of Cyclin E1-high, patient-derived, in vivo tumor models.
  • “We are excited to present new preclinical data demonstrating the utility of Cyclin E1 as a predictive marker to identify patients likely to respond to azenosertib,” said Mark Lackner, Ph.D., Chief Translational Officer of Zentalis.
  • “Our findings suggest that Cyclin E1 expression via gene amplification or independent mechanisms sensitizes ovarian cancer cells to azenosertib alone or in combination with chemotherapy.
  • The results show that high Cyclin E1 protein expression is significantly associated with sensitivity to azenosertib, and that artificial overexpression of Cyclin E1 in cell lines with low endogenous Cyclin E1 expression sensitizes those cells to azenosertib.