Venetoclax

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

Retrieved on: 
Friday, March 29, 2024
Patient, PTCL, G&A, IND, Prednisone, Neoplasm, Therapy, SMDC, Medicinal chemistry, Lymphoma, Research, Frontiers Media, RNA polymerase II, Body modification, Primate, RNA, NIH, CPT, Potential, Safety, CDK9, ADC, MCL1, Solubility, Oncogene, RNA polymerase, Venetoclax, Journal, Manuscript, Cancer, Peripheral T-cell lymphoma, AACR, Antibody, MYC, Downregulation and upregulation, DLBCL, Annual general meeting, HER2, European Hematology Association, EHA, Spacecraft, PDX, Bangladesh Technical Education Board, Journal of Medicinal Chemistry, Blood, Pharmaceutical industry

PALO ALTO, Calif., March 29, 2024 (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 fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models.
  • Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs.
  • For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively.
  • For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively.

Aptose Reports Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, March 26, 2024
Indian stock exchange, Absorption, Plasma, Exercise, Hanmi Pharmaceutical, AML, BID, Patient, APS, SAN, Venetoclax, G1, VEN, FLT3, EHA, LUX, Acute myeloid leukemia, Trial of the century, TUS, TSX, Hanmi, Azacitidine, G3, Pharmaceutical industry

This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.

Key Points: 
  • This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.
  • Total gross proceeds from the public offering were approximately $9.7 million before deducting underwriting costs, placement agent commissions and other offering-related expenses.
  • Private Placement – On January 31, 2024, Aptose closed a US $4 million private placement of common shares with strategic partner Hanmi Pharmaceutical.
  • Luxeptinib G3 Evaluation Completed – During 2023 and early 2024, clinical evaluation of the new generation 3 (G3) formulation of luxeptinib (LUX) was completed.

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, Aplastic anemia, Syros, Tamibarotene, AML, Patient, Fast Track, Venetoclax, Acute myeloid leukemia, Azacitidine, Prognosis, MDS, Bone marrow, RARA, Pharmaceutical industry

Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

Key Points: 
  • Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.
  • “We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML.
  • Syros is evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA overexpression in the ongoing SELECT-AML-1 Phase 2 trial.
  • In January 2023, the FDA granted Fast Track Designation to tamibarotene for the treatment of HR-MDS patients with RARA overexpression.

Syros Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Wednesday, March 27, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, Aplastic anemia, Pfizer, AML, Webcast, Patient, Venetoclax, NDA, G&A, Azacitidine, ID, MDS, Bone marrow, RARA, Pharmaceutical industry

Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.

Key Points: 
  • Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.
  • Cash, cash equivalents and marketable securities as of December 31, 2023, were $139.5 million, as compared with $202.3 million on December 31, 2022.
  • ET to discuss the fourth quarter and full-year 2023 financial results and provide a corporate update.
  • A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com .

MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

Retrieved on: 
Tuesday, March 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Toxicity, Aplastic anemia, Salvage therapy, CLL, AML, CRi, Patient, Venetoclax, Biomarker, Diarrhea, BCL2, University, Acute myeloid leukemia, ELN, Safety, Pharmacokinetics, CDK9, Phase 1, Associate professor, Pharmaceutical industry

The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.

Key Points: 
  • The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.
  • A total of 29 patients with R/R AML, median age 67 years (range 34-89), enrolled in the dose escalation stage of the study evaluating voruciclib in combination with venetoclax.
  • The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax.
  • Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax.

Syros Announces Completion of Enrollment of 190 Patients Necessary to Support Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial

Retrieved on: 
Monday, March 25, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, New Drug Application, Patient, Venetoclax, NDA, Standard of care, Acute myeloid leukemia, Clinical trial, Azacitidine, Bone marrow, Food, RARA, Pharmaceutical industry

This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.

Key Points: 
  • This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.
  • Syros expects to report these pivotal data by the middle of the fourth quarter of 2024.
  • “We are pleased to announce the completion of enrollment of the 190 patients necessary to support the primary CR endpoint in SELECT-MDS-1.
  • Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in the SELECT-AML-1 Phase 2 clinical trial in newly diagnosed unfit acute myeloid leukemia patients with RARA gene overexpression.

ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31, 2023

Retrieved on: 
Monday, February 26, 2024
Borderline personality disorder, HOPE, HDAC6, National Cancer Institute, EVOLUTION, CMT, Agitation, Data analysis, Convertible bond, ICIS, ALS, SCLC, Azacitidine, Duration, ICI, IIS, Sciatic nerve, Deficit spending, Paclitaxel, DSM-IV codes, Development, Genomics, ALS Association, FMS, LSD1, AML, Clinical Global Impression, MSKCC, Conference, Aggression, Safety, Biomarker, CNS, Venetoclax, CRADA, OHSU, MRD, Clinical trial, BPD, Measure (mathematics), IND, FCCC, Dor, Human, Innovation, EMA, Kabuki syndrome, NET, NCI, Aes, Glomus tumor, FDA, GST, Food, Platinum, Schizophrenia, Phase II, Charcot–Marie–Tooth disease, Medicine, Patient, BEST, Disease, Pharmaceutical industry

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.
  • Research and development (R&D) expenses were $3.9 and $16.6 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $5.0 and $18.1 million for the quarter and twelve months ended December 31, 2022.
  • General and administrative expenses were $1.2 and $4.2 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.2 and $4.8 million for the quarter and twelve months ended December 31, 2022.
  • Net losses were $1.4 and $5.0 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.6 and $5.9 million for the quarter and twelve months ended December 31, 2022.

Kura Oncology Doses First Patient in KOMET-008 Trial of Ziftomenib in Combination with Standards of Care, Including FLT3 Inhibitor, in Acute Myeloid Leukemia

Retrieved on: 
Monday, February 26, 2024
AML, Azacitidine, Menin, KMT2A, Safety, Prognosis, FLT3, Pharmacokinetics, Venetoclax, Patient, KURA, Kura, Acute myeloid leukemia, LDAC, Cancer, Pharmaceutical industry

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in KOMET-008, the Company’s Phase 1 trial of its menin inhibitor ziftomenib, in combination with gilteritinib, FLAG-IDA or LDAC for the treatment of NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML).

Key Points: 
  • “Roughly half of patients with relapsed or refractory NPM1-mutant AML have co-occurring FLT3 mutations, and the prognosis for these patients is particularly poor,” said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology.
  • Trial participants will be enrolled in one of five dose escalation cohorts, including a cohort of NPM1-mutant AML patients with a documented FLT3 co-mutation, who will be treated in combination with the FLT3 inhibitor gilteritinib.
  • Kura is conducting a series of studies to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations.
  • Preclinical data for menin inhibitors in combination with multiple FLT3 inhibitors demonstrate strong synergistic effects compared to either single agent alone.

Ryvu Announces Dosing of the First Patient in the RIVER-52 Phase II Study of RVU120 as a Monotherapy for the Treatment of Patients with Relapsed/Refractory AML and HR-MDS

Retrieved on: 
Wednesday, February 14, 2024
PD, Development plan, AML, Syndrome, MF, Part, Committee, Safety, NPM1, Therapy, EOD, Pharmacokinetics, Venetoclax, Phases of clinical research, Patient, Clinical trial, Ruxolitinib, Ethics, Pharmaceutical industry

Ultimately, the study will expand to other EU and non-EU countries, covering up to 80 clinical sites globally.

Key Points: 
  • Ultimately, the study will expand to other EU and non-EU countries, covering up to 80 clinical sites globally.
  • RIVER-52 is a multicenter, open-label clinical trial designed to evaluate RVU120 in adult patients with r/r AML and HR-MDS, without alternative therapies.
  • RIVER-52 represents the second of the four planned RVU120 Phase II clinical studies scheduled for launch in H1 2024.
  • In addition to RIVER-52, Ryvu has already started patient treatment in the RIVER-81 study (evaluating RVU120 in combination with venetoclax for treating r/r AML patients).

Kura Oncology Reports Positive Preliminary Ziftomenib Combination Data in Acute Myeloid Leukemia

Retrieved on: 
Tuesday, January 30, 2024
KURA, Failure, Acute myeloid leukemia, Venetoclax, Research, Division, MHS, Patient, Safety, QT interval, AML, Bone marrow, MBBS, QD, Yale Cancer Center, Disease, Therapy, Postcholecystectomy syndrome, Risk, ID, Cancer, Kura, Pharmaceutical industry

Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.

Key Points: 
  • Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.
  • The overall response rate (ORR) among R/R patients treated with ziftomenib and ven/aza was 53% (8/15).
  • As of the data cutoff, 80% (16/20) of patients remain on trial, including 100% (11/11) of all NPM1-m patients.
  • “We are highly encouraged by these preliminary combination data for ziftomenib and believe they support advancement into the frontline AML population,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology.