CML

IN8bio Announces New Preclinical Data for Gamma-Delta nsCAR-T Cell Therapy Platform at AACR 2024

Retrieved on: 
Tuesday, April 9, 2024
Acute leukemia, Canadian Aviation Regulations, Cell, CD33, AML, Patient, Tissue, CML, Acute myeloid leukemia, Leukemia, Death, AACR, Neoplasm, Cancer, Safety, CD123, Antigen, Vaccine

NEW YORK, April 09, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced new preclinical data from its non-signaling gamma-delta T cell based Chimeric Antigen Receptor-T cell (nsCAR) platform, known as INB-300, that demonstrated improved selectivity to target leukemia cells while preserving healthy ones. The data support the potential for nsCAR to have a wider therapeutic window and to be used to prevent on-target off-tumor killing of healthy tissue that may express the CAR-T target. The data was presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2024 on April 9, 2024.

Key Points: 
  • The data was presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2024 on April 9, 2024.
  • IN8bio's nsCAR platform is based on the natural ability of gamma-delta T cells to distinguish between healthy and malignant tissue.
  • Approved CAR-T therapies have shown remarkable efficacy against B cell malignancies, offering hope to patients with limited treatment options.
  • “These results can potentially improve INB-300, as we advance towards IND enabling studies of our next-generation gamma-delta T cell therapies to treat cancers.”

Enliven Therapeutics to Share Initial Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 and Host Virtual Key Opinion Leader Event on April 11, 2024

Retrieved on: 
Thursday, March 28, 2024
Patient, BCR, Acute leukemia, CML, Therapy, ATP, Pharmaceutical industry

ET to discuss initial proof of concept data on ELVN-001 and the evolving chronic myeloid leukemia (CML) landscape.

Key Points: 
  • ET to discuss initial proof of concept data on ELVN-001 and the evolving chronic myeloid leukemia (CML) landscape.
  • ELVN-001 is a highly selective, small molecule kinase inhibitor designed to specifically target the ATP-pocket of the BCR-ABL gene fusion, the oncogenic driver for patients with CML.
  • The discussion will cover ELVN-001’s Phase 1a initial proof of concept data, the evolving treatment paradigm in CML, and how ELVN-001 could fit into the CML landscape.
  • The event will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at https://ir.enliventherapeutics.com/ .

Inhibikase Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Activity

Retrieved on: 
Wednesday, March 27, 2024
Research, Malignancy, Absorption, PD, CSF, Imatinib, Central nervous system, International, Patient, Gastrointestinal tract, Journal, CML, NDA, Pharmacist, Traffic barrier, Cerebrospinal fluid, Insurance, D&O, Dark Ages, Therapy, Division, Blood, Bone marrow, FDA, SAD, Physician, Approximation error, Pharmaceutical industry

The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.

Key Points: 
  • The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.
  • Inhibikase will host a conference call and webcast to discuss its full-year 2023 financial results and business highlights tomorrow, March 28, 2024, at 8:00am ET.
  • The conference call can be accessed by dialing 1-877-407-0789 (United States) or 1-201-689-8562 (International) and referencing Inhibikase Therapeutics.
  • After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

Cousins Maine Lobster Celebrates Harrisburg Expansion, Grand Opening of Second Truck

Retrieved on: 
Tuesday, April 9, 2024
Growth, CML, FDD, Golden Joystick Awards, Franchise disclosure document, Multimedia, Lobster

SOUTH PORTLAND, Maine, April 9, 2024 /PRNewswire/ -- Cousins Maine Lobster announces the launch of their second food truck in Harrisburg, PA, further expanding their reach across Northeast and Central PA.

Key Points: 
  • SOUTH PORTLAND, Maine, April 9, 2024 /PRNewswire/ -- Cousins Maine Lobster announces the launch of their second food truck in Harrisburg, PA, further expanding their reach across Northeast and Central PA.
  • The Grand Opening of the second truck, led by husband-and-wife franchisees Cindy and Peter Sztankovits, will take place on Saturday, April 13th, at New Trail Brewing in Williamsport, PA.
  • Customers have traveled from all over Pennsylvania to enjoy Cousins Maine Lobster, fueling the opening of the second truck in Harrisburg.
  • Cousins Maine Lobster – Harrisburg, PA Truck Two Grand Opening Celebration
    Cousins Maine Lobster is seeking new franchisees nationwide.

Enliven Therapeutics Announces $90 Million Private Placement Financing and Provides Pipeline Updates

Retrieved on: 
Tuesday, March 19, 2024
HER2, Acute leukemia, Exercise, Index, Exchange, Colorectal cancer, MMR, Memorial, Headache, Patient, Research, Diarrhea, Brain, CML, KOL, Aes, Sale, Cancer, Security (finance), IND, MBA, Prospectus, MBC, Nausea, Therapy, CRC, PIPE, Pharmacokinetics, MTD, Food, Pharmaceutical industry

BOULDER, Colo., March 19, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced that it has entered into a securities purchase agreement for a private investment in public equity (PIPE) financing that is expected to result in gross proceeds of approximately $90 million, before deducting offering expenses. The financing includes participation from new and existing investors, including Commodore Capital, Fairmount, Venrock Healthcare Capital Partners, a biotech investor, a large mutual fund, Rock Springs Capital, Logos Capital, Woodline Partners LP and Acuta Capital Partners.

Key Points: 
  • “The additional funding further strengthens our balance sheet and enables us to achieve critical, longer-term clinical milestones as we advance our parallel lead programs, ELVN-001 and ELVN-002.
  • Enliven anticipates the gross proceeds from the private placement to be approximately $90 million, before deducting offering expenses.
  • The PIPE financing is expected to close on or about March 21, 2024, subject to satisfaction of customary closing conditions.
  • Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

Retrieved on: 
Thursday, March 14, 2024
Pharmacokinetics, Patient, Administration, Research and development, Weight loss, Obesity, BCR-ABL, CML, GIPR, Safety, Pharmaceutical industry

FOSTER CITY, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided corporate updates.

Key Points: 
  • Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $17.5 million and $63.5 million for the quarter and year ended December 31, 2023, respectively, as compared with $10.7 million and $39.6 million for the quarter and year ended December 31, 2022, respectively.
  • General and Administrative (G&A) Expenses: G&A expenses were $6.6 million and $39.1 million for the quarter and year ended December 31, 2023, respectively, as compared with $6.2 million and $22.4 million for the quarter and year ended December 31, 2022, respectively.
  • Net Loss: Net loss was $21.0 million and $90.2 million for the quarter and year ended December 31, 2023, respectively, as compared with $15.8 million and $60.3 million for the quarter and year ended December 31, 2022, respectively.

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

Retrieved on: 
Thursday, March 14, 2024
Research, U.S. FDA, Trastuzumab, Colorectal cancer, Patient, Food and Drug Administration, CML, Running, G&A, Disclosure, MBA, MBC, Therapy, Cancer, CRC, FDA, Food, Pharmaceutical industry

BOULDER, Colo., March 14, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today reported financial results for the fourth quarter and full year ended December 31, 2023, provided updated guidance on parallel lead product candidates and highlighted pipeline progress.

Key Points: 
  • Research and development (R&D) expenses: R&D expenses were $17.9 million for the fourth quarter of 2023, compared to $8.2 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2023 were $4.8 million, compared to $2.0 million for the fourth quarter of 2022.
  • Net Loss: Enliven reported a net loss of $19.4 million for the fourth quarter of 2023, compared to a net loss of $9.6 million for the fourth quarter of 2022.
  • Total net loss for the full year 2023 was $71.6 million, compared to $37.7 million for the full year 2022.

Comtech Names Telecommunications and Public Safety Leader Jeff Robertson as President of Terrestrial & Wireless Networks Business Segment

Retrieved on: 
Thursday, March 21, 2024
Semiconductor, Aerospace, Security, Manufacturing, Satellite, Audio, Video, Other Technology, Telecommunications, Software, Networks, Internet, Hardware, Electronic Design Automation, VoIP, Technology, Mobile, Wireless, Public Policy, Government, Public Safety, Intergraph, Terrestrial, Public security, Culture, Patent, Wireless network, Toronto Metropolitan University, Airbus, Strategic planning, CML, TCI, Human voice, CMTL, RapidSOS, Interim, Multimedia, Engineering, Management

March 21, 2024-- Comtech (NASDAQ: CMTL), a global technology leader, today announced the appointment of telecommunications and public safety industry leader Jeff Robertson as the Company’s new President of its Terrestrial and Wireless Networks business segment.

Key Points: 
  • March 21, 2024-- Comtech (NASDAQ: CMTL), a global technology leader, today announced the appointment of telecommunications and public safety industry leader Jeff Robertson as the Company’s new President of its Terrestrial and Wireless Networks business segment.
  • View the full release here: https://www.businesswire.com/news/home/20240321628144/en/
    Prior to joining Comtech, Robertson served as President & CEO of Intrado Life Safety, a company specializing in first responder technology in North America.
  • “Jeff will be instrumental in helping Comtech continue to grow and capitalize on core business objectives,” said John Ratigan, Interim CEO of Comtech.
  • “Jeff brings unique insights and deep industry expertise that are well aligned with our continued One Comtech journey, terrestrial and wireless technology developments, and long-term strategies in key markets.”
    As President of the Terrestrial & Wireless Networks segment, Robertson will have P&L responsibility across the enterprise.

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

Retrieved on: 
Tuesday, March 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, AP, Mutation, BP, Disease, New Drug Application, Patient, ALL, Shanda, CML, MD, University, MD Anderson Cancer Center, Priority review, MRD, CP, TKI, Glomus tumor, Food, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
  • This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

BIO-TECHNE RECEIVES EUROPEAN IVDR CERTIFICATION FOR DIAGNOSTIC TEST TO MONITOR CHRONIC MYELOID LEUKEMIA

Retrieved on: 
Friday, March 22, 2024
Certification, Acute leukemia, Kit, BCR-ABL, Patient, CML, Class, Bio-Techne, Sale, Cancer, IVDR, Diagnosis, Workflow, ABL1, Safety, Liquid biopsy, TKI, Physician, IVDD, Medical device

MINNEAPOLIS, March 22, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne's Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.

Key Points: 
  • Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.
  • The QuantideX qPCR BCR-ABL IS Kit gives labs a robust and reliable tool for monitoring chronic myeloid leukemia (CML) patients.
  • The highly sensitive qPCR-based in vitro diagnostic test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with CML to determine their response to tyrosine kinase inhibitor (TKI) therapy.
  • CML patients must undergo regular monitoring to ensure that they continue to receive the most appropriate treatment for their cancer.