Osteosarcoma

HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting

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fredag, maj 24, 2024

Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)

Key Points: 
  • Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)
    A propensity score matched comparison of fruquintinib (FRU) versus FRU combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic colorectal cancer: real-world data
    Efficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as third-line treatment in patients with metastatic colorectal adenocarcinoma: Results from a single arm, phase 2, multicenter study
    A phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases: An updated analysis of survival
    Fruquintinib combined with sintilimab and SOX as conversion therapy for unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trial
    Short-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer (LARC): a multicenter, single-arm, open-label, phase II study
    Fruquintinib plus capecitabine versus capecitabine as first-line maintenance treatment of metastatic colorectal cancer (mCRC): Update results from the randomized, controlled, phase Ib/II study
    Efficacy and safety of fruquintinib plus investigator's choice of chemotherapy as second-line therapy in metastatic colorectal cancer: updated results of a multicenter, single-arm, phase 2 trial
    Efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after developing resistance to several TKIs: A multi-centered retrospective study
    Disitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm study
    Surufatinib combined with TAS-102 in third- or later-line therapy of patients with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II Study
    Phase II study to evaluate surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy: updated analysis

Zentalis Pharmaceuticals to Present Promising Results from Phase 1 Trial of Azenosertib and Gemcitabine in Relapsed or Refractory Osteosarcoma at 2024 American Society of Clinical Oncology Annual Meeting

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torsdag, maj 23, 2024

NEW YORK and SAN DIEGO, May 23, 2024 (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 presentation of final results from a Phase 1 trial of azenosertib and gemcitabine in relapsed or refractory (R/R) osteosarcoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Key Points: 
  • “We are pleased to report the final results from our Phase 1 trial evaluating azenosertib administered with gemcitabine in patients with relapsed or refractory osteosarcoma,” said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis.
  • These results support studying the combination in patients facing this aggressive cancer, which we expect will occur in an upcoming investigator-initiated Phase 2 trial.
  • Data support further investigation of azenosertib administered in combination with gemcitabine in patients with R/R osteosarcoma in an upcoming investigator-initiated Phase 2 trial.
  • Title: Phase 1 Results of the WEE1 Inhibitor, Azenosertib, in Combination With Gemcitabine in Adult and Pediatric Patients With Relapsed or Refractory Osteosarcoma.

Feinstein Academy of Scholars Symposium and Elmezzi Graduate School Commencement draws top scientific minds: Peter J. Hotez, Robert S. Langer, others

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fredag, maj 24, 2024

Peter J. Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Key Points: 
  • Peter J. Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine.
  • In 2023, he received the Anthony Cerami Award in Translational Medicine and in 2021 was awarded an Elmezzi Graduate School Honorary Degree.
  • The Elmezzi Graduate School of Molecular Medicine is supported in part by a generous endowment from The Thomas and Jeanne Elmezzi Foundation.
  • To find out more about the Elmezzi Graduate School of Molecular Medicine and its programs, click here .

Lisata Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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torsdag, maj 9, 2024

BASKING RIDGE, N. J., May 09, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, provided a business update and reported financial results for the three months ended March 31, 2024.

Key Points: 
  • “2024, a pivotal year for Lisata, is off to a very strong start,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata.
  • The trial is actively enrolling with enrollment completion expected by the end of the third quarter of 2024.
  • As of March 31, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $43.3 million.
  • Lisata will hold a live conference call today, May 9, 2024, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions.

Zentalis Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Progress

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tisdag, maj 7, 2024

NEW YORK and SAN DIEGO, May 07, 2024 (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 March 31, 2024, and highlighted recent corporate accomplishments. "Zentalis continues to advance towards a catalyst-rich period during the second half of 2024 and into 2025, with a clear path to demonstrating the clinical profile of azenosertib, our potentially first-in-class and best-in-class WEE1 inhibitor, across various tumor types," said Kimberly Blackwell, M.D., Chief Executive Officer. "We believe that the data emerging this year and next have the potential to establish azenosertib’s monotherapy activity, differentiated safety and efficacy profile, and its ability to address significant unmet need for patients with serious gynecological cancers. Our clinical development plan remains on track as we work to bring azenosertib to patients living with gynecological cancers and other solid tumors.”

Key Points: 
  • NEW YORK and SAN DIEGO, May 07, 2024 (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 March 31, 2024, and highlighted recent corporate accomplishments.
  • On April 9, 2024, Zentalis presented preclinical data demonstrating that azenosertib exerts synergistic anti-tumor activity with KRASG12C inhibitors at the American Association of Cancer Research (AACR) Annual Meeting.
  • On April 5, 2024, Cam Gallagher was appointed interim Chief Financial Officer while the Company conducts a search for a new Chief Financial Officer.
  • This decrease of $0.7 million was primarily attributable to $0.8 million and $0.7 million decreases in depreciation and other expenses, respectively.

ELIAS Animal Health Expands Manufacturing Capacity Ahead of Product Approval and Pipeline Expansion

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tisdag, april 30, 2024

OLATHE, Kan., April 30, 2024 /PRNewswire/ -- ELIAS Animal Health , a leading companion animal cancer therapeutics company, is expanding its manufacturing capacity in a larger facility located in Lenexa, Kansas as it prepares for the commercial product launch of the ELIAS Cancer Immunotherapy (ECI®) later this year.

Key Points: 
  • OLATHE, Kan., April 30, 2024 /PRNewswire/ -- ELIAS Animal Health , a leading companion animal cancer therapeutics company, is expanding its manufacturing capacity in a larger facility located in Lenexa, Kansas as it prepares for the commercial product launch of the ELIAS Cancer Immunotherapy (ECI®) later this year.
  • This expansion of capacity in anticipation of demand reinforces the company's commitment to improving cancer treatment outcomes in veterinary patients through the advancement of innovative therapies.
  • In addition to accommodating increased demand for ECI®, the new manufacturing facility will enable the company to continue development work on its pipeline of innovation.
  • The company recently announced it has launched pursuit of a $10 million Series A capital raise to support manufacturing expansion, commercial launch of ECI®, and continued development on the company's product pipeline.

Y-mAbs to Present at 2024 ASCO Annual Meeting

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torsdag, april 25, 2024

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the acceptance of four abstracts at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.

Key Points: 
  • NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the acceptance of four abstracts at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.
  • “This year’s ASCO presentations feature our ongoing efforts to grow and diversify our portfolio,” said Mike Rossi, President and Chief Executive Officer.
  • Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA® (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs.
  • Researchers at MSK, including Dr. Nai-Kong Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs.

Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma

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tisdag, april 9, 2024

LSTA1 recently received Rare Pediatric Disease Designation for osteosarcoma, as announced by the Company on March 21, 2024.

Key Points: 
  • LSTA1 recently received Rare Pediatric Disease Designation for osteosarcoma, as announced by the Company on March 21, 2024.
  • “We are thrilled to have received another favorable regulatory designation from the FDA.
  • “Osteosarcoma, while rare, is a type of bone cancer that is often associated with high morbidity, early metastasis, rapid progression, and poor prognosis.
  • In addition to the financial benefits, it also may potentially shorten clinical development due to closer collaboration with the FDA.

Lisata Therapeutics Announces U.S. FDA Rare Pediatric Disease Designation Granted to LSTA1 for the Treatment of Osteosarcoma

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torsdag, mars 21, 2024

BASKING RIDGE, N.J., March 21, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Rare Pediatric Disease Designation (“RPDD”) to LSTA1, the Company’s lead product candidate, for the treatment of osteosarcoma, a rare cancer that can develop in children, adolescents and young adults.

Key Points: 
  • BASKING RIDGE, N.J., March 21, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Rare Pediatric Disease Designation (“RPDD”) to LSTA1, the Company’s lead product candidate, for the treatment of osteosarcoma, a rare cancer that can develop in children, adolescents and young adults.
  • A substantial benefit of a RPDD is receipt of a priority review voucher, often referred to as a “golden ticket,” once the FDA approves the new drug application (“NDA”) for the product and indication having received the RPDD.
  • The voucher may be used by the sponsor or sold to another sponsor for their use.
  • Priority review vouchers have sold for as much as $350 million USD historically and, more recently, have sold for $75 to $100 million USD.

Fennec Pharmaceuticals Reports Preliminary Unaudited Net Revenue for Fourth Quarter and Full-Year 2023 Results

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torsdag, februari 29, 2024

RESEARCH TRIANGLE PARK, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced preliminary unaudited fourth quarter and full-year 2023 net revenues.

Key Points: 
  • ~ Company Expects to Report 2023 Fourth Quarter and Audited Full-Year Results on or about March 26, 2024 ~
    RESEARCH TRIANGLE PARK, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced preliminary unaudited fourth quarter and full-year 2023 net revenues.
  • The information in this press release is based upon preliminary unaudited information and management estimates for the fourth quarter 2023 and is subject to the completion of Fennec’s financial closing procedures and year end audit.
  • Preliminary Unaudited 2023 Fourth Quarter Revenue and Year End Performance:
    Fourth quarter 2023 net revenues are expected to be approximately $9.2 to $9.7 million, which represents approximately a 41-49% increase over the third quarter of 2023.
  • Fennec expects to report its 2023 fourth quarter and audited full-year year results of operations on or about March 26, 2024.