MOS

Candel Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, November 9, 2023

“We are encouraged by the recent clinical and biomarker data for CAN-2409 in NSCLC and pancreatic cancer, and CAN-3110 in recurrent HGG.

Key Points: 
  • “We are encouraged by the recent clinical and biomarker data for CAN-2409 in NSCLC and pancreatic cancer, and CAN-3110 in recurrent HGG.
  • Research and Development Expenses: Research and development expenses were $5.8 million for the third quarter of 2023 compared to $5.4 million for the third quarter of 2022.
  • Research and development expenses included non-cash stock compensation expense of $0.3 million for both the third quarter of 2023 and the third quarter of 2022.
  • General and administrative expenses included non-cash stock compensation expense of $0.4 million for both the third quarter of 2023 and the third quarter of 2022.

Oqton Announces Build Quality to Improve Manufacturing Processes

Retrieved on: 
Monday, November 6, 2023

Oqton Build Quality encompasses 3DXpert Build Simulation, MOS Build Monitoring, and 3DXpert Build Inspection to monitor the entire manufacturing process and mitigate anomalies resulting from errors during the build setup, printing, or with materials.

Key Points: 
  • Oqton Build Quality encompasses 3DXpert Build Simulation, MOS Build Monitoring, and 3DXpert Build Inspection to monitor the entire manufacturing process and mitigate anomalies resulting from errors during the build setup, printing, or with materials.
  • Oqton Build Quality addresses the needs of a variety of manufacturers that rely on additive manufacturing technologies including product and equipment manufacturers (i.e., OEMs), service bureaus and engineering services teams, and those responsible for quality assurance.
  • Once the build begins, MOS Build Monitoring securely monitors, controls, and alerts the additive manufacturing print process in real time.
  • With the introduction of Build Quality, Oqton is delivering a single actionable, reliable solution that addresses all these aspects.

Cue Biopharma Presents New Positive Data from Phase 1 Trials of CUE-101 in Head and Neck Cancer and CUE-102 in Wilms’ Tumor 1 Positive Cancers at SITC 2023

Retrieved on: 
Friday, November 3, 2023

New clinical data will also be reported from the company’s ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive (WT1+) recurrent/metastatic cancers.

Key Points: 
  • New clinical data will also be reported from the company’s ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive (WT1+) recurrent/metastatic cancers.
  • I look forward to evaluating the trial results as they continue to mature and remain highly encouraged by the observations to date.
  • Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reduction in tumor burden.
  • Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study.

Chimerix Reports Third Quarter 2023 Financial Results and Provides Operational Update

Retrieved on: 
Thursday, November 2, 2023

DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today reported financial results for the third quarter ended September 30, 2023 and provided an operational update.

Key Points: 
  • ET Today –
    DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today reported financial results for the third quarter ended September 30, 2023 and provided an operational update.
  • Chimerix reported a net loss of $24.0 million, or $0.27 per basic and diluted share, for the third quarter of 2023.
  • Research and development expenses increased to $17.4 million for the third quarter of 2023, compared to $15.3 million for the same period in 2022.
  • Chimerix will host a conference call and live audio webcast to discuss third quarter 2023 financial results and provide a business update today at 8:30 a.m.

LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023

Retrieved on: 
Wednesday, October 25, 2023

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Key Points: 
  • 1527P)
    The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification.
  • Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
  • “China has an acute need for new effective treatment options as there is a disproportionately higher number of patients with gastric cancer in the region.”
    FGFR pathway aberrations are common in multiple cancer types, including gastric cancer.
  • Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer.

NANOBIOTIX Announces Updated Preliminary Results From Phase 1 Pancreatic Cancer Trial and New Exploratory Analysis From Completed Phase 1 Head and Neck Cancer Trial at ESMO 2023

Retrieved on: 
Monday, October 23, 2023

PARIS and CAMBRIDGE, Mass., Oct. 23, 2023 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the “Company”), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced updated data from two presentations at the 2023 Annual Congress of the European Society for Medical Oncology (ESMO).

Key Points: 
  • The 5-year overall survival rate for patients with unresectable locally advanced pancreatic cancer (LAPC) remains less than 5%.
  • Normally, these patients receive the combination of cytotoxic chemotherapy followed by concurrent chemoradiation if no metastatic progression has occurred.
  • Innovative new treatments that might extend survival and avoid additional harmful side effects are an urgent unmet need for this patient population.
  • “With the Phase 1 study now complete, our focus is to ensure that we learn everything we can to anticipate the potential results of NANORAY-312.

Immutep’s Efti in Combination with KEYTRUDA® Generates Excellent Overall Survival Benefit in Patients with Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Monday, October 23, 2023

SYDNEY, AUSTRALIA, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces excellent new clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC).

Key Points: 
  • A significant overall survival benefit was achieved, with a 35.5-month median Overall Survival (mOS) in patients with TPS ≥1%, 23.4-month mOS in TPS 1-49%, and mOS not yet reached in TPS ≥50%.
  • Exceptional durability and quality of responses are increasingly evident with strong overall survival (OS) and progression free survival (PFS) rates across patients expressing PD-L1.
  • The 12-month PFS rates are 46.8%, 42.1%, and 55.0% for TPS >1%, TPS 1-49%, and TPS >50%, respectively.
  • Table 1: Overall Survival of Efti + KEYTRUDA® versus standard-of-care IO, IO-IO, IO-chemo, and IO-IO-chemo

Phase Ib/II Results of Akeso's PD-1/CTLA-4 Bispecific Antibody for First-Line Treatment of Advanced Hepatocellular Carcinoma Published at 2023 ESMO

Retrieved on: 
Tuesday, October 24, 2023

HONG KONG, Oct. 24, 2023 /PRNewswire/ -- Akeso announced poster presentation at the 2023 European Society for Medical Oncology (ESMO) Congress from its cadonilimab ( PD-1/CTLA-4 bispecific antibody) combined with lenvatinib for first-line treatment of Advanced Hepatocellular Carcinoma (HCC).

Key Points: 
  • HONG KONG, Oct. 24, 2023 /PRNewswire/ -- Akeso announced poster presentation at the 2023 European Society for Medical Oncology (ESMO) Congress from its cadonilimab ( PD-1/CTLA-4 bispecific antibody) combined with lenvatinib for first-line treatment of Advanced Hepatocellular Carcinoma (HCC).
  • The results indicated that the novel combination therapy of PD-1/CTLA-4 bispecific antibody plus lenvatinib demonstrated promising efficacy and manageable toxicity that could provide an option of treatment in first-line treatment of advanced HCC.
  • The 2 years median follow-up results presented at the 2023 ESMO meeting further emphasized the efficacy of cadonilimab in improving overall survival (OS) among advanced patients.
  • Results demonstrated the outstanding efficacy of cadonilimab when combined with lenvatinib as a first-line treatment for HCC.

Inspirna Announces Clinical Data from Phase 1b/2 Study of Ompenaclid (RGX-202) in Advanced Colorectal Cancer at ESMO Congress 2023

Retrieved on: 
Monday, October 23, 2023

The Phase 1b/2 study of ompenaclid in combination with FOLFIRI/BEV in second-line (2L) advanced or metastatic CRC patients has completed enrollment, with an ongoing follow up period.

Key Points: 
  • The Phase 1b/2 study of ompenaclid in combination with FOLFIRI/BEV in second-line (2L) advanced or metastatic CRC patients has completed enrollment, with an ongoing follow up period.
  • The primary endpoint of the study is to determine maximum tolerated dose (MTD), objective response rate (ORR), and treatment-emergent adverse events (TEAEs).
  • The abstract is published in the ESMO Congress 2023 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.
  • Title: Phase 1b/2 study of ompenaclid (RGX-202-01), a first-in-class oral inhibitor of the creatine transporter SLC6A8, in combination with FOLFIRI and bevacizumab (BEV) in RAS mutated (RASm) second-line (2L) advanced/metastatic colorectal cancer (mCRC)

Agenus Unveils New and Updated Botensilimab Data in Colorectal, Pancreatic, Lung, Melanoma, and Sarcoma

Retrieved on: 
Sunday, October 22, 2023

“These new and updated data underscore BOT’s broad effectiveness across several advanced solid tumors, demonstrating its potential beyond first-generation immunotherapies and current treatments,” said Dr. Steven O’Day, Chief Medical Officer.

Key Points: 
  • “These new and updated data underscore BOT’s broad effectiveness across several advanced solid tumors, demonstrating its potential beyond first-generation immunotherapies and current treatments,” said Dr. Steven O’Day, Chief Medical Officer.
  • 12-month overall survival (OS) of 74% and median OS (mOS) not yet reached.
  • Subsequent data from expanded cohorts and early signals from a 230 patient Phase 2 trial is consistent with the earlier cohort of 70 patients.
  • "Prognostic value of liver metastases in colorectal cancer treated by systemic therapy: An ARCAD pooled analysis."