European Society for Medical Oncology

Junshi Biosciences Presents 11 Clinical Trials of Toripalimab at the ESMO Congress 2023

Retrieved on: 
Friday, October 27, 2023

At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters.

Key Points: 
  • At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters.
  • “This year’s ESMO Congress highlighted the most recent results from 11 clinical studies conducted with our core product, toripalimab,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences.
  • Study findings were unveiled for the first time during a proffered paper session at the ESMO Congress.
  • In terms of safety, toripalimab combined with chemotherapy has a manageable safety profile and no new safety signals were identified.

Guardant Health Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance

Retrieved on: 
Monday, November 6, 2023

Precision oncology gross margin was 60% in the third quarter of 2023, as compared to 61% in the prior year period.

Key Points: 
  • Precision oncology gross margin was 60% in the third quarter of 2023, as compared to 61% in the prior year period.
  • Operating expenses were $199.0 million for the third quarter of 2023, as compared to $221.5 million for the corresponding prior year period.
  • Guardant Health now expects full year 2023 revenue to be in the range of $553 to $556 million, representing growth of 23% to 24% compared to full year 2022.
  • Guardant Health will host a conference call to discuss the third quarter and full year 2023 financial results after market close on Monday, November 6, 2023 at 1:30 pm Pacific Time / 4:30 pm Eastern Time.

Bayer and Broad Institute of MIT and Harvard Extend Research Collaboration to Develop New Cancer Therapies

Retrieved on: 
Thursday, November 2, 2023

Bayer and the Broad Institute of MIT and Harvard today announced that they have extended their research collaboration of 10 years by an additional five years, to develop and advance innovative cancer treatments.

Key Points: 
  • Bayer and the Broad Institute of MIT and Harvard today announced that they have extended their research collaboration of 10 years by an additional five years, to develop and advance innovative cancer treatments.
  • “Bayer’s established collaboration with the Broad Institute has already resulted in three clinical oncology candidates.
  • Bayer with its Bayer Research & Innovation Center (BRIC) is closely located to the Broad Institute in Kendall Square, Cambridge, MA.
  • BRIC houses a center of precision oncology research equipped with state-of-the-art laboratories for the development of targeted next-generation cancer therapies for patients.

Mirati Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Monday, November 6, 2023

SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate updates.

Key Points: 
  • SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate updates.
  • We look forward to continuing our work to improve the lives of people with cancer through Mirati discovered and developed therapeutics."
  • Excluding the August 2023 financing, net decrease in cash, cash equivalents and short-term investments for the third quarter of 2023 was $135.5 million.
  • Net KRAZATI product revenue for the three and nine months ended September 30, 2023 was $16.4 million and $36.1 million, respectively.

KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Versus Placebo as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Nephrectomy

Retrieved on: 
Wednesday, November 1, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
  • At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo.
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were observed.
  • Results will be presented at an upcoming medical meeting and submitted to regulatory authorities.

CEL-SCI Issues Letter to Shareholders

Retrieved on: 
Monday, October 30, 2023

CEL-SCI Corporation (NYSE American: CVM) today released a letter to shareholders from the Company’s CEO, Geert Kersten.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today released a letter to shareholders from the Company’s CEO, Geert Kersten.
  • The shareholder letter can be read in full on the Company’s website ( https://cel-sci.com/ ) or by clicking HERE .
  • Below is the letter’s introduction:
    This shareholder letter will be longer and much more detailed than prior letters.
  • Fifth, there are regulatory pathways specifically designed for our situation where the target population is selected from the larger Phase 3 study population.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Monday, October 30, 2023

Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

Key Points: 
  • Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.
  • “We know that approximately 20% to 25% of patients diagnosed with urothelial carcinoma will experience disease metastasis, and an additional 5% of patients present de novo with metastatic disease.
  • The OS and PFS data from CheckMate -901 were presented at the European Society for Medical Oncology (ESMO) Congress 2023 .
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -901 clinical trial.

Oncolytics Biotech® Reports Third Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Friday, November 3, 2023

SAN DIEGO and CALGARY, AB, Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the third quarter ended September 30, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted.

Key Points: 
  • ET
    SAN DIEGO and CALGARY, AB, Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the third quarter ended September 30, 2023.
  • General and administrative expenses for the third quarter of 2023 were $5.2 million, compared to $2.4 million for the third quarter of 2022.
  • Research and development expenses for the third quarter of 2023 were $5.8 million, compared to $3.7 million for the third quarter of 2022.
  • The net loss for the third quarter of 2023 was $9.9 million, compared to a net loss of $4.4 million for the third quarter of 2022.

Oncolytics Biotech® Reports Third Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Friday, November 3, 2023

SAN DIEGO and CALGARY, AB, Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the third quarter ended September 30, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted.

Key Points: 
  • ET
    SAN DIEGO and CALGARY, AB, Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the third quarter ended September 30, 2023.
  • General and administrative expenses for the third quarter of 2023 were $5.2 million, compared to $2.4 million for the third quarter of 2022.
  • Research and development expenses for the third quarter of 2023 were $5.8 million, compared to $3.7 million for the third quarter of 2022.
  • The net loss for the third quarter of 2023 was $9.9 million, compared to a net loss of $4.4 million for the third quarter of 2022.

Apollomics Announces Report of Activity of Vebreltinib in Glioblastoma Multiforme (GBM) with PTPRZ-MET Fusion

Retrieved on: 
Thursday, October 26, 2023

The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .

Key Points: 
  • The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .
  • “PTPRZ-MET fusions are known to cause aggressive forms of GBM and are associated with poor prognosis.
  • We are pleased to achieve positive clinical results in patients with this deadly disease, further demonstrating the potential of vebreltinib as a new treatment for patients with cancers driven by MET alterations,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics.
  • GBM with MET fusion is an indication pursued by Apollomics and its China partner, Avistone Biotechnology.