Bevacizumab

SMC Laboratories Reveals Innovative STAM™-HCC/IO+ Mouse for Identifying and Developing Novel Therapeutic Drugs for Liver Cancer, Blazing a Trail in the Immuno-Oncology Field

Retrieved on: 
Tuesday, February 6, 2024

The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.

Key Points: 
  • The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.
  • Furthermore, it can be used for testing molecular target drugs and immune checkpoint inhibitors, and for other therapeutic targets while performing stable drug efficacy evaluations.
  • As the prevalence of liver cancer increases, it is anticipated that SMC Laboratories' STAM™-HCC/IO+ mouse will greatly contribute to the development of therapeutic drugs for liver cancer in the future.
  • Liver cancer is the fourth most common type of cancer in the world (Huang DQ et al, Nature Reviews Gastroenterology & Hepatology, 18, 223-238, 2021).

Anti-Cancer Drugs Publishes Preclinical Data Demonstrating the Broad Antineoplastic Activity of Panavance’s Misetionamide (GP-2250)

Retrieved on: 
Thursday, February 1, 2024

BERWYN, PA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Panavance Therapeutics Inc. (“Panavance” or the “Company”), a clinical-stage pharmaceutical company advancing the development of a novel oncology therapeutic intended to improve the outcomes and quality of life for patients, today announced publication of positive data in the peer-reviewed Anti-Cancer Drugs in an article titled, “Antineoplastic Activity of GP-2250 In Vitro and in Mouse Xenograft Models.”1 The publication by Sofia et al. (2024) provided early research evidence that misetionamide exhibits a dose-dependent antineoplastic effect on both established cancer cell lines and xenograft models from patient tissues.2 Antineoplastic activity was tested in over 300 cancer cell lines using the OncoPanel® cytotoxicity assay and was further tested in eight human cancer xenograft models.

Key Points: 
  • Most notably in the ovarian tumor xenograft model, misetionamide produced a regression in the original tumor volume.
  • Concentrations for IC50 and EC50 were determined as was the concentration at which a 10-fold increase in apoptosis was induced.
  • In addition, misetionamide was also shown to induce a cancer cell cycle block that would inhibit tumor cells from replicating and thus inhibiting tumor growth.
  • “The results from these studies demonstrate that misetionamide has a broad mechanism of action which could be impactful in treating most cancers.

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Retrieved on: 
Wednesday, January 31, 2024

Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Key Points: 
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
  • The start of patient enrollment in NORSE EIGHT represents an important step toward potential FDA approval and launch of ONS-5010.
  • Earlier this month, Outlook Therapeutics announced that it received written agreement from the FDA under an SPA for NORSE EIGHT.
  • Outlook Therapeutics is working to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.

Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010

Retrieved on: 
Tuesday, January 23, 2024

Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.

Key Points: 
  • Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
  • Outlook Therapeutics is working to address the open items and expects to resolve these comments prior to the expected completion of NORSE EIGHT.
  • The private placement is expected to provide up to $60 million in gross proceeds at closing, before deducting placement agent fees and offering expenses.

Coherus Presents Positive Phase 2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2024 ASCO GI Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024

REDWOOD CITY, Calif., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced data from the lead-in portion of the Phase 2 clinical trial evaluating casdozokitug (casdozo), a selective and potent IL-27-targeting antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (uHCC). These data are being presented at the 2024 ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 at Moscone West in San Francisco, California. Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment. Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.

Key Points: 
  • These data are being presented at the 2024 ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 at Moscone West in San Francisco, California.
  • Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment.
  • Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.
  • Coherus plans to evaluate the combination of casdozo/toripalimab-tpzi(Coherus’ anti-PD-1 antibody)/bev in future clinical trials.

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Reduced the Risk of Disease Progression or Death by 79% Versus Chemotherapy in Patients with Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer in CheckMate -8HW Trial

Retrieved on: 
Saturday, January 20, 2024

Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8).

Key Points: 
  • Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8).
  • Grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients in the Opdivo plus Yervoy arm and 48% of patients in the chemotherapy arm.
  • Any grade TRAE-related discontinuation was 17% in the Opdivo plus Yervoy arm and 32% in the chemotherapy arm.
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

MEI Pharma to Present Design of Ongoing Clinical Study Evaluating ME-344 at ASCO GI Cancers Symposium 2024

Retrieved on: 
Tuesday, January 16, 2024

MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, today announced the design of the ongoing Phase 1b study of the mitochondrial oxidative phosphorylation (OXPHOS) inhibitor ME-344 in combination with bevacizumab (Avastin®) in refractory metastatic colorectal cancer patients will be presented during a poster session at the 2024 ASCO Gastrointestinal Cancers Symposium to be held January 18 – 20, 2024.

Key Points: 
  • MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, today announced the design of the ongoing Phase 1b study of the mitochondrial oxidative phosphorylation (OXPHOS) inhibitor ME-344 in combination with bevacizumab (Avastin®) in refractory metastatic colorectal cancer patients will be presented during a poster session at the 2024 ASCO Gastrointestinal Cancers Symposium to be held January 18 – 20, 2024.
  • Session Title: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus

Bexion Pharmaceuticals, Inc. Announces Poster Presentation at ASCO GI 2024

Retrieved on: 
Tuesday, January 16, 2024

COVINGTON, Ky., Jan. 16, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), today announced a Trials in Progress poster presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), being held January 18-20, 2024, in San Francisco, CA.

Key Points: 
  • COVINGTON, Ky., Jan. 16, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), today announced a Trials in Progress poster presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), being held January 18-20, 2024, in San Francisco, CA.
  • Poster details are included below.
  • "We are excited to present our ongoing trial of BXQ-350 in mCRC during the 2024 ASCO GI Symposium" said Scott Shively, CEO and President of Bexion Pharmaceuticals.
  • "BXQ-350 in combination with FOLFOX and bevacizumab offers a unique opportunity to improve outcomes for 1st line patients with mCRC.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Retrieved on: 
Friday, January 12, 2024

Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Key Points: 
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • “Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
  • The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer.
  • In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303).

Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap

Retrieved on: 
Monday, January 8, 2024

Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.

Key Points: 
  • Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.
  • Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis.
  • Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization.
  • Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates.