Cancer treatments

Sesen Bio Announces Productive Late-Cycle Meeting with the FDA for Vicineum™

Retrieved on: 
Wednesday, July 14, 2021

We are very pleased with the outcome of the Late-Cycle Meeting and continue to feel encouraged by the level of engagement from the FDA in our ongoing discussions regarding the BLA for Vicineum, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.

Key Points: 
  • We are very pleased with the outcome of the Late-Cycle Meeting and continue to feel encouraged by the level of engagement from the FDA in our ongoing discussions regarding the BLA for Vicineum, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.
  • Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on our Company.

BriaCell Phase I/IIa Clinical Trial Combination Study in Advanced Breast Cancer Patients Open for Enrollment

Retrieved on: 
Wednesday, July 14, 2021

The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.

Key Points: 
  • The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.
  • The BriaCell and Incyte clinical program is a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates.
  • Under the agreement, Incyte is providing compounds from its development portfolio, including retifanlimab, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with Bria-IMT, in advanced breast cancer patients.
  • BriaCell and Incyte had previously treated two patients under this Phase I/IIa combination study subsequent to the corporate collaboration commencement in April 2019 .

Lixte Biotechnology Comments on Outside Research Citing LB-100’s PP2A Inhibition as a Potential Therapeutic Strategy for Triple-Negative Breast Cancer

Retrieved on: 
Tuesday, July 13, 2021

It was noted that LB-100 sensitizes TNBC cells to the chemotherapeutic drugs, paclitaxel and cisplatin, which are commonly used for the treatment of TNBC.

Key Points: 
  • It was noted that LB-100 sensitizes TNBC cells to the chemotherapeutic drugs, paclitaxel and cisplatin, which are commonly used for the treatment of TNBC.
  • Pimentel and his coauthors concluded that their data suggest that inhibition of PP2A activity could be a novel therapeutic approach to this notoriously unresponsive sub-type of breast cancer ( Uddin, Pimentel et al, Cell Cycle 2020 ).
  • A major driver of cancer is defects in the switches that turn the biochemical pathways in cells on and off.
  • This discussion should be read in conjunction with the Company's filings with the United States Securities and Exchange Commission at sec.gov/edgar.shtml .

Moleculin Receives Approval to Extend Dose Escalation in Phase 1/2 European Clinical Trial Evaluating Annamycin for the Treatment of Acute Myeloid Leukemia

Retrieved on: 
Tuesday, July 13, 2021

Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.

Key Points: 
  • Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.
  • Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin.
  • This amendment will allow us to continue dose escalation in the Phase 1 portion of the trial and establish the maximum tolerated dose as we work toward the recommended dose for the Phase 2 portion of the study.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Friday, July 9, 2021

The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

Key Points: 
  • The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
  • PADCEV is the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer who have received immunotherapy and cannot receive cisplatin, said Roger Dansey, M.D., Chief Medical Officer, Seagen.
  • In clinical trials, 14% of the 680 patients treated with PADCEV developed hyperglycemia; 7% of patients developed Grade 3-4 hyperglycemia.
  • Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicenter, single-arm, phase 2 trial.

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Friday, July 9, 2021

In 2019, the FDA granted accelerated approval for PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.

Key Points: 
  • In 2019, the FDA granted accelerated approval for PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.
  • The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
  • "PADCEV is the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer who have received immunotherapy and cannot receive cisplatin," said Roger Dansey, M.D., Chief Medical Officer, Seagen.
  • Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicenter, single-arm, phase 2 trial.

Galectin Therapeutics Announces Positive Top-Line Results from a Phase 1b Clinical Trial Extension of Belapectin in Combination with KEYTRUDA® in Advanced Metastatic Melanoma and Head and Neck Cancer

Retrieved on: 
Friday, July 9, 2021

Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and KEYTRUDA in treatment of advanced melanoma and in head and neck cancer.

Key Points: 
  • Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and KEYTRUDA in treatment of advanced melanoma and in head and neck cancer.
  • Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer.
  • Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
  • Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics galectin-3 inhibitor GR-MD-02.

AVEO Oncology to Host Key Opinion Leader Webinar on FOTIVDA® (tivozanib) for Relapsed or Refractory Renal Cell Carcinoma

Retrieved on: 
Thursday, July 8, 2021

AVEO's management team will provide a brief company overview and discuss the market opportunity and launch strategy for FOTIVDA.

Key Points: 
  • AVEO's management team will provide a brief company overview and discuss the market opportunity and launch strategy for FOTIVDA.
  • AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
  • FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.
  • FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

DESTINY-Gastric04 Head-to-Head Phase 3 Trial of ENHERTU® Initiated in Patients with HER2 Positive Advanced Gastric Cancer

Retrieved on: 
Thursday, July 8, 2021

Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

Key Points: 
  • Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients.
  • In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients.
  • The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01.

Silverback Therapeutics Announces Clinical Supply Agreement with Regeneron to Evaluate SBT6050 in Combination with Libtayo® (cemiplimab), initially in HER2-expressing Non-Small Cell Lung and Gastric Cancers

Retrieved on: 
Wednesday, July 7, 2021

We are eager to complete the ongoing dose escalation of SBT6050 combined with a PD-1 inhibitor, and look forward to working with Regeneron as we begin tumor-specific expansion cohorts.

Key Points: 
  • We are eager to complete the ongoing dose escalation of SBT6050 combined with a PD-1 inhibitor, and look forward to working with Regeneron as we begin tumor-specific expansion cohorts.
  • In the first quarter of 2021, Silverback initiated treatment in Part 3 of the Phase 1/1b study to evaluate the activity of SBT6050 in combination with a PD-1 inhibitor in dose escalation.
  • Under the terms of the agreement, Silverback will expand the ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo in tumor-specific dose expansion cohorts, initially in HER2-expressing non small cell lung cancer (NSCLC) and gastric cancer.
  • Libtayo is a PD-1 blocking antibody being jointly developed and commercialized by Regeneron and Sanofi.